International Regulatory Compliance

IS FDA's 510(k) A Plausible Solution For the EU's CE Marking Problem With Silicon Breast Implants?

 

Introduction

The preceding four blogs discussed some of the problems I have observed with clients concerning private for-profit Notified Bodies and regulatory compliance with the three EU Medical Devices Directives. In the January 31, 2012 blog, I wrote the following paragraph concerning one possible alternative Notified Body approach to Medical Device approvals: 

“Something akin to an FDA 510(k) also should be created with device efficacy built in as major requirement. It isn’t a perfect solution because the 510(k) predicate device requirement doesn’t always avoid device defects in design and materials, but it is overseen by FDA not a private third party.”

The Mutual Recognition Agreement (MRA) signed between the US and EU in 1997, covered four areas, one being medical devices. The MRA provided for the creation of CABs (Conformity Assessment Bodies) approved by FDA to administer 510(k)s for selected Class II Medical Devices. Several of these CABs also are EU Notified Bodies. In this blog I want to return to the statement, “It isn’t a perfect solution because the 510(k) predicate device requirement doesn’t always avoid device defects in design and materials.”

US Politics Today 

Presently, there is a move in the US House of Representatives supported by some Senators to ease medical device regulations for Medical Device Manufacturers, hypothetically to encourage innovation and speed devices to the market. Even though the US has just begun to emerge from the disaster of deregulation of the US economy that allowed financial institutions to run amuck and create the worst financial crisis since the Great Depression, a convoluted ideology continues to appeal, i.e., regulation is bad, deregulation is good! Political ideology is a powerful force, uninformed by scientific knowledge and intelligence. Teddy Roosevelt and Abe Lincoln would have been appalled.  

The regulatory and enforcement problem afflicting CE Marking breast implant manufacturing and enforcement for the EU Medical DEvices Directives is different from the regulatory problem in the US, namely the weakness of the 510(k) approach. On February 1^st my wife received the following correspondence from Jim Guest, the President of Consumer Reports.

“It's a nightmare scenario. The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.
This isn't science fiction. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled - 700 different products a year.

And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were "similar" to products already on the market.

Tell Congress we don't want to be guinea pigs anymore!

Every new prescription drug must undergo rigorous testing on humans before it can be sold, even if it is similar to another drug already in use. Not so with medical devices. Because of this loophole in our safety laws, more than 90 percent of medical devices aren't safety tested before being sold nor are they routinely tracked afterwards to identify safety problems.

For example, a metal hip implant marketed by Johnson & Johnson was approved in 2005 without first undergoing clinical safety trials. It was recalled five years later after having a 1 in 8 failure rate in the UK, and releasing potentially toxic metals into the body. Countless patients had to undergo a second, painful 'revision' surgery.

It's time safety standards for medical devices are as strong as those for prescription drugs! E-mail your members now!

The device industry has unleashed an army of lobbyists and they don't want things to change. It will take a wave of consumers weighing in to make sure medical devices are safe and effective. Please take action, then forward this to friends and family. Thank you!

Sincerely,

Jim Guest
President, Consumer Reports

(Note: Consumer Reports is the largest and oldest independent non-profit testing and information organization in the US, serving only consumers since 1936.)

What are some of the problems with the 510(k)? 

Today the 35 year-old 510(k) System is used by FDA to review 90 percent of medical device applications each year. After numerous problems and ongoing billion dollar lawsuits concerning 510(k) approved medical devices, in 2009 FDA commissioned the Institute of Medicine (IOM) to study the problem and report back to FDA, which they did in August 2011.

The IOM report stated, “the process of using existing or “predicate” devices as the basis for evaluating the safety and effectiveness of a new device is “untenable.” The authors recommended that the FDA immediately stop using the protocol for Class III devices – considered to pose the highest potential risk to patients. “As devices have evolved and become more complex, our device-approval system has become incapable of assuring safety and effectiveness,” wrote New England Journal of Medicine executive editor Dr. Gregory Curfman and Dr. Rita Redberg, editor of the Archives of Internal Medicine. The system we use today was created 35 years ago in an era of much simpler and fewer devices and it is now outdated.

The New England Journal of Medicine editorial discussing the IOM report, specifically pointed out the ongoing problems with metal-on-metal hip implants including Johnson & Johnson’s DePuy ASR Acetabular System and DePuy ASR Hip Resurfacing System. The DePuy ASR XL Acetabular System was introduced in the US in 2005.

 The [DePuy] ASR was constructed by borrowing a metal alloy cup from a different hip device known as the [DePuy] ASR Hit Resurfacing System and retrofitting it onto a standard hip implant. The manufacturer successfully made the case that the reengineered implant was “substantially equivalent” to a predicate device. Its marketing clearance was therefore based not on trials or other clinical data but on bench testing in a laboratory, which was inadequate to simulate the stresses that would be placed on it in patients’ bodies. It soon became clear that the device failed at the astonishing rate of at least one in eight. (Brett Emerson, Injury Board.com, October 20, 2011) 

The metal-on-metal hip implants were found to shred minute metal particles into patients’ bloodstreams over time.

What Are The Institute of Medicine Recommendations? 

To begin the IOM, recommended that the agency (FDA) ditch the program entirely and replace it with an “integrated pre-market and post-market regulatory framework. It’s not clear that the 510(k) process is serving the needs of either the industry or patients, and simply modifying again will not help, said David Challoner who chaired the committee that wrote the report. The 510(k) Process cannot achieve its stated goals – to achieve innovation and make safe, effective devices available to patients in a timely manner – because they are fundamentally at odds with statutes that govern how FDA must implement the process.

Other IOM recommendations are:

• Boosting post-market surveillance and strengthening the FDA’s post-market authority;

• Ban all Class III devices, those of the highest risk, from the 510(k) fast-track process;

• Eliminate clearance using multiple predicate devices, by which a new device can be cleared by demonstrating equivalence to device that was also cleared through equivalence, forming a chain of devices that were never clinically tested, and 
• 
  
• Implement a formal post-market surveillance program.

The [IOM] report concluded that it was impossible for 510(k) clearance to assure safety and effectiveness, because it assesses neither, instead establishing only “substantial equivalence” to an existing device. 

 Summary 

As anticipated, the medical device industry rose up to complain about the reforms even though billion-dollar product liability lawsuits are working their way through the courts right now and will cost medical device companies a substantial amount of money. Not to mention that patients who suffer pain from the existing device and need to have the devices explanted and a new device inserted with no clear indication of how the surgical costs will be covered.

To return to the question about whether FDA’s 510(k) might serve as a model for EU regulation of its medical devices directives, the answer is no. The two regulatory systems face different issues:

• In the EU the issue is the competence of Notified Body device experts, the effectiveness of 70 for-profit Notified Bodies overseeing medical device manufacturers’ ISO 13485 Quality Management Systems, and the professional quality of oversight by 27 EU competent bodies.

• In the US the issue is a regulatory process that employs two strategies, (1) clinical trials for new high-risk device medical device, and (2) a 510(k) System focused “substantial equivalence” and expedience that doesn’t assure the safety and effectiveness of medical devices and consequently doesn’t focus on patient safety and product (device) safety.

Both the EU and US will have to work out their respective regulatory systems in the context of what presently exists but is not working. It’s not a simple process and it will take some work but it is essential that it be resolved in both the EU and US. Hopefully, private self-interest, political interference and intrusion won’t create a corrupted process that worsens what exists today.

My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in compromised product safety and product liability lawsuits. In particular, I focus on product safety, patient safety and the steps necessary to create a safe product. I would be happy to help. If you have questions regarding CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com. 

Notified Bodies And CE Marking – Potential Legal Issues In US Lawsuits #4

 

Continuation 

In this blog I want to focus specifically on the Silicon Breast Implant controversy involving the breast implant manufacturer Poly Implants Prothèses (PIP) and the EU regulatory structure for CE Marking medical devices. In my preceding three blogs times I have noted several problems concerning medical device product quality. In the first blog I quoted former European Commission Vice President Martin Bangemen.

In his preface to The Guide to the Implementation of Community Harmonization Directives Based on the New Approach and the Global Approach, Brussels, 1995, Vice President of the European Commission, Martin Bangeman stated the following:

The novelty of this new approach resides essentially in the use of community technical rules of “quality instruments” such as European Standardization and conformity assessment procedures (testing, product certification, certification of manufacturers’ quality control procedures, accreditation, etc.). These instruments, drawn up on the basis of consensus of all the economic partners involved, enable manufacturers to affix the CE marking--a real “technical passport”--to their industrial products, which must conform to these community directives.

The idea of separating compliance into product quality and process quality seemed like a good and workable idea at the time. However, looking backward from 2012, the growth of the EU to 27 Member States and a population of 500 million people, the separation into product quality and process quality needs to be readdressed. 

EU Medical Device Oversight Structure 

Medical Device Product Quality

In the EU, device regulations are not conducted by member state Competent National Authorities, instead they are conducted by one of the 70 approved for-profit Notified Bodies that must be approved by one of the EU’s 27 Competent National Authorities (called competent bodies) to act as a Notified Body for one of the three Medical Devices Directives. Consequently, member states are removed from direct legal oversight and legal enforcement of medical device regulations and hampered in their ability to oversee medical device failures.

To reason that 70 for-profit Notified Bodies can employ 70, 60 or 50 device experts for hundreds of different medical devices in multiple offices around the world isn’t credible. Consequently, the dearth of available device experts will continue to negatively affect the quality of medical devices being manufactured. While it might be reasoned that large established Notified Bodies could field multiple device experts, even they struggle to provide adequate product safety oversight. The Notified Body chosen by Poly Implants Prothèses (PIP) was TUV Rheinland, a well-established and respected Notified Body. The inspection however, occurred with advanced warning at the PIP plant in China, which raises a whole set of questions.

I have talked with principals at several Notified Bodies who privately admit that it is difficult for them to hire and retain qualified medical device experts. The number of silicon breast medical device manufacturers approved by the EU Notified Body structure has been estimated in various newspaper accounts at 80 to 120. If this is even remotely true, it is outrageous. In the US FDA has approved 6 medical device manufacturers for silicon breast implants.

While 6 silicon breast implant manufacturers approved for 313 million people in the US might seem small, 80 to 120 silicon breast implant manufacturers for 500 million people in the EU is preposterous and beyond oversight. Further, FDA requires that US manufacturers must be able to continually demonstrate the efficacy of their medical devices. No such requirement exists in the EU. 

Medical Device Product Quality Recommendations

• While several approaches to correct the administrative structure should be explored, one approach that might work would be to draw upon CEN and EU Member State Standards Bodies (DIN, AFNOR, BSI, etc.) to identify and/or provide medical device  experts to evaluate medical devices. Their services could be paid for by Notified Bodies, but they must not be employees of for profit Notified Bodies so that their judgments could be compromised.

• Something akin to an FDA 510(k) also should be created with device efficacy built in as major requirement. It isn’t a perfect solution because the 510(k) predicate device requirement doesn’t always avoid device defects in design and materials, but it is overseen by FDA not a private third party.

Medical Device Process Quality

All in all, Notified Bodies do a better job with process quality oversight, not perfect but better than their oversight of medical device product quality. Unfortunately, in their zeal to obtain business, some Notified Bodies could be accused of providing the best oversight money can buy. 

Medical Device Process Quality Recommendations

• Notified Body process quality oversight must be improved, which means that Member State Competent Body oversight of Notified Bodies must improve. Notified Bodies also must have greater awareness of their liability exposure. Thus far they have dodged the proverbial litigation bullet, but this will change in the US as well as in the EU. Presently there are several US lawsuits involving CE marked PIP breast implants in the US and the number of lawsuits will increase.

• FDA’s QSIT (Quality System Inspection Technique) adopted in 1999 as a guidance tool for FDA inspectors and an instructional tool for medical device manufacturers was a clever move that accompanied the adoption of FDA’s Quality System Regulation (QSR) in 1996. It introduced the use of a quality management system as a Good Manufacturing Practices regulatory approach to medical device manufacturing in the US. It also set a serious tone concerning what to expect when FDA conducts a medical device plant inspection. The Internal Quality Management Audit Checklist (ISO 13485:2003/ISO 9001:2000) is the closest approximation I could find to QSIT for the EU. A formal adoption of such a structure for use by EU Notified Bodies and oversight by Member State Competent Bodies could serve the same purpose. Every US medical device manufacturer conducts QSIT audits before being visited by FDA. The same type of rigor should exist for the EU.

• In addition to Member State Competent Bodies acting as Third Party Registrars overseeing their Notified Bodies, some effort should be made to instruct their Notified Bodies to be conversant with and abiding by the legal requirements of ISO/IEC 17021:2006 Conformity Assessment – Requirements for bodies providing audit and certification of management systems. In 2008, I served as legal expert in a national lawsuit in a US Federal Court in Los Angeles. As we proceeded to collect material in legal discovery, I contacted the Registrar for the opposing company to verify that they were the ISO 9001:2000 Registrar for the company. Since the Registrar was a division of a European Third Party that also was a Notified Body with whom I had worked with for some of my EU medical device clients, I anticipated no problem. Instead, I was informed that their attorneys advised them that they could not share such information, which was in clear violation of ISO/IEC 17021:2006. I know that US attorneys are clueless when it comes to such standards, but it quickly became clear that the Registrar also was clueless about the standard. From that point on, the Registrar proceeded to violate the requirements of ISO/IEC 17021:2006 with impunity, including modifying he scope of their ISO 9001:2000 Certification three years after it had been granted, to accommodate their corporate client. We began preparing expanded depositions and inclusion of the Registrar in the lawsuit when the case was settled. Clearly, the Registrar had no moral compass whatsoever. Also, my opinion of the related Notified Body went downhill.

• Notified bodies also must be made aware of their legal obligations in the event of a product liability lawsuit. For example, litigants in US Federal Courts have a legal right to ask for relevant records and documents in discovery such as the Quality Manual and Quality Procedures, Contract Records, Certification Audits, Surveillance Audits, Management Review Minutes, Non Conformity Records, Corrective and Preventive Action Minutes and records, Internal Audit Minutes, design records, process control records, Technical File records, complaints, etc. It makes no difference if these records and documents describe devices manufactured outside of the US. If they are relevant to devices sold in the US, they must be produced or the company can be held in contempt of court and fined. It doesn’t end there. Additional fines and potential criminal prosecution could follow. I mention this because presently I am working as legal expert on a CE Marking lawsuit in US Federal Court where a German manufacturer has been resisting our requests for discovery of their ISO 9001 records and documents and CE Marking Technical Files, etc. under the mistaken impression that a US Federal Court can not compel discovery from a non US manufacturer, not realizing that any manufacturer that sell products in the US is subject to US law.

Conclusion

There is a lot I like about the EU approach to the administration of its new approach Directives. However after seeing first hand the problems with Notified Bodies attempting to find medical device experts and observing mixed success with their administration of quality management system oversight, something must be done to improve the regulatory administrative approach. Also, consideration must be given to the efficacy of their approach as applied in different countries.

When working with a company in Atlanta three years that owned a manufacturing plant in China, I was asked to review their CE Marking materials from China. They had concluded that their Chinese counterparts didn’t understand CE Marking and decided to shift the administration of CE Marking their products to the US. It was about the same time that a US Manufacturer of Heparin was caught up in a controversy where 80 people died and several others were gravely ill from their Heparin sold in the US. The response from the American manufacturer was that they bought their supplies from Consolidation Laboratories in China. At the same time I was looking at pictures in the New York Times of diseased pig intestines draped over concrete sinks in rural China being rinsed with dirty water and shipped to Consolidation Laboratories. The American manufacturer never checked the full depth of their supply chain.

The use of industrial grade silicon instead of medical grade silicon and the resulting problems it has caused thousands of women in the EU and throughout the world is appalling. It is encouraging that the French police have detained the founder of the company. I trust that he might also spend a substantial amount of his remaining time in a French prison.

Clearly it is time to revaluate the effectiveness of the approach for the manufacture of medical devices. I hope that some of my suggestions prove to be useful. As mentioned in my previous blog I would be happy to help. My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding CE Marking lawsuits or medical device regulatory oversight you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com.  

Notified Bodies And CE Marking – Potential Legal Issues In US Lawsuits #3

Continuation

I want to return to the issue of Notified Bodies and the problem with silicon breast implants in the EU. As noted in my two previous blogs, I have observed various problems with Notified Bodies and CE Marking clients over time. Medical devices present a more complex regulatory dimension for CE Marking. In the US, FDA regulates medical devices using its Quality System Regulation (QSR) for medical device design and manufacturing. While FDA employs a quality management system similar to the EU’s ISO 13485, FDA oversight is far more rigorous and intensive with an ability to impose a range of legal sanctions from Warning Letters to Civil and Criminal penalties. Further, FDA can issue a Federal Consent Decree and fines, (e.g. $100 million, $60 million and extended oversight follow up) for the most egregious cases. The key issue is public health and safety.

In the EU, device regulations are not conducted by member state Competent National Authorities, instead they are conducted by one of the 70 approved for-profit Notified Bodies that must be approved by one of the EU’s 27 Competent National Authorities (called competent bodies) to act as a Notified Body for one of the three Medical Devices Directives. Consequently, member states are removed from direct legal enforcement of medical device regulations and hampered in their ability to oversee medical device failures. There is no comparable enforcement structure to FDA.

In the US all medical device manufacturers must have a FDA compliant QSR quality management system. Unless a company wants to manufacture a Class I medical devices not requiring CFR 820.30 design controls it generally must submit a 510(k) to receive FDA approval before manufacturing a medical device or seek Pre Market Approval from FDA and conduct a Clinical Trial to obtain FDA approval before manufacturing a new type of (generally Class III) medical device. FDA has the legal authority to enforce its regulations.

Problems With Notified Body Governmental Oversight

As mentioned in my previous blog, Notified Bodies perform two oversight functions, evaluating and approving medical devices (product safety) and ongoing evaluation of manufacturers’ ISO 13485 Quality Management Systems (process quality). Of the two functions, product quality is the most difficult because of the lack of device experts. To reason that 70 for-profit Notified Bodies can employ 70, 60 or 50 device experts for hundreds of different medical devices in multiple offices around the world isn’t credible. Consequently, the dearth of available device experts will continue to negatively affect the quality of medical devices being manufactured.

As a result, most Notified Bodies focus on the quality management system, ISO 13485 and process quality. The certification audit and surveillance audits operate much like ISO 9001 certification and surveillance audits except that the requirements of the relevant Medical Device Directive are incorporated into the ISO 13485 Quality Management System. Likewise the type of Medical Device(s) will be central to the QMS.

As noted in my previous blog, the quality of Notified Body QMS oversight isn’t always as rigorous as it should be, certainly not as rigorous as an FDA plant inspection. No Notified Body has issued anything comparable to FDA’s QSIT (Quality System Inspection Technique) setting forth the procedure and questions a manufacturer should expect and be able to answer when FDA conducts an on-site inspection of a manufacturing plant. AdvaMed – Advanced Technology Association has developed papers, Different Points to Consider When Preparing For An FDA Inspection for different QSIT Subsystems. There is no comparable preparation for an audit by a Notified Body.

This is not to say that audits by Notified Bodies are treated lightly by medical device manufacturers rather it speaks to the legal authority of an FDA audit when compared to the legal authority of Notified Body audits. In addition to the audit example described in my previous blog where a Notified Body wrote good observations for a Class III medical device manufacturer but failed to issue non-conformities, did not serve their client well. Whether this was done to placate a client to retain their business isn’t clear. What it did accomplish was to prompt their client to ask me if I thought they would survive an FDA site inspection, to which I said no. 

In contrast, FDA at the very least would have issued a Warning Letter and might even have shut down the facility until major changes were implemented. This is not the only case where I have observed a Notified Body conduct an “audit-lite.” A few other examples are listed below:

• A colleague and I spent two days at a medical device manufacturer’s only US CE Marking plant in Arizona while conducting a GAP Analysis for the manufacturer. They wanted to extend CE Marking capability to all of their US manufacturing plants and asked if we could evaluate their Arizona operation. When we arrived at the plant we asked to examine their Technical Files for medical devices being manufactured at the Arizona plant. To which the plant manager responded, “What’s a Technical File?” Following this exchange we proceeded to conduct our audit. We found storage of medical devices in a warehouse lacking heating and cooling was having a serious adverse effect on device quality. We also found boxes containing devices that were marked with the corporate address 1000 miles away, but not the address of the plant in Arizona that was CE Marking the devices. Several more problems were found. We recommended that they identify the unique features of each QMS, but integrate their QSR and ISO 13485 Quality Management Systems for greater control in the future.

• I recently received a call from a Medical Device Manufacturer in Atlanta asking if I could meet them at their corporate office for consultation. They had just been told by their Notified Body that they received two major non-conformances on their most recent surveillance audit and had one month to make the necessary correction or they could no longer CE Mark their medical devices. The quality and regulatory managers flew in from the manufacturing plant in question with the surveillance audit report. The managers were shocked because this was their fifth surveillance audit report and previously they had not received any non-conformances. Nothing had changed in their manufacturing operation. The Notified Body informed them that their Competent National Authority (competent body) had just completed a review of all of their audits and found problems with their findings. The Notified Body was informed that they had to meet with all of their clients and inform of these changes and the reason for the changes or the Notified Body would be stripped of its CE Marking authority. Fortunately, my client was able to make the necessary corrections and continue CE Marking their medical devices.

• In another case I visited another manufacturing client in California at the request of their medical device insurance company to examine their Quality Management System and complaint handling system. The manufacturer had experienced some difficulties and wanted a legal perspective on corrective steps that might be taken. The quality manager mentioned that they had a recent surveillance audit from their Notified Body. (The manufacturer made radioactive plates for Magnetic Resonance Imaging machines.) They were surprised that the Notified Body device expert seemed to be afraid of entering the manufacturing area for fear of exposure to radiation. They weren’t convinced that he was much of an expert. The company has dealt with many experts in radioactive devices throughout their operation.

These are not idiosyncratic observations. While I have worked with several exceptional Notified Bodies administering CE Marking regulatory oversight for the EU Medical Devices Directives, they too have experienced glitches and these have been corrected when discovered. Clearly, strong Competent Body oversight is vital to the process. 

As mentioned previously there also are Notified Bodies more motivated by making money than quality medical device regulatory oversight. A colleague of mine encountered one such Notified Body a few years ago when working with a company that manufactured active implantable medical devices. He helped the manufacturer meet with the FDA regional office and review their quality management system. He was then asked by the manufacturer if he would review their most recent Notified Body surveillance audit, which he did. They asked his opinion and he said it was inadequate, which angered the Notified Body.

He subsequently learned that the company, however, was not fully candid with him, the FDA and the Notified Body. Not only were there manufacturing problems, four people had died from their implants and several others were experiencing serious problems with the device. FDA took action and several product liability lawsuits followed.

Had plaintiffs’ attorneys realized the role of the Notified Body in CE Marking these devices they could have sought Technical Files, ISO 13485 records, documents and notified body Certification Audits and Surveillance Audits in discovery to see what additional useful information could be obtained for use in the lawsuits. Notified Bodies are not exempt from US lawsuits. Further, the Notified Bodies could have been sued directly if their regulatory behavior could be partially attributed to device failures. The irony here is that the notified Body never realized how close they came to becoming a part of the lawsuits.

Observation – Privatized Oversight

The concept of privatized regulatory oversight is not unique. However, fragmented regulatory oversight involving 27 different Competent National Authorities (Competent Bodies) of different size, expertise and financial capability overseeing 70 Notified Bodies operating on their behalf is unique and extremely cumbersome. Until the structure is corrected, problems will continue to arise. The Friday January 27, 2012 issue of the New York Times contains an article about the breast implant manufacturer Poly Implants Prothèses, the founder Jean-Claude Mas and the apparently undetected use of industrial grade silicon in place of medical grade silicon.

The problem now is the immediate solution and the long-term solution. I understand the desire to create a strong EU structure while preserving national sovereignty. My political science and legal training tells me that it is possible, not easy but possible. I would be happy to help. 

My next blog will conclude this series and specifically address the problem with the silicon breast implants and prospective solutions. My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com. 

Notified Bodies And CE Marking – Potential Legal Issues In US Lawsuits #2

Introduction 

The preceding Blog reviewed the Minimum criteria to be taken into account by Member States for the notification bodies set forth in Annex XI of the 2006/42/EC Machinery Directive. I want to revisit the criteria to consider how they might come into play in a lawsuit. Several issues need to be kept in mind when dealing with notified bodies in lawsuits. To begin, notification varies for each directive. Therefore, it is critical to know what notification means for the Directive or Directives relative to a particular lawsuit and the role of notified bodies vis-à-vis your client.

Not All Notified Bodies Play According To The Rules

You must be aware that not all notified bodies behave ethically concerning their notified status. I have encountered notified bodies implying that their services are officially sanctioned (i.e., notified) by a Member State Competent National Authority to the European Commission for a Directive, such as the Machinery Directive, when in fact they are acting as consultants. This has been especially true for the Machinery Directive, where notification is confined to Annex IV of the Directive. Everything outside of Annex IV, is consulting with no official sanction by a Member State Competent National Authority. 

I mentioned previously an instance in 2003 where a Dutch Notified Body issued two EC Type Examination Certificates for machines a manufacturer wanted to CE Mark for the EU. They also issued a paper stating that other machines couldn’t be CE marked until certain steps were taken. Since none of these machines were listed in Annex IV, the issuance of the CE Type Examination Certificates was outside the legal authority of the notified body. The statements on the other machines were not identified as comments by a consulting body. Instead they were presented as the authoritative judgments of a governmentally recognized notified body. To accomplish these tasks the Dutch notified body sent a team to the US to conduct their work at great expense to my client.

Clearly, the notified body was aware that their American Clients didn’t understand CE Marking or the legal requirements of the Machinery Directive. I informed my client that their two EC Type Examination Certificates were worthless and had no standing in EU law or US law, however, if something happened where the certificates would be important in a lawsuit, the notified body could be sued for fraud. 

Since I had been working with representatives in the UK’s Department of Trade and Industry DTI (now the Department for Business, Enterprise and Skills BIS) on other projects, I asked them for help in contacting the Dutch Competent National Authority to complain about the behavior of the Dutch notified body. DTI tried for several months to contact the Dutch Competent National Authority and received no response.

They suggested that I should try to make contact directly and see if I fared any better. I wrote e-mails for several months to the Dutch Competent National Authority and even wrote directly to the head of the Dutch Competent National Authority and received no response. Finally, I transmitted my long train of e-mails to DTI & the Dutch to EU Commissioner Liikanen chief administrator of the EU Directorate General responsible for Machinery explaining what had transpired. Three weeks later I received a letter on March 23, 2004 from Mr. Fabrizio Sachetti of the Committee on Machinery affirming that our position was correct. They copied the Dutch Competent National Authority and the Dutch notified body of their statement. 

What Is The Operating Structure For Notified Bodies?

• Given the fact that notification varies with each Directive, it is essential that the precise legal authorization for notified bodies be known. It varies widely from Directive to Directive. The most stringent oversight was created for the Medical Devices Directives, however, recently the quality of notified body oversight of the Medical Devices Directive has been called into question concerning failed silicon breast implants in the EU and the French medical device manufacturer PIP (Poly Implant Prothèse). I will return to this case in my next blog.

• Every third party that wants to become a notified body for a new approach Directive must submit their credentials to the Competent National Authority of the country in which they are located. Presumably, each Competent National Authority has the technical expertise to evaluate the ability of the notified body to approve a CE Mark for a medical device and conduct effective continuous oversight of their notified bodies. Clearly, however, not all EU Member State Competent Authorities are equal. France, Germany, the UK, Italy, the Netherlands, Denmark, Ireland, Sweden and Finland have well developed oversight Competent National Authorities and are capable of being effective oversight bodies. Some of the smaller countries will not take on this task. A critical follow-up question is how effective is the oversight of the Member State Competent Authorities by the European Commission?

• Recall the discussion in my previous blog of January 9, 2012 regarding the dual function of many notified bodies concerning product safety and process quality. The dual function is particularly important to the oversight of medical device manufacturers. I have found, however, that some notified bodies address their dual function very well and others have been sloppy. This can be a problem when it comes to medical devices.

• Process Quality: Depending on the device classification, process quality refers to the type of Quality Management System, e.g. ISO 13485 used to assure that the medical devices are manufactured at a consistent quality level. The notified body conducts the certification audit and the surveillance audits to assure that process quality is being maintained. Basically, a medical device manufacturer contracts with a notified body as its "private FDA" for manufacturing medical devices for the EU, whereas in the US medical device manufacturers must follow FDA’s Quality System Regulation (QSR) and are subject to FDA oversight.

• Product safety: Medical device safety in the EU is governed by the classification of a device set forth in the Active Implantable, Medical Devices or In Vitro Diagnostic Directives. Once the classification has been determined, it is necessary to identify which Essential Requirements apply to a device, which EN Standards will allow a manufacturer to demonstrate conformity to the Essential Requirements and finally determine which Conformity Assessment Procedure applies to the manufacturing of a particular medical device.

• A medical device manufacturer in the EU, US, Canada, China, etc. can choose to contract with the notified body of their choice for a particular product, which means that manufacturers can shop around for price, service and convenience. While notified bodies are headquartered in the country where they have been approved, they have offices throughout the world. A fair question is the competence of the notified bodies in a country like China to carry on day-to-day functions as opposed to their US counterparts. I have worked with manufacturers who were not happy with the CE Marking abilities Chinese notified bodies and moved it to the US or EU.

What Are Some Of The Concerns Regarding Notified Bodies?

• Notified bodies must operate in accordance with the rules set forth in the particular Directive for which they have been approved by their Competent National Authority. While it might be obvious, it should be noted that each notification is different for each Directive. Notification for one Directive has nothing to do with another Directive.

• In spite of sincere pledges to create a firewall to prevent a conflict of interest between their official status as a notified body for a Directive and consulting for the same Directive, notified bodies are aware that Americans do not understand these subtleties and believe that consulting by a notified body is officially sanctioned by an EU Member State. A few years ago when I was working on a project with the California Manufacturing Technology Center in Fresno, we submitted a bid to a California packaging machine manufacturer. When we lost the bid, I asked my colleague in Fresno, if we were too high and he said no, the notified body quote was four times higher than ours. The manufacturer was under the impression the notified body was officially sanctioned by the German Government.

• Notified bodies are private for profit organizations. While most conduct themselves in a respectful manner, I am aware from a few former colleagues who have worked on a contract basis that a few notified bodies are rather mercenary with their employees violating criteria number two on the list, The body and its staff shall carry out the verification tests with the highest degree of professional integrity and technical competence and shall be free from all pressures and inducements, particularly financial… Some notified bodies essentially drive their employees to produce quotas or be dismissed, especially when conducting Quality Management System Certification and Surveillance Audits.

• Medical devices pose a special problem when it comes to device expertise. Often it is difficult for them to find and hold onto experts who can evaluate devices because medical device manufacturers will offer better pay to these persons. It speaks well to the quality of their expertise, but it creates a serious device quality and potential safety problem nonetheless.

• Medical Device Quality System oversight is another area where potential problems can arise. A few years ago I worked with a medical device manufacturer of a Class 3 Medical in California who had just completed a surveillance audit from their notified body. They asked if I would review the audit and write an Executive Summary. Their biggest concern was how I thought they would fare when FDA conducted an on site inspection. While it was a good audit, it had no teeth. It made some excellent observations, but it issued no non-conformities. I told my client that I thought they would not survive an FDA and could be shut down. They asked if I would highlight the areas for improvement in my executive summary. I did so and they called six months later to say they passed their FDA inspection with no write up in a FDA 483 Warning Letter.

Conclusion

The preceding are just a few experiences I have encountered working with notified bodies. It isn’t all negative, I have had excellent experience with several notified bodies and enthusiastically recommend their services to my clients. The recent experience with the French silicon breast manufacturer, however, points to areas where improvements are critically necessary. I also want to spend some time discussing notified bodies and potential US Federal Lawsuits since this area is beginning to heat up. Information provided in Technical Files could become fair game for CE Marked medical devices in legal discovery. Finally, I want to compare the European approach to medical device regulation with FDA’s medical device regulatory approach.

My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com. 

FDA’s Quality System Regulation – Management With Executive Responsibility #2

Continuation

In the first part of this Blog I reviewed what FDA expects of Management with Executive Responsibility as spelled out in its Quality System Regulation and what FDA inspectors will be looking for in on-site inspections as spelled out in FDA’s Quality System Inspection Technique (QSIT). The regulatory emphasis is quite clear. 

Insurance Company Litigation Study

Next I want to review the observations about Management With Executive Responsibility from the unpublished findings of the litigation history of a Medical Device Insurance Company. A sample list of observations about management is quite interesting:

• Management failures frequently occurred due to noncompliance with FDA, EU Medical Devices Directives and other regulations and unawareness of the requirement for notification to the appropriate regulatory bodies and the attention that regulators would place on clinical studies

• Management staff of new emerging medical device companys selected to conduct clinical trials/studies often do not possess the appropriate expertise/experience with clinical investigations. They are very familiar with the research and development of the device under study, but often do not have the professional clinical competencies needed to manage a clinical study.

• Management often has shown a failure to use proper or adequate legal assistance to review, launch or be involved in clinical studies.

•  Management often shows a lack of indemnities/disclosure in the informed consent agreements between IRBs, sponsors and patients of clinical studies.

• There often are ethics issues regarding “conflicts of interest.”

• The study found that medical device manufacturers and their contract manufacturers often relied on the mistaken belief that they are immune from product liability because of their manufacturing relationships with each other. These are situations where no risk management techniques have been applied before beginning the manufacturing – actions that could have helped avoid potential exposure to product liability litigation.

• Contract manufacturers supplying a component part to device manufacturers often did not carry any product liability insurance coverage and this was not questioned by the device manufacturer.

• The study found management failure to comply with FDA Quality Management System regulations for contract manufacturing agreements.

• In this era of outsourcing, the study found that contract manufacturing agreements often were deemed unenforceable in foreign legal jurisdictions.

• Management often failed to create a product safety policy statement or reference patient or product safety in the company’s quality statements under the mistaken belief by top management that the quality statement alone is adequate on the subject.

• Management had philosophical conflicts in which members of management teams wanted to fight FDA and their “observations” or “warning letters”, rather than mutually cooperate in resolving implementation plan for integrating the observations into their manufacturing processes.

• Several product liability claims that were taken to jury trials mentioned the use of the company’s quality management system and quality manuals against the manufacturer – the company’s own quality processes were not being followed or audited.

• The study noted a lack of company management staff training on product safety and quality management systems and the documentation of this training.

• The study found that in most cases management teams were very lean in young medical device firms in early commercialization; untrained and unfamiliar with the basic principles of product liability avoidance.

• Management ego issues were noted as confused in regards to product liability risks when management teams decided to fight FDA citations/observations versus demonstrating a spirit of committed cooperation to correct or arbitrate observations.

• In many medical device companies that experienced product liability claims, executive management underestimated the amount of time and corporate resources that would be needed to defend the company against product liability litigation.

• The silence of senior management in regard to product liability litigation was seen as their acceptance of the behaviors that caused or led to the product liability litigation.

• A lack of general and specific training for managers concerning their product safety responsibilities was noted as a recurring problem in the management of product liability avoidance.

As noted earlier, this is sample drawn from a much larger list of observations. Each observation came as a cost to each of these companies resulting in increased litigation expenses to the companies above the amounts paid by their insurance companies, possible FDA fines and punitive damage losses. And of course, increased  premiums and an increased deductible. 

Warning Letters

Finally, I wanted to look at some FDA 483 Warning letters regarding Management With Executive Responsibility: 

August 5, 2011 – Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency to established principles to ensure the quality system satisfies the requirements of 21 CFR 820, as required by 21 CFR 820.40.

For example, according to your firm’s Executive Vice President your firm has not established management review procedures.

For example, according to your firm’s Executive Vice President there are no quality audit procedures and no quality audits have been performed. [The letter goes on t detail other failings of top management.] 

March 16, 2011 – Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR 820 and the manufacturer established quality policy and objectives as required by 21 CFR 820.20(c). For example, your firm has not conducted any management reviews of your quality system.

October 1, 2010 – Failure of management with executive responsibility to review the suitability of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part, as required by 21 CFR 820.20(c). For example, your firm failed to establish and implement written management review procedures. 

 November 24, 2010 – Failure of management with executive responsibility to review the suitability of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure the quality system satisfies the requirements of 21 CFR 820, as required by 21 CFR 820.20(c). For example, according to your firm’s management, the firm does not conduct management reviews and has not established management review procedures.

*Failure to establish quality system procedures and instructions, as required by 21 CFR 820.20(e). For example, according to you, your firm does not have quality system procedures.

* Failure of management with executive responsibility to establish its policy objectives for, and commitment to, qualities required by 21 CFR 820.20(a). For example, according to you, your firm has not established a quality policy. 

Conclusion 

The preceding are just a few statements concerning Management With Executive Responsibility contained in FDA Warning Letters sent to medical device manufacturers. The full letters are much more extensive detailing other concerns specific to these companies. My point is that FDA’s Quality System Regulation (QSR) places significant emphasis on the responsibilities of top management. The issue concerns the health and safety of the American public. 

I want to repeat what was written in the first Blog. I have worked with numerous medical device companies where Management’s understanding of FDA’s Quality System Regulation ranged from intelligent to clueless. I find the latter condition to be scary because it usually is accompanied by that wonderful combination, “arrogance and ignorance.” This is especially true when the company is owned by a single individual and driven by his ego and self-perceived brilliance. Not a healthy combination or work environment. Consultants need to consider carefully which companies and management they choose to work with.

As noted at the conclusion of the first Blog, my focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a Federal or State courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions concerning medical device litigation, you can contact me for a free preliminary consultation at my new e-mail address jameskolka@gmail.com.

FDA’s Quality System Regulation – Management With Executive Responsibility #1

Introduction 

Not too long after FDA’s Quality Management System became the new Current Good Manufacturing Practice (CGMP), a colleague and I were asked by a client of our consulting firm to conduct a GAP Analysis to determine what needed to be done for them to comply with the Regulation and also to determine what needed to be done for all of their manufacturing plants and products to comply with CE Marking Requirements for the EU’s Medical Devices Directives. Since the company was (and is today) a major medical device manufacturer, our GAP Analysis audit took us to plants and operations throughout the US and Mexico. 

When we reported back our findings and recommendations to the CEO, he smiled and asked if they needed to comply with FDA’s new QSR. My colleague also smiled when she replied, "yes unless you think you look good in stripes!"

Of course this exchange occurred in good humor because FDA made it clear that they intended to hold Management With Executive Responsibility fully accountable for the implementation of the new QSR. “Good stripes” for bad management was and is a real possibility.

Today 

Since that friendly but intelligent exchange, I have worked with numerous medical device companies where Management’s understanding of FDA’s Quality System Regulation has ranged from intelligent to clueless. I find the latter condition to be scary because it usually is accompanied by that dangerous combination, “arrogance and ignorance.” This is especially true when the company is owned by a single individual and driven by his ego and self-perceived brilliance. Not a healthy combination and work environment. I think it is timely to review FDA’s definition of Management With Executive Responsibility in the QSR.

21 CFR Part 820 – Medical Device Quality System Regulation

§ 820.20 Management responsibility

(a) Quality Policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.

(b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the responsibilities of this part.

(1) Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interlation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

(2) Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.

(3) Management representative. Management with executive responsibility shall appoint, document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:

(i) Ensuring the quality system requirements are effectively established and effectively maintain in accordance with this part; and

(ii) Reporting on the performance of the quality system to management with executive responsibility for review.

(c) Management Review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure the quality system satisfies the requirements of this part in the manufacturer’s established quality policy and objectives. The dates and results of quality system review shall be documented. 

Enforcement

Another way to see how FDA views Management With Executive Responsibility is to examine the Guide To Inspections of Quality Systems that is used by FDA field staff to assess a manufacturers compliance with the Quality System Regulation and related regulations. It is also known as (QSIT) Quality System inspection Technique. Management with Executive Responsibility will be questioned about the Quality System at the beginning and at the end of an on site inspection. Page 18 of QSIT states:

Management Controls

Inspectional Objectives 

1.Verify that a quality policy, management review and quality audit procedures, quality plan, and quality system procedures and instructions have been defined and documented.

2.Verify that a quality policy and objectives have been implemented. 

3.Review the firm’s established organizational structure to confirm that it includes provisions for responsibilities, authorities and necessary resources.

4.Confirm that a management representative has been appointed. Evaluate the purview of the management representative.

5.Verify that management reviews, including a review of the suitability and effectiveness of the quality system, are being conducted.

6.Verify that quality audits, including re-audits of deficient matters, of the quality system are being conducted.

 At the conclusion of the inspection….

7.Evaluate whether management with executive responsibility ensures that adequate and effective quality system has been established and maintained. 

FDA field staff are guided through these inspectional objectives by a series of questions that are asked concerning each objective. Examples of the questions are,

• “ To determine what the firm’s organizational structure is, start by asking the authority and responsibility questions that are the start of every FDA inspection.”

• “ Determine whether personnel involved in managing, performing or assessing work affecting quality have the necessary independence and authority to perform those tasks.”

• “ Determine whether the appointed management representative actually has the purported responsibility and authority granted to him/her by the firm’s procedures or organizational structure.”

• “ Verify that the management representative is reporting back to the management with executive responsibility on the performance of the quality system. These reports should either be the subject of management reviews or at least provide a framework for those reviews.”

• “ Determine whether corrective action by upper management is being taken. Auditors may be asked if they observed any of the ongoing Quality System Regulation deficiencies during their prior audits (ongoing Quality System Regulation deficiencies may also be identified by reviewing prior FDA 483’s).”

• “ At this point in QSIT, you stop your review of the management system. You continue your inspection by evaluating the other subsystems. While you evaluate the other subsystems, keep thinking about what you are finding and whether it indicates that management is appropriately carrying out its responsibilities for providing adequate resources and overseeing the quality system to detect problems and address them.” 

Conclusion 

This, as they say, is only the tip of the iceberg. The on-site inspections are rigorous and a significant objective is to determine if Management With Executive Responsibility is actively engaged in overseeing the operation of the company’s quality management system. Egocentric executives who feel themselves above the day-to-day operations will be discovered and written up in a FDA 483 Warning Letter. If the behavior is too egregious, penalties can be levied and in the most extreme case criminal sanctions can be imposed. Therefore, the management of medical device company affecting the health and safety of the public is not treated lightly, nor should it be.

In the second Blog on this topic, I will examine some of the management observations by a medical device insurance company following an in-depth review of their insureds' litigation history. We will also look at a few published FDA warning letters on this topic. Holding executive management responsible for the operation of medical device and manufacturers is a significant step forward in addressing issues of safety. It requires continual vigilance.

My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a Federal or State courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions concerning medical device litigation, you can contact me for a free preliminary consultation at my new e-mail address jameskolka@gmail.com.  

Market Surveillance #1 – To Be Or Not To Be – When, Is The Question

Introduction

This is the first of two blogs about market surveillance in the EU. The first blog addresses some concerns evolving from my experience with self-certification with new approach Directives and possible ways to address those concerns. The second blog will address my experience with Member State response to accidents and fatalities in light of Decision No 768/2008.

I suppose it seems odd that an American is concerned about the issue of EU market surveillance, however, I have seen continued abuses and it irritates me. Those of you who have been reading my recent blogs are aware that I am serving as a legal expert in a lawsuit involving a non-compliant CE marked machine that has killed one person in the UK and so badly injured another that he will require 24 care for the rest of his life. What was put forth as a Technical File by the manufacturer could best be called a “junk file.” The manufacturers’ compliance with EN safety standards was a farce! Further, there was no Annex I Health and Safety Requirements Checklist indicating which Essential Requirements the manufacturer thought applied to all of the machines listed in their “Product Family Technical File.” And of course there was no meaningful Risk Assessment following EN ISO 14121-1: 2007.

One of the most troubling aspects of the case is the fact that the “junk file” and lack of serious compliance could only be discovered after the accident. It is a particular concern with new approach Directives when “self-certification” is an option. The new approach Directives and EN harmonized safety standards are a significant contribution to global product improvement and product safety. Unfortunately, all the potential gains are washed away if regulatory oversight is ineffective.

As a consultant, it is difficult to work with manufacturers who want to do as little as possible and whom I avoid as clients. I want my clients to fully comply with the requirements of the new approach safety Directives. Conversely, as an attorney it presents an opportunity to serve as a legal expert in product liability lawsuits against manufacturers who didn’t attempt to comply and whose machines have caused injury to persons and property. It is a perverse consultant/attorney dichotomy driven by a desire to improve product safety.

Decision No 768/2008/EC of the European Parliament and the Council of 9 July 2008 On a Common Framework For the Marketing Of Products and Repealing Council Decision 93/465/EEC

I wrote about this decision in a blog posted 30 October 2009. At the time it was exciting because it promised to address some of the issues concerning new approach directives and in particular improve market surveillance starting 1 January 2010. The machinery manufacturer lawsuit discussed in my recent blogs, however, brought home the problems inherent in self-certification where little regulatory discipline is exercised by Member State Competent Authorities over machines placed on the market in their countries. 

Unless an effort is made to require that Part A (the index) of a Technical File and an Annex I Checklist exist and are filed electronically with a member State Competent Authority, manufacturers will be able to play “fast and loose” with Directive requirements. While Part A of a Technical File and an Annex I Checklist don’t eliminate evasion and fraud, they do commit manufacturers to state which Essential Health and Safety Requirements apply to their products and which EN harmonized standards will be used to demonstrate conformity with those requirements.

Authorized Representatives

Hypothetically, Authorized Representatives also could hold Part A of a Technical File and an Annex I Checklist, but I have found Authorized Representatives to be a mixed bag. They range from manufacturers’ EU subsidiaries, to distributors, to an attorney’s post office box to professional Authorized Representatives, who range from modest to exorbitant in their fees.

In one instance I worked with a client who had been notified by their Authorized Representative that they would be reported to the Dutch Competent Authority if they didn’t produce their CE marking documents within eight days. Naturally, the company was panicked. Fortunately, they made a Class I non-sterile non-measuring medical device which meant that they could self-certify. Consequently, we were able to respond and the company was able to e-mail their documentation to the Authorized Representative and disaster was averted. 

I found it interesting that the Authorized Representative offered a “Dutch company” who could help my client meet these requirements. No doubt, it would have been expensive. It also raised the question of possible conflict of interest/collusion between the Authorized Representative and the “Dutch company.” Needless to say, I have become cynical about the business ethics of some of the professional Authorized Representatives.

Notified Bodies

EU Notified Bodies also could serve as Authorized Representatives, however, my concerns about their non-monetary ethical integrity is even greater than EU professional Authorized Representatives. I have worked with and have great respect for several Notified Bodies. Unfortunately, many others have not performed professionally. My concerns range from encountering outright malpractice to lax oversight to monetary ambitions that appear to dominate their behavior and quality of work. A few examples should suffice.

(1.) A few years ago I worked with a company that had requested a visit from a Dutch notified body to examine their Machinery Directive CE Marking Technical Files to see if they satisfied EU requirements to place two machines on the EU market. Representatives of the notified body flew to Atlanta from Amsterdam and spent time with the company going over their files. At the conclusion of their visit, they issued two EC Type Examination Certificates for two different machines and made extensive comments on the remaining machines not being ready for CE marking. The EC Type Examination Certificates were inappropriate because they could only be used for dangerous machines listed in Annex IV. Neither of these machines were listed in Annex IV.

My client assumed that the certificates that could be used in a court of law in the future. The notified body knew that the company was ignorant about the legal nature of their notification and the fact that they were acting as a consulting body and had no notified body status in this case. I first raised the question with the Department of Trade and Industry and the UK and they offered to contact the Dutch Competent Authority. After three months of no response, they suggested that I should try which I did for another three months, including e-mailing the head of the Competent Authority, again no response.

Finally I wrote to Commissioner Liikanen of the European Commission whose Directorate had oversight of the Machinery Directive as well as other Directives and received an e-mail letter three weeks later stating that I was correct in my concern, copying the Dutch Competent Authority and Dutch Notified Body of that fact.

(2.) In my last blog I described a weak surveillance audit by a German notified body of a California manufacturer of Class III medical devices. The company was concerned about how it might fare in a FDA plant inspection. They requested that I write an Executive Summary of the surveillance audit. Although the notified body audit made good observations, they did not issue any major or minor nonconformities calling for improvement. As a consequence, the surveillance audit was not helpful. I told the company that if they did not make significant improvements, they would fail an FDA plant inspection. I spelled out the weaknesses in the surveillance audit and what needed to be done to address those weaknesses.

I was aware from a colleague that the same notified body conducted a weak audit of another Class III Medical Device manufacturer in California. My colleague also was asked to address the quality of the manufacturer’s most recent surveillance audit. He said it was weak and inadequate. The Medical Device manufacturer then shared my colleague’s assessment with their notified body. The notified body in turn called the UK managers of our Training and Consulting firm and complained about his assessment. He stood by his assessment.

Shortly after my colleague’s visit, the company was cited for patient deaths from their devices. A few months later the Wall Street Journal announced that another medical device company dropped its acquisition offer for this company by $500,000 dollars. I don’t think the notified body ever realized how close they came to a lawsuit, if the acquisition had been aborted.

Summary

Previously, I have mentioned that I would be happy to work with interested parties to improve the quality of EU regulatory oversight. It doesn’t need a sledgehammer, but it does need strengthening to be effective. We have no such regulatory oversight in the US. Perhaps the best protection for the US market is product liability litigation. Recently, a congressman from New York suggested that the US Consumer Product Safety Commission should diminish its regulatory involvement with toy safety. (Swell bring back the lead paint and melamine!)

I also would like to work with European manufacturers and companies on steps that can be taken to reduce their liability exposure in the US market. It seems to fit the European philosophical approach to product safety and would help EU firms concerned about the litigious nature of the US marketplace.

In an earlier blog I describe working with several colleagues on an Enterprise Risk Management Program for a US medical device manufacturer that had been acquired by a European parent corporation. It was an excellent approach to future planning that I greatly enjoyed. Which is to say, that I think my philosophical sensibilities and interests in risk management are European. If anyone is interested in exploring this topic further, please contact me at jameskolka@gmail.com or jim@jameskolka.com. 

My Experience With Differences in FDA & EU Medical Device Regulatory Oversight – Not Equal Yet

Introduction

A few years ago I worked with a California Medical Device Company that made FDA and EU Class III medical devices. The company contacted their insurance company asking for help for their employees to better understand the similarities and differences between the two regulatory approaches. I conducted a GAP analysis that was used in training workshops at their two locations over two days in the Los Angeles Area. 

The company had encountered some difficulties in device labeling and wanted a complete review of their quality management system. They had recently been visited by their notified body and asked if I would read the notified body’s most recent surveillance audit and critique the findings. Among the questions they wanted addressed was whether they were ready for an FDA plant inspection. Consequently, the notified body surveillance audit provided a good recent snapshot of how well they were doing.

Notified Body Surveillance Audit

After reading the audit, I found it to be disconcerting both ethically and legally. The comments made were excellent, but they were not identified as major or minor nonconformities or even observations. Consequently, they may have been well-written but they carried no weight. My ethical concern was that if the comments had been given greater weight, it would have been helpful to the manufacturer in making needed changes to their quality management system. My legal concern was that a third-party conducting a surveillance audit of a Medical Devices Directive Class III Medical Device should be of equal rigor to an FDA plant inspection. It was not.

The FDA would not have issued its finding in such a low-key manner. Most likely, FDA would have issued a number of findings on a 483. In my opinion, both FDA and notified body audits ought to have the same level of rigor so that medical device manufacturers can feel that they are receiving the same level and quality of scrutiny whether it be from FDA or an EU sanctioned notified body. Consequently, when a medical device manufacturer completes a notified body audit, they ought to feel that they are fully prepared to sustain an FDA inspection. 

The question being asked by the manufacturer was, “were they in good enough shape to sustain an FDA inspection?” The answer was no. I suggested that they examine FDA’s Guide to Inspections and Quality Systems contained in Quality System Inspection Technique (QSIT) so they can see the questions FDA would ask during an inspection. At present, the manufacturer faced the distinct possibility that FDA might shut them down.

Observations

The full list is too extensive for a blog. Following are a few of the notified body observations contained in the notified body surveillance audit broken into two categories; (1) EU Medical Devices Directive, and (2) ISO 13485 

Medical Devices Directive

• There needs to be a quality system procedure on how to write a Declaration of Conformity and each Declaration of Conformity should specify the specific models (the product family) for which the declaration is applicable. The same can be found in the GAP analysis. 

• There needs to be a defined and documented quality system procedure to support the translation of device instructions and labeling into Member state user languages. The same observation can be found in the GAP analysis.

• Risk analysis reports should be controlled documents with a record number, revision status, dated and signed.

• The observation that risks should be reassessed whenever product or manufacturing changes are made and information from the post-marketing surveillance system is received identifying problems about new risks is sound and should be implemented. This should be implemented at all three levels – design, production and post-production.

• The observation that the company’s procedure for CE marking and labeling should be included in Part A of the Technical File, but was not found in the technical file is valid. My biggest concern here is what I was able to see as a Technical File did not in my opinion constitute a Technical File.

• The requirement that a quality system procedures specify that Part A of the Technical File be sent to your EU authorized Representative is valid.

 Quality System

• The request the quality objectives be defined and reviewed annually is a good suggestion. More clearly defined objectives and metrics to better measure performance and ensure continued effectiveness and suitability of the quality system would be particularly appropriate at this time. 

• The observation that the contents of the most recent Management Review Meeting minutes did not fully represent agenda items listed within the company’s Management Review Procedure is significant. While FDA will not look at the minutes of the meetings, they will look at the procedure to determine if you are doing what you say you are going to do. If FDA discovers that procedures are not being followed, it would be taken seriously. 

• The observation that Device Master Records are not being clearly defined documented and linked to the requirements of the Quality Manual would be taken seriously by FDA. Device Master Records should exist for all products, both CE marked and non CE marked

• The requirement for a mandatory independent evaluation of the design and development of a product is new from a notified body (at that time), but parallel to the requirement by FDA to have independent input in the design review process. It is a good recommendation.

• Clarification of the design change process (major vs. minor) should be made clear in the design control procedures and specifically in the design change procedure.

• The observation that the company should maintain relevant procedures, available at entry, for gowning and egress from a controlled environment is a valid requirement that would be a significant concern for FDA. This should have been written as a minor conformity that would’ve required a quick response.

• The observation that the controlled environment Worker Training Manual should become a control document also should have been written as a minor nonconformity. It would have required a very simple response, but assured that the matter had been attended to quickly. This would be a concern for FDA.

• The request that advisory notices and product recalls be further defined is excellent. A procedure on advisory notices and recalls should specify the methods of communication to be used and the system for determining the disposition or return product. This too would be a concern for FDA.

• The observation that compliance with high-level requirements should be checked during internal quality audits is sound. The requests that the Auditor Training Module be comprehensive and support the qualification of auditors is good suggestion. I recommend that training be expanded to include FDA’s Quality System Regulation in addition to the EU requirements. The internal quality audit should be looking at both EU and FDA requirements during the same audits.

• Finally, the observation that training records are not current and do not reflect the revision status upon which the training is based is legitimate. In general, training should be reviewed to make certain that people have been trained, the training outcome has been effectively measured and the information is current in each employees training record. It is an area that FDA will look at closely.

Summary 

It would be helpful for people to review this Executive Overview, the GAP analysis and relevant FDA documents affecting their area of operation and responsibility at the company. Becoming familiarized with the FDA’s Quality System Regulation and FDA’s expectations represented in QSIT will provide major insight on what to anticipate during an FDA inspection. Concurrently, QSIT will provide clues on what FDA expects in quality systems of companies that manufacture medical devices.

One of the first questions I was asked is what is an SOP? In short it stands for Standard Operating Procedure. Further, FDA expects that every company has a Standard Operating Procedure to write SOPs. The question, however, tells you that you have a way to go with your employees before you are able to survive an FDA inspection.

Conclusion

Eight months later I received a call from the company telling me that they had just finished a full plant inspection by FDA and didn’t receive a single write up on a 483. Unfortunately, the notified body did not provide the quality of assistance that would have been helpful had they elevated their observations to minor nonconformities requiring a prompt response.

This is not the only time that I have observed notified bodies operating at a more lenient and less helpful level than FDA. They are not equal yet. If you have questions about EU and FDA medical device regulations, product liability lawsuits and preventive steps such as product safety/product liability audits to reduce product liability exposure, you can contact me at my e-mail address jameskolka@gmail.com.  

 

 

Until Medical Device Manufacturers Conduct Product Safety & Product Liability Audits, Risk Management Does Not Exist!

Background

Several times since I began this blog in February 2009, I have mentioned a private “in-depth” litigation study conducted by a medical device insurance company of its litigation history. Since virtually all of their lawsuits have been settled out of court, there is no public record of mistakes to guide other medical device manufacturers, thereby allowing them to repeat the same mistakes over and over.

Quality Management Systems such as FDA’s Quality System Regulation (QSR), the EU’s Medical Devices Directives combined with ISO 13485:2003 Medical Devices – Quality will management systems – Requirements for regulatory purposes and Canada’s application of ISO 13485:20032 medical devices must be understood from a legal perspective.  They contain Quality Manuals and Quality Procedures developed by each company to comply with governmental regulatory requirements to manufacture a medical device. The system must be documented and must identify the processes that will be used to manufacture medical devices.

Quality system documents and records contain a wealth of information that can be obtained during discovery to determine if a company is satisfying governmental regulatory requirements and if a company is satisfying its own quality management procedures. Failure to follow regulatory requirements and/or follow the company’s quality management system requirements can be used against a company in litigation. Depending upon the seriousness of the regulatory failure, it could provide vital information to plaintiffs’ attorneys. 

Quality Manuals and Quality System Documents are intended to guide the operation of a company’s Quality Management System. Quality system documents are neither intended nor constructed to provide evidence of a company’s concern for patient safety and product safety. If a company wants to prove that it cares about patient safety and make safe products, it will have to build documentation to prove that point. 

Litigation

The three major areas of product liability litigation – Design, Manufacturing, and Post Sale Surveillance are specifically addressed by clauses in each regulatory Quality Management System. For example, to design a medical device using FDA’s Quality System Regulation (QSR), a company that wants to manufacture a Class III, Class II and certain Class I medical devices must follow 21 CFR 820.30 Design Controls. This means that there should be documents and records describing the stages of design development: 820.30 (b) Design and development planning, (c) Design input, (d) Design output, (e) Design review, (f) Design verification, (g) Design validation, (h) Design transfer, (i) Design changes, (j) Design history file. This means that records should exist documenting each of those stages, including risk analyses where and as needed. If records don’t exist, the device was not designed in accordance with FDA regulations 

All of this design information is available to plaintiffs’ attorneys in product liability lawsuits. Manufacturing a medical device follows its own set of QSR regulatory clauses. To be effective and not be blindsided by plaintiff’s allegations citing quality system breakdowns, corporate counsel and defense attorneys must understand regulatory Quality Management Systems in depth.

Quality Management Systems are audited internally following an audit protocol that visits each department at least once annually, more often if problems are found. Problems identified as nonconformities must be addressed by Corrective and Preventive Action CAPA). Departments are asked to make corrections following a timeline.  Internal audits, nonconformities and corrective actions are reviewed at least once annually (generally more often) by top management.  Management review minutes are kept. Internal audit records, nonconformities, corrective and preventive actions and management review minutes constitute a rich source of information for plaintiffs’ motions to compel. Consequently, corporate counsel and defense attorneys must understand what type of information and records are generated and be prepared to address these issues with their manufacturers.

What does this mean for product liability litigation?

The medical device insurance companies litigation study revealed several concerns regarding weaknesses of medical device manufacturers in product liability lawsuits. Remember the old saying, the question isn’t “if you are sued, will you be prepared” rather “when you are sued, will you be prepared!” A few of the findings are listed below:

• Several medical device manufacturers constructed Quality Management Systems to satisfy FDA and EU medical device regulatory requirements, but contained no documented methods, processes or procedures for communicating product safety concerns and/or incorporating those concerns into their business processes, thereby demonstrating no commitment to product safety.

• The study found a lack of internal processes and procedures in companies Quality Management Systems for escalating product safety concerns and a review of those concerns as well as a lack of any kind of cross functional committee to deal with product safety issues. Plaintiffs’ attorneys alleged that this demonstrated a lack of due care and concern for product and patient safety.

• The study found several instances of biotech firms failing to protect their documentation by asserting that attorney-client privilege prevented plaintiffs’ from examining their documentation during discovery, which assertion was not accepted by the court.

• The study found misconceptions by management of medical device manufacturers that compliance with FDA’s Quality System Regulation was enough to prevent product liability claims.

• The study found that management frequently continued to underestimate the risk of product liability litigation to the success and/or survival of their business.

• The study found that design research documents and agreements often contain hidden product liability exposures – the agreements were not reviewed by legal counsel familiar with clinical research or by insurers or brokers reviewing coverage limits and indemnification clauses.

• The study found a lack of qualified in-house personnel available to integrate product liability avoidance principles into the firm’s quality management system and establish an infrastructure for product safety, resulting in product liability post-production legal defense problems.

• The study found that company postproduction corrective and preventive actions were deemed to be inadequate for the degree of risk presented by individual complaint investigations resulting in both FDA regulatory actions and product liability lawsuits. 

Summary

These are but a few of the problems uncovered by the litigation study. The actual list is quite long and quite disturbing. The lack of training for product liability exposure is extraordinary. Virtually no firms conduct product liability audits or product safety audits of their operations. The assumption appears to be that compliance with FDA and EU regulations is sufficient. From my experience, quality managers do not see legal issues as their responsibility and therefore will pass them off to regulatory managers, corporate counsel and management. In turn regulatory managers do not focus on product liability exposure.

The focus on product safety and patient safety is inadequate and will continue to cause trouble. The maintenance of records often is poor. The wording of documents pays no attention to the legal consequences of what is said. Consequently, it appears that product liability lawsuits will continue to plague medical device manufacturers. There are steps that can be taken training personnel to conduct product liability audits, product safety audits and learn how to write documents so that the words don’t become minefields for litigation.

My wife has often told me that people don’t like to read they prefer getting their information in little word bites and sound bites. I generally respond that attorneys have always liked to read and will analyze what is said how it is said and use it in a court of law. If you have questions about product liability lawsuits and preventive steps such as product safety/product liability audits to reduce product liability exposure, you can contact me at my e-mail address jameskolka@gmail.com.

 

FDA Levies $ Billion Dollar Fines For Off Label Marketing Of Drugs

Background

A week ago yesterday, the Wall Street Journal reported that FDA is seeking $1 billion dollars from Johnson & Johnson to resolve a long running probe into the company’s marketing of an antipsychotic drug Risperal. The settlement of $1 billion would be among the largest in a string of settlements related to off-label marketing of drugs in recent years.  Since 2004 the federal government has been investigating whether J&J’s Janssen pharmaceutical unit improperly promoted Risperal for unapproved uses. The company said it set aside an unspecified amount of money for a potential settlement and it would likely face civil and criminal litigation if it didn’t settle.

Officials at J&J said they were surprised at the size of the sum that prosecutors are seeking. Prosecutors have been citing a benchmark $1.4 billion dollar settlement that Eli Lilly & Co. reached in 2009 to resolve a probe into alleged improper marketing of its antipsychotic drug Zyprexa. Lilly’s alleged off label marketing took place over a longer period of time. Under federal law, companies cannot market medicines for uses other than those approved by the Food and Drug Administration, although doctors can prescribe drugs for unapproved uses.

Prosecutors argue that Medicaid and other government programs are wasting tens of millions of dollars paying for medicines that drug makers encourage physicians to prescribe for uses that FDA hasn’t determined are safe and effective.  In 2009, Pfizer Inc. paid the pharmaceutical industry’s biggest settlement agreeing to pay $2.3 billion dollars to resolve an investigation into the marketing of the painkiller Bextra, which now has been withdrawn.

Since 2001, drug makers have paid more than $11 billion dollars in off-label marketing and other whistleblower fraud cases. The J&J case, like many others started as a whistleblower case. Company insiders (whistleblowers) can receive a portion of the settlement, if the government recovers money. Industry officials are upset about the millions of dollars that whistleblowers can earn from a successful case and argue that these people are often disgruntled employees whose allegations are taken out of context.

A guilty verdict could mean that medicines, e.g. drugs could no longer receive reimbursement from Medicaid and other government programs. Further, an unsuccessful court challenge by drug companies could result in expensive litigation brought by patients and might provoke some states, that don’t participate in the settlement, to seek reimbursement. While the allegations that prosecutors in Philadelphia and Washington DC are pursuing in the J&J case haven’t been disclosed, the FDA has approved Risperdal for treatment of schizophrenia and bipolar disorder. The agency, however, has warned that the drug should not be given to dementia related psychosis including elderly patients.

Off-Label Marketing of Drugs and Medical Devices

Off-label marketing has been an ongoing concern for FDA. The amount of money that drug and device companies can make from off-label marketing can run in the billions of dollars. It also can result in serious to fatal consequences for patients. Since Medicaid pays substantial amounts of money for these off-label abuses, the Federal Government has a dual interest in this problem, as a consumer and prosecutor. 

As a consequence, FDA and federal prosecutors are seeking to levy settlements to discourage companies from directly and indirectly encouraging off-label uses. FDA also has decided to take aim at corporate executives to rein in Pharma abuses. FDA warned in November 2010 and that it was resurrecting a 1970s legal doctrine to bring criminal charges against top executives.

The goal, said Eric Blumberg, FDA deputy chief counsel for litigation, was to ”change the corporate culture” at firms that have shrugged off $1 billion dollar penalties. “It is clear that fines are not working here”, Blumberg told a food and drug Law Institute meeting in Philadelphia. “We need to put something else on a scale to make people think twice, three times.” Blumberg was talking about illegal drug marketing.

FDA’s weapon of choice is the Park Doctrine, based on a 1975 case against Acme Markets president John Park. FDA charged Park personally with sanitation violations following multiple warning notices. The US Supreme Court agreed that Park as company president was ultimately responsible for ensuring compliance.

In 2007, three executives of Purdue Frederick Co. pled guilty to charges of misbranding OxyContin. The three paid $634.5 million to the Virginia Medicaid Fraud Unit and were barred from federal health care programs for 12 years.   

In 2010, four executives of Synthes pled guilty for off-label promotion of a bone cement. The four face fines of up to $10,000 each and a year in federal prison.

Other recent targets include former GlaxcoSmithKline vice president Lauren Stevens, indicted for making false statements and obstructing an FDA investigation into illegal marketing of Wellbutrin SR (buproprian sustained release) and former KV Pharmaceutical CEO and Chairman of the Board Marc Hamertin barred from participating in federal healthcare programs for 20 years.

Protecting the Nations Health

It is a remarkable when there is a push in Congress to ease up on regulations in the healthcare industry with the logic that it stifles innovation and slows delivery of new medicines to the market. It is understandable that the delivery of new medicines should be expedited as soon as possible, but not at the expense of patient safety and product safety.

It is difficult not to be cynical when there is a push in congress to ease up on regulating healthcare abuses. It is reminiscent of the words of Gordon Gekko, the main antagonist in Oliver Stone’s 1986 film Wall Street, when he said, “Greed, for lack of a better word, is good!” Apparently, that sentiment is alive and well in portions of America’s Healthcare Industry.

We read of medical mistakes in hospitals and hasty decisions by doctors that cause 100,000+ deaths each year. Compounding these problems with corporate greed is sad and troubling for the nation’s healthcare system. Unfortunately, it is nothing new. Prosecuting these abuses with adequate civil and criminal penalties appears to be the only way to dampen the onslaught.

Reducing regulations, while wildly popular among a few who dislike government oversight, enriches the few and hurts the many. If you have questions about healthcare abuses, product liability lawsuits and preventive steps such as product safety/product liability audits to reduce product liability exposure, you can contact me at my e-mail address jameskolka@gmail.com.

FDA Compliance & Product Liability Exposure

Introduction

In several blogs I have discussed a private study conducted by a medical device insurance company examining their litigation history, successes and failures. I want to revisit some of the findings as they relate to life science firms (medical devices, biotech, pharmaceuticals). In particular, I want to examine the issue of Quality Management Systems – (FDA’s Quality System Regulation, ISO 13485, ISO 9001) regulatory compliance and product liability exposure.

As often happens in a corporate setting or for that matter any large organization, responsibilities are defined in a structure that discourages or punishes “thinking outside the box”. Consequently, if a quality manager raises the question about regulatory issues or potential liability exposures, the response to their suggestions often is “stay in your own box” legal issues are the responsibility of the legal department. Likewise, if a regulatory manager suggests examining product liability issues they too may be chastised for stepping outside of their job description.

I saw this happen to a quality manager in the very first medical device firm I worked with on CE Marking their medical devices. The Quality Manager learned very quickly – “if I mention legal issues my hands will be slapped.” Therefore, if I see something that might have legal implications I am not going to get involved. That is for the legal apartment to find out and solve by themselves.

Unfortunately, this sort of separation of responsibilities and jealousy if anyone moves into another person’s area of responsibility is all too common. It happens in every organization. It happens in the government. It happens in universities. It happens in the military. Efforts to break down these walls/silos are difficult and the inability to communicate across job responsibilities and/or disciplines is extremely difficult. It strangles effective cross disciplinary communication.

Medical Device Litigation Study And The Product Liability Consequences

The medical device litigation study conducted by the medical device insurance company found several areas where the inability to address product liability exposure resulted in litigation losses, in some cases substantial losses and increased insurance premiums. Listed below are a few of the more prominent institutional failures to address product liability exposure.

• The study noted a lack of internal processes and procedures including company quality management systems for escalating product safety concerns or review of those concerns as well as a lack of any kind of cross functional committee to deal with product safety issues. Plaintiffs’ attorneys noted this failure and alleged that the failing demonstrate a lack of due care and concern for safety resulting in an expensive out-of-court settlement.

• The study found that management continued to underestimate the risk of product liability litigation to this success and/or survival of their business.

• The study noted that life science firms often lack a clear understanding of the potential risks and product liability exposure resulting from misunderstood and poorly written safety documents and communications.

• The study recorded a lack of qualified in-house personnel available to integrate product liability avoidance principles into the firm’s quality management system and establish an infrastructure for product safety, resulting in product liability post-production legal defense problems.

• Often post-production complaint data was poorly managed and not escalated to the attention of senior management and/or was ignored by senior management resulting in regulatory sanctions and product liability lawsuits.

• The Study noted that life science firms often did not conduct post legal settlement reviews and analyses over claims in an effort to learn from their litigation experience. Consequently, where a case was settled and believed to be over and finished, the failure to learn from experience often resulted in a similar case arising a few months later.

• Often, documented critical safety information was found to be carelessly worded and/or prepared and used against the firm to support the allegation of a lack of attention to patient safety and product safety resulting in product liability lawsuits and expensive out-of-court settlements.

• Too often life science firms did not conduct diligent reviews of their Internet websites and advertising materials for misleading claims and ‘testimonials’ resulting in the use of these claims and testimonials against the firms in product liability lawsuits.

Conclusion

Quality Managers and Regulatory Managers are not trained to understand or think about product liability exposure. They don’t know how to conduct product safety or product liability audits of their processes, documents and regulatory quality management systems for potential areas of product liability exposure. Therefore, it isn’t surprising that the number of product liability lawsuits is increasing. The phrase, “the best offense is a good defense” is an axiom apparently without meaning in the life science regulatory world.

Product liability lawsuits are a continual threat to the financial success and prosperity of life science firms. Unfortunately, too often the threat isn’t taken seriously. In addition, life science firms are subject to regulatory action by FDA and its counterparts in the EU, Canada, Australia and Japan. Failure to abide by FDA and other country regulations could lead to regulatory sanctions that in turn provide fuel for trial lawyers and product liability lawsuits.

Corporate counsel and product liability litigation attorneys do not fully understand and appreciate the impact of documented regulatory Quality Management Systems (QMS) on product liability litigation. Plaintiffs’ attorneys are becoming increasingly effective in using these regulatory quality management systems against life science firms in product liability lawsuits. To date, plaintiffs have only scratched the surface and are just beginning to examine the internal structure, quality procedures and documents required to operate these systems. Broken or failed QMS systems are rich with data and potential that can be used in product liability lawsuits.

Therefore, it is critical for life science firms and their attorneys to better understand the regulatory and legal milieu in which they exist and take pro-active steps to improve their lot by better grasp the legal significance of their regulatory Quality Management Systems and by practicing product liability avoidance, known also as lost control and preventive law. If you have questions about Life Science Firms, product liability lawsuits and preventive steps such as product safety/product liability audits to reduce product liability exposure, you can contact me at my new e-mail address jameskolka@gmail.com.  

Litigation Risk Management © & Regulatory Compliance – CE Marking for EU Directives – Machinery & Related Directives

Introduction

This blog follows my November 30, 2010 blog, Litigation Risk Management © & Regulatory Compliance – ISO 9001, ISO 13485 & FDA’s QSR. As with that blog the focus is on Litigation Risk Management ©, in particular, product safety and liability exposure in the US legal system resulting from CE Marking products for the EU. I have written several articles and blogs about CE Marking and liability exposure in the US. With several revised Directives, and revised EN standards also becoming EN ISO and EN IEC standards, the legal playing field has shifted.

The 22 EU New Approach Directives were adopted to improve product safety and open market entry in the EU. Except for the Medical Devices Directives that fairly closely mirror FDA’s Quality System Regulation (QSR), we have no governmental regulatory equivalent in the US. Most of our standards are developed by Trade Associations or private groups such as the Society for Automotive Engineering (SAE), Underwriters Lab (UL), Air Transport Association (ATA), American National Standards Institute (ANSI), American Society for Testing and Materials (ASTM) and the American Petroleum Institute (API), to mention a few.

The New Approach

While the American standards efforts are significant and steadily improving, they often are permissive in nature. They do not have the directive force and breadth of the EU new approach standards. In contrast to the old approach standards, which the EU continues to use, the European Commission adopted the “new approach” which sets forth the scope of the directive in a basic framework, outlines the conformity assessment procedures from which a company can choose to demonstrate compliance and lists the Directive’s Essential Safety Requirements with which a company must comply.  In turn, each new approach directive has prompted the writing of EN harmonized safety standards that help companies demonstrate compliance with the directive’s essential safety requirements.

Before it is complete, it is estimated that 10,000 new standards will have been written to address the Essential Safety Requirements. Basically, the Essential Safety Requirements (ESRs) state what must be done and the EN harmonized standards provide the path for demonstrating conformity with the ESRs (how it is to be done). By using the EN harmonized standards the EU will presume conformity to the Directives Essential Safety requirements.

To deal with the thousands of new EN safety standards required to implement these broad new approach directives, the Commission turned the standards writing program over to the European Regional Standards Organizations: CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization). These two organizations represent 29 of the 30 EU and EFTA (European Free Trade Association) nations.  (The only country missing is Liechtenstein.)  To this group have been added two new standards organizations: ETSI (European Telecommunications Standards Institute) and EOTA (European Organization for Technical Approvals).  ETSI deals with telecommunications standards and EOTA deals mainly with construction products.

The final step under the new approach structure is the writing of a Declaration of Conformity and affixing of a CE mark that is a legal requirement for the sale of new approach products in Europe.  CE, the French acronym for Conformité Européenne (European Conformity in English) is the only EU required safety mark that must be affixed for these products to travel freely throughout the EU. While most directives require the existence of a technical file containing the compliance requirements and many require an approved process control quality assurance system such as ISO 9001 or ISO 13485 (if medical) it is the CE mark and Declaration of Conformity that they all share in common.

The European regional standards organizations work with national standards organizations such as BSI (British Standards Institute), DIN in Germany, AFNOR in France as well as Professors from EU Universities, technical representatives from European Companies affected by the standards and in some cases public participation. It is a massive effort and it takes a great deal of time. We simply don’t have an equivalent structure or technical regulatory effort in the US.

Finally, through agreements with the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) in Geneva, most revised EN standards undergo a joint review at the European and International level. Since ANSI participates in the drafting of ISO and IEC standards, the new EN ISO and EN IEC standards also will be US standards. This is a legally significant point.

CE Marking for the Machinery Directive and Product Liability Exposure in the US

As everyone knows who has helped companies prepare the required documentation to CE Mark machines for the EU, except for very few machines, and those 23 dangerous machines identified in Annex IV of the Machinery Directive 2006/42/EC, the remaining machines can be self-certified.

I think it is an outstanding Directive that already has made a significant contribution to machinery safety. Unfortunately, it is also a Directive that can be easily abused by those companies, consultants and consulting organizations that want to cut corners and pay light attention to the Directives’ and required standards.

• The first instance of a US product liability lawsuit stemming from the Machinery Directive in the US was lawsuit in a Minnesota State Court in October 2002 when a worker in a packaging plant had his scull crushed between a moving mechanical arm and a conveyor belt moving below the arm. The 35 year-old worker became blind in one eye, losing sight in his other eye and would need 24 hour care for the rest of his life. The California manufacturer of the machine, the George M. Martin Co. sold the same machine in the EU with a laser light curtain required by the Machinery Directive that would shut the machine off if someone walked into the area of the machinery’s operation. Since a laser light curtain wasn’t required in the US, it wasn’t added. When the jury discovered that the company made a safe machine for the EU, but not for the US it was clear that they knew how to make a safe machine. The judge entered a punitive action judgment for $35,322,626 million dollars, the largest such judgment in the history of the state.  

• A few years after this case I was called by the corporate counsel of a company I had worked with to CE Mark large machines for their oilfield division. They asked me to study the litigation history in another division that manufactured several machines for use in a different industry. While conducting my review I looked at the Technical Files for two machines that they were making for the EU. The files had been examined by a Dutch notified body that sent a team to the US to conduct an expensive “on site” evaluation of their CE Marking activities. I discovered that the notified body had issued two EC Type Examination Certificates for two machines that weren’t listed in Annex IV of the Machinery Directive. The certificates were bogus! After receiving no answer from the Dutch notified body and Dutch national authority (competent body) for six months, I wrote to the European Commissioner responsible for this area and received a response in three weeks stating that I was correct and a cc to the Dutch informing them they could not issue the certificates. Long story short, the Certificates gave the company the impression they had legal documents that could be used in court, if necessary. Unfortunately, several notified bodies have implied an “official stamp of approval” when they are acting as consultants. Each directive specifies what constitutes official notification for that directive and it varies for each directive.

• EU companies that CE mark for the EU but not in the US will be held to the same accountability as US companies for machinery safety. In short, they can’t sell less safe machines in the US than the EU.

• EU Documents such as Technical Files, the content of those Files, including the EN ISO 14121-1:2007 Risk Assessment Standard must be available for legal discovery in a US Court, even if the machine isn’t CE Marked, to make certain that a less safe machine isn’t being sold in the US. I frequently conduct forensic examinations of Technical Files to make certain that what was declared was actually accomplished. This is particularly important when self certification is involved. A forensic engineer also might be involved to check technical compliance.

• Several Directives such as Machinery, Low Voltage, Electromagnetic Compatibility and Medical devices have been revised. On January 1, 2010 the EU is checking that every product entering the EU complies with the new Directives. They also stipulate that the EN standards used to demonstrate conformity with the Directives are up to date. This includes standards used to manufacture component parts from suppliers (see my October 30, 2010, July 31 & August 25, 2010 blogs discussing these topics).

• EN standards are now ISO & IEC and therefore ANSI American standards. Previously, some companies would argue that compliance with EN standards didn’t carry over to the US. This is no longer true. The revised EN standards have been drafted with parallel ISO and IEC standards committees with ANSI participation. Consequently, these ANSI standards are US standards which are recognized by US Courts. The EU Machinery Directive approach to product safety is going to be playing a much role in US product liability litigation in the future.

Conclusion

I could only cover a small portion on the Machinery Directive in this blog. I will devote more attention to the breadth of the revised Directive in future blogs. My focus here has been like the preceding blog posted on November 30, 2010, the requirements of regulatory authorities and the legal implications of compliance. In this case the legal implications of the EU Machinery Directive that could result in a lawsuit in a Federal or State courtroom.

As noted in my previous blog, I have decided to look for professional affiliations with organizations interested in Litigation Risk Management © and improving product safety. This can occur on both sides of a lawsuit. I am looking for US and/or EU affiliations for the future. If anyone is interested, please contact me at jameskolka@gmail.com.

Litigation Risk Management © & Regulatory Compliance – ISO 9001, ISO 13485 & FDA’s QSR

Introduction

After posting ninety-four blogs, I decided to spend a little time on my particular perspective on ISO 9001, ISO 13485 and FDA’s QSR. The second blog in this series will concentrate on CE Marking for Medical Devices, Machinery, related Directives and their legal implications.

To begin, I always use a Litigation Risk Management © focus when dealing with Quality Management System Standards.

When I first learned about the 1^st edition of ISO 9001:1987 in 1990, I thought it provided an excellent platform to reduce liability exposure. At that time a colleague and I both said, “The good news about ISO 9001 is that you now have a paper trail in the event of a lawsuit and the bad new is, you now have a paper trail in the event of a lawsuit.” If the documentation proves that product safety was a concern, it can be demonstrated by the paper trail but if the documentation is weak and makes little mention or no mention of product safety, it can be used to demonstrate that product safety was not a significant concern.

In truth, however, consultants at that time had (and today have) no interest in product safety and the legal implications of ISO 9001 certification. Quality managers do not accept product liability exposure as their legitimate responsibility. If anything, the thought that lawyers might become involved with ISO 9001 seemed unfair to them. Their interest was confined to obtain certification for their company, or if consultants, for their clients. Any suggestion that companies also should consult the Guidance Standard ISO 9004:1987 was rejected out of hand because it wasn’t required for certification.

The original ISO 9004:1987 Guidance Standard had a short section that addressed Product Liability which was promptly removed by the drafters of ISO 9004:1994. The drafters and their constituency wanted nothing in print that might hint at legal liability in ISO 9004:1994. Of course ISO 9001:2000 and ISO 9004:2000 retreated further from any hint of legal implications. The fact that I or anyone else would suggest that ISO 9001 & ISO 9004 might be important in a lawsuit was never given consideration by consultants. They didn’t want to ruin a good thing!

Product Safety

To attorneys, the idea that any human activity such as an ISO 9001:1987 Quality Management System (QMS) or ISO 9004:1987 Guidance Document should somehow be exempt from the law or potential litigation is absurd. Human activity and the law have been intertwined since recorded human civilization first emerged in ancient Mesopotamia 5000 years ago, probably earlier.

When I first encountered ISO 9001 & ISO 9004, I thought the combination would make an excellent platform to increase product safety and reduce liability exposure, so I drafted a Product Liability Control (PLC) System © following each clause in ISO 9001 with my own Liability/Safety (PLC)© clause. Because ISO 9001:1987 was especially weak when it came to product safety, my system emphasized product safety as key to reducing liability exposure. I also developed a Product Liability Audit Program © and Product Safety Audit Program © and an associated Product Liability Training Program © and Product Safety Training Program ©. 

Unfortunately, the subsequent versions of the ISO 9000 standards, ISO 9001:1994, ISO 9001:2000 and ISO 9001:2008 have continued to ignore product safety and product liability as a critical issue and continue to ignore ISO 9004 as a meaningful Guidance Standard to be used to improve certification.

Where Are We Now?

The illusion persists that ISO 9001 Quality Management Systems have not been involved in litigation in the US. Further, quality publications avoid the topic fearing it will turn off readers and potentially damage the QMS enterprise. It reminds me of Ibsen’s play, The Wild Duck where Doctor Ekdal finds that the water supply of a small town dependant on tourism is contaminated and wants to impose a quarantine until the problem is resolved. The community fearing economic hardship, of course, wants the Doctor to say nothing. The same is true with ISO 9001 – consultants say nothing about potential lawsuits.

Quality Management Systems & The Emperor’s New Clothes

The fact is that ISO 9001 and other Quality Management Systems such as FDA’s QSR have been involved in litigation involving millions of dollars. Most of these lawsuits and legal actions have been settled out of court leaving no court record. Consequently, the illusion continues to persist that Quality Management Systems do not have to worry about legal actions and protect themselves with preventive law and product liability audits.

• Defense Industry – In my March 09, 2009 blog, I discussed US Defense Department litigation concerning four defense contractors and ISO 9001. Between 2006 & 2008 Defense Contractors paid over $100 million dollars in penalties to the US Department of Defense for ISO 9001 Quality Management Systems that were broken and delivered shoddy merchandise. In some cases, merchandise such as bullet proof vests that had failed to protect military and police personnel, resulting in serious injuries and death. Defense cases involving ISO 9001 continue to be filed by the US Department of Justice.

• Civil Lawsuits Involving ISO 9001 – One of the first large product liability cases involving ISO 9001 was a class action lawsuit Case IH Cotton Picker Fire Products Liability Litigation filed in the US District Court for the Eastern District of Arkansas. The case involved 140 fires between 1994 and 1997 involving cotton pickers valued between $90,000 and $200,000. Plaintiffs requested ISO 9001 documentation stating, “The number of fires alone caused alarm and concern. However, the problem is magnified by the fact that these losses were preventable and that Defendant is doing nothing to correct and prevent the losses as required by its’ own ISO 9001 program.” The case was significant because it addressed several issues concerning ISO 9001 documents and records. The case was settled out of court for an amount reported by the Wall Street Journal to be in the mid 8 figures (approximately $50 million dollars). (You can find a more extensive discussion of the case in my March 23 & 30, 2009 blogs.)

• My Work With ISO 9001 Lawsuits – In the past six years, I have served as the ISO 9001 legal expert in four lawsuits involving ISO 9001. As with the Cotton Picker case, ISO 9001 was key to litigation in these cases. The Quality Management System Manual, Procedures, Documents and Records have been central in these cases. The requested documents and records have been key to claims by plaintiffs, but often not understood by defense counsel. In one case the provisions concerning contracts and design were pursued with corporate executives in depositions, where allegations of breach of contract and failure to follow design procedures were central. All of these cases were settled out of court and involved millions of dollars.

• FDA’s Quality System Regulation (QSR) – The biggest fine levied by FDA for failure to comply with the QSR was a $100 million dollar consent decree with Abbott Laboratories in November 3, 1999. Following that decree several lawsuits were filed by plaintiffs’ attorneys alleging damage to plaintiffs from in vitro diagnostic tests falsely diagnosing diseases that resulted in unnecessary expensive medical treatments. The following year FDA levied a $60 million dollar fine and obtained a guilty plea to federal criminal charges by Johnson & Johnson’s Lifescan Division for defective glucose monitors.

• Medical Device Insurance Company’s Litigation Study – I have discussed this twelve-year litigation study in several blogs. Perhaps the biggest surprise was the increased sophistication of plaintiffs’ attorneys in using FDA’s QSR, ISO 13485 and ISO 9001to demonstrate the failure of medical device companies to focus on patient safety and product safety. In addition, FDA has issued an increasing number of 483 Warning Letters citing failures of companies to comply with FDA’s QSR resulting in adulterated devices, followed shortly by product liability lawsuits. Almost all of these cases were settled out-of-court resulting in millions of dollars in damages. (It should be noted that these are the findings from only one insurance company.)

Conclusion

While it isn’t possible to give a complete tally in damages and losses from ISO 9001, ISO 13485 and FDA’s QSR quality management system breakdowns, a low estimate would be $500 million dollars and it is probably double that amount. A few observations are in order from the Medical Device Insurance Company Litigation Study:

• QSR Certification and Compliance do not address legal issues and Litigation Risk Management ©.
• QSR Document Control does not address legal issues, liability exposure and Litigation Risk Management ©. It isn’t just the existence of documents, but how they are written, what is said and their legal implications.
• QSR Design Control does not address Litigation Risk Management © including Product Safety and Product Liability Exposure.
• Regulatory Managers and Quality Managers are not trained in QSR Litigation Risk Management © and Liability Exposure.
• Top management generally does not understand the difference between QSR Compliance and Litigation Risk Management © and Liability Exposure.
• Corporate counsel and defense counsel generally do not understand the legal responsibilities of top management, QSR Litigation Risk Management © and Liability Exposure.

I have decided to look for professional affiliations with organizations interested in Litigation Risk Management © and working with companies to improve product safety and reduce litigation risk exposure. After working on projects involving Enterprise Risk Management for European Companies, I have concluded that Litigation Risk Management © and Product Safety appear to be of greater interest in the EU than the US. However, I am looking for US and/or EU affiliations for the future. If any one is interested in discussing the development of a Litigation Risk Management © Program, please contact me at jameskolka@gmail.com.

FDA’s 510(k), Adverse Events And Product Liability Lawsuits

Introduction

 Recently, I received an inquiry from a reader of one of my blogs:

Good evening.  I came upon an article from you while doing some research this evening.  I have a product liability question. It pertains to what would happen if a manufacturer is marketing and selling a product for which it has not received the necessary 510k clearance from the FDA and an adverse event occurs on a patient.  Who would be responsible if the hospital and surgeon were knowingly using a product that did not have a 510k from the FDA.  The product in question is a Class II invasive device?

Good question. The answer is quite simple. A trial attorney will include everyone in a product liability lawsuit, the surgeon, the hospital and the company that placed the medical device on the market without obtaining FDA clearance. The trial attorney’s objective is to pursue all possible persons involved (including their insurance companies) and make certain to reach the deepest pockets to pay for the physical and emotional damage to the patient as well as seek punitive damages. It is this type of careless behavior that often results in a financial loss that bankrupts a medical device company. It is also is extremely foolish, because it is so unavoidable.

Never place a medical device in the market that requires 510(k) clearance without first obtaining FDA clearance.

 

Medical Device Insurance Company Litigation Analysis

 In several of my earlier blogs, I referenced the private findings of a medical device insurance company after reviewing its twelve-year litigation history. Over 95% of these lawsuits resulted in out-of-court settlements. My colleague (who conducted the study for the insurance company) and I have been reviewing the findings and have made the following observations about medical device lawsuits:

• The findings revealed that researchers often did not reveal to patients that the device had not received FDA clearance at this stage in the device’s manufacture, thereby opening the door to product liability lawsuits.

• During the early development of a medical device, e.g. obtaining 510(k) clearance from FDA, it is critical for device firms to be in compliance with FDA regulations. Product liability claims during this time will use any negative regulatory information to prove their case.

• The lack of a product safety policy statement or reference to patient safety and product safety in a company’s quality management system statements often led company management to mistakenly believe that they would not be accused of indifference to safety in a product liability lawsuit.

• The lack of documented methods, processes or procedures for communicating product safety concerns and/or including these methods in the company’s business processes demonstrating the company’s commitment to product safety, has resulted in companies losing product liability lawsuits.                                     

• Several product liability claims that were taken to jury trials have used companies Quality Management Systems and Quality Manuals against manufacturers. Trial attorneys often noted that company’s own quality processes were not followed or audited.

• Often company managers were unaware of FDA Regulations or EU Medical Device Directives requirements for notification to the appropriate regulatory bodies and unaware of the attention regulators would place on these requirements.

• Attorneys have discovered that no documented methods, processes or procedures for communicating product safety concerns and/or including these methods in a company’s businesses process resulted in demonstrating the lack of a company’s commitment to product safety.

• Often companies lacked a Standard Operating Procedure (SOP) for obtaining 510(k) clearance from FDA when needed.

• The insurance company litigation study also found that philosophical conflicts often occurred in new management teams seeking 510(k) clearance wanting to fight FDA and their “observations” or “483 warning letters”, rather than mutually cooperate and resolve an implementation plan for integrating the observations into their manufacturing processes.

• Attorneys discovered that researchers and physicians who participated in implanting unauthorized devices that had not received 510(k) clearance assumed incorrectly that they were protected from liability exposure by the company that provided the medical device.

• Finally, as noted in a New York Times article on November 15, 2010, "Putting Money on Lawsuits, Investors Share in the Payouts", investment groups are backing product liability lawsuits including medical malpractice and device failure lawsuits. Consequently, there is more than enough money from investment groups to pursue device companies if a device that did not obtain FDA 510(k) clearance caused significant harm to the patient. Clearly, 510(k) compliance is more critical than ever.

Summary

It was clear from the medical device insurance company study, that many medical device “start ups” did not pay sufficient attention to FDA’s Quality System Regulation (QSR) resulting in FDA 483 Warning Letters followed by product liability lawsuits. The 510(k) submissions should have been incorporated into 21 CFR 820.30 Design Control as a beginning exercise in quality systems compliance. Unlike a CE Marking Quality Management System (QMS) such as ISO 13485: 2003 where a third party (notified body) will conduct a certification audit followed by surveillance audits, FDA will first view your compliance with their FDA Quality System Regulation when they visit your manufacturing facility. There is no practice audit or 3^rd party audit to use as a baseline for improvement, unless your company also complies with ISO 13485 or ISO 9001. Consequently, it will be necessary to be especially diligent in creating a QMS that will comply with FDA’s QSR.

My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a Federal or State courtroom. I also focus on product safety and the steps necessary to create a safe product. In my next blog, I will spend some time further delineating this approach. If you have questions concerning medical device lawsuits, you can contact me for a free preliminary consultation at my new e-mail address jameskolka@gmail.com.

 

ISO 9001& ISO 9004: A Framework for Disaster Preparedness Revisited – Risk, What Risk? Catastrophe in the Gulf #5

Introduction

This is the fifth and last in this series of blogs on ISO 9001 & ISO 9004: A Framework for Disaster Preparedness Revisited. (The preceding blogs were posted on December 29, 2009, & January 4, January 14 & February 12, 2010.) For those familiar with the first two blogs, you will recall that they briefly recapped a two-part article that appeared in the February 2002 issue of Quality Progress in response to a request from the editors for an article that applied ISO 9001 & ISO 9004 to the events of September 11, 2001.

The 3^rd blog described in brief outline a comprehensive Disaster Recovery and Service Continuity Plan for a major metropolitan area in the Northeast to identify the potential risks that could affect the provision of health care facilities. It involved the identification and analysis of risks and the preparation of a plan to respond to emergencies and the preservation of health care resources. The 4^th blog focused on the Political, Ideological and Geographic Problems with Disaster Planning. Since these four blogs were published, the Deepwater Horizon Oil Spill occurred. It is not my purpose to rehash the spill, but instead concentrate on the risk management decisions/non-decisions and regulatory weakness in response to the spill. 

Regulatory Oversight

At the time of the Deepwater Horizon explosion and spill US regulatory oversight was the responsibility of Minerals Management Service an agency of the U.S. Department of the Interior. In addition to leasing federal lands to oil and natural gas, the Minerals Management Service (MMS) collected leasing revenue, one of the largest revenue sources for the federal government after the IRS. Unfortunately, rigorous regulatory oversight was not the mission given to MMS in the first decade of the 21^st Century, nor for that matter, was rigorous collection of revenues owed to the federal government.

Consequently, MMS never appeared to receive a petition to drill that it didn’t like and it certainly didn’t request anything resembling a Disaster Preparedness Plan (if it ever conceived of such an eventuality) if anything went wrong while drilling. Questions were never asked about the potential risks of deep water drilling at different depths and what contingency plans a company and its contractors might have created to contain a deep water disaster should one occur. Questions were never asked about potential environmental risks and company financial liabilities for such a disaster. Questions appeared to never have been raised about the responsibility of MMS to the federal government, the American public and more specifically to the agency’s role to safeguard the environmental integrity of the delicate ecosystem in the Gulf of Mexico for the people who lived on the Gulf.

To say that MMS planning was sloppy is much too kind, it appears that no meaningful planning existed that even contemplated a disaster, since only minor disasters had occurred in the American portion of the Gulf. An earlier disaster had occurred in the Mexican portion of the Gulf, but that was never factored into agency thinking. Also, bigger disasters had occurred in Nigeria that still soak marshes in oil today, as well as drill site oil leaks in other parts of the world. A genuine “What me worry?” still attitude prevailed.

The concept of requiring a Hazards Analysis and Risk Analysis before drilling, (requirements for manufacturing medical devices and machinery for CE Marking), appears never to have entered the consciousness of the agency. Their managerial prowess was more akin to an adult Lemonade Stand instead of an agency responsible for serious oversight of drilling for oil in the Gulf and collecting revenue for the United States (which they did badly falling billions of dollars short).

Company Oversight

Company oversight was terrible as well. Four approaches to risk management should have been taken:

Disaster Preparedness – Given the depth at which BP was drilling in the Gulf of Mexico and the potential ecological and human consequences that could occur, this should have been a first step. In particular questions should have been asked, if an accident occurred (e.g., explosion, leak, break in the pipe, etc.) what could be the potential extent of the disaster (e.g., the well, the workers, the ecosystem and the affected population)? What must we (the company) do to control and limit the damage to the affected populations? How would the damage be limited? Do we have a strategy and the technological know how to accomplish this? What will be the cost? If we don’t have the technological know how, should we wait until we are able to drill a well at this depth? None of these questions were systematically asked by MMS or BP.

Enterprise Risk Management – Given the Global risks undertaken by BP, it should have employed the strategy taken by several other European Corporations and hired an outside firm to help conduct an assessment of corporate risks (e.g., physical, financial, geographic, political, ecological) faced by the corporation in its various global operations. Eventually, the risks would be refined and passed on to BP management, the CEO and members of the Board to consider. Such a list should be bold in concept to assure that risks aren’t ignored because they might disturb the sensibilities of key managers and Board members. Eventually, the list is prioritized and becomes the basis for future planning. Unfortunately, the only risks that seemed to occupy the company at the time were financial risks, i.e., how to reduce the cost of drilling and cut corners, which some commentators suggested helped precipitate the disaster. The objective is protect the future of the company

Hazards Analysis/Risk Analysis – This should have been a first step with any project that presented a degree of risk and it should have been revisited at key stages to make certain that all hazards and risks were visited and revisited to assess all of the possible risks presented by deep water drilling. It is an essential FDA & EU requirement for manufacturing any medical device and an essential requirement for manufacturing any product that is going to be CE Marked. It also is an essential requirement for equipment for NASA, but does not appear to been given a concern by BP. A program entitled Drill was aired by Frontline on PBS on October 26, 2010 reviewing the history of BP in the Texas City Refinery explosion, the largest pipeline spill on the North Slope of Alaska, the sinking of BP’s Thunder Horse oil platform in the Gulf of Mexico and finally the Deep Water Horizon explosion and leak in the Gulf of Mexico. Instead of assessing risk and taking steps to reduce the risks, the program, commentators safety specialists, investigators and other oil company CEO’s testifying before congress suggested that BP took unnecessary risks.

 Crisis Management – Crisis management appears to be the one area that received attention. It is the plan of action to limit the damage from adverse publicity when an event happens that could adversely affect the company. For example, in the case of Pepsi-Cola several years ago when syringes were reported to be in cans of Pepsi, it was necessary to dispel the rumors and control the damage. In the case of BP in the Deep Water Horizon the desire to deal with adverse publicity or “control the spin” was true.

Risk Management and Disaster Preparedness

The zeal to pursue offshore drilling of oil and natural gas on federal land in the Gulf of Mexico or anywhere else whatever the risks (“drill baby drill”) and the contempt of politicians for federal regulation in the first decade of the 21^st Century foredoomed the creation of a federal agency with any meaningful responsibility or clout. Following the Deep Water Horizon Disaster, MMS has been reformed into two major programs, Offshore Energy and Minerals Management and Minerals Revenue Management. Both are under the US Department of Interior. Deep water drilling and revenue are now tightly regulated. It remains to be seen how effective the new regulatory powers are exercised.

It will take years to learn the extent of damage to the Gulf’s sensitive ecosystem. It is not as horrible as Chernobyl, but it isn’t slight. Hopefully, future drilling will be more responsible. Only time will tell.

The cove pictured above in the photograph is virtually identical to the same cove captured by Salvador Dali in two of early his paintings in 1920 and 1921. The cove is on Cap de Creus near the resort town of Cadequés on Spain’s Costa Brava. Dali’s home and studio are located nearby and can be visited today. Fortunately, no mineral deposits or oil are found nearby to lure companies and destroy the beauty of the area.

If you would like to talk about comprehensive strategies concerning Disaster Preparedness, Enterprise Risk Management, Hazards Analysis/Risk Analysis or Crisis Management for a free preliminary consultation at my new e-mail address jameskolka@gmail.com.  

FDA’s QSR & EU’s CE Marking Requirements – A Medical Device Regulatory Design Failure

Introduction  

On the front page of the August 20, 2010 issue of the New York Times an article caught my attention, U.S. Inaction Lets Look-Alike Tubes Kill Patients. The article describes a pregnant mother who was losing weight and was hospitalized so that she could be fed through a tube until the birth of her daughter.  

But in a mistake that stemmed from years of lax federal oversight of medical devices, the hospital mixed up the tubes. Instead of snaking a tube through Ms. Rogers nose and into her stomach, the nurse instead coupled the liquid-food bag to a tube that entered a vein. Putting such food directly into the bloodstream is like poring concrete down a drain. Ms. Rogers was soon in agony.  

The baby died and soon after Ms. Rogers died. As noted in the article, Hospitalized patients often have an array of clear plastic tubing sticking out of their bodies to deliver or extract medicine, nutrition, fluids, gases or blood to veins, arteries, stomachs, skin, lungs or bladders. Much of the tubing is interchangeable, and with nurses connecting and disconnecting dozens each day, mix-ups happen – sometimes with deadly consequences.  

Possible Resolution

Presently, an International Standards Body is seeking consensus on specific designs for tubes for different bodily functions, but the work is not complete and apparently its formal recommendations will take years more. Efforts have been made by medical device manufacturers of dialysis machines to establish more effective controls, but a uniform system has not been adopted by FDA.  

Dr. Robert Smith, an FDA device reviewer who left the agency on July 31 and was among nine agency employees who in 2009 decried the agency’s device approval process as illegal and dangerous, said that the tubing problem, which had gone on for decades, was another example of how the agency failed to protect the public. “FDA could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die”. Dr. Smith said.  

Regulatory Requirements

FDA QSR Design Requirements  

FDA design requirements place responsibility on medical device manufacturers:  

§820.30 Design controls

(a) General  

(1) Each manufacturer of any class III or class II device and the class I devices listed in paragraph (a)(2) of this section shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.  

(b) Design and development planning. Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.  

(c) Design input. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to the device are appropriate and address the intended use of the device including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

To the QSR language could be added the FDA Guidance Document, Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, July 18, 2000.  

1.0 Introduction  

Addressing use-related hazards should be undertaken within the context of a thorough understanding of how a device will be used. Essential components of this understanding include:   ·      Device users, (e.g., patient, family member, physician, nurse, professional caregiver) ·      Typical and atypical use, ·      Device characteristics, ·      Characteristics of the environments in which the device will be used, and ·      The interaction between users, devices, and use environments.  

This, of course, is eminently sane advice. Unfortunately, it can’t be followed by the medical device industry until FDA, the EU and their international counterparts agree on a standard for tubing. Meanwhile, patients will suffer and many will die until the impasse is resolved.  

EU’s CE Marking Medical Device Design Requirements  

The EU medical device design requirements are a bit different. While ISO 13485: 2003 Medical devices – Quality management systems – Requirements for Regulatory purposes is similar to FDA’s Quality System Regulation, the EU also contains medical device requirements in the body of the revised Medical Devices Directive 2007/47/EC and Annex I Essential Requirements that would apply to the issue of medical device tubing. The question of tubing would be raised, but again could not be addressed because of the impasse in the International Regulatory Body.  

Risk Management  

Finally, questions would be raised about the tubing by ISO 14971: 2007 Medical devices – Application of risk management to medical devices. In Annex C, Questions that can be used to identify medical device characteristics that could impact on safety several questions are raised that would impact medical device tubing. The following questions are illustrative:  

C.2.26 Does installation or use of the medical device require special training or special skills?

Factors that should be considered include the novelty of the medical device and the likely skill and training of the person installing the device.  

C.2.29 Is successful application of the medical device critically dependent on human factors such as user interface?  

C.2.29.1 Can the user interface design features contribute to use error?  

Factors that should be considered are user interface design features that can contribute to use error. Examples of interface design features include: control and indicators, symbols used, ergonomic features, physical design and layout, hierarchy of operation, menus for software driven devices, visibility of warnings, audibility of alarms, standardization of color coding.  

Summary  

The answers to these questions are easy and low tech. The tubes all look alike, but carry different media, e.g., nutrition, blood, oxygen, dialysis fluid, air to inflate blood-pressure cuffs, anesthesia, intravenous medicines, etc. The New York Times article cited an example where a nurse mistakenly put a spinal anesthetic into a vein, killing a 16-yeqr old mother giving birth. The nurse had worked two eight-hour shifts the day before.   Clearly, skill and training are necessary, but skill and training can be compromised by fatigue, the complex array of tubes attached to each patient and the ability of the nurse or nurse practitioner to differentiate between the tubes when dealing with several different patients. I can only imagine what happens in a developing country or disaster relief field hospital with less trained personnel and a chaotic environment. It can only exacerbate the maze of look-alike tubing.

It is grimly ironic to read the statistic of 100,000 deaths per year due to medical errors and realize that several error deaths are due to a regulatory inability to agree on an International Standard for medical device tubing. If you have any questions about, FDA’s QSR, the EU CE Marking Medical Devices Directives, ISO 14971: Risk Management or Human Factors Analysis concerning medical devices, you can contact me for a free preliminary consultation at theguide1@comcast.net.      

Brussels You Have a Problem! – Out Of Date CE Marked Components & EC Declarations Of Conformity – Machinery #2

Introduction  

The first blog of this title identified the problem of out of date CE Marked Components and EC Declarations of Conformity, EC Declarations of Incorporation and EN Standards. Presumably, 1 January 2010 marked the date when CE Marked products must contain the latest revised EU Directives and latest EN harmonized standards. It is now six months later. As noted in my first blog on this topic, I discovered that component suppliers to my customers have been lax on this account. Not only have they not updated their EC Declarations of Conformity, EC Declarations of Incorporation and EN harmonized standards, in far too many cases they are out of synch by several years. This is a technical problem and potentially serious legal problem for component suppliers and their customers in both the EU and US. It also is extremely lazy and sloppy.  

Machinery Directive Market Surveillance  

I concluded the first blog in this set with a brief reference to provisions that were inserted into the Machinery Directive to improve market surveillance when the Directive was adopted in 2006. Below you will find those three provisions from the prior blog followed by several other provisions set forth in the revised Machinery Directive which are now supposed to be in force:  

·      Monitor conformity of machines with the relevant Directives  

·      Empower authorities to take action with necessary speed to remove machines from the EU market  

·      Fix rules concerning legal sanctions for non-compliance  

·      Organize surveillance activities to cover all stages of a machine lifecycle (placing on the market, use, withdrawal including recovery, recycling and destruction)  

·      Record and ensure the follow-up of complaints or reports concerning non-compliant machines  

·      Monitor accidents and damage to health concerning machines on the market  

·      Implement market surveillance programs for categories of machines and categories of risk  

·      Carry out checks of conformity of machines on the market  

·      Require the necessary documents and information for machines on the market

·      Where relevant, sample machines and subject them to the necessary inspections and tests  

·      Initiate the relevant infringement procedures for non-compliant machines  

·      Ensure that machines comply with the essential requirements of the relevant Directives  

·      Exchange market surveillance information with member states  

·      Develop joint member state projects for market surveillance  

·      Survey machines on the market to assure that CE marking and documentation requirements have been met and that machines have been designed and manufactured in accordance with the essential requirements of the relevant directives and don’t present any danger to personnel  

·      Create rapid and confidential exchange of information where machines could present a serious and immediate risk to the public interest  

·      Increase involvement of the machine manufacturer in the procedure  

·      Check for documents (essential requirements checklists, technical data, EN harmonized standards, risk analyses, notes, certificates of conformity, etc.)  

·      Physically examine machines, check on the presence of CE marking, other markings and possible regulatory labels  

·      Physically check on the name and address of the manufacturer and/or the person responsible for placing the machine on the market (authorized representative)  

·      Physically check for undue or incorrect CE marking or other regulatory marking

·      Where necessary, conduct laboratory tests to determine the conformity of the machine with the essential requirements of the relevant Directives  

·      Use robust practices to detect serious cases of non-conformity and the probability of risk  

·      Ensure effective communication and coordination between market surveillance activities and other organizations that intervene in the field of safety of machines (health and safety at work authorities and customs authorities)  

·      Provide for the rapid exchange of consumer machine information   ·      Implement EU Regulation 339/93 on the conformity of machines imported from third countries (now replaced by Regulation 765/2008)  

·      Take account of data concerning industrial accidents involving machines  

·      Link with the EU General Product Safety Directive  

·      Develop member state legal sanctions for non-compliant machines  

·      Improve administrative cooperation between EU member states for non-compliant machines  

·      Strengthen rules for worker safety and worker reporting on machines improperly CE marked  

Summary  

These are excellent steps and can’t be put in place soon enough. For those of us who take machinery safety seriously, enforcement of the rules would help us convince our clients in the US and other third countries that the EU is serious about machinery safety. Given the number of fly-by-night & bait-and-switch consultants filling the web pages with easy CE assurances and simple templates telling manufacturers that it won’t cost anything to CE Mark their products, serious enforcement can’t come fast enough.

The EU is unique in their systematic approach to product safety, and machinery safety in particular. Except for those products and machines covered by FDA, we have no comparable regulatory approach in the US. I would like to believe that US manufacturers share the EU belief in machinery safety (and some do share that belief), but I know better from personal experience.

Many clients have complained that safety increases the price of machines and makes them less competitive in the US market. I remind them of the 2002 Minnesota lawsuit where a US machinery manufacturer made a safe machine for the EU to satisfy CE Marking standards and a less safe machine for the US and paid the price in a $35 million punitive damages award to the plaintiff in a product liability lawsuit. Unfortunately, this fact doesn’t impress companies willing to take a risk, even if it harms people. Their question is, can I come up with an alternative?

I would love to work with the EU in improving their market surveillance and the hope for residual carryover to the US. As the world no doubt knows by now, antipathy to regulation runs high in the US (witness the US Materials Management Service paper mâché regulation of offshore drilling). Apparently, only catastrophe changes minds. If you have any questions concerning compliance and product liability vis-à-vis the revised Machinery Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net.

Medical Device Manufacturers – Product Liability Exposure & Product Liability Audits #3

Recap of the Two Previous Blogs  

Everybody loves a “one size fits all template;” it simplifies everything. It reminds me of the Greek myth about Theseus who traveled the road to Athens and encountered the bandit, Procrustes, the Stretcher, who had a bed which he offered to passers-by. He made his guests fit into the bed, either by stretching them to fit it or cutting off the feet of those who were too long. Fortunately, Theseus dispatched Procrustes and destroyed his bed.  

As you might gather, that is what I think of most templates designed to fit everyone; they are a cheap and simple approach sold by vendors and they don’t begin to address the complexity of issues that must be addressed by the buyer of the template. It’s bit of modern day “snake oil.”  

Blog 1# focused on FDA’s scrutiny of their Quality System Regulation. An increasing number of FDA 483 Warning Letters have emphasized the failure of medical device companies to abide by their quality system requirements. As noted, these letters are public via the Freedom of Information Act (FOIA) and used by plaintiffs’ attorneys as a platform for initiating product liability lawsuits. 

Blog 2# focused the litigation history of a medical device insurance company. Since over 90% of their product liability lawsuits were settled out of court, little was known about the nature of their product liability litigation. As noted in other blogs, increasingly plaintiffs’ attorneys have focused on the failure of medical device manufacturers to satisfy FDA QSR and ISO 13485 quality system requirements. The insurance company study also noted that medical device manufacturers did not examine their systems for product liability exposure. Instead, they assumed that their regulatory and quality personnel addressed these issues, which they didn’t. Basically, they possess neither the training nor the legal expertise to conduct such an examination.      

What also isn’t evident from recent product liability lawsuits is the financial magnitude of quality system product liability FDA sanctions and product liability losses. Two cases alone resulted in $160 million dollars in FDA fines and it is reasonable to assume that the real amount now exceeds $200 million dollars. (We already know that in non-medical device litigation that military contractors have paid in excess of $100 million dollars in sanctions for failed ISO 9001 Quality Management Systems.) Suffice to say quality management systems such as FDA’s QSR, ISO 13485 & ISO 9001 are fertile grounds for future product liability lawsuits.  

What To Do?  

By now, I am certain that you realize that a “one size fits all template” is not the answer. The approach will have to be diagnostic, sensitive to the medical device being manufactured and focus on the manufacturer’s quality management system, be it FDA’s Quality System Regulation, ISO 13485 or ISO 9001 or a combined effort incorporating more than one system. Critical legal information is contained in the quality manual, procedures, documents and records. Because medical devices are regulated, there are specific regulatory requirements for the manual, procedures, documents and records. In addition, every manufacturer tailors a quality management system to meet their unique needs.  

While corporate counsel and defense attorneys often fear documentation, remember that documentation cuts both ways – it allows a company to demonstrate its efforts to make a     medical device that was designed for patient safety and device safety. Little or no documentation means “if you can’t prove it, it doesn’t exist!” (For a larger review of Product Liability Lawsuits and Document Control read my March 30, 2009 & March 31, 2009 blogs.)  

As noted earlier, documents means all quality system documents, including audit reports, nonconformities, corrective and preventive action (CAPA), design documents, etc. In addition, other documents and communications include traditional memos, e-mail, voicemail, meeting minutes & discussions, human factors studies, hazards analysis/risk analysis, customer complaints, web site advertising and sales claims, etc. Documents be obtained in legal discovery by plaintiff’s request for production of documents. All parties named in a lawsuit will be deposed and answer questions about documents. Anything you say or have written can and will be used against you. Finally, destruction of documents after a lawsuit has been filed is a criminal offense. 

The Quality System Regulation, ISO 13485 and ISO 9001 do not focus on products and the liability exposure presented by those products. The persons who conduct internal and third party audits do not examine liability issues in a company’s Quality Management System. They don’t believe that this is part of their responsibility and they don’t feel competent to make such judgments. Most quality auditors would consider such behavior ”practicing law without a license.” It could expose them to personal liability. The question then is, What to do? First, examine what plaintiffs' attorneys use as their rationale for a lawsuit. 

What is the Basis for a Product Liability Lawsuit?  

Product Liability Lawsuits primarily focus on three areas – Pre-production (Device Design Defects), Production (Manufacturing Defects) and Post-Production/Post Sale Obligations. All three areas touch upon aspects of quality management systems. Pre-production - Design Defects include foreseeable risks that could have been reduced by adoption of a reasonable alternative design and this omission resulted in an unsafe product. Defective design also occurs where non-conformance with state-of-the-art design development or the allegation that alternative technologically feasible and practical designs were not used resulting in an unsafe product.  

Production – Manufacturing defects occur when a product departs from its intended design, is physically flawed, damaged or incorrectly assembled resulting in injury. Post-production/Post Sale Obligations occur when a product is in the marketplace and complaints arise concerning its effects on patients. For example, foreseeable risks in the use of a device could have been reduced by providing reasonable warnings and instructions to patients. The omission of these warnings and instructions renders the devices unsafe.  

Most Product Liability Lawsuits Are Based on Four Questions  

·      Did the manufacturer provide a product that was free of design defects?  

·      Was the product suitable for the use for which it was sold?  

·      Did the manufacturer establish an effective system to monitor and analyze post-sale problems and hazards?  

·      Did the manufacturer follow-up on its knowledge of hazards with appropriate and adequate action?  

Product Liability Audits  

Product Liability audits must examine every aspect of a medical device manufacturing operation with a special emphasis on patient safety and device safety. This includes the design, manufacture, sale and distribution of the device. Every aspect of communication must be examined and, including prompt attention to customer complaints. Further, FDA is placing increased attention on top management’s commitment and knowledge about the device(s) they manufacture and the Quality System Regulation that governs their manufacturing operations.

  The prudent step would be to engage a product liability attorney experienced with Quality management Systems to conduct a Product Liability Audit of a medical device manufacturer and help set up a Product Liability Training Program. If a company is interested in having such an audit conducted and developing a Product Liability Training Program, you can contact me for a free preliminary consultation/discussion at theguide1@comcast.net.    

Medical Device Manufacturers – Product Liability Exposure & Product Liability Audits #2

Product Liability Audits are one way to deal with the issue of product liability exposure. Such audits can also include, “Product Safety Audits”, “Preventive Law Audits” and “Loss Control Audits.” While the terms may vary and the emphases may vary, they share the objective of conducting some sort of in depth audit/review about how companies conduct their business and an attempt to reduce their exposure to product liability lawsuits.  

Concerning Medical Devices, however, the focus must be on the regulatory structure of Quality Management Systems, whether it is FDA’s Quality System Regulation (QSR), the EU’s Medical Devices Directives & ISO 13485: 2003 or Vendor compliance with ISO 9001:2000, now ISO 9001:2008. As mentioned numerous times in my previous blogs and underscored by the Medical Device Insurance Company’s Study of its litigation history (see previous blogs), plaintiffs’ attorneys are learning about the different quality management regulatory systems and successfully winning product liability lawsuits. The reason the outcomes of these lawsuits are unknown is that they are settled out of court.  

Consequently, there is no case law to study and there is an aversion by QMS consultants, trainers and publications to talk about the subject for fear that a discussion about the legal implications ISO 9001, ISO 13485 and FDA’s QSR could incite trial lawyers to use quality management systems for nefarious purposes. While the axiom “ignorance is bliss” may have some useful meaning (although I’m not sure what that could be), avoiding a topic because it might “threaten the QMS consulting, training, publication enterprise” gives new life to the “head in the sand” and “emperor’s new clothes” approach to knowledge about a topic. It is a profound disservice and it also allows consultants, trainers and publications to share their ignorance with their clients. Not very swift! 

FDA’s Quality System Regulation and Medical Devices Lawsuits  

As noted in previous blogs, medical device manufacturers have had serious problems with their Regulatory Quality Management Systems resulting in FDA 483 Warning Letters often followed by product liability lawsuits. In addition, plaintiffs’ attorneys also have successfully used manufacturers’ Quality Management Systems against medical device manufacturers in product liability lawsuits without an FDA 483 Warning Letter. To underscore this point, I am going to list QMS violations from the Medical Device Insurance Company Study that resulted in out of court settlements.  

·      Lawsuits successfully noting the lack of a QMS Quality policy Statement committing a manufacturer to “patient safety & product Safety”  

·      Lawsuits successfully revealing no manufacturer QMS documented methods, processes or procedures for communicating product safety concerns  

·      Lawsuits successfully revealing no concerns in the manufacturer’s QMS business processes demonstrating the company’s commitment to product safety  

·      Lawsuits where Plaintiffs’ attorneys successfully refer to medical device Quality Management Systems as “paper only” systems rather than a demonstrated commitment to patient safety and product safety  

·      Lawsuits where QMS documentation does not address product liability & product safety concerns allowing Plaintiffs’ attorneys to rely on manufacturers poorly conceived and written documents to win their cases  

·      Lawsuits where post-market incidents were not fully investigated and appropriate QMS CAPA actions taken, including design changes, resulting in Plaintiffs’ attorneys citing safety failures to win lawsuits  

·      Lawsuits where key aspects of QMS design control such as “hazards analysis/risk analysis” have been cited by Plaintiffs’ attorneys and ruled by courts to be inadequate for product safety

  ·      Lawsuits where Plaintiffs’ attorneys have successfully won lawsuits by citing manufacturers failure to comply with FDA QSR regulations for contract manufacturing agreements  

·      Lawsuits taken to jury trials successfully used manufacturers QMS, quality manual & quality procedures against the manufacturer because their quality processes were not followed or audited  

·      Lawsuits successfully revealed that “hazards analysis stage gates” in a company’s product development/product review processes often did not demonstrate adequate review of the sciences relating to human factors resulting in an adverse judgment against the manufacturer

  ·      Lawsuits where medical device manufacturers completed exhaustive testing of their device, but the Design History File poorly documented the hazards analysis/risk analysis resulting in adverse judgments  

·      Lawsuits where the hazards analysis/risk analysis did not include appropriate analysis of raw materials for biocompatibility or didn’t conform to a design specification for raw materials or components resulting in an adverse judgments  

·      Lawsuits successfully revealed that the lack of a triggering mechanism to provide an early warning within a manufacturer’s customer compliant handling system didn’t allow early intervention by QA/RA personnel resulting in an adverse judgments  

·      Lawsuits revealed misconceptions by management of biotech firms that compliance with FDA’s QSR or ISO 13485 standards was sufficient to prevent product liability claims  

·      Lawsuits revealed a lack of manufacturer management and staff training in product safety vis-à-vis quality management systems and the documentation of such training  

·      Lawsuits revealed that post-production complaint data often was poorly managed and not escalated to senior management and/or ignored by senior management  

·      Lawsuits revealed that post-production corrective & preventive actions were deemed to be inadequate based on the degree of risk presented in individual complaint investigations or in compiled complaint data  

·      Lawsuits revealed when the adequacy of warnings and user instructions were questioned, manufacturers had no method to counter the questions, because warnings, labels and instructions were not tested by a hazards analysis/risk analysis to demonstrate their appropriateness and adequacy  

Summary  

The list goes on, the monetary damages accumulate and the new insurance policies increase the premiums and the deductible (I mentioned in an earlier blog that I worked with a company where the insurance company increased their deductible to $2 million per lawsuit before the insurance company would pay for their next legal defense).   For medical device manufacturers several things must occur for a successful product liability audit:

·      The audit must focus on the product liability exposure created by a Medical Device Quality Management System, if not conducted by an attorney who is familiar with such systems, it should be critiqued by a product liability attorney, further the attorney should be familiar with the different QMS systems – FDA’s QSR, ISO 13485: 2003 & ISO 9001:2000 & ISO 9001:2008, including relevant EN harmonized standards such as ISO 14971: 2007  

·      The audit must focus on the primary causes of action against medical device manufacturers in product liability lawsuits, such as Design Defects (QMS requirements, foreseeable use, foreseeable misuse, failure to warn, incorrect labeling, inadequate hazards analysis/risk analysis, etc.); Manufacturing Defects (QMS requirements, process risk analysis, incoming raw materials and component parts inspection, finished device acceptance, verification, validation, processing controls, non conforming product, corrective & preventive action, handling, storage, packaging and distribution); Post-sale Obligations (QMS requirements, complaints, complaint handling, corrective & preventive action, device recalls & quarantine, design review, etc.)  

There are several additional issues to consider such as the product liability implications of FDA’s QSR, ISO 13485 & ISO 9001 documents, records and procedures which I will look at in my next blog. In addition, it is necessary to look at FDA Guidance Documents including Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk management, Design Control, Medical Device Quality System Manual: A Small Entity Compliance Guide, etc. and a full review of FDA’s Guide To Inspections Of Quality Systems (QSIT).  

All of these issues, however, must be looked at from both a Quality Management System perspective and a Product Liability Exposure perspective. While complementary, they are different. As noted several times plaintiffs' attorneys are rapidly learning about the legal implications of Quality Management Systems (they are not fully experienced yet), however, defense attorneys and corporate counsel have a very long way to go.  If you have product liability concerns regarding the US medical devices market, you can contact me for a free preliminary consultation at theguide1@comcast.net.  

Medical Device Manufacturers – Product Liability Exposure & Product Liability Audits #1

The Medical Device Insurance Company Litigation Study discussed in the previous two blogs frequently noted that there was an assumption by medical device manufacturers that compliance with FDA’s Quality System Regulation, ISO 13485 and/or ISO 9001 would be a sufficient defense in a product liability lawsuit. The insurance company litigators were especially surprised at the naïveté of management making this assumption. Further, the study found that medical device managers often assumed that their documents and records would answer any questions that might arise in the event of a lawsuit, a misguided assumption.  

The study found that very few medical device manufacturers looked at their Quality Management Systems from the perspective of product liability exposure – this included Top Management, Corporate Counsel, Quality Managers and Regulatory Affairs Managers. Further, no one thought to consult Defense Attorneys or Product Liability Attorneys about the company’s product liability exposure. The study noted that most medical device manufacturers have neither the personnel nor the expertise to conduct product liability or product safety audits. Consequently, medical device manufactures continue to be surprised when they receive a legal summons for a product liability lawsuit. The next blog will examine product liability audits. For the present, however, I want to look at the issue of product liability exposure.  

FDA Warning Letters  

I have discussed the issue of FDA Warning letters in previous blogs, in particular my July 24, 2009 blog, Lawsuits Involving ISO 9001: Hiding in Plain Sight. Just as Tigers and Lions wait for their prey to come and drink water, Plaintiffs’ attorneys read FDA 483 Warning Letters as a sign of potential medical device problems, knowing that they can use the FDA legal rationale to provide support for a product liability lawsuit. I have listed a three recent warning letters below to underscore this point. The focus here is failure to comply with FDA’s Quality System Regulation (QSR).  

Weartech International Inc., Santa Fe Springs, CA – September 29, 2009  

Weartech “manufactures dental alloy products.” An FDA inspection cited the following QSR failures:  

·      Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met as required by 21 CFR 820.30(a). For example, there are no design control procedures for the dental alloy products.  

·      Failure to establish and maintain a design history file (DHF) for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part, as required by 21 CFR 820.30(i). For example, there is no design history file for the Dentaflex and Dentalbond dental alloys.  

·      Failure to adequately ensure that when the results of a process can not be fully verified by subsequent inspection and test that the process be validated with a high degree of assurance and approved according to established procedures, as required in 21 CFR 820.75(a). For example, the following processes do not have established procedures for validation activities and results, nor documented validations: (a) Cleaning and polishing of the dental alloys; (b) cutting the dental alloys; and, (c) the mold process for the dentist.  

·      Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, the corrective and preventive actions procedures are inadequate in that they do not require the verification of corrective and preventive actions.  

·      Failure to adequately establish and maintain records of acceptable suppliers, contractors, and consultants, as required by 21 CFR 820.25(a)(3). For example, the vendors of the coolant, soap and ceramic used for manufacturing the dental alloys are not listed in the firms approved vendor list.  

Listed above are 5 of 15 failures cited in Weartech’s September 29, 2009 FDA 483 Warning Letter. Contemplate for a moment what a plaintiff’s attorney might do with this information. Dental alloys have been in the news following the discovery that a woman in Ohio had experienced pain and complications from lead found in a new crown. The tainted alloy material in the Ohio case came from a Chinese supplier whose material had not been adequately tested. How many similar cases might exist? This doesn’t suggest that Weartech committed a similar infraction, but it does create a paper trail and incentive for a potential lawsuit.  

Byrne Medical Inc. Conroe TX July 31 2009  

Byrne Medical Inc. “manufactures and distributes sterile disposable water bottle adapter tubing sets and accessories, and a peristaltic irrigation pump for use in endoscopy applications with original equipment manufacturers’ (OEM) endoscopes” An FDA inspection cited the following QSR failures.  

·      Failure to establish and maintain adequate procedures for implementing corrective and preventive actions as required by 21 CFR § 820.100(a), and a failure to document the adequate results of corrective and preventive action activities as required by 21 CFR § 100(b). See FDA 483, Observations 1,3,8, and 12.   

·      Failure to establish and maintain procedures for rework; failure to include retesting and reevaluation of the nonconforming product after rework; and failure to ensure that the product meets its current approved specifications, as required by 21 CFR § 820.90(b)(2). See FDA 483 Observation 16.  

·      Failure to establish and maintain adequate procedures for validating the device design in order to ensure that the devices conform to defined user needs and intended uses, as required by 21 CFR § 820.30(g). The design validation must include testing of production units under actual or simulated use conditions, and risk analysis, where appropriate. The design validation results must be adequately documented and filed in the design history file. See FDA Observation 11.  

Listed above are 3 of 7 failures cited in FDA’s 483 Warning Letter to Byrne Medical, Inc. on July 31, 2009. Again, contemplate what type of information in that letter might interest a plaintiff’s attorney. Since Byrne manufacturers and distributes equipment used in endoscopic surgery, it raises a question whether there have been any accidents or injuries to patients that might be attributable to Byrne equipment. If so, the failures cited in the FDA Warning letter could be useful in a product liability lawsuit.  

ELA Medical S.A.S. Montrogue France November 6, 2009  

ELA Medical S.A.S. manufacturers the Avalto 6750 Implantable Cardioverter Defribillator (ICD).   The FDA inspection “revealed that your Ovato 6750 with Situs OTW Lead devices are misbranded under section 502(t) of the Act, 21 U.S.C. 352(t)(2), in that the firm failed or refused to furnish materials or information respecting the device that is required under section 519 of the Act, 21 U.S.C. 360i and Title 21, Code of Federal Regulations (C.F.R.), Part 803 – Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:  

1. Failure to report to the FDA no later than 30 calendar days that your firm received or otherwise became aware of information, from any source, that reasonably suggests that your marketed device may have caused or contributed to a death or serious injury as required by 21 C.F.R. § 803.50(a)(1). For example:   a. Complaint No. (b)(4) was received by your firm on May 18, 2008, from France, for the Ovato 6750 (b)(6). The complaint indicates that the ICD was incapable of delivering shock during induction attempt of the ventricular fibrillation and that the patient was treated with external electrical shock.   b. Complaint No. (b)(4) was received by your firm on February 18, 2009, from Toledo, Ohio for the Ovato ICD 6550 (b)(6). The complaint indicates that the ICD failed to charge during implantation procedure and the patient received external shock.  

Listed above is 1 of 4 failures cited regarding ELA Medical S.A.S. defribillators. After listing the problems, FDA added language about immediate corrections before the company can import into the U.S. market. As with the preceding FDA 483 Warning Letters, plaintiff’s attorneys will examine the device failure vis-à-vis a potential product liability lawsuit.  

Summary  

I have only discussed a small portion of each FDA 483 Warning Letter and a very small sample of the list of FDA Warning Letters. These letters can be read on FDA’s excellent web site. Medical Devices are under the jurisdiction of the Center for Devices and Radiological Health (CDRH). Enter FDA Warning Letters and QSR if you want to focus on quality system issues.  

While FDA Warning Letters offer a good source of information to plaintiffs’ attorneys, they are not the only source of information. Most of the Medical Device Insurance Study examined lawsuit losses not involving FDA Warning letters. What is critical is that plaintiffs’ attorneys are beginning to use FDA’s QSR, ISO 13485 and ISO 9001 in product liability litigation. The second part of this blog will focus on product liability audits, product safety audits and preventive law as a way to reduce a company’s product liability exposure. This is particularly useful for medical device manufacturers concerned about liability exposure in the American Federal and State legal systems. If you have product liability concerns regarding the US medical devices market, you can contact me for a free preliminary consultation at theguide!@comcast.net.  

Medical Device Manufacturers – Product Liability Exposure & Product Liability Litigation #2

In Blog #1 I reviewed some of the findings of a US litigation study conducted by a Medical Device Insurance Company to identify recurring patterns of behavior resulting in product liability lawsuits. As noted earlier, because 90% of these cases were settled out of court and sealed, there is little public knowledge of what happened. Among the issues discussed in the last blog was the finding that plaintiffs’ attorneys have been successful in using medical device manufacturers’ quality management systems (FDA’s QSR, ISO 13485 & ISO 9001) against them to successfully support plaintiffs’ product liability claims.  

Product liability lawsuits are a continual threat to the financial success and prosperity of medical device manufacturers. Unfortunately, too often the threat isn’t taken seriously. Also, from my personal experience as a lawyer/legal expert in ISO 9001 litigation, I have found defense attorneys to be almost clownish in their efforts to deal with the legal implications of quality management systems, e.g. arguing that as soon as a product is discontinued, their QMS no longer has to receive and respond to customer complaints concerning that product.

Recurring Patterns in Product Liability litigation

Returning to the Medical Device Insurance Company’s recurring patterns of behavior resulting in product liability lawsuits, the following additional issues were identified:  

·      The study found when the adequacy of warnings and user instructions has been questioned manufacturers had no way to effectively counter these allegations. Too often device warning labels and instructions were incorporated without documentation of the testing of the warnings or instructions to demonstrate the adequacy of the warnings. More often than not, there were no Standard Operating Procedures (SOPs) or guidelines to follow to document how and why the manufacturer developed its warnings and instructions resulting in product liability lawsuits.  

·      The study revealed that warranty claims and allegations arise as failures in product liability pleadings from advertising materials when devices don’t work as claimed in medical device advertising documents  

·      Plaintiffs’ have successfully alleged that manufacturers’ internet web sites contained misleading claims and testimonials that should have been considered at the product design stage following a full hazards analysis/risk analysis.  

·      Manufacturers frequently lacked a clear understanding of the potential risks and product liability complications with misunderstood safety documents and communications.  

·      The study revealed a lack of qualified in-house personnel available to integrate product liability avoidance principles into the manufacturers quality management system to establish an infrastructure for device safety, resulting in product liability post-production legal defense problems. Regulatory personnel often were tasked with product safety and product liability responsibilities that exceeded their professional experience and expertise.  

·      Often post-production complaint data was poorly managed and not escalated to the attention of senior management and/or further compounded by being ignored by senior management resulting in regulatory sanctions by FDA followed by product liability lawsuits.  

·      Too often manufacturer post-production corrective and preventive actions have been deemed by FDA to be inadequate for the degree of risk presented by individual complaint investigations and compiled complaint data, resulting FDA regulatory actions and product liability lawsuits.  

·      Several cases were observed where manufacturers did not conduct post settlement reviews and analyses of claims in order to learn from their litigation experience. Consequently, when a case was settled and believed to be over and finished, the failure to learn from past experience often resulted in a similar case arising a few months later.  

·      A review of several similar cases revealed that when medical device manufacturers learn of post-sale device risks and hazards and take little corrective action or worse attempt to cover up the severity of the potential risk, they are in an indefensible position in product liability litigation.  

·      Often, documented critical safety information is carelessly worded and/or prepared and used against a manufacturer to support the allegation of a lack of attention to and concern for patient safety and device safety in product liability lawsuits.  

Documentation  

Medical device Quality Management Systems are document rich, accommodated by the document and records requirements of their QMS and driven by the document and record requirements of regulatory agencies such as FDA and their national counterparts in the EU, Canada, Australia and Japan. If a mandated document or record has been lost or destroyed, it can be seen as the illegal destruction of evidence. If it has been poorly articulated or prepared it can be seen as unacceptable incompetence.  

Paper trails exist everywhere, recording device design, design changes, device distribution, device complaints, process controls, non-conformance, corrective and preventive action, post-production reviews, device recalls, etc. Plaintiffs’ attorneys are aware of this rich source of data and defense attorneys and corporate counsel should be fully conversant with the same to better serve their manufacturer clients. They need to think like QMS auditors when using their legal antennae.  

Summary  

In an earlier blog I described working with Corporate Counsel and the Risk Manager of a Corporation concerning one of their Divisions that had been experiencing significant losses from a series of product liability lawsuits. They asked me to study the problem and make some recommendations. As I was conducting the study the Division was notified by their insurance company and litigation team that the insurance company was going to pay a $5 million dollar claim and raise their deductable to $2 million dollars per lawsuit in the future. The moral of this story is that product liability losses can quickly threaten profit margins and company survival  

Recently, I went to large building supply store to buy some non-latex gloves for my wife. She found that she had developed a rash on one of her hands when using latex gloves to clean a professional kitchen after teaching a cooking class. I mentioned that latex allergies can develop in people after continued use. Doctors and nurses had discovered this in hospitals and clinics.  

When I found the glove section in the supply store, most were latex and only two were non-latex. The glove markings were obscure. On the latex gloves there was a statement, “in the unlikely event that you might have an allergic reaction to these gloves, discontinue use.” It wasn’t that useful nor was it direct. In the EU these gloves would have had a CE Mark and a latex symbol indicating compliance with the Personal Protective Equipment Directive, instead of a snide self-serving “in the unlikely event” non-warning. The moral of this story is to provide intelligent warnings to potential users or anticipate a product liability lawsuit for failing to adequately warn. If you have product liability concerns regarding the US medical devices market, you can contact me for a free preliminary consultation at theguide1@comcast.net.  

Medical Device Manufacturers – Product Liability Exposure & Product Liability Litigation #1

In several blogs posted in March, April, May, June, July 2009, I discussed the private findings of a Medical Device Insurance Company that examined its litigation history to identify recurring patterns of behavior that resulted in product liability lawsuits. Since more than 90% of the cases were settled out of court, however, there is little public knowledge of what happened, i.e. what liability claim caused the case to come to trial and what, if any, were the critical errors?  

For EU medical device manufacturers, FDA sanctions followed by private product liability lawsuits, is a uniquely American phenomenon for two reasons: (1) EU medical device regulatory sanctions have yet to be made as rigorous as the FDA, and (2) there is little product liability litigation in the EU. I expect this to change over time, but for the present the US presents more pitfalls for manufacturers.

Except for the insurance company and their attorneys involved in this litigation, little is known in the way of product liability lessons to learn and pitfalls to avoid for medical device manufacturers. Also, little is known about the product liability litigation history of FDA’s Quality System Regulation, ISO 9001 and ISO 13485. This blog will review those patterns of manufacturer behavior resulting in medical device product liability lawsuits.  

Product Liability Litigation  

While attorneys are central to litigating product liability claims, their success depends upon their understanding of the regulatory process, the quality of information provided by their clients, medical device manufacturers, and it depends upon manufacturers working with their attorneys at key decision making stages to make certain that legal counsel is sought when needed.   

Medical device (also drug & biotech) litigation is a specialized field requiring knowledge of FDA and EU regulatory requirements and sanctions, and how they might impact litigation. Not every litigator is equipped with the necessary experience and skill to be successful in defending a medical device manufacturer in a product liability lawsuit. While corporate counsel, generally are not equipped to litigate a product liability claim, they can help in selecting a strong litigation team.

• The adoption of a Quality Management System (QMS) as a regulatory structure by FDA, Australia, the EU and Canada for medical device regulation is new to the legal world. Plaintiffs’ attorneys have just begun to exploit the QMS format and have had some initial success by alleging that patient safety and product safety should be contained in the quality policy if a company is serious about those issues. They have only begun to scratch the surface of how they can utilize elements of a regulated quality management structure in product liability litigation, but they are learning rapidly.

• Defense counsel and defendant litigators are neophytes in dealing with documented quality management systems and will need to develop a rapid learning curve to effectively defend their clients and not be overwhelmed. It is essential that they understand more about regulated quality management systems and how they can impact product liability litigation.

Recurring Patterns in Product liability Litigation  

Each bullet point listed below describes manufacturer problems that were decided in jury convictions or in out of court settlements against medical device manufacturers.  

·      The Insurance Company study revealed that plaintiffs’ attorneys have successfully used the absence of Quality Policy Statements “declaring that a manufacturer is committed to patient safety and device safety” as evidence that the medical device manufacturer is indifferent to patient safety and device safety.  

·      The study found a failure of many manufacturers to comply with FDA’s Quality System Regulation (QSR) for “contract manufacturing agreements.”  

·      Several medical device manufacturers “did not adequately investigate and analyze post sales medical device incidents and integrate reporting of these incidents” (non-conformities) in their FDA & EU mandated quality management systems.  

·      Several product liability claims successfully taken to jury trials “used the manufacturer’s quality management system and quality manuals against the manufacturer because their quality processes and quality procedures were not being followed or audited as required by FDA and EU notified bodies.”  

·      Several medical device manufacturers “created quality management systems to satisfy FDA & EU medical device regulatory requirements, but their QMS systems contained no documented methods, processes or procedures for communicating device safety concerns and/or incorporating those concerns into their business processes, thereby demonstrating no commitment to device safety.” 

·      Several product liability cases were recorded where a manufacturer’s “quality management system did not include aspects of device design as required by FDA & EU regulatory requirements, thereby opening regulatory non-compliance as evidence of design failure.”  

·      Several product liability cases were recorded where “customer complaint feedback was not treated as an indication of a non-conformity requiring corrective and preventive action in the manufacturer’s quality management system requiring a design review, risk analysis, design change and production change.”  

·      The study found numerous instances of medical device manufacturers “failing to protect and preserve their documentation by asserting attorney-client privilege prevented plaintiffs” from examining their documentation during discovery, which assertion was not accepted by the court.”

  ·      The study found several instances “where medical device manufacturers exhibited a lack of internal processes and procedures in manufacturer quality management systems for escalating device safety concerns and a review of those concerns, as well as an absence of any kind of cross functional committees to deal with device safety issues.” Plaintiffs’ attorneys successfully alleged that this failing demonstrated a lack of due care and concern for safety.  

Summary  

There is an old saying regarding medical device product liability litigation, “It’s not if you are sued will you be ready, but when you are sued will you be ready!” Medical device manufacturers continue to ignore product liability risks in medical device manufacturing, often at their peril. The costs of losing a product liability lawsuit can be financially devastating, compounded by the negative publicity for future sales, and increased insurance costs. Further, the “legal playing field” is fueled by negative findings by FDA that can be used by plaintiff’s to support their case.  

The litigious nature of US product liability lawsuits often looks like a legal minefield to medical device manufacturers planning to import products into the US market as well as contemplate building manufacturing facilities in the US. I will discuss these medical device product liability issues in future blogs as well as address a solution, “product liability audits” to reduce the risks. It is an approach I use when working with US & EU medical device manufacturers. If you have product liability concerns regarding the US medical devices market, you can contact me for a free preliminary consultation at theguide1@comcast.net .  

CE Marking Cosmetics & Pharmaceutical Machinery Starting 1 January 2010

Introduction 

I have just finished working with two clients CE Marking machines for the UK, Italy, Spain, Cyprus and Israel and will begin working with a client who wants to comply with the legal requirements of the Directive on Cosmetic Products and the Directive on Medicinal Products for Human Use which raises some interesting questions. While it may not be apparent, Cosmetics and Pharmaceuticals intersect with machinery in an interesting way in the revised Machinery Directive 2006/42/EC, namely in the Annex I Essential Health and Safety Requirements, Section 2.1 Foodstuffs Machinery and Machinery for Cosmetics or Pharmaceutical Products.  

The basic language of the revised Machinery Directive is straightforward:  

“Machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products must be designed and constructed in such a way as to avoid any risk of infection, sickness or contagion.”  

The following requirements must be observed:  

(a) materials in contact with or intended to come into contact with, foodstuffs or cosmetics or pharmaceutical products must satisfy the condition set down in the relevant Directives. The machinery must be designed and constructed in such a way that these materials can be cleaned before each use. Where this is not possible disposable parts must be used.

Conceptually, the expanded rules parallel FDA’s authorization under the Federal Food, Drug and Cosmetics Act, which has now been expanded to include tobacco. The big difference, however, is the focus here is on the machinery that manufactures foodstuffs, cosmetics and pharmaceuticals, whereas FDA’s focus is on the manufacturing of  these products. FDA doesn’t prescribe how to build machines, but they will inspect manufacturing processes to see if they are satisfying FDA’s Good Manufacturing Practices.  

Manufacturing Cosmetics and Pharmaceutical Products in the EU  

Prior to 1 January 2010 cosmetics and pharmaceutical machines had to be CE Marked to be used in manufacturing cosmetic and pharmaceutical products. This meant, however, that they only had to satisfy Section 1 Essential Health And Safety Requirements of Annex I of the Machinery Directive. Starting on 1 January 2010, under the revised Machinery Directive, cosmetic and pharmaceutical machines must also satisfy Section 1and Section 2 Supplementary Essential Health And Safety Requirements For Certain Categories of Machinery and Section 2.1 Foodstuffs Machinery And Machinery For Cosmetics Or Pharmaceutical Products. This means these machines now have to meet additional requirements, “to avoid any risk of infection, sickness or contagion”  

“The following requirements must be observed:”  

(a) materials in contact with or intended to come into contact with, foodstuffs, or cosmetics or pharmaceutical products must satisfy the conditions set down in the relevant Directives. The machinery must be designed and constructed in such a way that these materials can be cleaned before each use. Where this is not possible disposable parts must be used.  

(b) all surfaces in contact with foodstuffs or cosmetics or pharmaceutical products other than the surfaces of disposable parts, must:  

--be smooth and have neither ridges nor crevices which could harbor organic materials. The same applies to their joinings,  

--be designed and constructed in such a way as to reduce the projections, edges and recesses of assemblies to a minimum,  

--be easily cleaned and disinfected, where necessary after removing easily dismantled parts; the inside surfaces must have curves with a radius sufficient to allow thorough cleaning;  

(c) it must be possible for liquids, gases and aerosols deriving from foodstuffs, cosmetics or pharmaceutical products as well as from cleaning, disinfecting and rinsing fluids to be completely discharged from the machinery (if possible in a cleaning position);  

--(d) machinery must be designed and constructed in such a way as to prevent any substances or living creatures, in particular insects, from entering or any organic matter from accumulating in, areas that canny be cleaned;  

--(e) machinery must be designed and constructed in such a way that no ancillary substances hazardous to health, including the lubricants used can come into contact with foodstuffs, cosmetics or pharmaceutical products. Where necessary, machinery must be designed and constructed in such a way that continuing compliance with this requirement can be checked.  

Instructions  

The instructions for foodstuffs machinery and machinery for use with cosmetics, pharmaceutical products must indicate recommended products and methods for cleaning, disinfecting and rinsing, not only for easily accessible areas but also for areas to which access is impossible or inadvisable.  

How this will be enforced is not yet clear to me, but I have no doubt that it will be enforced. The EU is ramping up its market surveillance activities this year. To a degree, this falls into the same category as the new requirements for medical device machines having to satisfy both the Medical Devices and Machinery Directive. Also, the Cosmetics Directive is being revised with an expectation that the revised Directive will be published later this year. I expect some association with the new machinery requirements will be made in the revised Directive. I also expect greater emphasis on the  EN ISO 14121-1: 2007 Safety of Machinery Risk Assessment Standard to assure compliance,as well as other EN standards on basic Hygiene of food, cosmetics and pharmaceutical products.

What About the US And Third Countries?  

This new requirement to CE Mark machines should not only apply to EU manufactured foodstuffs, cosmetics and pharmaceutical products, but all foodstuffs, cosmetics and pharmaceutical products manufactured in third countries and placed by those companies on the EU market. This would apply to companies in the Third Countries like the US, Canada, Brazil, China, Australia, India, etc.  

Just as FDA will inspect any manufacturing facility in the world to make certain that they are satisfying FDA Health and Safety Good Manufacturing Practices before exporting to the US, I anticipate that the EU will develop a means to accomplish the same Health and Safety objectives about exporting into the EU. Therefore, this means that companies in the US should now be preparing their foodstuffs, cosmetics and pharmaceutical products in CE Marked machines to satisfy, EU Health and Safety Requirements. If you have any questions regarding the new Machinery Directive requirements for Foodstuffs, Cosmetics or Pharmaceutical Products, you can contact me for a free preliminary consultation at theguide1@comcast.net.      

ISO 9001& ISO 9004: A Framework for Disaster Preparedness Revisited #3

The Disaster Setting  

In Spring 2004, I was contacted by a health care group from a major metropolitan area in the Northeast – they had read my February 2002 Quality Progress article using ISO 9001 & ISO 9004 for Disaster Preparedness. They asked for assistance in preparing a Disaster Recovery and Service Continuity Planning effort for their metropolitan area concerning the provision of healthcare services in the event of a disaster. What follows is a brief outline of my proposed plan.  

The Disaster Preparedness Outline  

To begin it is necessary to establish a map of health care resources and facilities in the metropolitan area and then determine what will be included in the Disaster Preparedness Plan. Next it is necessary to establish what secondary and tertiary resources and facilities will be needed to provide services in the event of a disaster. The provision of resources and facilities will require several alternative backup strategies since the nature and impact of a disaster is unknown and could adversely impact hospitals, health care facilities and surge resources included in one version of a disaster of a disaster plan.  

Next it will be necessary to identify the potential risks that could affect the provision of health care facilities. Once the risks have been analyzed, it is possible to prepare a plan to respond to emergencies more effectively as well as preserve health care resources. A disaster plan will:  

·      Help the planning authority fulfill its moral responsibility to protect citizens, health care workers, healthcare resources, the community and the environment;  

·      Facilitate compliance with government agencies;  

·      Enhance the healthcare community’s ability to recover from destroyed facilities, personnel losses, financial losses and the interruption of services;  

·      Reduce time loss in restoring services and facilities;  

·      Enhance image and credibility with the community. 

Elements Needed In A Disaster Recovery Plan  

The plan should be in two parts. The first part should evaluate operations, beginning by defining goals and appointing a steering committee. It should look for capabilities and resources, as well as hazards and vulnerabilities. It should look at evacuation plans, safety and health programs, physical security and risk management plans that may already exist and might be used. In addition, it is necessary to look for those areas that are vulnerable in the event of a disaster such as critical equipment and supplies, critical services – electricity, water, heat and cooling, vital personnel, etc.    

The second part is the plan. It is necessary to compile a list of emergencies and the likelihood of their occurrence. Based on this list, it will be possible to prepare a plan to minimize the effects of these occurrences on health care operations. The implementation of a plan would include employee training, as well as conducting drills, testing equipment and coordinating activities with the communities in the metropolitan area.  

Senior management (which must be identified and agreed upon) sets the tone for this project by issuing and supporting a mission statement. In it senior management should link the success of this recovery plan to the provision of healthcare services. In addition, the mission statement should define the purpose and help foster an atmosphere of cooperation.  

Project Initiation and Planning  

Project Initiation – Initiating a project for disaster recovery planning requires that certain factors be considered by senior management during initial planning, including: ·      Establishment of project objectives ·      Mission statement issued by senior management  

Project Planning – The purpose of project planning is to clearly identify the project tasks to be completed, responsibility for their completion and the schedule, including: ·      Determining what facilities, departments and processes will be reviewed ·      Establishing project milestones, including timelines ·      Assigning personnel and scheduling  

The Steering Committee – The development of a Disaster Recovery Plan must be completed by a group rather than a single individual. This group, the Disaster Recovery Steering Committee, reports directly to senior management and is chaired by a member of senior management. It provides the management vehicle for the project. They arrange for the necessary resources and report to senior management. Important responsibilities of the steering subcommittee are operations, information services, finance, auditing, personnel, risk management, safety and security personnel.  

Assessment of Risks and Vulnerabilities – The various healthcare facilities in the metropolitan area, at the very least, have liability, property insurance and workers compensation in place. This coverage will afford some financial support in the event of an emergency. FEMA also should be contacted for the potential range of their support (especially following the disaster of Hurricane Katrina). Other items would be a safety and health program, a process safety evaluation using ISO 9001/ISO 9004, a facilities closing plan, and so on.  

Threats and vulnerabilities need to be evaluated based on their potential impacts. Determination of the maximum permissible downtime for healthcare operations as a whole and key operations in particular must be gauged. Further determination needs to be made as to how long the healthcare operation can be down without a significant negative impact on any one critical application or function. The maximum permissible downtime will determine how quickly an alternative healthcare processing system or operating system must be made available. Again, ISO 9001/ISO 9004 can speed evaluation of health care processes.  

Elements of the Plan  

One of the first actions to be taken during the planning process is the most effective method of operation during backup. Where there is no backup capability, it is necessary to look for actions to mitigate downtime. Emergency operating methods must address both immediate and long-term backups. The three-phase of emergency operations are:  

Emergency Backup – actions taken during this phase are reactionary. The purpose is to protect life and property and minimize loss. This phase is measured in hours.  

Immediate Backup – this phase provides short-term operating capability for critical activities, usually in a degraded mode. The speed with which an organization must move into immediate backup after a disruption in services is a function of the maximum allowable downtime. This phase is measured in days. 

Long Term Backup – when there is major damage to a facility, provision must be made for alternative operating methods and sites where operations can be brought back to acceptable levels. This phase is usually measured in weeks or months.  

Off-Site Storage of Critical Supplies – an important action that must be taken early in the planning process is the establishment of off-site storage of critical records, data and software as well as healthcare supplies The specific materials should be identified in the risk analysis phase of the project. Information technology is a critical element of disaster recover and contingency planning.  

Summary  

The importance of a well organized and fully documented Disaster Preparedness Plan can’t be overemphasized. Policies and procedures governing activities prior to, during, and following an emergency situation must be understood by all persons involved in the planning process. Use of ISO 9001/ISO 9004 is employed throughout the planning process. While blog space doesn’t permit an in-depth  discussion of disaster preparedness planning, this brief outline provides an understanding of how ISO 9001/ISO 9004 can be applied to healthcare services in a metropolitan area. If you have disaster preparedness concerns, you can contact me for a free preliminary consultation at theguide1@comcast.net.  

ISO 9001& ISO 9004: A Framework for Disaster Preparedness Revisited #2

Applying ISO 9001 and ISO 9004

This is the second blog revisiting my 9/11 Disaster Preparedness article in the February 2002 issue of Quality Progress. How can ISO 9001 & ISO 9004 be used in disaster planning? While these standards provide a basic structure from which to approach the planning process systemically, the focus must be on developing a comprehensive disaster plan, not just on managing processes.

Once a basic set of questions has been developed after meeting with senior management, the focus can be further refined to tailor the plan to meet the needs of the organization. In the section entitled “Questions to Ask,” sample questions are framed within some of the elements of ISO 9001 & ISO 9004.

As noted in the article, no one likes to be surprised, least of all senior management. Senior management will expect to review the plan as it evolves. The following points are critical:

·       Companywide planning objectives must be established.

·       A mission statement must be issued by senior management before the disaster planning   

      process begins.

·       The scope of the review, planning milestones and timelines must be established.

·       Personnel must be assigned to tasks and schedules established.

A Systemic Focus

Companies using ISO 9001 & ISO 9004 to develop a strategic disaster plan do not need to become certified to ISO 9001, but it can be helpful. Once clauses from the two standards have been used to provide a systemic focus to the planning effort, planners can revisit the elements to determine what might be missing. For example, since financial planning and R&D often are not included in many ISO 9001 Quality Management Systems, these functions would need to be incorporated into a viable disaster plan.

Questions to Ask

The following sample questions are framed within the structure of one element of ISO 9001 and ISO 9004. The objective is to illustrate how the standards can be used in the planning process. Of course they must be adapted to the needs and type of organization.

Managing Systems and Processes

·      What are the needs of the organization?

·      What organizational and management structure is used to accomplish these objectives?

·      What is the legal structure of the organization?

·      Who are the stakeholders?

·      What is the overall planning structure of the organization?

·      What plans are in place at present?

·      How many corporate divisions and sites are managed by the organization, and what is their  

     function (for example, corporate management, R&D, production or service delivery)?

·      What is the financial structure of the organization?

·      What type of security systems are employed in the divisions and at different sites?

·      What type of information & communications systems (hardware and software) are used to operate the business and manage production and services?

·      Do any fail-safe backup systems exist?

·      How is proprietary information and intellectual property handled?

·      What contingency plans exist for shifting production and service delivery to alternative  

     locations?

·      How much and what type of insurance is carried by the organization?

·      What are the processes used to manage the organization?

·      What are the sequence of these processes and their interaction?

·      What criteria and methods are used to ensure that the operation and control of these processes are effective?

·      How are these processes monitored, measured and analyzed?

·      Are any processes that affect product conformity outsourced?

·      If so, how are these processes monitored within the quality system?

The February 2002 Quality Progress article developed additional ISO 9001 & ISO 9004 questions to illustrate the approach for Documentation; Statutory and Regulatory Requirements; Quality Policy; Responsibility; Authority and Communication; Production and Service Operations; Control of Nonconformity; Corrective Action; Resource Management; Human Resources; Infrastructure; Work Environment; Information; Financial Resources; Design and Development Planning.

Again, the demonstration of the approach did not use all of the elements of ISO 9001 & ISO 9004 and did not develop the full complement of possible questions for each element. The objective was to demonstrate how this type of approach would work.

Critical Issues to Remember

Timing is critical. Catastrophic events happen quickly and, in most cases, without warning. It is necessary to develop an emergency response procedure and create a crisis management team to deal with the public and press.

·      Companies need to have both immediate and long-range responses that are planned and timed. The impact of downtime will depend on how rapidly a company is able to begin intermediate and later long-term operations.

·      Clearly, all critical information, including operational records and documents and environmental compliance records should also be stored off-site so that they can be retrieved when needed. Also, the QMS manual, procedures, records, work instructions, flowcharts, minutes and other critical data should be in electronic form and also stored off-site as well.

·      Backup computer operations (hardware and software) should exist in duplicate form so that they can be accessed whenever necessary. Quality records and documents such as design documents, production records, financial records and supplier records also should be stored in duplicate off-site so that operations can begin again as quickly as possible.

·      Companies that manufacture one-of-a-kind products should have duplicate design records. Companies that CE Mark products should have their Technical Files (Parts A&B) stored electronically off-site as well.

·      Depending on the nature of the disaster (for example, flood, mudslide, explosion, terror attack, sabotage, etc.), personal liability lawsuits could ensue. Operational data will become critical in defending the company.

·      Product liability and criminal liability lawsuits also could be initiated after a plant or facility is destroyed by disaster. Such lawsuits often occur several years after a product is first manufactured. Without data to prove that products were designed to be safe, production was under control and complaints were dealt with in a timely fashion, an organization could be at the mercy of juries that must determine the facts of a case. The truth is that if you can’t prove it doesn’t exist.

The shopworn American aphorism, “If it ain’t broke, don’t fix it” is meaningless in disaster planning. If you don’t plan for all possibilities, your company likely will be out of business.

Summary  

When writing the February 2002 article, I remembered three events in my life that made vivid impressions concerning disaster planning. First, when I was in Law School a fire broke out in some commercial buildings that had been acquired by the University of Wisconsin for graduate student offices and laboratories. The newspaper accounts said that the work and records for over 40 doctoral dissertations were destroyed. Second, when I was a doctoral candidate at the University of Kansas, I made duplicate copies of my dissertation and as soon as a chapter was finished, I stored three separate copies at three separate locations in the city. Finally, when I was vice president of a university, I discovered that student records and transcripts have always been created in duplicate and stored in different locations to avoid any possibility of a records disaster.

Parts 3 and 4 of this blog will deal with disaster planning and the response to catastrophic events since 9/11. Have any lessons been learned? If you have disaster preparedness concerns, you can contact me for a free preliminary consultation at theguide1@comcast.net.  

FDA’s QSR & CE Marking to the Medical Devices Directive – Case Study of a Custom Device Manufacturer #2

My first blog in this case study reviewed some of the unique issues facing a manufacturer of custom-made devices for the EU. As noted in that blog, FDA does not use the term custom-made for devices prescribed by a dentist for a specific patient. It does, however, differentiate between an orthodontic lab and a medical device manufacturer concerning on site inspections.

Since my client decided to consider becoming a manufacturer of orthodontic components, they  began constructing a quality management system that would satisfy FDA’s Quality System Regulation (QSR). Also, a measure of alarm had spread among orthodontic labs in the US because of FDA inspections of “offshore labs” in the Caribbean and Central America, causing all manner of rumors to spread that FDA was going to inspect all of the orthodontic labs in the US. My client asked me to call to FDA to confirm or deny the rumor. FDA said it was untrue. FDA, however, was becoming concerned about “offshore labs” because FDA was not monitoring their operations and suppliers resulting in tainted orthodontic products reaching US patients. Nonetheless, the rumors continued to spread.  

Many of my client’s orthodontic devices were Class II medical devices requiring an FDA 510(k). My client therefore obtained licenses from various orthodontic labs to manufacture their devices. At one point they decided that they wanted to put together their own 510(k) for a new orthodontic device and asked if I would take on that task, which I did. After reviewing the alternative paths to a 510(k), we decided to follow the traditional path as that best suited their device. My client provided me with some sample 510(k) predicate devices and I went online to find some additional choices. It is an interesting process requiring time and patience to succeed. It also requires following an FDA prescribed path. The submission went rather smoothly and was aided by assistance from the FDA reviewer.

Shortly after we received notice from FDA that our 510(k) was approved, my client called to say that we would have to rename our 510(k) because a competing orthodontic lab called and threatened to sue for name infringement. My first reaction was “Oh No” we will have to start over from scratch and take another six months. A name change is not a simple thing, it is an integral component of a 510(k) submission. I asked what was the alleged infringement and he said the name [Orthodontic Infuser](not the real name) in the title. I replied that the term [Orthodontic Infuser] is an FDA product classification and consequently is in the public domain. Your competitor can’t sue for infringement because they don’t own the name! Every manufacturer of sequential aligners who has a 510(k) is entitled to use the name provided that they add their own designation, e.g. XYZ Orthodontic Infuser, ClearView Orthodontic Infuser, QRS Orthodontic Infuser, etc. Crisis averted.  

About the same time, my client asked if I had done any Trademark work, to which I replied that I had worked on three Trademarks for a client earlier in my professional career. It wasn’t something I trained for in law school, but law school also taught me that you can develop new legal skills throughout your career. (For example, CE Marking and ISO 9001, ISO 13485 and FDA’s Quality System Regulation didn’t exist when I went to law school.) My client asked if I could help with some Trademarks for orthodontic components they wanted to manufacture and sell in the US. They had initiated four Trademark applications earlier that needed additional attention. Fortunately, the work can be done online, but the process is prescriptive and precise. I reviewed the work to date and signed on as the attorney of record for my client and for one examiner had to prove that I was a member of a state bar association. Each trademark had been assigned randomly to four different attorneys in the US Patent and Trademark Office. I soon discovered that each attorney acted quite independently and had their own discretion on the process just as US District Court Judges operate independently within a general framework. It took a while, but we successfully obtained the Trademarks.  

While preparing for CE Marking manufacturing in the future, my client was notified by a Norwegian dentist that he had CE Marked one of their Trademarked orthodontic components and sent them a letter informing them of his action. I said he can’t do that, he is not the manufacturer of the device component you are! He couldn’t possibly have an ISO 13485 QMS approved by a notified body in place for manufacturing a Class IIa device, because he isn't the manufacturer he only plans to sell your manufactured component. Further, you haven’t placed it on the EU market for sale. Clearly, the Norwegian dentist didn’t grasp the basics of the CE Marking process for medical devices. My client contacted the dentist and he was indignant and threatened to sue. I suggested that we contact the European Commission asking that they forward the issue to the Directorate General Medical Devices Committee for review and possible action. Hopefully, the new EU market surveillance that will go into effect on January 1, 2010 will address some of these kinds of issues.  

The irony is that Norway participates in the CE Marking protocol because they are one of the three remaining non EU members of the European Free Trade Association (EFTA) that is allowed to participate in CE Marking (Iceland and Lichtenstein are the other two). (The other three former EFTA members, Austria, Finland and Sweden joined the EU.)          

I have enjoyed working with this client, because the new challenges are varied and fascinating. I do think, however, that orthodontic medical devices will come under increasing scrutiny in the future, especially in regard to suppliers and the quality of supplies. The incident of a lady in Ohio suffering because of lead from China in her dental crown occurred in the US. Not all US suppliers are as careful as they should be when it comes to purchasing supplies.   After all, most suppliers are Middlemen who purchase materials from a wide variety of sources. Not all scrutinize the origins of their sources. As a consequence, my client sends all of their orthodontic material to labs for analysis before using them in their devices. If you have a product liability or hazards analysis/risk analysis concerns with CE Marking custom-made medical devices for the Medical Devices Directive or FDA’s QSR, you can contact me for a free preliminary consultation at theguide@comcast.net  

EU Regulation To Tighten CE Market Surveillance & Regulatory Enforcement On January 1, 2010

In an effort to tighten the EU market and prevent products from entering the EU that are not CE Marked, illegally CE Marked and/or do not satisfy the CE Mark requirements of new approach safety Directives, on 9 July 2008 the European Parliament and Council adopted Regulation (EC) No 765/2008 “setting out the requirements for accreditation and market surveillance relating to the marketing of products and Repealing Regulation (EEC) No 339/93. The subject matter and scope of the new Regulation is set forth in Article 1.

1.     This Regulation lays down rules on the organization and operation of accreditation of conformity assessment bodies performing conformity assessment activities.  

2.     2.   This Regulation provides a framework for the market surveillance of products to ensure that those products fulfill requirements providing a high level of protection of public interests, such as health and safety in general, health and safety in the workplace, the protection of consumers, protection of the environment and security.

  3.     This Regulation provides a framework for controls on products from third countries. [e.g., US, China, Japan, etc.]  

4.     This Regulation lays down the general principles of the CE Marking. [emphasis added]

 

The implementation date for this new Regulation is January 1, 2010. The reasons for this new Regulation are obvious. All manner of evasions have been created to schlep products into the EU under the guise of CE Marking. Listed below are a few examples from my experience:

 

·      CE Marks stamped on products that have not satisfied any health or safety requirements, simply a CE stamp. This first appeared from Asian toy manufacturers in the early 1990s and gave rise to the first market Regulation 339/93 in February 1993.  

·      Products shipped into the EU stating that they satisfy EC safety requirements, with no paperwork to prove their point.  

·      Custom-made orthodontic devices stating on their EC Declaration of Conformity “This device conforms to Annex I Essential requirements” on a form used by most if not all custom-made orthodontic manufacturers. Except for a client discussed in my October 20 blog, custom-made orthodontic manufacturers have no clue about what this statement means. Who knows how many other types of custom-made medical devices have entered the EU market equally clueless about Medical Devices Directive Annex I Health and Safety Requirements?  

·      Products from China stamped CE only to reveal that this stands for Chinese Exports.  

·      Non CE Marked metal cribs from a US manufacturer headed for children’s hospitals in the EU that are not CE Marked because the manufacturer doesn’t want the bother or expense of satisfying the requirements of the Medical Devices Directive. It would only seem fair that EU hospitals purchasing the cribs should be sanctioned as well.  

·      Machines shipped from a US manufacturer that have Technical Files containing bogus EC Declarations of Conformity issued for non-dangerous machines by a Dutch notified body and which contain no Risk Assessments, leaving the US manufacturer with inadequate safety documentation. 

·      Machinery self certification documents that are a hodgepodge of foolishness with no evidence of compliance with EN harmonized standards, a risk assessment or Checklist of Annex I Essential Health and Safety Requirements. 

·       CE marks on products that can’t be CE marked, from books of matches, to small pieces of hardware, electrical pieces, etc. This type of violation is found more frequently in the EU.  

These are only a few examples of misuses of CE Marking products under the 20+ new approach directives. Another type of issue I encountered within the last few months was a manufacturer who wanted to CE Mark their products for the EU. When I visited their manufacturing facility they showed me a few products that had already been CE Marked and shipped into the EU.  

Since they really hadn’t done anything to demonstrate compliance with the directives that applied to their products, I noted that they were in the market illegally. When asked why, I replied that the operative words in EU legislation were “placing on the market” or “ making available on the market”, whether for sale or free. They found my response to be irritating, to which I said it’s their law. They decided that they didn’t want any help. As I left their plant I picked up a pamphlet describing their products and their Christian religious commitment as a business. Interesting!  

Article 2, paragraph 1 of the new Regulation states:   ‘making available on the market’ shall mean any supply of a product for distribution, consumption or use on the Community market in the course of commercial activity, whether in return for payment or free of charge. [emphasis added]  

I sincerely hope that the new Regulation is more effective than its predecessor. I like the EU new approach health and safety directives. Such a comprehensive standards effort would not occur in the US. Too many competing interests, protection of turf and arrogance that such an effort would be antithetical to the US way of doing things. So we will have to inherit most of our safety standards via ANSI, ISO and IEC from our European friends and the international community.  

The best cooperative effort between the US and the EU is with FDA and their European counterparts in medical device regulation. It has been a great success and will get better.  It has opened markets for US medical device manufacturers that were not as available prior to CE Marking. In addition the US/EU June 1997 Mutual Recognition Agreement (MRA) addressing six product sectors (electrical safety, electromagnetic compatibility (EMC), pharmaceutical good manufacturing practices (GMPs), recreational craft and telecommunications) holds considerable promise.  

January 1, 2010  

Several EU publications have admonished manufacturers to update their CE Marking products to comply with the various Directive and EN standards revisions and updates by January 1. This applies to Medical Devices, Machinery (including medical machinery – see my October 26 blog) EMC and Low Voltage to mention a few of the more prominent examples. It will be easy for customs and member state national accreditation bodies to examine EC Declarations of Conformity and see if manufacturers are complying with the new requirements for Directives and EN harmonized standards. Time will tell how effective this new EU Market Surveillance is working. If you have any questions or concerns about the new CE Marking requirements, you can contact me for a free preliminary consultation at theguide1@comcast.net  

FDA’s QSR & CE Marking to the Medical Devices Directive – Case Study of a Custom Device Manufacturer #1

For the past five years I have worked with a client who has a full service orthodontic laboratory registered by FDA. Their initial call came to me because of their interest in possibly CE Marking some of their products for the EU. Historically, they had not manufactured any orthodontic products for sale. Rather, they made orthodontic devices for dentist’s prescriptions for specific patients in the US and other countries, including the EU. They made custom-made devices for EU dentists for specific patients. Since custom-made products are one-of-a-kind, they can not be CE Marked.

Under the EU Medical Devices Directive 93/42/EEC Custom-made devices are addressed under Article 11 Conformity Assessment Procedures, paragraph 6 and Annex VIII, Statement for Devices for Special Purposes, Custom-made devices. Consequently, Custom-made orthodontic devices can enter the EU without question as long as the shipment contains an EC Declaration of Conformity identifying it as a custom-made device.

Now, however, they were contemplating manufacturing CE Marking orthodontic components for sale and selling them in the EU and the US. Because orthodontic devices are classified “long term” “Normally intended for continuous use for more than 30 days” as defined by Rule 1.1 Classification Criteria in Annex IX of the Medical Devices Directive, and

2.1 Rule 5 “All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device:

-- are in Class IIb, if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in any ear canal up to the ear drum or in a nasal cavity and are not liable to be absorbed by a mucous membrane, in which case they are in Class IIa. All invasive devices with respect to body orifices, other than surgically invasive devices intended for connection to an active medical device in Class IIa or higher are in Class IIa.

2.4 Rule 8 All implantable devices and surgically invasive devices are in Class IIb unless they are intended:

-- to be placed in the teeth, in which case they are in Class IIa.

Long story short, this meant that their orthodontic component was in Class IIa which meant that my client needed to comply with Article 11 Conformity assessment procedures for Class IIa medical devices.

2. In the case of devices falling within Class IIa, other than devices which are custom made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, followed by a procedure relating to the EC declaration of conformity set out in Annex VII with either:

Instead of applying these procedures the manufacturer may also follow the procedure referred to in paragraph 3 (a).

3. (a) follow the procedure relating to the EC declaration of conformity set out in Annex II; in this case point 4*of Annex II is not applicable;

Point *4 of Annex II refers to design.

(This means that the examination of design and design controls do not apply to Class IIa devices. It is the same as FDA’s exclusion of Design Controls for most of Class 1 devices.)

Therefore, in order for my client to become a device manufacturer and sell orthodontic components in the EU they would have to have an ISO 13485 Quality Management System (minus design controls) approved by a Medical Devices Directive notified body. Also, if they wanted to become a US device manufacturer they would need a QMS that would satisfy FDA’s Quality System Regulation. Since they did not have a QMS, I conducted a dual Gap Analysis to determine what procedures they had in place that might satisfy a dual FDA/EU QMS and what procedures would need to be created to satisfy the Medical Devices Directive, ISO 13485: 2003 and FDA’s Quality System Regulation. I also drafted a sample procedure for the Structure and Content for Part A & B of a Technical File and a sample EC declaration of Conformity.

The company decided that the potential EU business didn’t warrant creating an ISO 13485 QMS at this time, but probably they would do so in the future. I suggested, however, that they should begin to construct a QMS that would satisfy FDA’s Quality System regulation, which they began to do. Out of curiosity, I asked what type of documents were sent when a custom-made orthodontic device was shipped to a dentist in the EU. They showed me an EC Declaration of Conformity type of document that contained the information stipulated in Annex VIII Statement Concerning Devices for Special Purposes, Paragraph 2.1 for custom made devices:

-- data allowing identification of the device in question,

-- a statement that the device is intended for exclusive use by a particular person, together with the name of the patient,

-- the name of the medical practitioner or other authorized person who make out the prescription and where applicable, the name of the clinic concerned

-- the particular features of the device as specified in the relevant medical prescription,

-- a statement that the device in question conforms to the essential requirements set out in Annex I and where applicable, indicating what he sets requirements have not been fully met, together with the grounds;

I asked where the Form came from and was told that it was used by all US manufacturers’ of custom-made orthodontic devices. At the bottom of the Form was the statement “This device conforms to Annex I Essential Requirements.” I asked if they knew what this meant and they said no. I told them that we needed to construct an Annex I Essential Requirements Checklist, identify the EN standards necessary to demonstrate conformity to the relevant essential requirements, an ISO 14971 hazards analysis/risk analysis and construct a Technical File Part A & B containing this information in order to be in compliance with their statement, “This device conforms to Annex I Essential Requirements.” This was done.  

I realized that except for my client, most likely 99% of all custom-made orthodontic devices shipped from US orthodontic laboratories to EU dentists made the same statement on their EC Declarations of Conformity and had no clue as to its meaning. Virtually none complied with the custom-made requirements of the Medical Devices Directive. We will see if the EU’s push to tighten “Market Surveillance” starting on 1 January 2010 catches some of these companies. If you have product liability or hazards analysis/risk analysis concerns with CE Marking custom made devices for the Medical Devices Directive or FDA’s QSR, you can contact me for a free preliminary consultation at theguide1@comcast.net  

Enterprise Risk Management Study & Medical Device Manufacturing

Three years ago, a friend asked if I would join a small team of experts on a risk management project for his medical device company. The company was in the process of being acquired by a larger global European medical device company. The European company stipulated that his company conduct an Enterprise Risk Management (ERMS) Study identifying all of the risks facing their medical device manufacturing operations, break down the risks into categories and submit a final list of the eight most significant risks to top management who would then review the findings and make a prioritized presentation of the top risks at the European corporate headquarters of the acquiring company. ERMS is done frequently in Europe, but less often in the US.

Having watched the financial meltdown on Wall Street this past year and the sale of bundled mortgages into meaningless financial instruments, I wondered if such an exercise might have prompted a few people to realize the insanity of their scheme and the outrageous risks that were perpetrated on global financial markets. Unfortunately, Wall Street greed and a lack of ethical judgment easily overcame rational decision making. But I digress.   

Nothing was out of bounds for the Enterprise Risk Management Study. We examined all risks –  manufacturing operations, future directions, new global markets, contract manufacturing, new designs, marketing, FDA & EU compliance, litigation history, worker sabotage, rising materials costs, impact of the acquisition, Sarbanes Oxley, etc. Each team member concentrated on identifying all potential risks while applying specific expertise to certain aspects of the study. Among other things, I concentrated on their Quality Management System as it supported FDA’s QSR, ISO 13485 and the EU Medical Devices Directive and political risks of specific country markets. We conducted the study visiting manufacturing operations and interviewing key managers during three visits over two months. Everyone in the company was open and understood the ERMS requirement.

As mentioned in previous blogs, design control is critical in the design and development of medical devices. Device safety and design safety are critical, but are not automatic elements in Quality Management Systems. A medical device manufacturer must build safety into device design. In addition, it would be helpful if a device safety committee were created to broaden the examination of safety issues. To heighten safety concerns it would be useful if product liability issues were examined as well. Such a review examines product safety, but from the other side of the mirror – what could happen if the company experiences a lawsuit and couldn’t prove that it made the safest device as revealed by their device design records.

Among the areas identified for greater analysis were the following:

>It was clear that the company’s manufacturing operations were confined to a few sites. Should adverse weather (e.g. hurricane, tornados, mudslides, prolonged electrical outage) affect manufacturing operations for a significant period of time, revenue could be adversely affected. Clearly, additional buildings needed to be acquired or built to reduce this risk.

>Outsourcing certain manufacturing operations to politically questionable countries could have a profound affect on revenue generation along with rapidly increasing transportation costs from those locations. All locations would need to be reviewed with alternatives selected to facilitate a rapid change.

>Foreign markets offered great promise for future growth, but political stability continued to cause concern about the long-term viability of such markets. Fortunately, some new employees with international experience, converted an ISO Risk Management Standard to a political risk management standard to identify the risks inherent in each of these markets.

>We reviewed the ability of their Quality Management System to satisfy FDA’s Quality System Regulation, EU’s Medical Devices Directive, ISO 13485 for CE Marking and Canadian Medical Device Regulations and Japan’s Medical Device Regulations. They were doing well on all counts. 

>As the company began plans to move toward manufacturing new types of medical devices, questions were raised about the potential product liability risks presented by these devices. In addition to creating a Product Safety Committee that would work hand-in-hand on device design, they decided to create a separate Product Liability Committee to look at device design from a different perspective following the advice of their insurance company.

>Worker sabotage had never been a significant concern of the company, but recent complaints from a few disgruntled workers interjected sabotage as an issue that needed more serious consideration. Given the nature of their manufacturing operation, it would be easy for an employee to destroy the sterile integrity of a significant quantity of their devices.

>Acquisition by the new European parent raised questions about the company continuing with its present medical device focus and raised questions about a portion of the company being spun off and sold. The question at least had to be raised.

>The company’s insurance policies were reviewed with an eye to increasing coverage for future operations and as assurance to financial institutions that a sudden calamity wouldn’t adversely affect the companies to pay its loans and obtain additional money when needed.

>Existing and future competition was reviewed with an eye to determining if the company was vulnerable to a significant reduction of their market share.

Summary

When we completed our task, our work was turned over to an executive committee of the company who then identified the critical risks and presented these to their new corporate management. With this step complete, a plan was created to reduce the most critical risks within the next two years.

While working on the Enterprise Risk Management exercise, I was reminded of a conversation I had a few years earlier at another medical device company. The regulatory affairs manager said, “Why didn’t someone warn me that our new manufacturing plant in Honduras could be shut down by a Hurricane and mudslides?” Having lived in Costa Rica for a while when I was in graduate school, I thought that should have been obvious to anyone familiar with Central America. However, the driving force behind their decision to locate in Honduras was cheap labor and low manufacturing costs, not weather.

It took their company six expensive months to overcome lost production and lost market share. It also underscores the wisdom of undertaking an Enterprise Risk Management Study. If you have risk management concerns regarding the manufacture of medical devices, you can contact me for a free preliminary consultation at theguide1@comcast.net

Ostomy Appliances & FDA’s QSR – A Case Study

 

Shortly after FDA’s Quality System Regulation went into affect, I received a call from a medical device manufacturer in Central Connecticut that manufactured rubber Ostomy appliances. They were aware of FDA’s QSR and wanted help in preparing to meet the new requirements. The first step was to conduct a GAP Analysis to determine where they were and what would need to be done to bring the company into compliance.

The company was started by the owner’s father in his garage in Brooklyn, New York and subsequently moved to a building they constructed in rural Connecticut. It was a nice facility with ample space for expansion. The particular type of Ostomy appliances they manufactured were made from rubber, rather than latex or plastic and were made to physicians’ specifications for their patients.

The GAP Analysis revealed not only that they had no quality system in place, but that the manufacturing operation was casual to say the least. For example, I asked what type of system they had for determining the size of the ostomy appliance. The owner said that Margaret was responsible for assembling the pieces of the appliance. When asked how this was done she walked over to a wall on which hung multiple flat wooden forms in multiple shapes and took one down for me to inspect. The form was then placed on a rubber sheet onto which a pattern was drawn that would be used to cut both sides of the bag.

The owner said that Margaret worked four days a week cutting out forms. I asked if there was a written procedure for receiving orders, determining the size, drawing the pattern and cutting the sides of the bags. He said no, it was entirely within Margaret’s hands and she was the only employee with that responsibility. I said, I don’t mean to be impolite, but what would happen if Margaret was hit by a Mack Truck and incapacitated, what would you do? He seemed alarmed at the question. I then asked if we could have Margaret write down each step of her operation so that we could create a procedure for their new quality management system. First, it would be necessary to create a standard operating procedure SOP to satisfy FDA’s Quality System Regulation and follow that procedure. Margaret said she would be glad to write down the steps and did an excellent job of writing a standard operating procedure for her operation.

I asked what happened next in the manufacturing operation and the owner walked over to a bank of autoclaves into which the assembled Ostomy appliances were placed and heated to temper the rubber and achieve a solid seal. He identified how long the appliances were heated in the autoclaves. I asked about the calibration cycle for the autoclaves and he looked puzzled. I asked how do you know if they are performing according to their manufacturer’s requirements? He said we don’t calibrate the autoclaves, should we? To which I responded yes and suggested that he contact the autoclave manufacturer to ask for calibration instructions and then create SOPs for both the calibration of and use of the autoclaves.

The rest of the visit to the plant continued in a similar fashion. There was no order to their operation and clearly no system in place. I was amazed that they had not been inspected by FDA for 20 years, since their move to Connecticut. Meanwhile, the owner’s father had died and he was now the sole source of management. It took some time for them to create a functioning quality management system that would satisfy FDA’s QSR requirements. I suggested that they also consider certifying to ISO 9001 to develop some rigor in their system and use internal audits and registrar audits as a check on their compliance (this was before ISO 13485). Otherwise, an FDA plant inspection could be a rude awakening resulting in multiple write-ups on a 483 letter from FDA. Over time their quality management system was put into place.

Observation

This wasn’t the first time that I visited a medical device company where news of FDA’s Quality System Regulation was a surprise. I have discussed other visits in earlier blogs. Quite often, these manufacturers had grown accustomed to the prior cGMPs and did not understand the quality management system structure and rigor of the QSR. In most cases these were small companies that were not certified to ISO 9001. Consequently, the new structure came as a surprise, if not a shock.

Another anomaly are those companies that manufacture a non-measuring, non-sterile Class I medical device and are able to self certify to the EU Medical Devices Directive. Since these manufacturers will not be visited by an EU notified body, they don't need an ISO 9001 (now ISO 13485) QMS. When told, however, that they will need a QMS to satisfy FDA's Quality System regulation, they are surprised

If you have any product liability and risk assessment concerns regarding FDA and EU regulation of medical devices, you can contact me for a free preliminary consultation at theguide1@comcast.net

Warnings, Instructions & Product Liability Lawsuits #3

The two previous blogs with this title discussed when warnings are necessary and offered some pointers on creating warnings and instructions. This blog will examine the legal consequences when warnings fail to warn and instructions fail to instruct. A few years ago I participated in a legal seminar on loss control sponsored by an insurance company. The seminar attendees were clients of the insurance company and the participants (mostly defense attorneys) represented the insurance company in various product liability lawsuits. The purpose of the seminar was to learn from past mistakes and avoid similar pitfalls in the future. The defense attorneys stressed that the question isn’t “If you are sued will you be ready?” The question is “When you are sued will you be ready?” What follows are lessons on what not to do.

Some Ways to Lose A Failure To Warn case

> Don’t disclose risks revealed by your hazards analysis. 

A properly done hazards analysis will reveal a number of risks associated with the use and misuse of a product, including information about the probability and severity of harm. The hazards analysis is a road map for the creation of product warnings. It represents your company’s best efforts to analyze the potential risks in a product, to design out hazards, guard against those that can’t be designed out and warn against those that can’t be designed out or guarded against. Therefore, a warning is a last resort. A hazards analysis should be performed by competent personnel who identify and classify all potential hazards, including information about the probability and severity of harm to serve as a basis for drafting warnings and instructions. 

Remember, plaintiffs attorneys dream of discovering risks that a manufacturer knew about and didn’t disclose to the end user. Further, expect plaintiffs’ attorneys to ask for your hazards analysis, design material, ISO 14121-1:2007, ISO 14971:2007, Technical File, etc., and have it examined by experts for flaws.

> Create warnings to compensate for shortcomings in design.    

Warnings are not a substitute for adequate design. If there are feasible design alternatives that will reduce the inherent risk of harm posed by a product, the furnishing of warnings about product hazards, whether obvious or not, will not protect a manufacturer from liability. For example, The Massachusetts Supreme Judicial Council stated;

An adequate warning may reduce the likelihood of injury to the user of a product in some cases. We decline, however, to adapt any rule which permits the manufacturer or designer to discharge its total responsibility to workers by simply warning of the dangers of a product. Whether or not adequate warnings are given is a factor to be considered on the issue of negligence, but warnings cannot absolve the manufacturer or designer of all responsibility for the safety of the product…. Balanced against the somewhat limited effectiveness of warnings is the designer’s ability to anticipate and protect against possible injury. We think that in such a case the burden to prevent needless injury is best placed on the designer or manufacturer rather than on the individual user of a product. (Uloth v. City Tank Corp., 384 N.E.2^nd 1188, 376 Mass. 874, 1978)

The American Law Institute Restatement (Third) of Torts: Products Liability has adopted a new approach to the sufficiency of warning. Comment I provides, inter alia:

Reasonable designs and instructions or warnings both play important roles in the production and distribution of reasonably safe products. In general, when a safer design can reasonably be implemented and risks can reasonably be designed out of a product, adoption of the safer design is required over a warning that leaves a sufficient residuum of such risks. For example, instructions and warnings may be ineffective because users of the product may not be adequately reached, may be likely to be inattentive, or may be insufficiently motivated to follow the instructions or heed the warnings… Warnings are not… a substitute for the provision of a reasonably safe design.

Consequently, manufacturers may, more than ever, bear the burden of eliminating risks by design, not by supplying warnings.

> Have your marketing people design the labeling. 

Marketing likes to sell products, not scare potential customers. Warnings should be devised by an appropriate labeling committee or product safety committee. First of all, that’s who you want to tell the jury designed the labeling, and second, that’s who you really want to design labels so that it delivers the warning and instructions in the most effective fashion. Plaintiffs’ attorneys love to put marketing people on the witness stand.

> Have your salespeople make express representations that are in contradiction to the labeling.

If your sales force or marketing people are going to make representations about the characteristics or use of the product that undercut or contravene warnings and instructions, you might as well take all the labels off now, for all the good they will do you in court.  Plaintiffs’ attorneys love to find salespeople or advertising materials that minimize, undercut or contradict the labeling. It is important to sensitize the marketing staff of a company to the liability risk created by such representations, as difficult as this might be.

> Take inadequate steps to deliver your warnings to the end user. 

The best warning cannot work if it doesn’t get to the proper person. Are your warnings affixed to the product, or on a throwaway insert? If the product is reusable is the warning durable and indelible A warning worth giving is worth giving twice, or more. Consider putting it on the product, on the insert, and on any packaging. Anticipate the environment of use. In a medical device setting, is an operating nurse likely to be the only one to see the warnings and then discard them? If so, is there a way of delivering them to the physician?

> Ignore feedback from the field.

The creation of warnings is a dynamic, not a static process. As your knowledge or experience of the product grows, you need to consider whether any changes or additions to warnings are called for. What have you learned from field maintenance records, service calls, medical device reports and product liability claims or lawsuits? Are there any trends emerging that suggest there is room for improvement in warnings or instructions? Have you learned of new ways that your product can be misused? It is easy to view incidents as being the result of user error, but remember that user error may be induced by inadequate instructions and warnings regardless of what you conclude to the FDA. Keep an open mind as to the lessons that might be learned from product related mishaps. Resist the temptation to write them off as user error without examining them for feedback on your warnings and instructions.

Furthermore, do not take lightly the role of feedback from the field in creating situations where a “post-sale, pre-accident” duty to warn may be imposed. If there is a claim that the product is defective either in design or for lack of better warnings, you may find that the Court holds that you have a duty to conduct a notification campaign or a recall.

> Ignore what the competition is doing. 

Most companies have competitors. Perhaps their warnings are bigger, better, more detailed or different from yours. When you get to trial you should expect that the plaintiff will show the jury those bigger, better, longer, more detailed or different warnings and argue that if you had followed that path, the injury would have been avoided. What is different isn’t necessarily better, but you must be aware of what is going on in your industry, it is an aspect of  “state-of-the-art”. Custom and practice in an industry are relevant considerations and admissible in court on the issue of negligence and defect. 

At least consider that another company’s material might represent an improvement over your approach. When working on a company’s safety and maintenance manuals, I reviewed the approach used by all of their major competitors and found the competitions' warnings, cautions and instructions to be much more coherent than those of my client. Since my client had lost several product liability lawsuits, I recommended that they draft new manuals ASAP, making suggestions on how this should be done.

 

If you have product liability concerns with FDA's QSR, other FDA regulatory requirements, product liability lawsuits EU's Medical Devices Directives, EU machinery Directive, Product Liability Directive or EU Product Safety Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net

The two previous blogs with this title discussed when warnings are necessary and offered some pointers on creating warnings and instructions. This blog will examine the legal consequences when warnings fail to warn and instructions fail to instruct. A few years ago I participated in a legal seminar on loss control sponsored by an insurance company. The seminar attendees were clients of the insurance company and the participants (mostly defense attorneys) represented the insurance company in various product liability lawsuits. The purpose of the seminar was to learn from past mistakes and avoid similar pitfalls in the future. The defense attorneys stressed that the question isn’t “If you are sued will you be ready?” The question is “When you are sued will you be ready?” What follows are lessons on what not to do.

Some Ways to Lose A Failure To Warn case

> Don’t disclose risks revealed by your hazards analysis. 

A properly done hazards analysis will reveal a number of risks associated with the use and misuse of a product, including information about the probability and severity of harm. The hazards analysis is a road map for the creation of product warnings. It represents your company’s best efforts to analyze the potential risks in a product, to design out hazards, guard against those that can’t be designed out and warn against those that can’t be designed out or guarded against. Therefore, a warning is a last resort. A hazards analysis should be performed by competent personnel who identify and classify all potential hazards, including information about the probability and severity of harm to serve as a basis for drafting warnings and instructions. 

Remember, plaintiffs attorneys dream of discovering risks that a manufacturer knew about and didn’t disclose to the end user. Further, expect plaintiffs’ attorneys to ask for your hazards analysis, design material, ISO 14121-1:2007, ISO 14971:2007, Technical File, etc., and have it examined by experts for flaws.

> Create warnings to compensate for shortcomings in design.    

Warnings are not a substitute for adequate design. If there are feasible design alternatives that will reduce the inherent risk of harm posed by a product, the furnishing of warnings about product hazards, whether obvious or not, will not protect a manufacturer from liability. For example, The Massachusetts Supreme Judicial Council stated;

An adequate warning may reduce the likelihood of injury to the user of a product in some cases. We decline, however, to adapt any rule which permits the manufacturer or designer to discharge its total responsibility to workers by simply warning of the dangers of a product. Whether or not adequate warnings are given is a factor to be considered on the issue of negligence, but warnings cannot absolve the manufacturer or designer of all responsibility for the safety of the product…. Balanced against the somewhat limited effectiveness of warnings is the designer’s ability to anticipate and protect against possible injury. We think that in such a case the burden to prevent needless injury is best placed on the designer or manufacturer rather than on the individual user of a product. (Uloth v. City Tank Corp., 384 N.E.2^nd 1188, 376 Mass. 874, 1978)

The American Law Institute Restatement (Third) of Torts: Products Liability has adopted a new approach to the sufficiency of warning. Comment I provides, inter alia:

Reasonable designs and instructions or warnings both play important roles in the production and distribution of reasonably safe products. In general, when a safer design can reasonably be implemented and risks can reasonably be designed out of a product, adoption of the safer design is required over a warning that leaves a sufficient residuum of such risks. For example, instructions and warnings may be ineffective because users of the product may not be adequately reached, may be likely to be inattentive, or may be insufficiently motivated to follow the instructions or heed the warnings… Warnings are not… a substitute for the provision of a reasonably safe design.

Consequently, manufacturers may, more than ever, bear the burden of eliminating risks by design, not by supplying warnings.

> Have your marketing people design the labeling. 

Marketing likes to sell products, not scare potential customers. Warnings should be devised by an appropriate labeling committee or product safety committee. First of all, that’s who you want to tell the jury designed the labeling, and second, that’s who you really want to design labels so that it delivers the warning and instructions in the most effective fashion. Plaintiffs’ attorneys love to put marketing people on the witness stand.

> Have your salespeople make express representations that are in contradiction to the labeling.

If your sales force or marketing people are going to make representations about the characteristics or use of the product that undercut or contravene warnings and instructions, you might as well take all the labels off now, for all the good they will do you in court.  Plaintiffs’ attorneys love to find salespeople or advertising materials that minimize, undercut or contradict the labeling. It is important to sensitize the marketing staff of a company to the liability risk created by such representations, as difficult as this might be.

> Take inadequate steps to deliver your warnings to the end user. 

The best warning cannot work if it doesn’t get to the proper person. Are your warnings affixed to the product, or on a throwaway insert? If the product is reusable is the warning durable and indelible A warning worth giving is worth giving twice, or more. Consider putting it on the product, on the insert, and on any packaging. Anticipate the environment of use. In a medical device setting, is an operating nurse likely to be the only one to see the warnings and then discard them? If so, is there a way of delivering them to the physician?

> Ignore feedback from the field.

The creation of warnings is a dynamic, not a static process. As your knowledge or experience of the product grows, you need to consider whether any changes or additions to warnings are called for. What have you learned from field maintenance records, service calls, medical device reports and product liability claims or lawsuits? Are there any trends emerging that suggest there is room for improvement in warnings or instructions? Have you learned of new ways that your product can be misused? It is easy to view incidents as being the result of user error, but remember that user error may be induced by inadequate instructions and warnings regardless of what you conclude to the FDA. Keep an open mind as to the lessons that might be learned from product related mishaps. Resist the temptation to write them off as user error without examining them for feedback on your warnings and instructions.

Furthermore, do not take lightly the role of feedback from the field in creating situations where a “post-sale, pre-accident” duty to warn may be imposed. If there is a claim that the product is defective either in design or for lack of better warnings, you may find that the Court holds that you have a duty to conduct a notification campaign or a recall.

> Ignore what the competition is doing. 

Most companies have competitors. Perhaps their warnings are bigger, better, more detailed or different from yours. When you get to trial you should expect that the plaintiff will show the jury those bigger, better, longer, more detailed or different warnings and argue that if you had followed that path, the injury would have been avoided. What is different isn’t necessarily better, but you must be aware of what is going on in your industry, it is an aspect of  “state-of-the-art”. Custom and practice in an industry are relevant considerations and admissible in court on the issue of negligence and defect. 

At least consider that another company’s material might represent an improvement over your approach. When working on a company’s safety and maintenance manuals, I reviewed the approach used by all of their major competitors and found the competitions' warnings, cautions and instructions to be much more coherent than those of my client. Since my client had lost several product liability lawsuits, I recommended that they draft new manuals ASAP, making suggestions on how this should be done.

 

If you have product liability concerns with FDA's QSR, other FDA regulatory requirements, product liability lawsuits EU's Medical Devices Directives, EU machinery Directive, Product Liability Directive or EU Product Safety Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net

Warnings, Instructions & Product Liability Lawsuits #2

In the first segment of this blog, I discussed warnings and instructions vis-à-vis products and product liability lawsuits. This segment will focus on advice for writing warnings and instructions. Writing is a combination of art (it must be visible) and behavioral science (it must be understood by the user). It isn’t simple, but it is vital that it be effective.

Advice for Writing Warnings and Instructions*

• ·      Meet or exceed the laws, standards and industry practices

• ·      Make warnings part of a company-wide product safety/liability prevention effort – look at other documentation such as sales brochures, advertisements, web sites, media presentations, technical specifications, maintenance manuals, safety manuals, etc.

            * (this will help translation costs as well)

Know Your Product and its Physical Environment(s) of Use

• ·      Consider the entire life cycle of the product

• ·      Think of cleaning, maintenance, and service (hazards often show up here that aren’t present during normal operation)

• ·      Understand the intended use

• ·      Consider foreseeable misuse/modification

Know Your Products Real Users

• ·      Language and literacy

• ·      Age, sex, physical abilities

• ·      Skills, training

• ·      Diversity of backgrounds

• ·      Psychological and emotional environment of use

Know Possible Hazards

• ·      Do a hazards analysis (you can’t write warnings and instructions without first conducting a hazards analysis)

• ·      Do a risk assessment (ditto for a risk assessment)

 Respond to Hazards in Terms of Their Potential Harm

• ·      Design them out

• ·      Shield, guard, interlock against

• ·      Warn against

 Focus on the Greatest Danger First

• ·      Put important information first

• ·      Use selective repetition

•      Don’t overload warnings

Focus on Need-To-Know Information

Develop Warnings/Instructions and Product Together During the Design Stage (Work as a Team; Don’t Allow Silo Mentality)

Speak to the Product User as “You”

Use Simple Everyday Language

Use the Active Voice

Be Specific and Concrete (Especially for the Consequences of Actions – Touching the electrical generator when in operation can cause severe injury or death!) 

Keep your Sentences Short

Pay Attention to Type

• ·      Use larger font size

• ·      Avoid all “uppercase”

• ·      Don’t overemphasize with bold type

Pay Attention to Design

• ·      Use white space

• ·      Use lists (bullets, numbered sequence)

• ·      Use headings (to group, to help users navigate the text)

• ·      Avoid justified text

• ·      Avoid centered text

• ·      Remember “form follows function”

Use Visuals as Well as Text

•     Conform to standards
  

• ·    Make visuals big, simple, clear, accurate
  

Consider Multiple Languages (Translation will be critical)

Remember Translation

Test Your Warnings for Usability

Where Possible, Use Pictograms and/or Pictographs

Revisit your warnings periodically

• ·      Look for patterns (problems tend to appear in clusters or patterns)

• ·      Refresh the familiar

• ·      Make sure the information is accurate

• ·      As much as possible, follow the KISS principle (Keep It Simple Stupid)

Summary

As mentioned at the beginning of this blog, warnings and instructions are a mixture of art and behavioral science. When warnings and instructions move from one language and culture to multiple languages and cultures the issue becomes much more complicated. This, of course, applies to CE Marking products for use in the EU’s 27 Member States as well as US manufacturing sites with a diverse ethnic workforce. Idioms frequently do not transfer from one culture and language to another.

For example, while working in Costa Rica on a University of Kansas/University of Costa Rica Ford Foundation Research Grant while in Graduate School, I prepared a set of questions for use with populations in Cartago, Costa Rica; Leon Nicaragua; Fort William (now Thunder Bay), Ontario and Lawrence, Kansas. One of the tests was an Efficacy Test developed at the University of Chicago. Among the questions was, Government is like the weather, everyone talks about it, but no one does anything about it! The respondents could choose between Strongly Agree, Agree, N/A, Disagree, Strongly Disagree.

Respondents in Kansas and Ontario had strong feelings about the question while respondents in Costa Rica and Nicaragua showed no intelligible pattern in response. When I mentioned this to my friend who was the Dean of Arts and Sciences at the University of Nicaragua, he said in my country it is always hot, the only question is whether or not it will rain. The saying doesn’t mean anything here! We then discovered similar responses to other questions, so we had to develop sets of questions that would eliminate the cultural bias and elicit honest responses in all four countries. It took some time to do this.

 

The creation of cultural bias exists when writing warnings and instructions, however, the consequence of misunderstanding won’t be confusion over responses, it will be exposure to serious or potentially lethal hazards. Professional help should be sought before finalizing your warnings and instructions. It is far too serious to be left to amateurs. Everyday, I see warnings and read instructions that are a disaster waiting to happen, not to mention the basis for a product liability lawsuit. If you have product liability concerns with FDA’s QSR, other FDA regulatory requirements, EU’s Medical Devices Directives, EU Machinery Directive & related Directives, EU Product Liability Directive or EU Product Safety Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net.

Warnings, Instructions & Product Liability Lawsuits #1

Several previous blogs have discussed warnings and instructions in regard to medical devices, machinery, electrical equipment and product design, which the EU calls "the principles of safety integration" in its CE Marking new approach directives. To reiterate, a manufacturer first attempts to create a safe design by designing out hazards, guarding against those that can't be designed out and guarding against those that can't be designed out or guarded against.

In the United States, strict liability in tort means the manufacturer is liable if the product is defective regardless of negligence or warranty issues. The manufacturer is considered to be the "expert" in knowledge of the product and of standards in regard to the product. The manufacturer is liable if:

• the product has a defect
• the defect is present when the product leaves the manufacturers control
• the plaintiff suffers injury or damage
• the injury or damage is caused by the defect 

Under product liability law, a product can be defective

·       in design

·       in manufacture

·       in warnings

The manufacturer’s duty is

·       to provide a safe product

·       to provide proper instructions

·       to warn of hazards that are not “open and obvious”

The manufacturer must warn

·       against unreasonable dangers

·       anyone likely to come in contact with the product

·       after the sale as well as before the sale

·       against foreseeable misuse or modification of the product

The greater the degree of danger the greater the duty to warn. Failure to provide adequate warnings can make a product defective.

Warnings and instructions are considered to be inadequate when “the foreseeable risks of harm posed by the product could have been reduced or avoided by the probation of reasonable instructions and warning… and the omission of the instructions or warnings renders the product not reasonably” safe (3^rd Restatement of Torts). The standard is “reasonableness”, no easy guideline exist for courts to adopt in assessing the adequacy of product warnings and instructions… courts must focus on various factors, such as content and comprehensibility, intensity of expression and the characteristics of expected user groups (3^rd Restatement of Torts).

A good warning therefore, meets or exceeds laws and standards, communicates clearly by informing, reminding, getting the user’s attention and helping him/her avoid injury. A good warning seeks to protect the user and a good warning protects the company by protecting the user. While this may seem obvious, warnings and instructions often result in confusion and misunderstanding resulting in injury and giving rise to product liability lawsuits. American National Standards Institute (ANSI) standard Z535.4-2007 states that a good warning protects the user by:

·      identifying the hazard

·      indicating how to avoid the hazard

·      advising of the probable consequences of not avoiding the hazard

·      clearly communicating to the user.

The ANSI focus is the product user’s understanding of information, The word message should be written so that it can be understood by the target audience (i.e., those who are to use and/or service the product). It means choosing words that accurately describe the specific hazard and avoidance information in terms the intended audience will understand.” Warnings that protect the user:

·       attract attention

·       use everyday language

·       contains specific information

·       appear where they are needed

·       focus on the serious hazards.

 A sample of a user warning is:

“WARNING: This product contains chlorine. Missing this product with other household cleansers, such as toilet bowl cleaners, Ross removers, and products containing ammonium, may release deadly chlorine gas. Do not use this product with other chemicals!”

Warnings and instructions go wrong when they

·       assume too much

·       use ambiguous language

·       use confusing language structure

·       speak outside of the user’s world

 Examples of;

 Assuming too much “You can also use the mouse to move a partition into adjacent free space larger than the partition.’

 Using ambiguous language  “Use with adequate ventilation” or “Use proper oil bi-monthly”

 Using confusing structure  “Warnings come too late” or “Passive voice makes responsibility unclear”

 Speaking outside the users frame of reference “Take a piece of resin the size of a walnut” or “The mixing speed can be checked with a digital tachometer”

 Where else can warnings go wrong?

       the language level is too high “assiduously apply yourself”

·       partial or vague information is conveyed “look for gradations of black”

·       inconsistent terms are used “loosen the bolt”

·       jargon ( technical or in-house terms) are used

·       using idioms such as “everybody talks about the weather but nobody does anything about it”

·       weasel words such as “may be” or “it is recommended that”

We have only just begun to explore the topic of warnings and instructions. In the regulated sector, FDA enforces warnings and instructions for Medical Devices and Pharmaceuticals with product liability lawsuits following. In the unregulated sector, product liability lawsuits will come first from plaintiffs’ attorneys. If you have product liability concerns with FDA's QSR, other FDA regulatory requirements, product liability lawsuits, EU's Medical Devices Directives, EU Machinery Directive, EU Product Liability Directive or EU Product Safety Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net

CE Marking Training and Consulting for the Machinery & Medical Devices Directives

In previous blogs I have mentioned working with the California Manufacturing Technology Center (CMTC) during its start up phase. My role was to train their people on CE Marking for the Machinery & Medical Devices Directives and work with various field offices and their clients. Initially, I met with managers in their Hawthorne Headquarters in Los Angeles and then met with interested manufacturers in Long Beach and Ventura. Next I conducted a two-day training session on the EU Machinery and Medical Devices Directives at Loyola Marymount University in West Los Angeles.

Shortly after the preliminary visit I returned to California in March after first working with a Machinery Manufacturer in Buffalo, NY (where it was warm) via Chicago to meet with National Marine Manufacturers Association on a project (where it was chilly) to California (where it was pouring rain) in Ontario, Burbank and Fresno to meet with CMTC staff and interested manufacturers. I only mention the weather because it was a striking contrast to what one would normally find in New York and California at that time of year. The people were interested in CE Marking at all three sites, which resulted in follow-up meetings described in previous blogs.

It was an interesting approach to CE Marking that was being replicated in others states such as New York, where I had given an earlier presentation on CE Marking in Poughkeepsie. Because California and New York did not have a public technical assistance program, they created their own programs using some federal money, state money and charges for services rendered to create a non-profit technical effort to help businesses develop technical capabilities, including the ability to export their goods. CMTC offered assistance for ISO 9001 Quality Management Systems, ISO 14001 Environmental Management Systems, compliance with FDA’s Quality System Regulation and CE Marking products for EU new approach directives such as Machinery, Medical Devices, EMC, Low Voltage and Toy Safety. Working with various CMTC Centers we put together proposals for manufacturers wanting to ship products into the EU. Today, CMTC is known as California Manufacturing Technology Consulting.

The technical delivery system in Georgia is older and more established. Georgia Tech was created by the legislature in 1885 with a desire to build a manufacturing base in the State. The idea of creating Engineering Experiment Stations (EES) was initiated in1919, anticipating federal funding that never materialized. In 1934 EES (now the Georgia Research Institute) opened at Tech with a budget of $5,000 using no federal funds. In 1946 EES used matching state funds for regional economic analysis to identify opportunities for new industry. In 1956, the Industrial Development Branch (IDB) of EES was formed – the first time there was a specific budget for industrial development research at EES. In 1960 the Georgia Assembly passed a bill replacing the 1919 EES legislation and creating an Industrial Extension Service (IES) providing technical assistance to industries.

In 1985 EES became the Georgia Tech Research Institute (GTRI) In 1994, with funding from the Georgia General Assembly to support consortia, academia and government and federal funding, the Georgia Manufacturing Extension Alliance (GMEA) was created and expanded to 18 offices statewide. Georgia is one of 14 states with an Industrial Extension Program. Conceptually, the programs operate similar to the Agricultural Extension Programs created by Federal Morrrill Acts of 1862 and 1890 for Land Grant Universities.

In Georgia as in other states that aspired to improve their industrial base, the effort to create an Industrial Extension Program was considered essential to growth. Historically, Georgia Tech has had a profound effect on the economy of the state. Healthdyne and Scientific Atlanta (now a division of Cisco Systems) are just a few of the industries that started either in a lab at Georgia Tech and/or by a Georgia Tech grad. I first began to teach CE Marking for the Machinery and Medical Devices Directives at Georgia Tech in 1992

In recent years Georgia Tech has nurtured one of the more successful federally funded Centers for Business, Education and Research (CIBER) in their College of Management and in 2008 was awarded a European Union Center of Excellence (EUCE) by the European Commission. I continues to serve on the advisory committee for CIBER, give guest lectures on campus and work with the new European Union Center of Excellence.

 

If you have questions regarding CE Marking to the Medical Devices Directive, Machinery directive and related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net

 

FDA & EU Regulatory Oversight – Medical Device Manufacturers & Supplier Audits

Every medical device manufacturer knows that the quality of their supplies affects the quality of the medical device being manufactured. It is an issue of increasing concern to regulatory authorities as inferior and often toxic materials make their way into the supply chain. Over the past several years I have worked with a number of medical device manufacturers that have experienced problems with vendor supplies.

Sometimes the problem isn’t with the supplies, but with the quality of control that the manufacturer exercises over their vendors. One of the earliest calls I received was from a North Carolina manufacturer of liquid sutures. FDA had inspected their plant and complained that the manufacturer wasn’t auditing key suppliers frequently enough. I was asked to conduct a two-day supplier audit training course and work with the company to develop an audit schedule that would satisfy FDA. They made an excellent product, but were dependent on a few suppliers critical to the quality of their sutures. The manufacturer had to assure FDA that they were in full control of their device quality.

Another medical device company in the Atlanta area manufactured a medical device system to eliminate impacted bowels. The device was sound, but most of the component manufacturing occurred in China, with final assembly occurring at their US manufacturing plant. Both the EU notified body and FDA insisted that the supplier have a certified ISO 9001 Quality Management System in China. They also suggested that some supplier audits were required in order to assure supplier quality.

About the same time I worked with a company in metropolitan Detroit that manufactured (perhaps assembled would be the more appropriate term) barium enema bags and tubes and sold kits. All of the components were made in the US and the kits were assembled at their plant near Detroit. They wanted to CE Mark their products for sale in Europe. The first thing they discovered was that including the barium solution with the kit would require additional approval of a chemical solution in the EU which was not covered by their medical device CE Mark. Therefore, they wisely decided to eliminate the barium solution from their kit and instruct medical personnel to buy the solution at their local pharmacy.

Next, we reviewed the steps required to CE Mark their product and discovered that it was a Class I non-sterile, non-measuring device that would allow the company to self certify without notified body approval. We created an Annex I Checklist, identified the EN harmonized standards, EN 1441:1994 Medical Device Risk Analysis, Technical File (Parts A&B), Authorized Representative and EC Declaration of Conformity. I then mentioned the FDA Quality System Regulation that was coming into effect. While their Medical Device Class I self certification CE Marking requirements did not include an ISO 9001 Quality Management System for their device, FDA did require a QSR quality management system. They said they had been visited by FDA a few years earlier and their cGMP was in good order, to which I responded that the QSR changed its compliance structure.

While I had been brought in to help them with CE Marking and not FDA compliance, in my report to them after the visit, I repeated the admonition to create a QMS that satisfied FDA’s QSR. Approximately six weeks later I received a call from the CEO who said FDA had finished a site inspection and they received five citations in a FDA Warning Letter for not having implemented the Quality System Regulation. He said I guess we should have paid attention to your warning.

For the past five years I have worked with a manufacturer of orthodontic devices in North Georgia. They make different orthodontic devices for dentists who prescribe devices for specific patients. The EU classifies these orthodontic appliances as custom-made devices, but the FDA does not. While my client personally hasn’t experienced supplier problems, several offshore orthodontic manufacturers have been cited for supplier problems, such as importing supplies from unconfirmed sources. As a result, FDA has indicated that they intend to inspect offshore manufacturers more vigorously in the future alarming the manufacturers. FDA concern with orthodontic manufacturers amped up this year with the discovery in the US that a woman suffered pain from a crown made with material that contained lead. The lead had not been disclosed by a supplier from China.

In earlier blogs I have discussed problems with vendors and the analysis of its litigation settlements by a medical devices insurance company. A colleague and I reviewed their record of settlements and identified some of the reasons that these vendors and medical device manufacturers ended up in court. As mentioned previously, while all of these lawsuits were settled out of court, they involved the manufacturers Quality Management Systems. I mention this to dispel a current illusion that FDA’s QSR, ISO 9001 or ISO 13485 are not central to product liability lawsuits.

A few of the findings were:

•    The insurance study found a failure by several new life sciences technology firms to comply with FDA’s Quality System Regulation for vendors and suppliers.

 

•    Often medical device, drug and biologic firms did not apply a basic hazards analysis and risk analysis examination of raw materials or biocompatibility. Further, hazards analyses and risk analyses often did not conform to design specifications for the raw materials and components.

 

•    The study found that contract manufacturers of finished devices often were not aware that such manufacturers must comply with applicable requirements of their quality system and register their establishments with FDA. Further, they were unaware that under certain circumstances both the contractor and manufacturer may be held jointly responsible by FDA for the activities performed. Naturally, product liability lawsuits followed such FDA findings.

 

•    While some manufacturers were diligent in conducting audits and examining the credentials and capabilities of their suppliers and vendors, other manufacturers did not audit sufficiently unless instructed to do so by FDA or an EU notified body.

 

The topic of vendor and supplier quality has emerged as a hot topic over the past three years. Incidents such as toxic heparin being outsourced by suppliers in China and toxic dental materials also being outsourced by suppliers in China have raised serious questions about manufacturer oversight of supplies.

 

In the case of heparin, medical device companies in the US cited immediate medical suppliers in China, such as consolidation laboratories, completely ignoring that the raw material was being prepared in concrete sinks from diseased pigs using water supplies that were dirty and probably infected. In other words, the logic of the US companies that stopped at the doorstep of a laboratory consolidator that couldn’t and wouldn't account for the quality of its basic materials was incredibly ignorant in a global economy. Possibly 80 persons died in the US from toxic heparin.

 

Clearly, medical device, drug and biologic companies will have to account for the total supply chain from its origin to its receipt by them. It isn’t going to be easy and steps need to be taken immediately to prevent further harm. As noted earlier, I expect a considerable amount of product liability litigation will follow these incidents.

 

If you have product liability and risk assessment concerns concerning FDA and EU regulation of medical devices, you can contact me for a free preliminary consultation at theguide1@comcast.net

 

FDA’s QSR, CE Marking Medical Devices & ISO 13485 – Training Medical Device Workers

In the June 5, 2009 blog I discussed teaching a training course on FDA’s Quality System Regulation for a diverse multi-ethnic workforce in California. At the conclusion of the blog mention was made of my work with two IT colleagues to create an FDA QSR training program that could be accessed by companies on the Internet. We also thought that the idea could be extended to the EU’s three Medical Devices Directives and ISO 13485.

To this end the three of us developed a strategy for testing medical device personnel that could be posted on a secure web site and accessed by company personnel on a designated computer(s) with the test results recorded by human relations (or some other appropriate person). The correct answers would be tallied and incorrect answers would receive the correct answer citation from FDA’s QSR, October 7, 1996 Guidance materials, multiple FDA Guidance Documents (that often use the word shall instead of should), and FDA Warning Letters. We allowed for 4 tests per year per employee with the results posted to the employees personnel file.

The rationale for such testing is derived from FDA’s Quality System Regulation. QSR 820.25 Personnel states:

(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to ensure that all activities required by this part are correctly performed.

(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

1.     As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.

2.     Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

Training also is cited in QSR 820.70 Production and Process Controls;
 
(d) Personnel.  Each manufacturer shall establish and maintain requirements for the health, cleanliness, personal practices, and clothing of personnel if contact between such personnel and product environment could reasonably be expected to have an adverse affect on product quality. The manufacturer shall ensure that maintenance and other personnel who are required to work temporarily under special environmental conditions are appropriately trained and supervised by a trained individual.

Since we were dealing with a range of medical device workers, we created true/false, multiple choice and multiple-multiple choice questions for eight categories of personnel from management to quality managers to regulatory managers to production line workers to marketing. The questions covered FDA’s QSR fifteen subparts A to O. Presently we have 2,582 questions and counting. I had an opportunity to test the concept verbally when I taught a CE Marking Training Course to FDA CDRH Division Heads at their Headquarters in Rockville, MD. Naturally, FDA personnel must remain neutral concerning private endeavors, however, the concept was well received.

The most difficult aspect of this venture was finding an acceptable and affordable (to us) Internet server and possibly tying personnel to testing to training and testing. Too many servers were successful in other commercial applications and found our needs a bit quaint. Some servers were pricey. Further, we found human relations often wanted to pay as little as possible (understandable) and to achieve that end desired to “dumb down” the test to the lowest common denominator, which we felt could render the test meaningless. Therefore, we have placed the effort on the proverbial back burner, to be re-visited in the future.

Concerning ISO 13485:2003, no less should be expected from medical device employees concerning personnel testing. For example 6.2 human resources states:

6.2.1 General

Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

6.2.2 Competence, awareness and training

The organization shall

a) determine the necessary competence for personal performing work affecting product quality,

b) provide training or take other actions to satisfy these needs,

c) evaluate effectiveness of the actions taken,

d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and

e) maintain appropriate records of education, training and experience (see 4.2.4 – control of records).

NOTE: National or regional regulations might require the organization to establish documented procedures for identifying training needs.


6.4 Work environment

The organization shall determine and manage the work environment needed to achieve conformity to product requirements.

The following requirements shall apply.

a) The organization shall establish documented requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product work environment could adversely affect the quality of the product (see 7.5.1.2.1 – cleanliness of product and contamination control).

b) If work environment conditions can have an adverse effect on product quality, the organization shall establish documented requirements for the work environment conditions and documented procedures or work instructions to monitor and control these work environment conditions (see 7.5.1.2.1 – cleanliness of product and contamination control).

c) The organization shall ensure that all personal who are required to work temporarily under special environmental conditions within the work environment are appropriately trained or supervised by a trained person [see 6.2.2b) – provide training or take other actions to satisfy these needs].

d) If appropriate, special arrangements shall be established and documented for the control of contaminated or potentially contaminated product in order to prevent contamination of other product, the work environment or personnel (see 7.5.3.1 – Identification).

While I have seen several warning letters issued to FDA regulated medical device companies concerning training and have conducted such training to remedy the issue, I have not seen as much training rigor from EU notified bodies. While both testing and training efforts would have to be conducted respecting FDA & EU requirements, some collaboration is possible that could benefit both regulatory systems. If anyone has an interest in testing, training and/or Internet delivery, please contact me at theguide1@comcast.net

EU & FDA Medical Device Regulations – Enforcement Strategies & Product Liability Lawsuits #2

As mentioned in my July 28 blog, the EU is about to tighten its regulatory oversight of its market with EU Regulation No. 765/2008 of the European Parliament and The council of 9 July 2008 Setting out the Requirements for Accreditation and Market Surveillance Relating to the Marketing of Products and Repealing Regulation (EEC) No. 339/93. The new Regulation sets January 1, 2010 as the date for strengthened enforcement of CE Marking. For me, this welcome news, whether it addresses the shoddy notified body work with the Medical devices Directive I have seen or the indifference to questions about the illegal use of the Machinery Directive and favoritism toward a single notified body I experienced with the Netherlands Competent Authority, remains to be seen. But it is a welcome start.

The focus here is the three Medical Devices Directives. As related in my July 28 blog, FDA has long experience with medical devices oversight and also has an array of powerful enforcement options to protect public health and make certain that medical device manufacturers follow its Quality System Regulation. It also was extremely helpful to FDA to have the EU employ ISO 9001 and subsequently ISO 13485 as conformity assessment options for its three Medical Devices Directives (Active Implantable, general Medical & In Vitro Diagnostic Medical Devices).

The issue of effective enforcement remains to be seen. When I see non CE Marked, false CE Marked and shoddy CE Marked Medical Devices excluded from the market, I will be convinced that regulation 765/2008 has taken effect. It is hard to work with medical device manufacturers (or machinery manufacturers) in the US who can point to other manufacturers who have entered the market doing little or nothing to comply with CE Marking requirements. It is irritating to listen to US engineers say that an EMC Lab assured them that they have tested their products and declared them in full compliance with the EMC and Low Voltage requirements, when you know the lab director’s knowledge of EU requirements is right up there with his knowledge of water quality laws in Ulan Bator. Granted, too many EMC labs previously blessed by a competent body or notified body under the original EMC Directive have charged fees that would make Wall Street Bankers proud.

Enough of recounting past abuses, there are too many. Regulation 765/2008 sets forth a series of definitions in Article 2. Listed below are some of the key definitions:

•    ‘making available on the market’ shall mean any supply of a product for distribution, consumption for use on the community market in the course of a commercial activity, whether in return for payment or free of charge;

•    ‘ placing on the market’ shall mean the first making available of a product on the community market;

•    ‘ manufacturer’ shall mean any natural or legal person who manufactures a product or has a product design for manufacture, and markets that product under his name or trademark;

•     ‘authorized representative’ shall mean any natural or legal person established within the community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter’s obligation under relevant community legislation;

•     ‘technical specification’ shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service;

•     ‘harmonized standard’ shall mean a standard adopted by one of the European standardization bodies listed in Annex 1 to Directive 98/34/EC of the European Parliament and of the of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information Society services on the basis of a request made by the commission in accordance with article 6 of that Directive;

•     ‘conformity assessment’ shall mean the process of demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled;

•    ‘conformity assessment body’ shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection;

•    ‘recall’ shall mean any measure aimed at achieving the return of a product that has already been made available to the end user;

•    ‘market surveillance authority’ shall mean an authority of a Member State responsible for carrying out market surveillance on its territory;

•    ‘CE marking’ shall mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonization legislation providing for its affixing.

‘Placing on the market’ is an EU term that means placing a product in the EU market, whether for money or giving it away. If it isn’t CE Marked but should be CE marked, it is in the market illegally. Depending on the laws of the Member State, the company could be fined, fined and subject to the criminal code and excluded from all 27 EU Member States until reparations and reforms are made. If an EU company tells you they will take care of everything, they can’t! The manufacturer is responsible for placing a product on the market and the answer, “they (a customer) said they will take care of it” or “they (the customer) made me do it” doesn’t cut any slack.

Turning specifically to medical devices, the question is how well the new Regulation will be enforced. Larger member states such as Germany, France, Italy and the UK with established medical device regulatory authorities and smaller states such as Sweden, Denmark and the Netherlands with a history of technical expertise have the regulatory capability to be effective. The newer member states will need assistance from their more seasoned counterparts. The EU Medical Device Vigilance System is well established, but it only applies in extreme medical emergencies. The new market surveillance regulation raises two questions.

First, and most important, what will be used that is comparable to FDA’s Warning Letters, Civil Penalties, Consent Decree for Permanent Injunction and Criminal Sanctions for failing to follow their ISO 13485 Quality System Requirements and Technical File, thereby endangering public health and safety?

Second, it appears that the new regulation is focused on preventing non CE Marked, false CE Marked or shoddy CE Marked products from reaching the market. It is a welcome regulation. It is difficult working with companies in the US who point to all manner of competitors who are doing little or nothing to comply with CE Marking requirements. Personally, I think the new approach directives are a significant contribution to improved product safety in the global marketplace, but they have to be enforced! Not only should they exclude products that are not properly CE Marked and levy appropriate sanctions, but they also should sanction companies in the EU who purchase these products because they are cheaper knowing that they are not properly CE Marked.

Ten years ago, in a letter to the European Commission, Directorate General III, Committee responsible for Medical Devices, I suggested that Member State competent authorities ask for Part A of a manufacturer's Technical File when they come across a suspect medical device. If the medical device company can’t produce Part A or it appears that Part A is incomplete, they could open an investigation. I also suggested that when they came across an EC Declaration of Conformity for a custom made medical device, such as an orthodontic appliance that stated “this product satisfies all of the requirements of Annex I of the MDD” (which routinely appears at the bottom of such declarations) they should ask for Part A of their Technical File or at least ask for their Annex I Checklist. While these are simple requests, requiring little time or energy, they could prove to be particularly effective in improving market surveillance

If you have questions regarding CE Marking to the Medical Devices Directive and other related Directives, and/or product liability concerns, you can contact me for a free preliminary consultation at theguide1@comcast.net

EU & FDA Medical Device Regulations – Enforcement Strategies & Product Liability Lawsuits #1

I have addressed aspects of this topic before in several blogs. This time I want to make it the primary focus of two blogs. FDA’s use of its Quality System Regulation is becoming well established. It also provides an insight into the shape of future US product liability lawsuits.

The EU is about to tighten its regulatory oversight of its market with EU Regulation No. 765/2008 of the European Parliament and The council of 9 July 2008 Setting out the Requirements for Accreditation and Market Surveillance Relating to the Marketing of Products and Repealing Regulation (EEC) No. 339/93. The new Regulation sets January 1, 2010 as the date for strengthened enforcement of CE Marking. This means that the company in western New York selling non CE Marked metal baby cribs to hospitals in the EU (mentioned in an earlier blog) can no longer smile that they are getting away with something and numerous companies selling non CE Marked or falsely CE Marked medical devices can anticipate being fined and thrown out of the EU, but more about that in the next blog.

FDA’s Enforcement Strategies

Now that there is an administration in Washington DC that believes that FDA should enforce the law (underscored by all manner of health disasters this past year with food recalls) we can anticipate stepped up QSR medical device enforcement in the future.

FDA Warning Letters

In my July 26 blog I printed parts of two recent FDA warning letters. An additional recent warning letter should help to emphasize this point.                        

On June 26, 2009 FDA sent a Warning Letter to Saint Jude Medical, inc. in Minnesota informing them, among other things, about the findings from FDA investigators visit to their Plano, Texas plant where Saint Jude manufactured implantable spinal chord stimulation systems. The following violations were cited in bold:

1.    Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a), and failure to document the results of corrective and preventive action activities as required by 21 CFR 820.100(b);

2.    Failure to investigate the cause of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100 (a)(2);

3.    Failure to establish and maintain adequate procedures for validating the device design in order to ensure that the devices conform to defined user needs and intended uses. The design validation must include testing of production units under actual or simulated use conditions, and risk analysis, where appropriate, and the design validation results must be documented, as required by 21 CFR 820.30(g);     

4.    Failure to establish adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria and that acceptance activities are documented and reviewed prior to releasing the device for distribution, as required by 21 CFR 820.80(d) and 820.80 (e);

5.    Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing and evaluating complaints by a formally designated unit to ensure that all the requirements of 21 CFR 820.198 are met.

In responding to the Warning Letter St. Jude was informed:

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in enforcement action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.

FDA Civil Penalties

Another type of FDA action is to impose civil penalties for violations, including:

•    $10,000 a day for clinical trials information that is false, misleading or not submitted to the national registry,
•    $1 million dollars for violating FDA’s Risk Evaluation and Mitigation (REMS) Requirement and up to $10 million in additional fines for violations after notice from the Health & Human Services (HHS) Secretary,
•    $250,000 for the first instance of disseminating false or misleading direct-to-consumer (DTC) ads and $500,000 for each additional violation within a 3 year period advertising after notice from the HHS secretary.

FDA Consent Decrees

Except for Criminal Penalties, a Consent Decree is FDA’s toughest enforcement tool. The largest medical device consent decree to date (November 1999) was levied against Abbott Laboratories for $100 million dollars for failing to comply with FDA’s QSR with the possibility of significant additional fines if they failed to address their problems in accordance with their FDA timeline. Abbott had one year to satisfy FDA requirements or face additional fines. In addition, FDA would oversee Abbott for five years.

FDA Criminal Sanctions

Finally, FDA has the power to levy criminal sanctions. If convicted for a strict misdemeanor crime, a defendant, if an individual, could be jailed for up to one year. They also could be forced to pay a heavy criminal fine and penalties and ordered to “disgorge” profits gained through criminal conduct. In November 1998, a federal jury found Kenneth Thiefault and his wife Mardel Barber formerly of Jupiter, Florida guilty. They were sentenced in the US District Court for Southern Florida to prison terms that together totaled more than 8 years and fines adding up to $100,000 for illegally distributing ozone generators, devices that turn oxygen into ozone, claiming that the devices could cure a variety of diseases, including cancer and AIDS. (Modern day electronic snake oil.) 

Summary

FDA clearly has the ability to levy penalties and sanctions against companies for failing to follow its Quality System Regulation. As noted in a recent blog, enterprising trial attorneys and law firms review warning letters, civil penalties, consent decrees and criminal sanctions vis-à-vis prospective clients who may have experienced medical problems from these devices. For example, immediately after the announcement of the Abbott Consent decree, a Seattle law firm initiated a class-action product liability lawsuit alleging that Abbott “in vitro diagnostic test defects” caused the misdiagnosis of Tropoblast Disease and unnecessary medical treatment for thousands of women.

If you have any product liability, risk assessment or preventive law concerns vis-a vis ISO 9001, FDA’s QSR and other Quality Management Systems, you can contact me for a free preliminary consultation at theguide1@comcast.net

Lawsuits Involving ISO 9001 – Hiding in Plain Sight

I have written extensively about ISO 9001 and product liability lawsuits. A few days ago I received a telephone call from a law firm I have been working with as a legal expert for the past year and a half on a lawsuit involving ISO 9001. He called to tell me that the parties decided to settle their lawsuit out of court and seal the record. Otherwise, I was preparing to fly out to testify next week in a trial concerning my legal findings and observations. The call wasn’t surprising, I’m certain the other party realized that a trial discussing the damage caused by their failed product, their non-response to the failures and their denial that they had any records or documents would be commercially damaging in the media. This also underscores a point made in previous blogs, that almost all ISO 9001 product liability lawsuits are settled out of court.

Unfortunately, most ISO 9001 consultants have convinced themselves that ISO 9001 is impervious to litigation and, of course, any attorney knows that nothing is impervious to litigation. The only surprise to me has been how slow the plaintiffs’ bar has been in using ISO 9001 documents and records to obtain information to support their claims. The exception to this observation is FDA’s Quality System Regulation QSR which combines a good bit of ISO 9001 with FDA’s previous good manufacturing practices. Also, FDA uses the QSR as the principal component in its regulatory structure. Therefore, a reading of FDA 483 warning letters and consent decrees containing elements of the QSR are instructive about the impact of a failed QMS.

A Few FDA Examples to Underscore this Point:

On May 22, 2009 FDA sent a Warning Letter to Crystal Care International in Florida informing them, among other things of their:

1.    Failure to establish procedures for quality audits, as required by 21 CFR 820.22;

2.    Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b);

3.    Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100;

4.    Failure to establish and maintain procedures to control labeling activities as required by 21 CFR 820.120;

5.    Failure to establish procedures for receiving, reviewing and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

The Warning Letter goes on to cite five additional failures to comply with FDA’s QSR. It states the firm’s products are misbranded, their establishment registration is not current and the responses to an earlier FDA 483 were unacceptable. The company has 15 working days to indicate what specific steps have been taken to correct the violations, including an explanation of how the company plans to prevent these violations, or similar violations from occurring again in their Quality management System. They are to include documentation of the corrective action taken.

 On June 5, 2009 FDA sent a Warning Letter to Franz Design, Inc. in Texas informing them that their devices were adulterated within the meaning of 501(h) of the Act (Food Drug and Cosmetics Act), in that the methods used in, or facilities or controls used for, the manufacture, packing, storage or installation are not in conformity with the Current Good Manufacturing Practice (QSR), concerning their:

1.    Failure of the management with the executive responsibility to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization, as required by 21 CFR 820.20;

2.    Failure to establish and maintain procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i);

3.    Failure to validate with a high degree of assurance a manufacturing process whose results cannot be fully verified by subsequent inspection or test, approve validation according to established procedures, and document validation results and activities as required by 21 CFR 820.75(a).

The Warning Letter goes on to cite seven additional failures to comply with FDA’s QSR. The letter additionally states that the company has 15 working days to indicate what specific steps have been taken to correct the violations or similar violations, from occurring again. The company is instructed to include documentation of the action taken. (Failure to promptly address these issue could result in fines and additional actions from FDA.)

These are just two of hundreds of Warning Letters issued by FDA every year. Also, the letters are public. Consequently, enterprising attorneys and law firms review these letters vis-à-vis their clients or prospective clients who may have experienced medical problems from these devices. Clearly, a federal agency that must publicly report what it does is a different oversight entity affecting day-to-day business. It does, however, underscore the product liability vulnerability created by a nonperforming or ineptly performing Quality Management System.

I will return to discuss other aspects of FDA’s QSR and Warning Letters in future blogs. For the moment it serves to illustrate the two-sided nature of Quality Management Systems and product liability litigation. In 1991 I wrote an article Turn Your QMS into a Risk Management Platform: ISO 9001:2000/Risk Management: A Preventive Law Approach in the September 2001 The Informed Outlook. It was the culmination of eight preceding articles discussing ISO 9001: 2000 that had appeared in earlier articles in The Informed Outlook. (I will discuss the concept of a QMS risk management platform at greater length in future blogs)

An ISO 9001: 2008 QMS, or any other quality management system for that matter, would benefit from building risk management preventive law principles into their QMS. This means using the ISO 9001 platform to address product liability exposure and taking steps to reduce that exposure. Failure to do that means that the company’s QMS becomes a platform for supporting a product liability lawsuit. The choice is clear and simple but requires extra effort and consequently will be ignored by most companies. Also, quality managers do not see this as their responsibility and CEOs, CFOs and Corporate Counsel generally are oblivious to the legal opportunity and threat presented by their QMS.

If you have any product liability, risk assessment or preventive law concerns vis-a vis ISO 9001, FDA’s QSR and other Quality Management Systems, you can contact me for a free preliminary consultation at theguide1@comcast.net

Dual Regulatory Compliance – FDA’s QSR & EU’s Medical Devices Directive

In 1998, a client asked if I could help them with a new medical device manufacturing facility they were establishing in rural South Carolina. Previously, I had conducted Medical Device CE Marking training courses for them at their corporate headquarters in Tennessee. The new facility was in fact an old textile mill that had been modified to produce a burn treatment gauze like fabric that could be applied directly to the burn surface and be absorbed by the patient’s body instead of tearing away flesh when it is removed. The material was not a cotton substance, rather it was a special calcium alginate that absorbs exudate and maintains its integrity after absorption at the wound site and on removal. The fabric was combined with a powder and gel and applied to the burn area.

My client wanted me to conduct an audit of the facility to make certain that it would satisfy FDA’s new Quality System Regulation as well as EU’s ISO 9001/EN 49001 (prior to ISO 13485) for the Medical Devices Directive. The Medical Devices product classification was IIb. The site had been visited six months earlier by a Danish notified body for a Pre-evaluation report, Type-examination according to Annex III. The three products manufactured at the site were issued EC Type-examination certificates. FDA issued 510(k) certificates for the same three products.

The Danish notified body asked for greater detail and description of the products, primarily concentrating on the products being manufactured instead of their ISO 9001/EN 46001quality management system. My role was to look at their quality management system operations from the perspective of a FDA Quality System Regulation plant inspection. As should be expected of an established medical device manufacturer, they were well organized and efficient.

While I found some areas needing improvement, I was surprised that the notified body missed these same areas. From previous experience following in the footsteps of a notified body, I often found them to be reasonably strong in their QMS certification and surveillance audits, but weak in their device expertise. In this case the reverse was true.

As we walked through the device manufacturing operation it appeared to be well laid out and the product moved from one stage to another. The biggest problem was clearly demarking the stages. When I asked what was happening, the manufacturing supervisor identified the different operations, but there were no lines or barriers to prevent product from moving forward and skipping a stage. I asked about the containers where a device would be placed when it completed a stage and the manager said the workers kept track of the stages. To me, one container looked like another.

Although, it may be true that the workers knew what they were doing, to an observer the different stages appeared to look like one another. It was a system where mistakes could easily be made. Since FDA is meticulous on production and process controls (CFR 820.70 – 820.75), I suggested that they clearly set boundaries between the stages by partitions, painting lines on the floor or some other step to clearly differentiate one stage from another. The choice was theirs, but it had to be clear.

While watching the production process, I observed one older worker with earphones attached to a radio or CD player walking around near some sewing machines. I asked if the sewing machines were dangerous and the supervisor said yes they could cause significant harm to fingers and hands if a worker were to become entangeled in the sewing operation. I also asked what the older worker with earphones was doing and he said he is receiving on-the-job training. I asked if he had read any material or received any direct instruction from a more seasoned worker and he said no.

I said this will never fly with FDA inspectors. First, the sewing machines needed some sort of barrier so that other workers couldn’t become entangled in the operation and an emergency stop be created should a worker become entangled. Second, on-the-job training has to follow a specific training regimen and the workers need to be tested on what they are supposed to know to safely do their jobs (b) Training Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented. As part of their training personnel shall be made aware of device defects which may occur from improper performance of their specific jobs. [CFR 820.25 (b)(1)] Finally, I said no one can listen to a radio or CD while they are supposed to be focused on doing their jobs. (Today, most likely texting would be the biggest distraction.)

The company made changes in response to the recommendations and called four months later to say thanks. Their FDA plant inspection was successful with no write up by FDA.

Training EU Medical Device Manufacturers on FDA’s Quality System Regulation

 

On October 7, 1996 FDA published its new CGMP Quality System Regulation in the Federal Register. The new regulations went into effect on June 1, 1997 and the full regulation, including design controls, went into effect on June 1, 1998.

In 1997, I conducted Training Courses on FDA Quality System regulation in Manchester & London. Attendees to the training class came from the UK, Ireland, Germany, the Netherlands, Belgium, Denmark and Sweden. They wanted to learn how the QSR differed from the requirements of the EU Medical Devices Directive and ISO 9001. I reviewed the structure of the QSR and compared it to the structure of medical devices directives.

Since FDA, at that time, did not use third parties such as notified bodies (and later would use Conformity Assessment Bodies on a limited basis), it was important to stress that their quality management systems should be in compliance with FDA regulations as well as EU Medical Device Directive regulations. Since FDA does not employ private third parties to oversee its regulatory inspection responsibilities, the first time a European medical device manufacturing facility would see FDA inspectors would be when they visit their site.

Therefore, it would be useful for EU medical device companies to use notified body quality management system certification and surveillance audits as a trial run for potential FDA plant inspections. I stressed that the use of the Technical File for device quality could serve them well for device design and ISO 9001 would provide the quality management system component. The QSR utilized CFR 830.30 Subpart C Design Controls for device design.

The good news was that FDA and the EU had collaborated on creating medical device regulatory structures that complemented each other. Of course this was no accident, because FDA worked diligently with the EU, ISO Technical Committee 210 – General Aspects for Healthcare Products (now known as Quality Management and Corresponding General Aspects for Medical Devices) and the Global Harmonization Task Force GHTF (a joint effort by regulatory representatives from Canada, the EU, Japan and the US). It was and is an impressive collaboration and the only instance where the US Government via a Federal Agency (FDA) has worked with other nations and international bodies to create a collaborative regulatory structure. All other EU Directives have no US Government counterpart regulatory agencies and US industry wanted none created.   

While in Manchester I met two young Irish device designers who had developed an antimicrobial sterile seal on the body for surgical drapes used in laparoscopic surgery. The antimicrobial sterile seal could minimize the chance for infection during surgery. When they first developed the sterile seal they had hoped that they could sell their idea to a major medical device company for further development in clinical trials. Frustratingly, they found no interest at the time, so they secured their own funding and were in clinical trials when I met them. However, they said they had just been contacted by a major American medical device company and would be flying to Massachusetts to meet the President.

Then in one of those “it’s a small world” moments they mentioned the name of the President of the company they were flying to meet. I said I know him, he attended a Medical Device CE Marking Class I taught in New Jersey four years ago. He was a medical device designer in Odessa Ukraine who emigrated to the United States as soon as he and his family could leave Russia. I remembered how excited he was to be able use computer assisted design in developing new devices for the medical device company where he is now president. His son was a student at MIT also excited to use computers and equally excited to read literature, in fact devouring every novel he could find.

In London, the class was equally interested in comparing the QSR and the Medical Devices Directive. We spent time looking at the process of device design in both regulatory frameworks. I mentioned that I thought the Medical Devices Annex I Health and Safety Requirements framework was an excellent way to identify essential requirements when designing a device. We have no such equivalent in the US. Annex I provides an exhaustive checklist. When completed, a designer could then ask what additional requirements might apply to their device. It is a more efficient and I think more exhaustive way to begin device design than try to conjure requirements from scratch. 

The London class was notable for another reason. The training class was held a few days after Princess Diana was killed in the car crash in Paris. After we finished the training session on the first day of the class one of the students said he was going to walk over to her residence at Kensington Castle and asked if I would like to come along. As we approached Kensington we could see large crowds laying bouquets of flowers at the gated wrought iron fence around the perimeter. The flowers were piled several feet high against the fence and extended eight to ten feet from the fence. It was a most extraordinary sight, one that I shall never forget.                                                                           

FDA’s QSR – Training Medical Device Workers

A few years ago, I traveled to Santa Clara, California to train medical device workers on FDA’s Quality System Regulation and how it related to their responsibilities. The company made a device that holds the ribs open after the surgeon makes an incision between the fourth and fifth ribs to allow for bypass surgery while the heart is beating. The device was developed by a heart surgeon in the San Francisco Bay area and had the particular virtue of not requiring that the patient’s chest be cracked open and the patient placed on a heart machine during surgery. As a result, recovery is much faster and trauma to the body is substatially reduced.

The device itself is quite interesting. It is made of a robust plastic material that is a dark hospital blue color and has a knob on top that allows the surgeon to place the device’s plastic fingers that are faced away from each other so that ribs are gripped by the fingers. By turning the knob, the ribs are spread apart to allow the surgeon access to the heart. The device is locked in place during surgery and when the bypass operation is finished, the knob reverses to allow the ribs to resume their normal position. 

One problem experienced by the company is the robust nature of the device itself. Even though the device is labeled for single use only, hospitals have been sterilizing the device and using it multiple times. Of course this is expensive to the company and frustrating because eventually it will fail to operate.  A failure, however, is not a catastrophic problem for the surgeon or patient and consequently the sterilization option is attractive to hospitals. The device designers have contemplated using a porous plastic that would absorb blood and therefore look somewhat disgusting after use, but they had not finalized that option when I was working with the company. The company was a Silicon Valley startup that since has been sold to a major medical company.

The work force was talented, diverse, multi-ethnic and commuted to the plant from all over the San Francisco Bay area.  Consequently, the training program had to be responsive to the work force and to FDA’s Quality System Regulation Training requirement. QSR 820.25 Personnel states:

(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to ensure that all activities required by this part are correctly performed.
(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
(1)     As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.
(2)     Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

Training also is cited in QSR 820.70 Production and Process Controls
(d) Personnel.  Each manufacturer shall establish and maintain requirements for the health, cleanliness, personal practices, and clothing of personnel if contact between such personnel and product environment could reasonably be expected to have an adverse affect on product quality. The manufacturer shall ensure that maintenance and other personnel who are required to work temporarily under special environmental conditions are appropriately trained and supervised by a trained individual.

In addition to a diverse work force, their varied job responsibilities meant that the training program needed to focus on their different job functions as they related to FDA’s training requirements. To accomplish this we divided the employees into smaller groups such as production workers, maintenance workers, quality managers, regulatory managers, management, etc., to more specifically relate to their job functions. I then worked with their managers to divide responsibilities among us and then have each of us rotate so that we worked with each group.

Ultimately the managers would have day-to-day training responsibility and needed to develop a strategy for accomplishing this objective. We also had to be sensitive to the fact that English was a second language for at least 80% of the workers and therefore we needed to make certain that they understood what we were talking about. In time, additional persons would be added to the training team for whom English was a second language.

Personally, I found this task to be pleasantly challenging. My background as a university professor and one who had worked to develop more flexible and responsive educational programs for adults returning to earn a baccalaureate degree was helpful. Also, being able to speak Spanish and having worked on educational programs in Costa Rica, Mexico, Spain and Italy (and having struggled to communicate in other cultures) makes one sensitive to learning new responsibilities in a new language.  

We reviewed the FDA Quality System Regulation training requirements as they related to the medical device being manufactured. In particular, we discussed the requirement that, personnel shall be made aware of device detects which may occur from the improper performance of their specific jobs. Likewise, we discussed training for, personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

We discussed the requirement that, each manufacturer shall establish and maintain requirements for the health, cleanliness, personal practices, including personnel if contact between such personnel and product requirement could reasonably be expected to have an adverse effect on product quality. Finally, we discussed the requirement that, the manufacturer shall ensure that maintenance and other personnel who are required to work temporarily under special environmental conditions are appropriately trained or supervised by a trained individual.

We spent two days on the training exercise and it appeared to go rather well. We elicited input from the various workgroups and asked what would be helpful for them in future training programs. In turn, the instructors debriefed each other to learn what might be done to improve instruction in the future. We also talked about a training timeline to make certain that training was ongoing and that it addressed the critical manufacturing concerns of the company. And we discussed the need for training new employees in the manufacturing plant and the requirement that training records be maintained for all employees.

My experience with this training program subsequently prompted me and two IT colleagues to create an FDA QSR training program that could be accessed on the Internet. We also think this training effort could be extended to the EU’s three Medical Devices Directives. Our efforts to date are not complete but we think the idea has great promise for the future. This training concept will be discussed in future blogs.

If you have concerns with FDA's QSR, other FDA training requirements, the EU's Medical Devices Directives training requirements, you can contact me for a free preliminary consultation at theguide1@comcast.net

FDA’s Quality System Regulation – Medical Device Classification: A Case Study

Recently, I worked with a company in North Georgia that manufacturer’s regulators for industrial and medical use. While most of their business involves industrial regulators, their medical device business has been growing and becoming more profitable. They have partitioned off a separate area of the plant for manufacturing their medical regulators. Because they are manufacturing medical regulators for oxygen, air, carbon dioxide and nitrous oxide, their manufacturing processes must satisfy FDA’s Quality System Regulation (QSR). I conducted a GAP Analysis of their manufacturing operations and we discussed some modifications to improve their compliance with the QSR.

One area of concern, however, was the classification of their nitrous oxide regulator as a Class I medical device. In one of FDA’s design guidance documents, “DO IT BY DESIGN: An Introduction to Human Factors in Medical Devices”, December 1996, FDA described an oxygen control valve on page 6 where a physician treated a patient with oxygen and set the flow control knob between the numbers 1 and 2 liters per minute, not realizing that the scale numbers represented discrete instead of continuous flow settings. In other words, there was no oxygen flow between the numbers 1 and 2 even though the control knob rotated smoothly (and did not click on the numbers) suggesting that intermediate settings were possible. The patient was an infant and became hypoxic causing brain damage before the error was discovered. Similar errors have occurred where the medical device designer did not attempt to understand how a physician or health-care worker would interpret a flow control knob.

The nitrous oxide regulator manufactured by my client was designed to be used by dentists as a mild anesthetic and analgesic in dental surgery. The nitrous oxide regulator was an infinitely variable valve allowing the dentist to determine how much or how little nitrous oxide would be administered to a patient. Rather than submit a 510(k) for a Class II medical device, my clients believed that their regulator should be classified as a Class I medical device. I called FDA and asked how I might proceed. They suggested that I file a 513(g) device classification request with the FDA 513(g) Coordinator.

I submitted the request contending that the classification of the nitrous oxide regulator should be a Class I medical device equal lead to Class I oxygen regulators for the following reasons:

•    The definition given for a pressure regulator in Section 868.2700 is, “a pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure.”

•    We believe that the definition is generic and should include all pressure reducing regulators used for medical purposes.

•    Oxygen regulators and nitrous oxide regulators manufactured by my client function identically. The purpose is to convert medical gas pressure from a high variable pressure to a lower more constant working pressure.

•    The nitrous oxide regulators manufactured by my client should not be confused with anesthesia analyzers defined in 868.1700, “A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide and anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.” The analyzer, which is a Class II device may contain one of my client’s regulars, but the regulator does not “measure the concentration of nitrous oxide.” It simply "converts nitrous oxide from a high variable pressure to a lower were constant working pressure,” as described in section 868.1700. Therefore, we believe that my client’s regulator should be treated as a Class I medical device. The Class II classification belongs to whatever company incorporates my client’s regulator into their anesthesia analyzer.

•    Even if my client’s nitrous oxide regulator is used as a freestanding device in the dentist’s office, the principle of operation of the regulator is, “to convert gas pressure from a high variable pressure to a lower more constant working pressure.”  The dentist determines the actual amount of nitrous oxide administered to a patient by adjusting the amount of the nitrous oxide flow through an infinitely variable valve allowing the dentist to determine how much or how little nitrous oxide they choose to administer to a patient.

We then enclosed a detailed description of oxygen and nitrous oxide regulators and my client’s catalog as well as individual pages describing the regulators. All the information is available at their website, along with a copy of the Instruction Manual sent out with each regulator and copies of the device label. We also enclosed copies of regulators from the FDA Device Listing Database that we considered to be predicate Class I devices comparable to my client’s nitrous oxide regulators.

Subsequently, we received a letter from FDA agreeing with our analysis that my client’s nitrous gas regulator was a Class I medical device. It was a satisfying moment. The company also fine-tuned their quality management system to improve their compliance with FDA’s Quality System Regulation.

If you have classification concerns with FDA's QSR, you can contact me for a free preliminary consultation at theguide1@comcast.net

CE Marking Medical Devices – Disposable Lasers for Retina Attachment

In 2000 I worked with a company in suburban St. Louis that made disposable lasers for attaching the retina to the back of the eye. In addition they made a disposable device for cauterizing blood vessels in the eye and devices (cannulas) for removing the fluid from the eye and introducing silicon oil into the eye after surgery was completed. They wanted to CE Mark their devices for the EU. Because this also was the time when FDA’s Quality System Regulation (QSR) was recently mandatory, the company wanted a strategy for implementing a quality management system that would encompass both FDA’s QSR and ISO 9001 (later ISO 13485).

On my first visit on site, we reviewed their manufacturing operation and their quality control procedures. When asked about their design files, the chief engineer walked over to a file cabinet, pulled open a drawer and said these are our design files pointing to a design file with a few notes. Since FDA hadn’t implemented their mandatory design requirement as a part of their Quality System Regulation until June 1, 1998, this had been an acceptable response, but going forward they would have to implement FDA’s QSR 820.30 Design Controls requirement along with the rest of the QSR. Concerning CE marking to the Medical Devices Directive, an ISO 9001 system would be mandatory.

The first step was to cluster their devices into product families and then determine the product family classifications. After examining their devices, we created three product families: retinal lasers, the retinal cauterizing device and the cannulas for removing and introducing fluids into the eye. The most complex devices were the disposable lasers and the disposable cauterizing device because they were electric. Following the classification steps in Annex IX, we concluded that the device classification was Class IIa.

1.Definitions for the classification rules

1.1. Duration
      Transient
      Normally intended for continuous use for less than 60 minutes.

1.2 Invasive device
     A device which, in whole or in part, penetrates inside the body, either through a body
     orifice or through the surface of the body.

    Surgically invasive device
     An invasive device which penetrates inside the body through the surface of the body, 
     with the aid or in the context of a surgical operation.

1.4 Active medical device
     Any medical device operation of which depends on the source of electric or energy or
     any source of power other than that directly generated by the human body or gravity
     and which asked by converting this energy.

2.3 Rule 7
     All surgically invasive devices intended for short-term use are in Class IIa

The same classification applied to the disposable cauterizing medical device. Since the cannulas were simple metal tubes that had to be sterilized before use they came under

Rule 6 All surgically invasive devices intended for transient use are in Class IIa unless they are:
--reusable surgical instruments, in which case they are in Class I.

This classification, however, has been changed to Class IIa under Directive 2007/47/EC that amended the original Medical Devices Directive 93/42/EC.

Once the classifications were established, the company began to modify its existing ISO 9001 Quality management System to satisfy the Directive’s conformity assessment requirements. For the EU, their notified body would hold them accountable for an ISO 9001 QMS not including examination of the design of the device (Article II, Clause 3a). However, FDA would hold them accountable for their quality management system and design. I recommended that, since they had to include design to satisfy FDA’s QSR, they should build a full ISO 9001/FDAQSR to satisfy both sets of requirements.

Three Product Family Technical Files (Parts A&B) were created with an Annex I Checklist, a list of the EN harmonized standards that allowed for a demonstration of conformity to the Essential Requirements, the Risk Analysis Standard, the Quality Manual & Procedures, the list of Standard Operating Procedures (SOPs) needed to satisfy the Medical Devices Directive, the EC Declaration of Conformity and the Authorized Representative.

At this point we discussed the common requirements between FDA’s QSR and ISO 9001 and the separate compliance requirements needed to satisfy each regulatory system. We also discussed conducting separate internal audits until the differences were clearly understood. At the point they could continue separate internal audit protocols or combine them. We also spent some time walking through the specific design requirements of FDA’s QSR and how they would address design in the future.

Perhaps the most surprising discovery after an extensive Risk Analysis/Hazards Analysis was to learn that the disposable lasers that plug into a laser power source presented a low safety hazard. The engineer noted that the equipment was low tech. The high tech part of this type of surgery is the skill of the eye surgeon.

If you have product liability concerns with ISO 9001, FDA's QSR, ISO 13485 or EU's Medical Devices Directives you can contact me for a free preliminary consultation at theguide1@comcast.net

FDA & Product Liability Lawsuits – Medical Drug & Device Labeling, Warnings & Instructions #3

This blog follows the May 14 & May 18 blogs to complete my discussion of FDA requirements for Medical Drug & Device Labeling, Warnings & Instructions, which FDA calls Misbranding, False or Misleading Labeling, Adequate Directions for Use and Labeling for Sterile devices.

Sterile Devices

Special attention must be given to the labeling of sterile devices. In some cases, sterility may be needed only for a portion of certain devices and this condition should be clearly identified in the labeling. Devices that are not sterile in their entirety should be labeled to properly inform users what is actually intended to be “sterile” in the package. An example of a possible limiting statement might be:

“Caution: Only the fluid path of this set is sterile and nonpyrogenic. Do not use in a sterile or aseptic area without proper precautions.”

The label all of multi-device kits containing a combination of sterile and nonsterile products will be considered to be false or misleading if it implies that all contents are sterile.

Some devices are intended to be sterilized by the user before use. In this situation, the labeling should provide adequate information about suitable methods of sterilization and any precautions or safeguards to be followed. For example, labeling should describe any:

•    special cleaning methods required;

•    changes in the physical characteristics of the device that may result from reprocessing which affect its safety, effectiveness, or performance; and

•    limit on the number of times resterilization and reuse can be done without affecting the safety or effectiveness of the device.

In the case of single-use devices, many manufacturers include labeling to advise against resterilization and reuse. Some devices are not designed or constructed to be re-cleaned, and may not be capable of withstanding the necessary re-cleaning and re-sterilization procedures. Where reuse is a common practice, manufacturers are encouraged to provide the information described in the bulleted list.

The need for users to have instructions on how to open a sterile device package to avoid contamination of the device also needs to be evaluated. When necessary, such instructions should be included in the labeling.

If a manufacturer modifies a device, the manufacturer also should review the labeling to ensure that it reflects current revisions and specifications. Thus, change control forms should contain a check-off box for labeling and packaging. Some manufacturers identify labeling with a drawing number plus a revision code or date as an aid in identifying current labeling. The package insert or other labeling for in vitro diagnostic products is required to contain the revision date [21 CFR 809.10(b)(15)].

 Shelf-life dating solely for package integrity and stability is not usually required for general medical devices. (It should be noted that the EU has more stringent shelf-life requirements, than the FDA.) There may be a need for expiration dating when a particular component of the device, such as a battery or diagnostic reagent, has a finite useful life. Labeling for in vitro diagnostic devices [809.10(a) and (b)] requires an expiration date or some other means by which users may be assured of quality at the time of use. This requirement applies to both sterile and nonsterile in vitro diagnostic devices.

Although not required by regulation, most manufacturers of complex devices and sterile devices voluntarily use lot or serial numbers for production control and, if the need arises, to expedite failure investigations, repairs, modifications, or recalls. Lot, batch, or other control numbers are required for:

•    Implantable and life-sustaining devices [820.65, traceability];

•    Some products subject to radiological health standards [1002.30(b)(1), records to be maintained by manufacturers]; and

•    In vitro diagnostic devices [809.10(a)(9), labeling for in vitro diagnostic products].

FDA has several guidance documents that can be used for help in labeling drugs and devices. They deserve close attention. In addition they have guidance documents about writing, e.g. “write to the reader”, “refer to the actual device”, “don’t distract the reader”, make it “ short and to the point” (to which could be added the KISS principal, keep it simple stupid), “avoid gobbledygook”, “introduce each item”, “ use accurate key terms” and “select words wisely.”

Test Labeling

It is critical to have someone not familiar with the product test the labeling by operating the device according to the draft instructions. There should be no coaching. During the trial test period, problems should be noted and corrections made.

Label Integrity

FDA states that all labels shall be designed and applied to devices and containers so that the labels will remain in place and legible during the customary conditions of distribution, storage, and use [820.120(a). Likewise, other labeling such as user instructions should remain legible during customer storage and use. Labeling printed by machines onto plastic in vitro diagnostic media plates often is smeared and therefore inadequate [FD&C 502(f)]. (One of my clients in California had labeling for device dosage amounts for individual patients blurred prompting a quick recall, new packaging and labeling and resulting in an internal reorganization in their quality department.)

Approval Policy and Procedure

The review of labeling from the design stage through to the finish device must be documented just like the review of other significant components. This includes labeling development, any changes, and final approval. Documentation should be included in the Design History File of procedures used, signature of the responsible person, and date.

Before release for use, labeling should be reviewed and approved by product development, service, marketing, quality assurance, and other appropriate managers (see 21 CFR 820.30 Design Controls). Manufacturers must have a policy/procedure that covers the drafting, review, and approval of labeling. Approval forms are generally developed and used in conjunction with such a policy/procedure. The procedure also should cover a correct Device Master Record, correct transfer of labels into production, lot control, change control, etc.

Design Transfer

Finally, a design must be transferred in accordance with 21 CFR 820.30(i) Design transfer, Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

Conclusion

Labeling, warnings and instructions have been the source of a significant number of FDA drug and device company sanctions and have become the basis for numerous product liability lawsuits. It is a significant component of the design process and post-production complaints. It requires competent professional attention.

If you have product liability concerns with FDA's QSR, other FDA regulatory requirements, product liability lawsuits EU's Medical Devices Directives, Product Liability Directive or EU Product Safety Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net

FDA & Product Liability Lawsuits – Medical Drug & Device Labeling, Warnings & Instructions #2

This is a continuation of the May 14 blog. As noted earlier, there are two aspects to drug & device labeling warnings and instructions. First the design steps that must be taken when the drug or device is being designed. Following the principle of safety integration: design out hazards, guard against those that can’t be designed out and warn against those that can’t be designed out or guarded against. This must occur when the drug or device is being designed and revisited if a design change is required. It is a part of a rationale design process.

Second, Section 502(f)(1) & (2) of the Food, Drug & Cosmetics Act (FD&C) requires that device labeling bear adequate directions for use, operating and servicing instructions, and either adequate warnings against uses dangerous to health, or information necessary for the protection of users. All devices require directions for use unless specifically exempted by regulation. Conditions for exemption from this requirement are in 21 CFR 801, Subpart D.

False or Misleading Labeling

Section 502(a) of the Food, Drug & Cosmetics Act states that a drug or device is misbranded if its labeling proves false or misleading in any particular.  It is not a necessary condition that labeling should be flatly and blatantly false for the FDA to take action. The word “misleading” in the FD&C Act means that labeling is deceptive if it creates or leads to a false impression in the mind of the reader. A “false impression” may result not only from a false or deceptive statement, but may be instilled in the mind of the purchaser by ambiguity and indirection. It might be caused by failure to inform the consumer of facts that are relevant to statements already made. In other words, a label that remains silent concerning certain consequences may be as deceptive as a label that contains extravagant claims.

Examples of mislabeling include: ambiguity; half truths; trade puffery; expressions of opinion or subjective statements; and failure to reveal material facts, consequences that may result from use, or the existence of differences of opinion. In the past, labeling found by FDA to be objectionable has featured such practices as: deceptive pictorial matter; misleading testimonials; misleading lists of parts or components; and brand or trade names instead of “established names” (see Sections 201(h), 502(e)(2), and 508 of the FD&C Act.) examples of false representations are:

•     incorrect, inadequate or incomplete identification;

•     unsubstantiated claims of therapeutic value;

•     inaccuracies concerning condition, state, treatment, size, shape, or style;

•     substitution of parts or material;

•     subjective or unsubstantiated quality or performance claims; and,

•     use of the prefix U.S. or other similar indications suggesting government or agency approval or endorsement of the product.

 Adequate directions for Use

Title 21, CFR Part 801.5, defines “adequate directions for use” as “directions under which the layman can use a device safely and for the purpose for which it is intended.” See Part 801.4 for a definition of “intended use.” Other reasons that directions for use may be inadequate is a partial or total omission or incorrect specification of one or more of the following items:

•    Statement of all conditions, purposes, or uses for which the device is intended. This includes conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising. This statement also includes conditions, purposes, or uses for which the drug or device is commonly used. These statements should not refer to conditions, uses, or purposes for which the drug or device can be used safely only under the supervision of a practitioner licensed by law; those conditions, uses, and purposes may only be referred to in advertisements directed to a licensed practitioner.

•    Quantity of dose including usual quantities for each intended use and usual quantities for persons of different ages and physical conditions.

•    Frequency of administration or application.

•    Duration of administration or application.

•    Time of administration or application in relation to meals, onset of symptoms, or other time factors.

•     Preparation for use, adjustment of temperature, or other manipulation or process.

Prescription Devices

Labeling exemptions for prescription devices are in 21 CFR Part 801.109. These are devices which because of a potential for harmful effect, potential for misuse, or the collateral measures necessary to use, are not safe except under the supervision of a practitioner licensed by law. Hence “adequate directions for use” cannot be prepared for these devices. They are exempt from section 502(f)(1) of the FD&C Act provided that all conditions specified in the labeling regulation are met.

These conditions state that the device shall be in possession of a person, or his or her agents, or employees regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale distribution of prescription devices; or the possession of a practitioner such as a physician, dentist, or veterinarian licensed by law to use or order the use of these devices. The devices can be sold only to, on the prescription of, or by the order of such a practitioner for use in the course of their professional practice.

 The label of the prescription device, other than surgical instruments, is required to bear:

•    The statement “Caution: Federal law restricts this device to sale by or on the order of a ________”, the blank to be filled with word “physician”, “dentist”, “veterinarian”, or with the descriptive designation of any other practitioner licensed by the law of the State in which he or she practices to use or order the use of the device; and 

•     The method for its application or use.

Labeling on or within the package from which the device is to be dispensed shall also bear information for use under which the practitioners licensed by law to administer the device can use the device safely and for the purposes for which it is advertised or represented. This labeling information includes indications, effects, dosages, routes, methods, frequency, and duration. Safety labeling includes relevant information on hazards, contraindications, side effects and precautions.

When a device is capable of producing serious injury, even when used by a person thoroughly familiar with its operation, the directions for use shall provide detailed information. FDA has specific regulations on the labeling of intrauterine contraceptive devices, 21 CFR 801.427, and for diagnostic x-ray devices, 21 CFR 1020.30(h). In addition, FDA has issued general guidance for labeling certain devices, i.e., transcutaneous electrical nerve stimulators and electronic muscle stimulators.

Where appropriate, directions for use should be supplemented with adequate warnings against the use of the drug or device under certain conditions. Any caution statement, similar to the directions statement, may appear in the labeling of the product; it is not necessary that it be printed on the label. In each instance, the responsibility for the adequacy of the warning statement appearing on labeling rests with the manufacturer or distributor. For some devices there are national consensus standards that specify that certain caution statements be on the device. There is no list of prescription devices in the CFR.

Part three of this blog will examine FDA requirements for labeling sterile devices. As noted previously, for any drug or device company intending to sell their products in the United States, these FDA requirements should be given special attention, both to satisfy regulatory requirements and to avoid expensive product liability litigation. For companies CE marking medical products for Europe, it would behoove them to study FDA requirements and any additional EU requirements regarding labeling, warnings and instructions. Part three also will examine the product liability consequences of inadequate labeling and instructions. Almost daily, the news media report adverse health consequences of inadequate or misleading labeling.

If you have product liability concerns with FDA's QSR, other FDA regulatory requirements, product liability lawsuits EU's Medical Devices Directives, Product Liability Directive or EU Product Safety Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net

FDA & Product Liability Lawsuits – Medical Drug & Device Labeling, Warnings & Instructions #1

While I have discussed some aspects of drug & device labeling, warnings & instructions in previous blogs, I want to emphasize the critical role they play in product liability lawsuits. Too often labeling, warnings & instructions are an afterthought for drug and device companies. Foreseeable use and foreseeable misuse must be considered for every drug and device on the market. It is an integral part of the design process. It is the reason that hazards analysis and risk analysis are a fundamental element of design. To this should be added human factors analysis – how do people understand the warnings, cautions and user instructions?

Basically, there are two aspects to drug & device labeling warnings and instructions. First, the design steps mentioned in the previous paragraph and blogs must occur when the drug or device is being designed. Following the principle of safety integration; design out hazards, guard against those that can’t be designed out and warn against those that can’t be designed out or guarded against. This must occur when the drug or device is being designed and revisited if a design change is required. It is a part of a rational design process.

Second, Section 502(f)(1) & (2) of the Food, Drug & Cosmetics Act (FD&C) requires that device labeling bear adequate directions for use, operating and servicing instructions, and either adequate warnings against uses dangerous to health, or information necessary for the protection of users. All devices require directions for use unless specifically exempted by regulation. Conditions for exemption from this requirement are in 21 CFR 801, Subpart D.

The term label has a very specific meaning to the FDA. Section 201(k) of the (FD&C) defines the term “label” as “a display of written, printed, or graphic matter upon the immediate container of any article…” Under section 201(l) of the FD&C the term “immediate container” does not include a package liner. Any word, statement, or other information appearing on the immediate container should also appear on the outside container or wrapper, if any, of the retail package or be easily legible through the outside container or wrapper. The label is not required to appear on the shipping carton.

Section 201(m) of the FD&C Act defines the term “labeling” as all labels and other written, printed or graphic matter: (1) on the device or any of its containers or records, or (2) accompanying the device. The term applies any time while the article is in interstate commerce, or being held for sale after shipment or delivery in interstate commerce. The term “accompanied” is interpreted liberally. It extends to posters, tags, pamphlets, circulars, booklets, direction sheets, fillers, etc., that may be displayed in proximity to the article or shipped to the user before or after shipment of the device.

Another aspect of FDA regulation should be given careful consideration is the distinction between labeling and advertising, while both draw attention to the article to be sold, it is often nebulous or superficial. The FDA considers both to be forms of publicity and that they are used for identical purposes. An appellate court described the relationship between the two as follows: most, if not all, labeling is advertising. The term ‘labeling’ is defined in the act [FD&C Act section 201(m)] as including all a matter of accompanying any article. Congress did not, and we can, exclude from this definition printed matter which constitutes advertising. To this should be added websites, published advertisements, circulars, etc.

Therefore, in addition to integrating labels, warnings & instructions as a part of the design process, a company must be aware of FDA’s regulatory requirements and oversight, it is necessary to understand the terms Misbranding, False or Misleading Labeling & Adequate Directions for Use. Failure to understand these terms can result in FDA sanctions that almost certainly will be followed by product liability lawsuits. Remember that FDA sanctions are available through the Freedom for Information Act (FOIA). (This is the first of two blogs addressing this subject.)

Misbranding

Section 502 of the Food Drug & Cosmetics Act contains the misbranding provisions for drugs and devices. It states that a device is misbranded under a number of different circumstances. These include:

•    The labeling is false or misleading.

•    The packaging does not bear a label containing the name and place of business of the manufacturer, packer, or distributor, and an accurate statement of the quantity of the contents.

•    Words, statements, or other required information are not prominent on the labeling or not stated clearly.

•      It is intended for human use, and the label fails to state the name and quantity or proportion of any narcotic or habit-forming substance contained in the product, and fails to display the statement, “Warning: May be habit forming.”

•    Its label does not contain adequate directions for use. These include warnings against use in certain pathological conditions; against use by children where its use may be dangerous to health; and against unsafe dosage, methods, duration of administration or application unless exempt as unnecessary to protect public health.

•    It is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling.

•    It does not comply with the color additive provisions listed in Section 706 of the Food, Drug & Cosmetics Act.

The Medical device Amendments expanded the authority of the Food, Drug & Cosmetics Act over misbranded devices. These amendments contain further circumstances under which a device is misbranded. 

•    The device’s established name (if it has one), name in an official compendium, or including common or usual name, is not printed prominently in type at least half as large as used for any proprietary name.

•    The device is subject to a performance standard and it does not bear the labeling requirements in that standard.

•    There is a failure or refusal to comply with any requirement prescribed under Section 518 on notification and other remedies; failure to furnish material or information requested by or under Section 518; or failure to furnish any materials or information requested by or under Section 519 on records and reports.

•    The device is commercially distributed without FDA concurrence ob a 510(k) premarket notification number.

Part two of this blog will examine False or Misleading Labeling, Adequate Directions for Use and Labeling for Sterile devices. For any drug or device company intending to sell their products in the United States, these FDA requirements should be given special attention, both to satisfy regulatory requirements and to avoid expensive product liability litigation. For companies CE marking products for Europe, it would behoove them to study FDA requirements and any additional EU requirements regarding labeling, warnings and instructions. While the EU is not as litigious as the US, litigation is beginning to gain traction in some EU member states such as the UK and Germany. Therefore special attention should be given to the EU Product Liability Directive and Product Safety Directive and EU member state court decisions. (These Directives will be discussed in a future blog.)

If you have product liability concerns with FDA's QSR, other FDA regulatory requirements, product liability lawsuits EU's Medical Devices Directives, Product Liability Directive or EU Product Safety Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net

FDA QSR & EU Medical Devices Compliance Gap Analysis – A Case Study #2

One of the objectives of the Health Care Company described in A Case Study #1 was to extend CE Marking manufacturing throughout the entire company and not keep it restricted to its Arizona manufacturing site. To that end the company asked if I would give an overall presentation on FDA’s QSR and CE Marking medical devices in Spanish to a group of managers of their machilidoras at a site in Nogales, Arizona while my colleague examined two of their machilidoras in Mexico as part of our Gap Analysis. This also afforded time for me to ask questions of the managers concerning their operations.

Meanwhile, my colleague examined two of the Company’s Mexican facilities. All in all she found them to be operating in accord with the Medical Devices Directive, except that that male workers in the clean rooms were reluctant to cover their beards and hair with hairnets and on one occasion she watched a male worker jump upon the table with his street shoes where they were cutting surgical shields to be more efficient in cutting. Needless to say, his actions compromised the integrity of the shields and the clean room operation. Other than that incident, the clean rooms appeared to be well managed.

From Arizona, we traveled to some of the other manufacturing plants in the Southeast and Midwest that were manufacturing devices for the US Health Care Market. The plants were not involved in design, instead they were manufacturing to specifications from the design group in the corporate office, which meant that their quality management systems were ISO 9001, exempted from design. Later we would return to these plants to conduct CE Marking Training for Medical Devices and FDA’s Quality System Regulation.   

Finally, we returned to re-visit the corporate office before writing the Gap Analysis and making a presentation to the President and his staff. Our visit to the Arizona manufacturing plant made it clear that design was not being done in Arizona, instead it was being generated by the design team at corporate headquarters and then shipped out to Arizona for implementation. What the managers at the Arizona site called design, was actually implementation. Further, the Technical Files had been developed at the corporate office. This, of course, became one of the observations in our final report.

The Gap Analysis covered the entire global Health Care design and manufacturing operation. Since FDA’s QSR contained more design requirements than ISO 9001, we spent some time discussing the differences, emphasizing the need for a tight design protocol paying strict attention to recording all of their activities concerning the elements of QSR 820.30, including design risk analysis, production risk analysis and delivery risk analysis. In particular, since they would not let FDA look at their design processes before FDA adopted its QSR, we suggested that they should be prepared to expect an FDA inspection in the near future. Their full compliance with the QSR should be in place.

Concerning customer complaints, we observed that while most of the persons handling complaints were nurses familiar with their health care products, some of the new hires were not fully conversant with their health care products and did not fully understand how to classify some of the complaints. They also were unsure when a complaint should be escalated to top management. We recommended that they institute a training program for complaint handling personnel. We also suggested that they re-visit how they were handling complaint handling in the EU and globally.

We shared our observations concerning their CE Marking efforts, noting the fact that the Arizona design and manufacturing operation was not independent as they thought. We also shared our observations about the fact that their notified body missed the design breakdown between the corporate office and the Arizona site, the origination of their Technical Files from the corporate office and the identification of the corporate office on their shipping containers instead of the Arizona manufacturing operation.

We also emphasized that they needed to re-visit their entire CE Marking operation at the corporate level so that they had an integrated and cohesive operation, including their new manufacturing plant in the EU. (They soon created a new EU operating division under the supervision of a new vice-president located in the EU.) We also suggested that they institute a comprehensive training program at corporate headquarters and all of their manufacturing sites. Finally, among the recommendation’s we made was that they create a regulatory position and fill it as soon as possible. When we finished our presentation, the President said, with a grin, “Do we have to do this?” To which my colleague responded, “Unless you think you look good in a striped suit, the answer is yes!”

Postscript: One month after our visit we received a paniced call from the Arizona plant saying that their UK notified body had just informed them that their plant had two major non-conformities that had to be resolved within a month. The plant manager said, “After five surveillance audits, you are telling us this?” To which the notified body representative responded that they had just received their audit results from the UK Competent Authority who told them they had to make several corrections in the audits of their clients and they had to inform their clients of this action or they would lose their notified body status. Fortunately, the company was able to eliminate its non-conformities within a month and continue CE Marking its devices.

If you have product liability concerns with ISO 9001, FDA's QSR, ISO 13485 or EU's Medical Devices Directives you can contact me for a free preliminary consultation at theguide1@comcast.net

FDA QSR & EU Medical Devices Compliance Gap Analysis – A Case Study #1

A few years ago a colleague and I met with the new President of the Health Care Division of a major east coast US multinational corporation. They wanted us to conduct a Gap Analysis of their business and its compliance with FDA’s Quality System Regulation and the EU’s CE Marking Medical Devices Directives. At that time they were transitioning from ISO 9001 to FDA’s QSR and their CE Marking activities were confined to a single manufacturing plant in Arizona.

To accomplish this objective we first met with the President and his staff at their corporate headquarters, traveled to Arizona to examine their CE Marking operations, traveled to Mexico to examine their maquiladora plants and traveled to various manufacturing plants in the US before returning to the corporate office to present our report and recommendations. When we were finished they asked us to conduct FDA QSR & CE Marking training at various plants in the US. They also had plants in Central America, Southeast Asia and one plant in a new EU country in Eastern Europe.

To begin, we spent several days meeting with the corporate staff and managers at the corporate office. This included various business officers, research staff, quality personnel and safety personnel. We examined various facets of their operation, including supplier selection, design protocols, process management, storage and delivery of medical devices in the EU and US. We also looked at the Technical Files of the medical devices that were stored in the US. Among the issues we noticed was a design protocol that clearly would not satisfy FDA. They had struggled with the design of a new device, but didn’t keep records of their early failures. Instead, they would start over again with a clean slate. They were unhappy when we told them that they had to keep records of all their efforts from the beginning so FDA could see how they had progressed in their reasoning. Further, they would have to keep records of design changes as required by the QSR 820.30 (i) design changes and track the new start.

Next, we walked by a laboratory where they were opening several boxes containing sterilized devices. Apparently, the company conducting the sterilization had blown open the plastic seal thereby compromising the devices. Unfortunately, instead of taking the first run of production as required by QSR 820.30 (g) design validation, they allowed all of their production to be boxed by the sterilization company and shipped across the country and then purchased random boxes for validation inspection. As a result, they had to issue a recall of all the boxes of devices shipped across the country and to the EU. It was an expensive lesson.

When we asked about the storage of devices and shipping to their customers, the company noted that they were changing how their sterilized devices were being packaged. Previously, customers would order a box of devices, but now many customers said they didn’t want to buy devices in large quantities. Instead, they wanted to order in quantities that they might use in a month. This meant that their devices would have to be re-packaged with other medical devices and shipped to the customer. It also meant that their medical devices had to be capable of being re-packaged without breaking the sterile seal of the package. This involved creating new more robust packaging that wouldn’t be compromised when placed in a box with other medical devices. It also meant that they had to re-visit and conduct a packaging risk analysis to evaluate how they were handling packaging and storage, including the influence of heat and cold on the integrity of their medical devices.

When we visited their only plant manufacturing CE Marked devices in Arizona for shipping devices to the EU, we asked if we could see their Technical Files. To which one of their managers responded, “What is a Technical File?” Not a good sign. As we learned, while some of the managers were familiar with the Technical Files, they had been generated at corporate headquarters by their safety management.

As we toured the facility and examined audits by their notified body, it became apparent that the Arizona site wasn’t as independent as we had been led to believe. We found the shipping cartons in the warehouse had the address of the corporate headquarters, not the Arizona plant. It wasn’t that anyone was trying to be surreptitious, they just didn’t see anything wrong with the way they were conducting business. Of course it raised the immediate question about their notified body, why didn’t they raise these questions during their certification audit?

When we examined their technical files against the devices they were manufacturing, we both stated that they had been certified to the wrong Annex of the Medical Devices Directive. We also found problems with their storage of supplies and finished devices, it was in a part of the plant that wasn’t air-conditioned and was experiencing the full heat of Arizona. It also contained rodent and insect traps that were not being handled properly by a certified company. The manufacturing area, however, was clean and met health and safety requirements and the personnel had been well trained, but their internal auditing system needed to be improved. The management review minutes were responsive to their internal auditing program, but it didn’t appear to be independent of their corporate office. The question again was raised, how did this slip by their notified body, a well recognized UK notified body? We would learn more in the future.

If you have product liability concerns with ISO 9001, FDA's QSR, ISO 13485 or EU's Medical Devices Directives you can contact me for a free preliminary consultation at theguide1@comcast.net

ISO 9001 Product Liability Lawsuits – Product Design Amplified

Until now we have looked at ISO 9001: 2000 & ISO 9001: 2008 focusing on the three areas where virtually all product liability lawsuits occur, pre-production/product design, production and post-production/post sales surveillance. This blog will focus on Product Design Amplified including risk assessment, risk analysis and hazards analysis.

Product Design – General

First, returning to product design and ISO 9001. As discussed earlier, product design accounts for 60% of all product liability lawsuits. Consequently, the seven clauses under 7.3 Design and Development will be critical to defending a company’s product design in the event of a product liability lawsuit. The clauses are: 7.3.1 Design and development planning; 7.3.2 Design and development imports; 7.3.3 Design and development outputs; 7.3.4 Design and development review; 7.3.5 Design and development verification; 7.3.6 Design and develop validation and 7.3.7 Control of design and development changes. The last sentence of the section states, Records of the results of the review of changes and any necessary actions shall be maintained.

If the design and development section is to be of any use to company to defend itself in a product liability lawsuit, however, records must be kept when the decisions were made, in other words when the product was designed. These records cannot be created after the fact. Any employee who might attempt to make a false claim about when the records were created can be tried for perjury.

One other critical aspect of the section is that most product liability claims focus on the issue of product safety. ISO 9001 is weak on product safety. Therefore, it will be necessary for a manufacturer to build in the key safety issues that should be addressed in regard to a product. It will not happen by itself. While few companies examine ISO 9004, it would be a good time to visit its language in regard to creating a safe product. Unfortunately, most quality managers and auditors tend to disregard ISO 9004, because it isn’t required for certification –  shortsighted and foolish, but a common attitude nonetheless. As a result, ISO 9004 makes a good entry point and provides excellent cross examination material for plaintiffs’ attorneys.

In response to product safety, every product design must include a systematic risk assessment and hazards analysis. Whether it is a Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA) or ISO 14121, a systematic effort must be undertaken to identify the hazards and demonstrate how the risks are reduced to an acceptable level when the product is design is complete, before the product is placed on the market. It also must be written in clear English so that it can be understood in a court of law should that be necessary. Further, if a company plans to post cautions and warnings and issue safety instructions it must be the end product of a logical deliberative process. It can’t be the idiosyncratic language of some employee tasked with a last minute work order.

Product Design – Medical Devices

FDA’s Quality System Regulation (QSR) and ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes are very close to ISO 9001 in design control requirements, except that regulatory oversight is much tighter and more exacting when it comes to the issue of device safety. In 820.30 Design Controls (a) General (FDA specifies those devices subject to the design controls requirement), followed by (b) Design and development planning, (c) Design input, (d) Design output, (e) Design revi(unique to FDA), ew, (f) Design validation, (g) Design validation, (h) Design transfer (unique to FDA) and (i) Design history file (unique to FDA). In addition to the basic QSR requirements, FDA also has published several design guidance documents addressing issues such as Human Factors Analysis, Software Validation and Sterilization Requirements, to mention a few. The EU likewise has several requirements addressing aspects of medical device design using EN ISO & EN IEC harmonized standards.

Risk Analysis/Hazards Analysis is a much more exacting process for medical devices. Fortunately, the Global Harmonization Task Force (GHTF) in collaboration with ISO Technical Committee 210 developed ISO 14971: 2000 & ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices. It is a good standard with considerable rigor that can be used in conjunction with an FMEA, if desired. It also can be used to comply with FDA and EU Medical Devices Directives Requirements.

I was especially grateful for its existence in 2003 when I worked with an In Vitro Diagnostics Medical Devices Company on CE Marking its Blood Typing In Vitro Medical Devices for the EU. Annex B. Guidance on risk analysis for in vitro diagnostic medical devices and Annex C Guidance on risk analysis procedure for toxicological hazards were invaluable in complying with EU regulatory requirements. Again every question must be answered Yes, No or N/A with clear language stating the basis for each decision.

Design Safety & Product Liability

As mentioned numerous times, product safety is the key issue in product liability lawsuits. Not only do companies fail to give adequate attention to product safety, they don’t take the time to record their actions to protect themselves in the event of a lawsuit. “If you can’t prove it doesn’t exist!” The issue of product safety and patient safety is even more profound in the design and manufacture of medical devices, drugs and biologics. The Medical Device Insurance Company internal litigation study mentioned in previous blogs repeatedly noted lapses when it came to product safety and patient safety:

•    Management frequently continued to underestimate the risk of product liability litigation to the success and/or survival of their business

•    Management often failed to hire or train qualified in-house personnel and make them available to integrate product liability avoidance principles into the firm’s quality management system to establish a loss control infrastructure for product safety design

•    Management often failed to ensure that device safety and patient safety are an integral part of device design in the company’s quality management system

As noted previously, “No quality management system will provide an effective legal defense if it isn’t structured to provide a legal defense. Any thing else is chance. Risk management without Preventive Law is not risk management and ISO 9001 without Preventive Law is unmanaged risk!”

If you have product liability concerns with ISO 9001, FDA's QSR, ISO 13485 or EU's Medical Devices Directives you can contact me for a free preliminary consultation at theguide1@comcast.net