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. 

Notified Bodies And CE Marking – Potential Legal Issues In US CE Marking Lawsuits #1

Introduction

I received an e-mail this week asking this question, “Are you aware whether or not the notified bodies in Europe are expected to possess professional indemnity insurance, to cover them in cases of a poor opinion of compliance or failure of post Market surveillance, with thanks for your advice.”

I answered, “Yes, in every new approach Directive there is an Annex that spells out the criteria for notified bodies. For Example, in the 2006/42/EC Machinery Directive, Annex XI sets forth, "Minimum criteria to be taken into account by Member States for the notification of bodies" Paragraph 6 states, "The body shall take out liability insurance unless its liability is assumed by the State in accordance with national law or the Member State itself is directly responsible for the tests."

Notified Body Requirements

The question about notified body “indemnity insurance” raises a number of questions that should be explored concerning the EU legal requirements for notified bodies and their potential legal implications in US courts. The full list is stated below:

Minimum criteria to be taken into account by Member States for the notification bodies 

1. The body, its director and staff responsible for carrying out the verification tests shall not be the designer, manufacturer, supplier, or installer of machines which they inspect, nor the authorized representative of any of these parties. They shall not become involved, either directly or as authorized representatives, in the design, construction, marketing or maintenance of the machines. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.

2. 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, which might influence their judgments on the results of their inspection, especially from persons or groups with an interest in the result in result of verifications.

3. For each category of machinery for which it is notified, the body must possess personnel with technical knowledge and sufficient and appropriate experience to perform a conformity assessment. It must have the means necessary to complete the technical and administrative tasks connected with the implementation of the checks in an appropriate manner, it must also have access to the equipment necessary for the exceptional checks.

4. The staff responsible for inspection shall have:

-- sound technical knowledge and vocational training,

-- satisfactory knowledge of the requirements of the tests they carry out and adequate experience of such tests,

-- the ability to draw up the certificates, records and reports required to authenticate the performance of the tests.

5. The impartiality of inspection staff shall be guaranteed. The remuneration shall not depend on the number of tests carry out or on the results of such tests.

6. The Body shall take liability insurance unless its liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the tests.

7. The staff of the body shall be bound to observe professional secrecy with regard to all information obtained in carrying out its tasks (except vis-à-vis the competent administrative authorities of the State  in which its activities are carried out) under this Directive or any provision of national law giving effect to it.

8. Notified bodies shall participate in coordination activities. They shall also take part directly or be represented in European standardization, or ensure that they know the situation in respect of relevant standards.

9. Member states may take all necessary measures they regard as necessary in order to ensure that, in the event of cessation of the activities of a notified body, the files of its customers are sent to another body or are made available to the Member State which has notified it.

Notified Bodies 

Notified bodies are created by each New Approach Directive.  The criteria are established by each Directive.  Notification may be to a specific clause, such as Annex IV of the Machinery Directive dealing with dangerous machines, which is the only clause to which a body may be notified for that Directive. Notification also may be confined to those clauses for which it has technical competence or it may extend to all of the clauses of a directive.  The decision belongs to Competent National Authorities who use the EN 45000 series to evaluate notified bodies. When a Competent National Authority approves one of their third parties for a Directive, they “notify” the European Commission. The Commission periodically publishes the list of notified bodies in The Official Journal of the European Communities.

Product Safety and Process Quality--Two Elements of CE Marking A Product 

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.

Considered one of the architects of the new approach, vice president Bangeman’s quote deserves some attention.  To begin, when he talks about a “consensus of all the economic partners involved” he is referring to the fact that the CEN, CENELEC and ETSI working groups that draft EN safety standards are comprised of manufacturer representatives, representatives of Member State standards organizations (e.g., BSI, DIN, AFNOR, etc.), testing laboratories, academic faculty and in some cases consumer representatives.  While Member State standards organizations direct working group schedules, there is a conviction that the affected parties are participating in writing the standards.

The reference to “quality instruments” such as European standardization and conformity assessment procedures points to two aspects of virtually all new approach directives.  One aspect is the element of product safety. The technical file referred to in most directives contains a checklist of the directive’s essential safety requirements and the EN harmonized safety standards and/or the tests performed and approvals granted which a manufacturer has used to demonstrate conformity to the Directive’s essential safety requirements.  Generally, among those tests will be an application of the principles of safety integration applied to the product in question and a risk assessment. The technical file should demonstrate and record the companies’ efforts to achieve an acceptable level of product safety.

The second aspect is the element of process quality. Once an acceptable level of product safety has been built into a product, the manufacturing process must be able to assure consistent quality so that products number 5, 905, and 20,005 are of consistent and dependable quality. This dual objective of achieving acceptable product safety and consistent process quality will be familiar to manufacturers of regulated products such as medical devices using ISO 13485, and ISO 9001 for manufacturers of products covered by other Directives.

Conclusion

Notified bodies play an integral role in New Approach Directives such as the Medical Devices Directives and variable role in other New Approach Directives, e.g. except for Annex IV of the Machinery Directive where notified body involvement is required, manufacturers self-certify to the requirements of the Directive.

The areas where third parties are “notified” varies for each Directive. Since Notified Bodies (along with ISO 9001 Registrars) will increasingly become involved in CE Marking lawsuits in US Federal Courts, I want to examine notified body involvement and behavior since the beginning of CE Marking products and identify areas where notified body involvement in US lawsuits should be anticipated.

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.  

US Federal Courts – The New Venue For CE Marking Lawsuits

 

Introduction

I have discussed the CE Marking implications of product liability lawsuits in US Federal Courts several times. I want to expand on this topic. As mentioned in previous blogs, presently, I am serving as legal expert in three lawsuits involving the EU Machinery Directive in US Federal Courts. ISO 9001 also is involved in two of these cases. 

As long as one of the litigants is a US resident (individual or corporation), the dollar amount meets federal monetary requirements and a legitimate cause of action exists, the suit can proceed. This means the following types of lawsuits can be filed:

• Non US citizens, corporations or companies that suffer injury and/or damage from a CE Marked product manufactured by a US corporation or company can file a lawsuit, e.g. product liability claim, breach of warranty, breach of contract, etc. in a US Federal Court.

• US citizens, corporations or companies that suffer injury and/or damage from a CE Marked product manufactured by a US, EU or other foreign corporation or company can file a lawsuit, e.g. product liability claim, breach of warranty, breach of contract, etc. in a US Federal Court.

What Does This Mean?

To begin, it means that citizens of other countries who are injured by a CE Marked product manufactured by a US company can bring a product liability lawsuit against a company, a legal remedy not available in their own country. It also means that a foreign manufacturer of a CE Marked product that injures a US resident or company can be sued for damages in a US product liability lawsuit. It is a reason that manufacturers can anticipate product liability lawsuits for their CE Marked product failures in US Federal Courts. It is one of the reasons that I am presently serving as legal expert in three CE Marking lawsuits in three different Federal Courts. I have also served as a legal expert in ISO 9001 lawsuits between US corporations and EU corporations. 

For foreign companies selling their CE Marked products in the US it likely will be their first exposure to legal discovery. From what I have experienced thus far, it means that many of these companies will experience requests for information and documentation for the first time and try to resist turning over anything that might be injurious to their legal position. That certainly has been the behavior of some German corporations involved in a few product liability lawsuits. Thus far, it has not been the behavior of ISO 9001 lawsuits between UK corporations and US corporations. The sample, however, is quite small.

Another surprise is the request for CE Marking Technical Files. As mentioned in previous blogs, one of the cases I am working on involves a US corporation manufacturing a CE Marked machine. They turned over a Technical File that has to be described as a junk file or gibberish. Clearly, the company had not paid attention to or chose to ignore the specific requirements of the Machinery Directive. The manufacturer also was found to be duplicitous in their dealings with UK authorities and opposing counsel. Fortunately, as this case moves along, the failure to comply with the requirements of the Directive have become apparent to the Court and likely will result in an adverse judgment which most likely will be settled out of court to the monetary detriment of the US machinery manufacturer. 

Of course, the request for information contained in Technical Files will be an even bigger surprise for EU manufacturers of CE Marked products and the intense scrutiny concerning the quality of compliance of these manufacturers with EU Directives. One attorney asked me why EU EN harmonized standards would be relevant in a US court. After all they are not  American standards.

I told him that EN standards like all ISO and IEC standards are revised on a periodic basis, approximately every 5 to 7 years. By agreement between the European Committee for Standardization (CEN) and ISO and the European Committee for Electotechnical Standardization (CENELEC) with IEC the new standards that emerge from this collaboration will be both International and European standards. In addition and even more important in the US, ANSI (American National Standards Institute) participates in all of the ISO and IEC standards deliberations and revisions. Consequently, at the end of the revision process the new standards also will be both European and American standards.

Litigation Attorneys

The role of litigation attorneys dealing with CE Marking Directives, CE Marked products, European standards and occasionally ISO 9001 or ISO 13485 is another issue. Often I have found that the attorneys proceed in a somewhat routine fashion not fully understanding the product requirements and the issues they are dealing with. On occasion, I have seen botched discovery requests and frustrated Judges regarding ISO 9001 records and documents requests.

Also, I have seen some, not all, attorneys become rather arrogant and possessive about "their" lawsuit and not helpful in providing information so that I can be of greater value to their case. They tend to think they can puzzle their way through the CE Marking process. However, with 27 New Approach Directives in various stages of revision and new combinations and thousands of EN harmonized standards in various stages of revision, it isn’t remotely as simple as it might appar. When I do work with attorneys who are open and share the issues at hand, the collaboration can work extremely well. My role is to serve as a legal expert not a litigation attorney.

Timing

Timing is critical to understanding the relevant facts concerning a lawsuit. For example, in some of the Machinery Directive lawsuits it is important to know when the machine was manufactured, the status of the Directive, e.g. revisions of the relevant EN standards that should have been followed to satisfy the Annex I Essential Health and Safety and Requirements.  It is also important to know what other Directives may be involved. I have worked on CE Marking several machines that involved the Machinery Directive, Low Voltage Directive, EMC Directive, Pressure Equipment Directive and Explosive Atmospheres (ATEX) Directive. Other Directives could be added today, e.g. RoHS2. This information may seem arcane, but it could be quite critical to the manufacturer’s actions regarding the machine. The same is true for ISO 9001, e.g. are we talking about ISO 9001:1994, ISO 9001: 2000 or ISO 9001: 2008? I’ve seen several instances where the attorneys did not understand the revision of the standards and didn’t realize that there was continuity in compliance with one standard to the next.

The same issue comes into play regarding EN standards. For example, I recently discovered that CE Marked components that were incorporated in a machine by a client were in fact “out of date.” We called the component manufacturer and brought this matter to their attention saying that we have to have components that comply with current EN standards. After some grumbling, the component suppliers produced components compliant with the most recent standards. This may seem like a small matter, but it could be quite costly for the manufacturer in case of a product liability lawsuit.

Conclusion

While it can be hard breaking litigation attorneys of some bad habits and reining in their egos, it is to their advantage to approach a lawsuit having all of their facts in order to achieve the best possible result for their client. Fortunately, I’ve worked with several attorneys who have achieved this objective and prevailed on behalf of their clients. 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.