International Regulatory Compliance

Holding Registrars And Notified Bodies Accountable In ISO 9001 Lawsuits

Introduction

In several blogs I have mentioned the standard, ISO/IEC 17021: 2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems. In a previous blog, I reviewed working as Legal Expert in a lawsuit where ISO 9001: 2000 became a central focus of litigation between a US plaintiff and defendant. In this particular case, the opposing party stated that they did not have a recall or quarantine procedure for their products, further, they did not have records concerning the product in question.

The law student intern who first contacted me for the law firm said he thought that the opposing party was certified to ISO 9001. I replied that I could find out if they were certified and if they were, what records and documents could be obtained in legal discovery. After filing an Affidavit identifying the opposing party’s certification to ISO 9001 and identifying the records and documents we wanted to examine, their response was, “Oh those records!” The judge was not amused by their duplicity and ordered the company to produce the records and documents requested.

In their response, one of the corporations employees stated that he was the management representative and that he worked with all of the plants in question concerning this product. His statement resulted in a second Affidavit where I noted that his comment was interesting because management representatives usually report to a plant manager. However, since he worked with several plants involved in manufacturing the product in question, this meant that he was a management representative at the corporate level and reported to corporate management. It also meant that in addition to the plants being certified to ISO 9001 there was a corporate ISO 9001 certification.

The immediate response was no, we do not have corporate ISO 9001 certification, however, within a couple of weeks a full corporate Quality Manual, Procedures, Documents and Records were sent to our attorneys and “lo and behold”, there was a formal corporate recall and quarantine policy. By now the judge was approaching livid, not amused and quite angry.

Enter The ISO 9001 Registrar 

The Registrar in this case was well known to me. I was familiar with their work as a notified body for the EU Medical Devices Directive and had recommended them to some clients who wanted to CE Mark their medical devices. They always acted professionally. I also was familiar with their work as a Registrar for ISO 9001 and had visited their US Registrar headquarters. Consequently, I was startled by their behavior vis-á-vis their client in this lawsuit.

ISO/IEC 17021: 2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems

To provide a basis for evaluating the behavior of the Registrar in this case, I wrote a Critique for the law firm to use in deposing the Registrar and consider bringing them into the lawsuit if their behavior could adversely affect the outcome of the lawsuit. The basis for such a move would derive from comparing their behavior with their client (the opposing party in this lawsuit) with the requirements of the International Standard (ISO/IEC 17021: 2006) that governs their behavior as a third party ISO 9001: 2000 Registrar.

In the Critique I stated my opinion that the Registrar violated its role as an impartial third party and instead:

1) chose to act on behalf of their client to deny access to information regarding the ISO 9001 certification status of their client;

2) chose to help their clients obtain a consultant to address the company’s certification to ISO 9001; and

3) chose retroactively to change the long standings certification status (seven years) of a company site during a lawsuit between the company and our client to help their client win their lawsuit.

This Registrar, along with all ISO 9001:2000 Quality Management System certification Registrars must abide by the requirements set forth in ISO/IEC 17021:2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems.  This Critique will draw from the requirements of the standard to substantiate and highlight these points.

1.) When I called the US headquarters of the Registrar, I asked if the opposing party in this lawsuit was a client of theirs, if they had certified several plants and the corporate headquarters to ISO 9001:2000. I was told that they would have to consult with their attorneys to see if they could divulge such information. A few hours later I received a call stating that their attorneys advised them that such information could not be given without their client’s consent. (Basically, US attorneys are clueless about international compliance standards, unless informed of such standards by their clients.)

 ISO/IEC 17021:2006, Clause 4.5 Openness

4.5.1 A certification body needs to provide public access to, or disclosure of, appropriate and timely information about its audit process and certification process, and about the certification status (i.e., the granting, extending, maintaining, renewing, suspending, reducing the scope of, or withdrawing of certification) of any organization, in order to gain confidence in the integrity and credibility of certification. Openness is a principle of access to, or disclosure of, appropriate information.

 

4.5.2 To gain or maintain confidence in certification, a certification body should provide appropriate access to, or disclosure of, non-confidential information about the conclusion of specific audits (e.g. audits in response to complaints) to specific interested parties.

2.) Certification bodies (e.g. Registrars) must maintain impartiality in their operations. Recommending an ISO 9001:2000 consultant to a client violates their duty of impartiality and creates a conflict of interest for the Registrar.

3.) The Registrar retroactively changed the long-standing corporate certification status of their client during the lawsuit to help the client win its case.

5.1 Legal and contractual matters

5.1.1 Legal responsibility

The certification body shall be a legal entity, or a defined part of a legal entity, such that it can be held legally responsible for all of its certification activities. A governmental certification body is deemed to be a legal entity on the basis of its governmental status.

5.2 Management of Impartiality

5.2.1 The certification body shall have top management commitment to impartiality management system certification activities. The certification body shall have a publicly accessible statement that it understands the importance of impartiality in carrying out its management system certification activities, manages conflict of interest and ensures the objectivity of its management system certification activities.

5.2.5  The Certification body and any part of the same legal entity shall not offer or provide management system consultancy. This also applies to that part of government identified as a certification body.

5.2.1.2 All Certification by personnel, either internal or external, or committees, who could influence the certification activities, shall act impartially and shall not allow commercial, financial or other pressures to compromise impartiality.

5.2.13 Certification bodies shall require personnel, internal and external, to reveal any situation known to them that may present them or the certification body with a conflict of interests. Certification bodies shall use this information as input to identifying threats to impartiality raised by the activities of such personnel or by the organizations that employ them, and shall not use such personnel, internal or external, unless they can demonstrate that there is no conflict of interests.

Conclusion

What you have read is an abbreviated portion of my 16 page Critique of the Registrar for a lawsuit. We conducted some preliminary depositions and were preparing to return for more in depth depositions that would be used to bring the Registrar into the lawsuit, however, the opposing party signaled that they would like to settle the case. The results, of course, were sealed.

Most appalling in this case was the either the ignorance and indifference (or both) of the Manager of the Registrar who wanted to please a wealthy client, not realizing the liability exposure for his company. Further, the Registrar would face potential sanctions from ANAB (ANSI-ASQ National Accreditation Board), assuming that ANAB Registrar oversight is rigorous. Unfortunately, this is one of several times that I have watched third parties like Registrars or Notified Bodies demonstrate unethical behavior – the absence of a Moral Compass.   

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 Court. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding ISO 9001 or CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com. 

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.  

CE Marking Lawsuits – Applying Forensic Law To Evidence & Discovery

Introduction

As I mentioned in my previous Blog, US Federal Courts – The New Venue For CE Marking Lawsuits, posted on November 30, 2011, we can expect to see an increasing number of CE Marking lawsuits in US Federal Courts. The rationale for the increased number of lawsuits is spelled out in the Blog. I have previously mentioned that I am serving as legal expert in three such lawsuits in US Federal Courts. The earliest lawsuit is nearing completion and appears to have met with success in translating European EN Safety Standards and EU Directive Essential Safety Requirements in a US courtroom. The other two lawsuits are still underway. I also mentioned having served as legal expert in lawsuits involving ISO 9001. These have been settled out of court, however, based on some recent inquiries I anticipate more such lawsuits in the future.

The purpose of today’s Blog is to revisit a few of the previous observations and amplify the points being made. I noted previously that US litigation attorneys often proceed in a somewhat routine fashion not fully understanding the different product safety requirements of EU New Approach Safety Directives and EN safety standards. Also as noted, I have seen botched discovery requests and frustrated Judges regarding ISO 9001 records and document requests in discovery. 

New Territory

This area, CE Marking New Approach Safety Directives, often intermingled with a quality management system, such as ISO 9001 is new territory that requires competent legal understanding if litigation attorneys and defense counsel hope to succeed on behalf of their respective clients.

To begin there are 27 New Approach Safety Directives, drafted at different times. Several are in various states of revision and new Directive combinations. These Directives affect approximately 65% of products entering the EU. They range from Directives addressing Machinery Safety, Medical Devices (General, Active Implantable, In Vitro Diagnostic), Toy Safety, Low Voltage, Electromagnetic Compatibility, Pressure Equipment, Equipment and Protective Systems in Potentially Explosive Atmospheres (ATEX), Construction Products, Personal Protective Equipment, Radio and Telecommunications Terminal Equipment to mention some of the more prominent Directives. 

Each Directive also has Essential Safety Requirements and EN standards that allow for demonstration of conformity to the Directive’s essential safety requirements. There are thousands of standards that are reviewed every 5 to 7 years to consider whether they should be maintained in their present state, revised or eliminated. As noted in the prior Blog, the revision of these standards is now coordinated between the EU Standards Bodies, CEN, CENELEC and ETSI and ISO and IEC to improve the revision process and invite EU standards expertise into these considerations. Also participating in ISO and IEC deliberations on behalf of United States is the American National Standards Institute (ANSI). Consequently, these revised standards will become both American and EU standards. Therefore, the time when a product is manufactured could determine if a standard in question was also an American Standard, if that issue is relevant to a lawsuit.

Also, depending on the Directive or Directives in question and the nature and safety of a product, a company might have chosen what the Europeans call a Conformity Assessment Procedure to assure that the product is manufactured at a consistent quality level. In these cases, third parties which the Europeans call “Notified Bodies” will be involved in the product compliance process. Therefore, notified body records, often including ISO 9001 Quality Management System documents and records could be involved.

It is critical for litigation attorneys and defense counsel to understand how these safety standards are applied and how this information could critically impact a lawsuit affecting their clients. Sophomoric American assumptions could adversely affect the outcome of a lawsuit. 

Timing

As noted in my previous Blog, timing is critical to understanding the relevant facts concerning a lawsuit. It is important to know when a product is manufactured in order to determine the legal status of a Directive, e.g. whether or not it had been revised at the time of design and manufacture, and it is important to know which standards apply to a product. If a Conformity Assessment Procedure was involved and a Notified Body also was involved, certification audits and surveillance audits could become important to the disposition of a lawsuit. Likewise, it is important to know how many Directives might be involved in the manufacture of a product.

For example, I have worked with machinery manufacturers whose machines had to comply with the Machinery Directive, Low Voltage Directive, Electromagnetic Compatibility Directive, Pressure Equipment Directive and the Explosive Atmospheres Directive. Therefore the requirements of each directive and the standards necessary to comply with the requirements of each directive need to be examined. Likewise, it is critical to know what requirements were in place when the product was manufactured. Of course, attorneys will want to know how this all might be litigated in a US Federal Court. 

Observation

In previous Blogs where the topic was a malfunctioning product such as machine, specific compliance with the requirements of these New Approach Safety Directives can be examined to see if the company actually attempted to satisfy the requirements of the Directives and the relevant standards. In one case presently being litigated in a US Federal Court, it was clear that the company, a US machinery manufacturer, did not create a Technical File containing all of the steps required by the manufacturer to comply with the Directive. The file also contained no risk assessment standard and risk assessment judgments.  Further, after two accidents that killed one worker in the EU and maimed another worker in the US who will require 24 medical care for the rest of his life, it was clear that the company did not comply with the safety requirements of the directive and this failure caused both accidents. 

Forensic Law   

In order to address these cases and effectively use this information in a US Federal Court, it is necessary how these Directives and their Standards interplay and the status of each at the time the machine in question was designed and manufactured. Simple assumptions will not work. Knowing when critical components were manufactured also is important as well as the date that the product itself is manufactured. Knowing how the EU directives and standards work is different, but it can be successfully tackled and lawsuits can be won.

I first encountered the term “forensic” when I received a call several years ago from young man was working with a law firm applying the requirements of ISO 9001 and ISO 9004 to some product failure cases in Atlanta. I asked what his background was and he said he was a forensic engineer. 

Since then, and in a totally different application in California involving a product that was causing a medical device manufacturer to experience manufacturing difficulties with diabetic test trips, I was asked to determine if a supplier had failed to follow requirements of its ISO 9001 Quality Management System and if that failure caused the test strip difficulties. It did. I also was working with a forensic accounting firm who were determining if the financial loss calculated by the manufacturer was accurate. It was. 

The term forensic applies equally to the law and litigation. Attorneys continually attempt to dissect products and events to understand what happened and apply this knowledge on behalf of their clients. In the case of the 27 EU New Approach Safety Directives and thousands of EN harmonized safety standards the forensic analysis is complex, but doable. The biggest problem I have observed are US attorneys who transmogrify an EU legal issue into a more familiar American setting thereby mutilating the critical issues and facts affecting their clients.  

Conclusion

To successfully tackle a CE Marking lawsuit, it is necessary to apply forensic analysis to the Directives and Standards that apply to a case. As noted in my prior Blog, while it can be hard breaking litigation and defense 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 and achieving 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 EU Directives and Standards and product liability litigation, you can contact me for a free preliminary consultation at my new 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.

Market Surveillance #3 – To Be Or Not To Be – When, Is The Question

 

Continuation

I decided to add a third installment to my blog on Market Surveillance and the revised Machinery Directive 2006/42/EC. As noted several times the impetus for these comments has been driven by serving as legal expert in a lawsuit involving a CE Marked machine that has killed one worker and injured another worker who will need 24 hour care for the rest of his life. These accidents involved the same machine model in two separate incidents in two different countries.

While the Technical File was a junk file that did not comply with the requirements of the Machinery Directive, the contents of the file and the pathetic state of compliance was unknown until the first accident occurred and the file was turned over to the Health and Safety Executive (HSE) in the UK. In reality, the pathetic state of compliance is still unknown because, as noted in the previous blog, HSE investigates workplace accidents and BIS (Department for Business Innovation and Skills) the Competent UK Authority that oversees CE Marking for the Machinery Directive has not received the HSE investigation report. Meanwhile, the non-compliant machines are still on the market.

CE Marking Litigation And Its Future

I only reiterate these facts because in the past two weeks, I have received calls from two new clients involved in lawsuits in the US concerning CE Marking for the Machinery Directive. I anticipate more in the future. There are several reasons for this increased litigation activity, among them:

• CE Marking safety requirements and standards for machines have grown in number and sophistication since the Machinery Directive was first published on 14 June 1989.

• Following the Vienna and Dresden agreements between the EU Standards Bodies (CEN and CENELEC) with ISO and IEC respectively (to avoid duplicating standards writing efforts) these new international standards writing activities automatically include the participation of ANSI (American National Standards Institute) in drafting ISO & IEC standards resulting in EN ISO and EN IEC standards that are also American National Standards, recognized by US Courts of Law. In sum, EN standards are rapidly becoming American standards.

• US Federal Courts offer a litigation venue for product liability, Breach of Warranty and Breach of Contract lawsuits concerning CE Marking between US Citizens and US machinery manufacturers, US Citizens and EU machinery manufacturers and EU Citizens and US machinery manufacturers.

• The oft cited 2002 Minnesota case where a California Packaging Machinery Manufacturer sold a less safe machine in the US injuring a worker who will require 24 hour care for the rest of his life (it didn’t have a laser light curtain to turn off the machine when a worker entered the area of machinery activity), but sold safer CE Marked machines with laser light curtains in the EU for 6 years because of the Machinery Directive safety requirements, resulted in a $35 million punitive damages award (the manufacturer knew how to make a safer machine and chose not to do so). This means that US manufacturers who follow the same path of selling less safe machines in the US and safer machines in the EU and EU manufacturers who sell non CE Marked less safe machines in the US can expect a similar result in US Courts. It is a whole new area of litigation for American trial attorneys.

• Just as trial attorneys can ask for ISO 9001 records and documents that are relevant to a product liability lawsuit in the US and EU, they can now ask for Machinery Directive Technical File records and documents in discovery in Product Liability, Breach of Warranty and Breach of Contract lawsuits. The fact that these records and documents may belong to a European manufacturer is irrelevant. Whether the EU manufacturer is suing or being sued the cause of action arises from doing business in the US, making the litigants subject to US Courts and US rules of civil procedure.

These are a few of the legal nuances for US Courts of Law brought about by the evolution of the Machinery Directive and its supporting standards writing activities.

The Response of EU Competent Authorities 

In future blogs I will spend more time examining the substance of 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. In the preceding two blogs (July 30 & August 15) and this blog, however, I have concentrated on administrative issues not touched on in Decision No 768/2008/EC that I believe are critical to the success of effective Market Surveillance as it relates to the Machinery Directive.

In the section titled “A View Thoughts” in the preceding August 15 blog, my Fifth recommendation was, “once a complaint or accident involving a CE Marked machine is recorded by a Competent Authority, a checklist protocol should be developed utilizing Annex VII of Machinery Directive 2006/42/EC to determine if all the elements of a Technical File contained in A. Points 1,2 & 3 are compliant. Listed below are those points

1. The technical files shall comprise the following:

  (a) a  construction file including:

-- a general description of the machinery,

-- the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery,

-- full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements,

-- the documentation on risk assessment demonstrating the procedure followed, including:

  (i) a list of the essential health and safety requirements which apply to the machinery,

  (ii) the description of the protective measures implemented to eliminate identified hazards or to reduce risks, when appropriate, the indication of the residual risks associated with machinery,

-- the standards and other technical specifications used, including the essential health and safety requirements covered by these standards,

-- any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorized representative,

-- a copy of the instructions for the machinery,

-- where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery,

-- a copy of the EC declaration of conformity.

 (b) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.

The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.

2. The Technical file referred to in point 1 must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of machinery or, in the case of series manufacture, for the last unit produced. (Emphasis added)

The technical file does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity. (I suggested 48 hours, similar to the Medical Devices Directives)

The Technical file does not have to include detailed plans or any other specific information as regards the subassemblies used for the manufacture of the machinery unless a knowledge of them is a central for verification of conformity with the essential health and safety requirements.

3. Failure to present the technical file in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements. (Emphasis added)

Conclusion

As noted in the two previous blogs, I think these types of steps are essential for effective Market Surveillance for the revised Machinery Directive 2004/42/EC. I also noted previously that I would like to work with European manufacturers and companies on steps 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 about the US marketplace. If anyone is interested in exploring these topics further, please contact me at jameskolka@gmail.com or jim@jameskolka.com. 

Market Surveillance #2 – To Be Or Not To Be – When, Is The Question

The Quandary

The preceding blog described some of the issues and concerns I have encountered working with companies CE Marking their products for the EU. Recently, however, my concern has been heightened by issues raised in an ongoing lawsuit in the US & EU regarding a machinery manufacturer whose machines have caused the death of one worker and a severe injury to another worker who will require 24 hour care for the rest of his life. 

While 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 presumably went into effect on 1 January 2010, the implementation details are evolving rather slowly.

The lawsuit underscores some of problems. In the UK, an industrial workplace accident is investigated by HSE (Health and Safety Executive). The fact that a machine is CE marked is of no immediate concern to HSE, their focus, as it should be, is on the accident. When they conclude their investigation, they will pass on their findings to BIS (Department for Business Innovation & Skills) the CE Marking Conformity Assessment Body in the UK. It is a nice linear progression, but it delays immediate action concerning the CE Mark of the machinery manufacturer and disadvantages the family of the worker who was killed in the accident and leaves similar machines in place throughout the EU to potentially cause more workplace injuries.

As noted in previous blogs, in my opinion the machine in question did not begin to satisfy CE Marking requirements of the Machinery Directive 93/37/EC at the time the machine in question was manufactured:

A Comparison – The Manufacturer vs. Annex V, paragraph 3

The requirements for the technical file can be found in Annex V, paragraph 3 of the Machinery Directive where it is identified as a, “technical construction file”:

“(a.) a technical construction file comprising:

-- an overall drawing of the machinery together with drawings of the control circuits,

-- full detailed drawings, accompanied by any calculation notes, test results, etc., required to check the conformity of the machinery with the essential health and safety requirements

-- a list of:

   -- the essential requirements of this Directive (a sample checklist and sample

      identification of relevant EN harmonized technical standards is attached) 

   -- standards, and

-- a description of methods adopted to eliminate hazards presented by the machinery,

-- if he so desires, any technical report or certificate obtained from a competent body or laboratory,

-- if he declares conformity with a harmonized standard which provides therefore, any technical report giving the results of tests carried out in his choice either by himself or by a competent body or laboratory

-- a copy of the instructions for the machinery;

(b.) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.

The manufacturer must carry out necessary research or tests on components, fittings or the completed machine to determine whether by its design or construction, the machine is capable of being erected and put into service safely.

Failure to present the documentation in response to a duly substantiated request by the competent national authorities may constitute sufficient grounds for doubting the presumption of conformity with the requirements of the directive."

While the language is quaint, it sets forth the substance of a technical file. The reference above in (b.) to series manufacture refers to the quality system.

As noted in previous blogs, in my opinion the machine in question did not begin to satisfy CE Marking requirements of the Machinery Directive:

• There was no coherent Technical File

• No Part A providing an index containing all of the elements in the file

• No Annex I Essential Health and Safety Requirements Checklist identifying which essential health and safety requirements the manufacturer applied to their Product Family Machines

• No complete listing of EN harmonized standards selected to demonstrate conformity to the relevant Essential and Safety Requirements of the Directive

• No listing of EMC standards

• No ISO 14121-1:1999 Risk Assessment, FMEA, FTA

• No identification of the manufacturer’s certification to ISO 9001: 2000

• No complete EC Declaration of Conformity

• No identification of an Authorized Representative on the Declaration of Conformity

From my perspective, the machinery manufacturer clearly failed to satisfy the safety requirements of the Machinery Directive. There is Prima Facie evidence that the machine is not compliant with the Machinery Directive. I believe that the manufacturer should have had his machines impounded until he could present documentation demonstrating compliance.

Annex V, paragraph 3 (b), final paragraph:

Failure to present the documentation in response to a duly substantiated request by the competent national authorities may constitute sufficient grounds for doubting the presumption of conformity with the requirements of the directive."

There is no reason that parallel investigations cannot proceed, each triggered by a machine that caused a fatal accident. I just received an e-mail from an engineer, “I am working on a project in Ireland and curious to know what penalty a manufacturer would face if they knowingly provided an EC Declaration of Conformity under the Machinery Directive for a machine that did not comply with the Essential Safety Requirements.” I suggested that he contact the Competent Authority in Ireland and the country where the machine was manufactured. I wish I had confidence that he would be listened to carefully and could expect action if he is correct in his assertion

Presently, I don’t know what will happen. While it may not be intended, the HSE handoff to BIS suggests a certain bureaucratic logical cleanliness in response. I don’t blame HSE because they are doing what OSHA (Occupational Safety and Health Administration) would do in the United States in the case of an accident. In the US, however, there is no BIS Competent Authority overseeing machinery safety. Perhaps a complaint could be lodged with the US Consumer Products Safety Commission and action might be taken. Unfortunately, the aversion of some Americans to any kind of regulation coupled with corporate distaste for all regulation make it difficult to create a regulatory response in the US akin to FDA oversight for drugs and medical devices.

The most effective response in the US comes through the court system via product liability, breach of warranty, breach of contract and other lawsuits challenging manufacturers in a court of law. At present, there is no equivalent legal response in the EU, so the oversight of Competent Authorities in the EU Member States is critical to the successful implementation of the Machinery Directive and related Directives. The issue then is how to go about this task to improve compliance.

A Few Thoughts

In my first “Market Surveillance” blog posted on 30 July 2011, I mentioned several issues and possible responses concerning self-certified machines:

• First, I believe it is critical that Part A of a Technical File should be a requirement of all machinery manufacturers (past and present) and it should be filed with a reliable entity, in my opinion a Competent Body, and it should be entered electronically in a shared European Commission Competent Body Database.

• Second, I also believe that an Annex I Essential Health and Safety Requirements Checklist identifying which essential requirements apply to the machine in question and which EN harmonized standards will be used to demonstrate conformity, linked to Part A of the Technical File should be filed with the same Competent Body entered into the same shared European Commission Competent Body Database.

• Third, as noted in my prior blog, I don’t think either Authorized Representatives or Notified Bodies should assume this task. In my personal experience, I have found both to be widely variable in behavior and capability and too anxious to make money in most everything they do.

• Fourth, a protocol should be developed to trigger a response to complaints about CE Marked products and potential investigation of reports of accidents involving CE Marked products, independent of workplace accident investigations conducted by agencies such as HSE. The two responses should be separate from one another. While accidents must be investigated, non-compliant CE Marked machines should be impounded or removed so that additional accidents don’t occur.

• Fifth, once a complaint or accident involving a CE Marked machine is recorded by a Competent Authority, a checklist protocol should be developed utilizing Annex VII of Directive 2006/42/EC to determine if all of the elements of a Technical File contained in A. Points 1, 2 & 3 are compliant. The same could be done for "B. Relevant technical documentation for partly completed machinery." Machinery manufacturers should be asked to provide this information within 48 hours of a request, similar to medical device manufacturers for the Medical Devices Directives.

• Sixth, all manufacturers of machines should be instructed to create the required documentation to comply with the Machinery Directive and Related Directives within a set time period and to make certain that all new machines and modified machines are compliant with the most recent revision of EN standards. (Last year I found three suppliers of Declarations of Incorporation had not updated their products to meet new standards.)

Conclusion

Presently there are tens of thousands of CE Marked machines in the EU market with Technical Files that range from full compliance to incomplete compliance to junk compliance to drivel. Finding out that compliance is a farce and records are a mess, as we discovered in the lawsuit, is unacceptable. I fully support self-certification, but I think it needs to have effective enforcement. As noted in my last blog, I would be happy to work with interested parties, including EU authorities, to improve the quality of EU oversight. I have developed some templates for Checklists and Part A of the Technical File which could be adapted to provide a measure of uniformity to the process that would make it easier for machinery manufacturers to understand compliance and Competent Authorities to determine compliance. 

As noted previously, I 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. 

Also, as noted previously I enjoyed 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. 

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. 

EU Machinery Directive & US Product Liability Lawsuits – A New Era Begins

Introduction

I have written several times about the US product liability implications of the EU Machinery Directive. What makes this blog different is the evolution of EN harmonized standards into ISO and IEC standards and by virtue of ANSI participation drafting ISO and IEC standards, the former EN standards are now also American standards. This fact will have significant implications for future litigation in the US. 

Back-story

In some earlier blogs I described working with an American corporation concerned about the increasing losses from product liability lawsuits and operator deaths in one of their Manufacturing Divisions, losses sufficiently large that they threatened to erase the profits of the division.

Since I had earlier helped another Division in the corporation CE Mark several large exploration and drilling machines, their corporate counsel, vice president and risk manager asked me to examine the litigation history of the Division and give them a report. Reading through their litigation history, it was clear that plaintiffs’ claims focused on allegations of design defects with 60% of claims on defective design, 30% of claims on defective design and manufacturing and 10% of claims on defective manufacturing. Plaintiffs’ attorneys also alleged failure to warn and inadequate instructions (which would come under design) and frequently asked questions about Product Analysis Files.

A review of the manufacturers’ machine design files revealed drawings, schematics, operator/maintenance manuals but no records of the steps that had been taken to design safe machines. Engineering change orders frequently had been made to accommodate customers, but no historical document records of the change orders existed. Operation and maintenance manuals were introduced with titles, “Safety Features” and “Safety Options,” without any realization of the liability exposure created by mentioning “Safety Options” that should never have been optional. In other words, it was a mess. If plaintiffs’ attorneys had any clue about the total lack of any design coherence and meaningful documentation, the litigation results would have been even more devastating. 

Since the manufacturer had CE Marked two machines for placing on the EU Market, I suggested that they use the EU model for all of their machines to address the issue of machinery safety. Corporate counsel and management resisted this approach because they thought it would price their machines out of the US market with their competitors. They asked if they could use US standards such as SAE (Society of Automotive Engineers), ASME (American Society of Mechanical Engineers) and a few industry association standards. In other words, use US standards for machines in the US market and EU standards for machines in the EU market.

I said that could be done, but there are some problems with the approach:

• First, US industry standards tend to be permissive in approach and EU EN harmonized standards are prescriptive in approach. In other words, tougher safety standards in the EU.

• Second, machines models headed to the EU would be meeting higher safety standards than for the US. To knowingly sell a safer machine in the EU and less safe machine in the US could result in significant punitive damages if someone was injured in the US by a less safe machine than was being sold in the EU and that fact was discovered by plaintiffs’ attorneys and the jury.

• Third, if a manufacturer is aware that a higher level of machine safety, the state-of-the-art in the marketplace, and competitors achieving that higher level of safety, a machinery manufacturer is basically is asking for a product liability lawsuit when the less safe machine causes an injury.  

After contemplating their approach to their product liability litigation problem, corporate counsel and management decided to sell the division. While unintentional, I had conducted due diligence. It was cheaper to sell the division rather than correct all of the problems and defend against new product liability lawsuits. Further, their insurance deductable for future lawsuits had just been raised to $2 million dollars per lawsuit.

Concerning the second problem, readers of previous blogs will recall a discussion of a 2002 Minnesota lawsuit where a California manufacturer of packaging machines deliberately omitted a laser light curtain safety device that was required of machines sold in the EU for six years. Consequently, a 28 year old young man working around one of their machines in St. Paul Minnesota walked into an area where the packaging machine was actively moving, was struck in the head and would require 24-hour care for the rest of his life. Had the light curtain been in place, the movement in the area would have been detected by the laser light curtain and shut down the machine. When the jury discovered that the company knew how to make safer machines and was selling them machine in Europe, but decided not to add the safety device to the machine in the United States, they awarded $34 million dollars in punitive damages.

EN ISO Safety Standards and Product Liability Exposure in the US Today

In three blogs posted on March 31, April 30 and May 18 I have related issues regarding a machine that killed a worker in the UK and maimed a worker for life in the US. One of the concerns of the trial attorneys has been the validity of the EN standards used to design and manufacture a machine in a US courtroom. While most of the standards involved in the case were also ISO or IEC standards, a few were EN standards. The possibility existed that defense attorneys might argue that EN standards have no validity in a US courtroom. As noted in my earlier blogs much more obfuscation existed in the “Technical Files” which could be better called “Junk Files.” Yet, the concern existed. Today everyone of the standards involved in that case is now an EN ISO or EN IEC standard. 

For those of you readers who say so what if it’s an ISO or IEC standard, what do International Standards mean in an American courtroom? Read the ANSI web site where you will discover that ANSI is the official US representative to and facilitates US participation in drafting ISO and IEC standards, thereby making them American Standards.

If you still ask so what, read Judge Lisle’s language in a 2000 class action lawsuit where defense attorneys argued that ISO 9001 had no standing in the case. The judge stated, “the Eighth Circuit has consistently held that compliance or noncompliance with ANSI standards is admissible in strict liability and/or negligence cases to prove a design defect.” It should be noted that the other US Circuit Courts Of Appeal have made similar decisions concerning ANSI standards.

Conclusion

The transition of EN Safety Standards is now pretty much complete. Very few safety standards remain that are only EN standards and those will transition to ISO and IEC standards in the near future. If you ask why, the answer is quite simple. All EN. ISO and IEC standards are reviewed approximately every 5 to 7 years to decide whether to retain, modify or eliminate the standard. The EU/European standards authorities CEN and CENELEC agreed to work with ISO and IEC to merge their efforts. ANSI is the American representative in these reviews. Expect to see more ISO, IEC, ANSI standards entering product liability litigation in the future. If you have questions about product liability lawsuits and preventive steps such as product safety/product liability audits to reduce product liability exposure in machinery design and manufacturing, you can contact me at my e-mail address jameskolka@gmail.com.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CE Marking Machinery & US Product Liability – The Lawsuits Begin #3

Introduction

This blog is a continuation of two blogs posted on February 25, 2011 and March 31, 2011 respectively. I noted in the second blog my frustration with EU Market Surveillance and the Machinery Directive. I have examined many manufacturers' Machinery Directive Technical Files, some well done and too many done badly.

In spite of early efforts by the European Commission to structure Technical Files into Part A (the index of the file) and Part B (the substance of the file in hardcopy, electronic copy,  samples, etc.) the concept appears never to have gained traction. The virtue of a Technical File divided into two parts with an index is the ability to look at Part A and see if a company attempted to fully comply with the requirements of the Machinery Directive and related Directives.

As a consequence, the mess I have described in the two previous blogs has materialized into a legal case in the UK & US. I have been examining a presumed Technical File that does not contain a comprehensive list of the Directives, Standards and elements required for compliance with the requirements of the Machinery Directive. If I were cynical, I could conclude that the company in question deliberately constructed a “junk file” to cover their tracks in the event of a lawsuit. Or, I might conclude that the personnel who constructed the file were sloppy, indifferent and incompetent. Either conclusion is plausible. 

The only section of the file constructed by the company that purports to resemble a type of index is their EC Declaration of Conformity which is incomplete and inaccurate, e.g. not all standards are cited and several cited are inaccurate, e.g., wrong date of publication, expired or missing. Unfortunately, this pathetic document came to light only after a worker had been killed and another severely injured. These documents should have been reviewed before the manufacturer placed these machines on the EU Market.

Some Ideas for Improving Market Surveillance of the Machinery Directive and Related Directives

While I believe that self-certification can work well and that notified body oversight isn’t necessary, save for exceptional circumstances, I think that there should be a requirement that every manufacturer that places a CE Marked Machine on the EU market should file a document with a member state competent authority that briefly provide the basic elements of the machine which also is shared electronically with the Competent Authorities of all 27 Member States and the European Commission Enterprise and Industry. Further, I think that document should be Part A of their Technical File.

I construct a Part A Technical File for every manufacturer I help to CE Mark their machines.For example, in a recent Part A Technical File developed for a client that recorded the following:

• Annex I Health and Safety Requirements Checklist identifying every essential requirement, the answer (Yes, No, N/A) and if Yes the EN Harmonized Standard(s) that will be used to demonstrate conformity with the requirement  
• EN ISO 14121–1:2007 Safety of machinery – Risk assessment (56 pages written and edited by me and the company’s engineering staff)
• A list of EU Directives – Machinery, Low Voltage, Electromagnetic Compatibility
• A list of 16 EN harmonized standards relevant to the manufacture of this machine
• The overall design, detail drawings and diagrams describing the machine
• Standards calculations
• Guide to the application of the Machinery Directive 2^nd Edition
• EU Compliance Protocol for the machine written by me for my client identifying all of the legal requirements and how they were satisfied
  
• A copy of the EC Declaration of Conformity
• Operating Manual
• Maintenance Manual
• Training Manual
• Sales Materials describing the machine
• Protocol for translating Manuals
• Instructions, Cautions and Warnings
• EC Declaration of Conformity for an electric motor manufactured by another company
• EC Declaration of Conformity for laser equipment manufactured by another company
• IEC System for Conformity Testing and Certification of Electrical Equipment provided by Underwriters Laboratories
• Certificate of Calibration for a machine component
• EC Declaration of Conformity for an Electromagnetic component. 

All of this information was contained in a two-page matrix of 20 items in Part A of a Technical File. Since this was a one-of-a-kind machine, no quality standard was cited. The manufacturer shared this information with their client in the EU as the machine was being constructed. I have provided this level of information for every client with whom I have worked and it is often shared with clients and occasionally member state Competent Authorities. In the case of three different machines being shipped to Turkey where CE Marking was stipulated, the company had to courier all of the CE documents for review by the client company and Turkish national authority for clearance before the ship could be docked and the machines unloaded. I thought this was a fair requirement.

Summary

The only other document that is required for machines to be shipped into the EU is an EC Declaration of Conformity, however it is prepared primarily for customs and, in my opinion, far too cryptic to be useful for the purpose described here. Further, customs officials are far too busy to scrutinize these documents for compliance with the Machinery Directive. In the case of the manufacturer of a deadly machine described in my first two blogs in this series, the only recognizable document in their “junk technical file” was an EC Declaration of Conformity, most notable for what required information wasn’t provided.

Recommendation

In order to exercise some control over the plethora of machines flooding the EU market, I recommend that that the concept of a Technical File with two parts (Part A & Part B) be revived. Further, I recommend that Part A be filed with a legal entity such as a Member State Competent Authority and digitally transmitted to all Member State Competent Authorities and the European Commission, Enterprise and Industry. Part A should include reference to all of the elements required to comply with the requirements of the Directive and related Directives (which will vary for each machine).

Further, I think some type of effort should be made to deal with all of the “junk technical files” for machines already on the market. This could be accomplished in part by citing Decision No. 768/2008/EC of the European Parliament and Of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/ EEC and requiring every machine to submit Part A for existing machines as well as reminding manufacturers that starting 1 January 2010 they had to comply with revised Directives and revised EN standards.

I would be happy to help with this effort, if there is an interest. In my opinion, the EU Machinery Directive is the most significant contribution to the improvement of machinery safety that has been made. Its ripple effects extend globally to improve machine safety. If you have any questions about the EU machinery Directive and its US product liability implications, you can contact me for a free preliminary consultation at my new e-mail address at jameskolka@gmail.com.

 

 

CE Marking Machinery & US Product Liability – The Lawsuits Begin #2

Legal Issues in the EU and EU Member States

This is a continuation from blog #1 posted on February 25, 2011 concerning a fatal accident in the UK and severe accident in the US involving the same CE Marked machine. This blog focuses on the legal issues and social consequences of the UK fatal accident. A future blog will examine the US product liability implications of the severe accident involving the same CE Marked machine.

As noted in that blog, I have been examining what purports to be a Technical File for a machine manufactured in 2005. In addition to the Technical File being sloppy, seemingly inaccurate and lacking critical details, there appear to be few records retained that can be examined concerning the design the machine, such as the design records for ISO 9001:2000 and series manufacture. 

Because most machines CE Marked for the Machinery Directive are self-certified, Technical Files aren’t examined until something happens, such as an accident. It is only then for the first time that a hodgepodge Technical File materializes to be examined for potential problems. The first governmental agency that examines workplace accidents usually is that country’s equivalent of the US OSHA (Occupational Safety and Health Administration) concerned about workplace safety.

In the UK, that would be HSE (Health and Safety Executive). Only at the next level when CE Mark issues are turned over to the UK agency responsible for the Machinery Directive, BIS (Department for Business Innovation & Skills) is there any technical knowledge of the CE Marking process and Directive requirements, (e.g. Directive Annex I Essential Health and Safety Requirements, EN harmonized standards to demonstrate conformity, Risk Assessment, EC Declaration of Conformity, etc.). Only then are the workplace safety responsibilities of a manufacturer considered vis-à-vis the Machinery Directive.

If this occurs promptly after an accident, in tandem with the HSE investigation, compliance with the Machinery Directive and the CE Mark compliance or noncompliance of the machine will receive consideration on a timely basis. Unfortunately, the fractured Technical File and apparent noncompliance with the requirements of the Machinery Directive and related Directives (Low Voltage Directive and EMC Directive) may be reviewed so late in the process that injured workers and their families may be denied appropriate compensation, time having expired for prompt consideration. It is a perverse Catch 22.

The EU Machinery Directive 98/37/EC in place in 2005 when the machine that caused these accidents was manufactured and the subsequent revised Machinery Directive 2006/42/EC both contain the Article 7 Safeguard Clause that allows for the removal of a CE Marked machine that is not in compliance with the requirements of the Machinery Directive. It states:

1.Where a Member State ascertains that:

--machinery bearing the CE marking, or

--safety components are accompanied by the EC declaration of conformity, used in accordance with their intended purpose are liable to endanger the safety of persons, and, where appropriate domestic animals or property, it shall take all appropriate measures to withdraw such machinery or safety components from the market, to prohibit the placing on the market, putting into service or use thereof to restricted free movements thereof.

Member States shall immediately inform the Commission of any such measure, indicating the reason for its decision and, in particular, whether nonconformity is due to:

(a) failure to satisfy the essential requirements referred to in Article 3;

(b) incorrect applications of these standards referred to in Article 5(2);

(c) shortcomings in the standards themselves referred to in Article 5(2).

3.Where:

-- machinery which does not comply bears the CE marking,

-- a safety component which does not comply is accompanied by an EC declaration of conformity, the competent Member State shall take appropriate action against whom so ever has affixed the marking or drawn up the declaration and shall so inform the Commission and other Member States.

4. The Commission shall ensure that Member States are kept informed of the progress and outcome of this procedure.   

In other words, the Article 7 Safeguard Clause could have been used to remove noncompliant CE marked machines from the EU market. Unfortunately, since no effort was and/or is made to review incomplete, inaccurate or faulty technical files, knowledge to invoke the Article 7 Safeguard Clause would always be “after the fact”. Only if a consumer or more likely a competitor complained about a machine would the Safeguard Clause be used.

Regulation (EC) No 765/2008 setting out the Requirements for Accreditation and Market Surveillance Relating to the Marketing of Products and Repealing Regulation (EEC) 339/93

 The subject matter and scope of the new regulation as set forth in Article 1.

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

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

 (As noted in earlier blogs, the implementation date for this new Regulation was 1 January 2010)

Among the initiatives set forth by the new regulation are:

•  Market surveillance measures
  

•  Products presenting a serious risk

•  Restrictive measures

•  Exchange of information – Community Rapid Information System

When EU market authorities find a product that presents a serious risk, they will take measures to prohibit the product from being placed on the market and mark products and documentation with:

•  Dangerous product – release  for free circulation not authorized – Regulation (EC) No 765/2008

When the product is not in conformity with CE marking requirements, the marketing surveillance authority shall require the authorities in charge of external border controls not to release the product for free circulation and market it:

•  Product not in conformity – release for free circulation not authorized – Regulation (EC) No 765/2008

 

Timing & Transparency 

 To date nothing has happened concerning the machine in question and consideration of applying the Article 7 Safeguard Clause to remove it from the marketplace. It may have to move through BIS to and an accreditation authority. The final disposition has not been resolved and the machine and its garbled technical file remain on the market. Clearly, the prospect that a noncompliant machine can only be discovered if a customer complains, a competitor complains or fatal or serious accident occurs is not an acceptable outcome and certainly doesn’t result in improved market surveillance.

I have some ideas to improve supervision of compliance with the Machinery Directive that I will expand upon in my 3rd blog on this topic. I greatly respect the improvement in machine safety already delivered and promised by the EU Machinery Directive and the ambition to improve market surveillance. As a legal consultant, however, it is difficult to persuade US manufacturers to adhere to Directive Requirements if they know of companies treating them lightly, trying to do as little as possible. The legal consequences in the US will be profound! If you have any questions about the EU Machinery Directive and its US product liability legal implications, you can contact me for a free preliminary consultation at my new e-mail address jameskolka@gmail.com

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CE Marking Machinery & US Product Liability – The Lawsuits Begin #1

Prologue

I have been writing about and working with machinery manufacturers on the EU Machinery Directive since 1991. In 1992, another attorney, Gregory Scott, and I wrote "European Community Product Liability and Product Safety Directives", Published by CEEM Information Services, Fairfax, VA, which included several chapters about the Machinery Safety Directive and Product liability Directive. In 1995, Bruce McIntosh, the Product Safety Manager for Graco, Inc. in Minneapolis, and I wrote "The European Union Machinery Directive: Compliance Manual for Trade", published by Simcom, Inc., Atlanta, GA. In December, 1996 in Washington DC I chaired an American Society for Quality Control Seminar (now the American Society for Quality ASQ), “CE Marking in the U.S.: An Overview”, which reviewed the Machinery Directive with Trade Associations and notified bodies. In 1998, I discussed the legal implications of the Machinery Directive in "ISO 9000… A Legal Perspective", co-published by, ASQ, Milwaukee, WI & Inform, Montclair, VA.

I have been teaching public Seminars on the Machinery Directive since 1992 at the University of Wisconsin, School of Engineering, Madison, WI, Georgia Institute of Technology, Atlanta, GA, Clemson University, Charlotte, NC, Indiana University Purdue University, Indianapolis, IN, QSI Qualified Specialists Inc, Houston, TX and CMTC California Manufacturing Technology Centers, Los Angeles, CA, Ontario, CA & Fresno, CA. I have worked with manufacturing companies CE Marking Machinery throughout the US and Canada, written numerous articles and for the past two years posted 40 blogs on my blog site jameskolka.typepad.com.

Finally, I have worked with numerous manufacturers shipping machinery into the EU requiring a CE Mark (UK, Spain, France, Italy, Germany, the Netherlands, Cyprus, Turkey, etc.) On one occasion I served as legal expert and successfully filed a grievance concerning the legal scope of a Dutch notified body authorization with Commissioner Liikanen and the Machinery Committee of the European Commission. During the past decade, I have served as attorney legal/expert in US product liability lawsuits involving ISO 9001, the Machinery Directive & related Directives, the Medical Devices Directives and FDA’s Quality System Regulation. 

Litigation: US Product Liability, The Machinery Directive & Related Directives

Presently, I am working on litigation in the UK & US concerning a CE Marked machine that has caused a death and severe injury requiring lifetime medical care for operators of a specific machine. A review of the manufacturer’s Technical File or what the manufacturer alleges is a Technical File reveals sloppy and incomplete documentation. It does not contain a Part A index of the File, does not contain an Annex I Essential Requirements Checklist identifying (Yes, No or N/A) answer for each of the essential requirements and does not identify which EN or EN ISO harmonized standards will be used to address the “Yes” marked essential requirements to allow for a presumption of conformity.

While the EC Declaration of Conformity lists EN 1050:1996 as its Risk Assessment standard (it should have been 1997, and given the date of manufacture of the machine in 2005 it should have been EN ISO 14121-1:1999), there is no Risk Assessment following that standard. It appears that the manufacturer assumed that compliance with a C Standard could substitute as the Risk Assessment standard for the machine. I can not! There is no Hazards Analysis/Risk Assessment that would allow for a reasoned determination of Cautions, Warnings and Instructions if hazards could not be designed out or guarded against. This is particularly important in establishing the legitimacy of such language in the US.

The EC Declaration of Conformity listed the Machinery, EMC and Low Voltage Directives, but identified no EMC Standards used for emissions or shielding the machine (nor is there a EMC Certificate from a Competent Body approved test facility identified elsewhere in the Technical File). In addition to listing EN 1050 with the wrong date and not identifying the replacement Risk Assessment standard EN ISO 14121-1:1999, the EC Declaration of Conformity listed EN 12100-1:2001 and EN 12100-2:2001 which for the UK should have been BS EN ISO 12100-1: 2003 and BS EN ISO 12100-2: 2003. Further, reading of the calculations in the file mentions EN 292-1 and EN 292-2, which had been replaced by 2005. (It isn’t clear if the manufacturer simply replaced EN292-1 with BS EN ISO 12100-1 without understanding the substantive changes that had been made.)  As observed earlier, the kindest word for the file would be sloppy. The EC Declaration of Conformity also does identify an Authorized Representative in the EU.                  

Finally, mention is made of ISO 9001 in the body of the file, but not listed in the EC Declaration of Conformity. Since these machines were not “one-of-a-kind”, they would also need to satisfy Annex V, paragraph 3 (b.) for series manufacture, the internal, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive. Given the 2005 date of the manufacture of the machine, the Quality management System Standard would be BS EN ISO 9001: 2000. This means that the design requirements for the standard should also be examined – 7.3 Design and development, including 7.3.1 Design and development planning, 7.3.2 `Design and development inputs, 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 development validation, and 7.3.7 Control of design and development changes.

ISO 9001: 2000 also has records requirements that could be useful to attorneys wanting to examine the types of steps taken to design the machine. Annex V, paragraph (b) The Documentation referred to in 3 above must be retained and kept available for the competent authority [member state national agency for the Machinery Directive] for at least 10 years following the date of manufacture of the unit produced or of the last unit produced, in the case of series manufacture.

Summary

Thus far I have only discussed some of the issues relevant to the UK and EU. In my next blog, I will expand on additional UK and EU issues and expand the discussion to product liability litigation in the US. Also, remember that this litigation involves a machine manufactured in 2005 and the Directives and Standards current at that time. Since all of the Directives and many of the Standards have been revised, the machine and the accidents would be approached differently at this time. However, new EU Regulations now exist that could be invoked at this time. I will discuss these issues in my next blog and a third blog will discuss EU regulatory compliance and the US product liability implications of the EU Machinery Directive in 2011 – they are not the same thing. If you have questions about the EU Machinery Directive and its US product liability legal implications, you can contact me for a free preliminary consultation 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.

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.  

CE Machinery Malpractice: “The Whole Machine Must Be Greater Than The Sum Of Its Parts!” #2

Introduction  

In my July 31 blog #1, I discussed US companies combining drive systems, such as a generator mounted on a flatbed truck attached to partly completed machines such as a drilling rig or an excavator, then declaring the combination “Voila” to be a complete machine. It is a lazy way to CE Mark a machine and it is a form of malpractice. I’m sure manufacturers in other third countries (the EU term for all countries outside the EU) are doing the same thing, however, it is illegal. This blog is going to explore this issue in greater depth, using the Guide to application of the Machinery Directive 2006/42/EC, 2^nd Edition, June 2010, General Editor, Ian Fraser published by the European Commission Enterprise and Industry.  

Machinery Directive Definitions  

Article 2, Definitions States, “For the purposes of this Directive, ‘machinery’ designates the products listed in Article 1 (1)(a) to (f).   The following definitions shall apply:  

-- an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,  

-- an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,  

-- an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or structure,  

(g)’partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a complete a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies.  

The Problem  

There are companies that manufacture partly completed machinery such as drilling rigs and excavators that claim to have CE Marked their equipment before being connected to a drive system, such as a generator, which isn’t legally possible. Instead, they must issue a Declaration of Incorporation. As noted in the June 2010 Guide Section  

§18 However, the manufacturer of partly completed machinery must state, in a Declaration of Incorporation, which of the essential health and safety requirements he has fulfilled – see §385: comments on Annex II 1 B, and §394: comments on Annex VII, B.  

In addition, the June 2010 Guide states:  

For machinery to be supplied without a drive system:  

-- the manufacturer’s risk assessment must take into account all the risks associated with the machinery, including those relating to the drive system to be fitted to the machinery – see §158: comments on General Principle 1 of Annex I;  

-- the machinery manufacturer must set out in his instructions all the necessary specifications for the drive system to be fitted such as the type, power and means of connection, and provide precise fitting instructions for the drive system – see §264: comments on section 1.7.4.2 (i) of Annex I;  

-- the conformity assessment of the machinery must cover the specifications of the drive system to be fitted and the fitting instructions ;  

-- the CE-Marking on the machinery and the EC Declaration of Conformity that accompanies the machinery must cover the specifications and instructions relating to the drive system to be fitted.  

§ 37 Machinery to be installed on a specific support  

The third indent of the definition of machinery refers to machinery intended for installation on a means of transport or in a building or structure.  

If such machinery is mounted on road vehicles or trailers that are excluded from the scope of the Machinery Directive, the requirements of the Machinery Directive do not apply to the vehicle or the trailer itself, however the requirements of the Machinery Directive apply both to the mounted machinery and to all aspects of the interface between the machinery and the chassis on which it is mounted which may affect the safe travel and operation of the machinery.  

The third indent of the definition of machinery implies that the manufacturer of machinery intended to be installed on a means of transport or installed in a building or structure is responsible for the conformity of the machinery with the relevant health or safety requirements. He must affix the CE-marking on the machinery and draw up and sign the EC Declaration of Conformity. The manufacturer of such machinery must take into account in his risk assessment all the risks associated with the machine, including those relating to installation of the machinery on the chassis of a vehicle or trailer or an a supporting structure. (Emphasis added)  

Manufacturers of machinery intended to be installed on a means of transport must therefore specify the vehicles or trailers on which such machinery can be safely installed, either by reference to their technical characteristics or, were necessary to specific models of vehicle.  

The conformity assessment of machinery intended to be installed on a means of transport or in a building or structure covers the machinery itself, the specifications for the supporting structure and the installation instructions. The necessary tests and inspections must be carried out on the machinery installed on its support in order to check the conformity with the essential health and safety requirements. The CE-marking on the machine and the EC Declaration of Conformity that must accompany the machine cover the conformity itself and the specifications and instructions relating to its installation. (Emphasis added)  

What Does All of this Mean? 

The manufacturer of CE Marked machinery mounted on a means of transport is responsible for the conformity of the machinery with the Machinery Directive Annex I Essential Health and Safety Requirements applicable to the complete assembly and the Final Risk Assessment taking into account all of the risks associated with the machine, including those relating to the installation of the machinery on the chassis of a vehicle or trailer; including the partly completed drill rig or excavator and the partly completed generator.  

Both partly completed machines should have documents detailing what Annex I Essential Health and Safety Requirements apply to their partly completed machines, the EN standards that allow for a presumption of conformity, an ISO 14121-1:2007 Risk Assessment and an EC Declaration of Incorporation. The generator also should demonstrate how it satisfies the revised Electromagnetic Compatibility Directive 2004/108/EC, the CE Marking Directive 2000/14/EC of 8 May 2000 relating to the noise emission in the environment by equipment for use outdoors and EU Directive 2004/26/EC relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery.  

Legal Implications of CE Marking Machinery Malpractice  

Market Surveillance – The revised Machinery Directive in …”The ninth and tenth recitals introduce several provisions in the new Machinery Directive which establish a stronger legal basis for market surveillance and enforcement action.”  

Product Safety Directive – The revised EU Product Safety Directive 2001/95/EC strengthened the requirement that “products placed on the market are safe”  

US Product Liability Exposure – Any US Machinery manufacturer who places a machine on the EU market can be sued for cause in a US District Court for failing to manufacture a safe machine, i.e. one that complies with the safety requirements of the EU Machinery Directive. While this may seem a little far-fetched, I have served as legal expert in lawsuits filed in a US District Court by European Companies against American manufacturers. The rationale is quite simple, since European Courts do not encourage product liability lawsuits and US Courts are receptive to product liability lawsuits and the two parties meet the legal requirements to sue in a US Court, then why not use US law to seek monetary relief? Expect an increase in such lawsuits in the future. If you have product liability concerns regarding the Machinery Directive & related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net

When CE Marking Machines, “The Whole Machine Must Be Greater Than The Sum Of Its Parts!” #1

Or put another way, a manufacturer cannot assemble a series of CE Marked machines and declare “Voila” this assembly is synergistically CE Marked. The assembly itself must itself be CE Marked, have a Technical File (Parts A & B), an Annex I Health and Safety Requirements Checklist, identify the EN Harmonized Standards that allow for a demonstration of conformity with the Essential Requirements, include a Risk assessment/hazards analysis and a Compliance Protocol including a copy of the EC Declaration of Conformity.  

The Machinery Directive and Amendments in 1996 (Machinery Directive 89/392/EEC as Amended by 91/368/EEC and 93/68/EEC)  

My first complex machine assembly was described in my April 6, 2009 Blog. The company had a contract to create an automated assembly line to manufacture fuel injection systems for a new GM automobile plant that was being built in Portugal. I worked with company employees to CE Mark two stand-alone machines to create components of the fuel injection system.   

Next they had to purchase four additional CE Marked machines from other companies to manufacture components of the fuel injection system, which was achieved. Finally, they had to CE Mark the whole assembly line, comprised of the six CE Marked machines and the conveyor system that carried the fuel injection system through each stage of its manufacture to the finished fuel injection system.  

The assembly system had to be subjected to the rigors of a every CE Marked Machine, e.g. Annex I Essential Health and Safety Requirements Checklist, identification of those EN Harmonized Standards to satisfy the identified essential requirements and allow for a presumption of conformity to the essential requirements, conduct a risk assessment/hazards analysis (at that time using EN 1050) to determine if the system satisfied the essential health and safety requirements of the Machinery Directive, complied with the Low Voltage and EMC Directives, create a Technical File (Part A& B) and draft an EC Declaration of Conformity.  

Since that time I have worked with other companies CE Marking complex machines. Most have followed the path described above, but one asked for initial help on the first three machines on an assembly line, purchased additional CE Marked machines and decided that they could finish the remainder of the work by themselves, including CE Marking the whole assembly line and complying with the new EMC Directive by conducting “in situ” testing on the site of the installation.  

Reading between the lines it was clear that the division CEO wanted to declare that the several CE Marked Machines constituted a completed “CE Marked machine” and did not want to subject the whole assembly to the rigors of the CE Marking process. Since this occurred after I finished my work with the company, I don’t know what finally transpired, however, the complexity and size of the final assembly presented some significant risks that could not have been resolved by declaring that the, “whole was equal to the sum of its parts.” It might even mask some serious safety risks created by the interaction of the several CE marked machines.  

The Machinery Directive in 2010 (Directive 2006/42/EC Of The European Parliament And Of The Council of 17 May 2006 on Machinery, and amending Directive 95/16/EC (recast)  

While the behaviors described above still exist, the revised Machinery Directive is more precise in what is meant by a machine. Nonetheless, I still see efforts to collect CE Marked components and machines and declare that the combination is therefore CE Marked. The Definition of a Machine in the revised Directive is stated in Article 2.  

Article 2  

Definitions  

The following definitions shall apply: 

(a)‘machinery’ means:  

--an assembly, fitted with or intended to be fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,  

-an assembly referred to in the first indent, missing only the components to connect it on site or for a specific application,  

--an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or structure,  

--assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,  

--an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort,  

(b)’interchangeable equipment’ means a device which, after the putting into service of machinery or of a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool;  

(c)’safety component’ means a component:  

--which serves to fulfill a safety function,  

--which is independently placed on the market,  

--the failure and/or malfunctions of which endangers the safety of persons, and  

--which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function.  

(g)’partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies.  

I included paragraph (g) to underscore an earlier point. Recently, I was contacted by a company that makes a wide variety of machines that “cannot perform a specific application” or task unless connected to a power source, i.e. “a drive system.” The person who contacted me said that their partly completed machines were CE Marked and they wanted to purchase a power source that also was CE Marked.  He assumed that the combination would therefore be CE Marked.  

Needless to say, he was wrong on several counts. He could not CE Mark his partly completed machines, however, he could do all of the work required for CE Marking and issue a Declaration of Incorporation. Next, he could purchase an appropriate drive system, attach it to his partly completed machine and then CE Mark the whole combination as a machine, but he could not put he two together and declare that they were “Voila,” CE Marked.  

The Machinery Combination Confusion Continues In 2010  

It is frustrating to say the least. The lack of understanding about the safety dimensions of the Machinery Directive continue today. Too many companies want to adopt a quick and mindless route to CE Mark their machines. Combining a powerful drive system with a powerful drilling or excavation machine without a full CE Marking protocol for the combination, including an ISO 14121-1:2007 Risk Assessment & Hazards Analysis is as foolish as the BP Deep Water Horizon venture that didn’t attempt to calculate the risks of Deep Water Drilling in the Gulf of Mexico. The potential liabilities could erase any benefits and destroy the company. Clearly, Disaster Preparedness and Enterprise Risk Management weren't even being contemplated by such companies.  

Blog #2 will focus on additional aspects of the Machinery Directive discussed in the Guide to application of the Machinery Directive 2006/42/EC, 2^nd Edition, June 2010, General Editor, Ian Fraser. I will also discuss the potential US product liability exposure of non-compliant machines sold in the EU, in the event of an accident. If you have product liability concerns regarding the Machinery Directive & related Directives, 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.

Brussels You Have a Problem! – Out Of Date CE Marked Components & EC Declarations Of Conformity #1

During the past few months I have worked with three clients preparing their CE Marking compliance materials (Applicable Directives, Annex I Checklist, Applicable EN Standards, Legal Protocol, Technical File, ISO 14121-1 Risk Assessment, identification of a Authorized Representative), for placing their machines on the market in the EU. In each case these clients purchased CE Marked Components for parts of their machines and received EC Declarations of Conformity from the component suppliers. All well and good!  

On closer examination, however, I noticed that one of the EC Declarations of Conformity for a part purchased in 2009, was dated November 2003 and listed four BS EN Standards dated 1997, 1994, 1999 & 1993. Out of curiosity I went to the BSI website and entered the numbers and titles of the standards. Three had been replaced in 2001. Only the 1994 standard was current. When contacted, the component supplier said, you purchased the component last year, ignoring the fact that three standards cited were even out of date when the Declaration was signed in 2003. My client was assured that the component satisfied the requirements of the 2001 standards, after some additional work by the components manufacturer.  

Another EC Declaration of Conformity from the supplier of a key component had to update 10 EMC & Low Voltage EN Standards that had been replaced by a more recent version of the standard. Only three of the standards remained the same. In this case, the recent versions of the standards had been used to manufacture the component, but the EC Declaration of Conformity had never been updated to reflect the changes.  

Following these two discoveries, I examined four other EC Declarations of Conformity for three clients and found all four to contain EN standards that had been replaced by a more recent version. To see if this same phenomena existed elsewhere, I called a client I will be working with in August and asked if he had received a Declaration of Incorporation for a machinery part we will be adding to his machine. He sent the Declaration to me and it too was out of date. The world of CE Marking compliance and market surveillance may have been tightened on 1 January 2010, but you couldn’t tell that from these component suppliers.  

Finally, I received a call from another client concerning CE Marking electrical components for the revised Low Voltage Directive. On one web site a components supplier listed compliance with a 1981 EN Standard. When I looked up the standard on the web, I found that the standard did not exist. It was so old that any connection to an existing replacement standard was lost, yet the company’s electrical components were proudly listed as CE Marked on their website. Further, the company somewhat sanctimoniously noted that they complied with the Low Voltage Directive 72/23/EEC as amended by 93/68/EEC. There was no mention that the new EU Low Voltage Directive 2006/95/EC repealed the prior Directive as of 16 January 2007. Clearly this supplier was and is out of date.

Some of these suppliers are American, some are multi-national and some are European. All were sloppy and somewhat peeved to have their shortcomings called to their attention. While my sample of 10 suppliers is small, I suspect that the failure to update may be widespread, if not endemic. Worse yet, these suppliers were not aware of the EU Regulation 765/2008 designed to tighten EU market surveillance. (For an expanded discussion of the regulation, see my October 30, 2009 blog.) 

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  

Presently, I want to underscore some additional aspects of the Market Surveillance measures of Regulation (EEC) No 339/93:  

·      Market surveillance measures – Article 19 (1.) Market surveillance authorities shall perform appropriate checks and, where appropriate, physical and laboratory checks on the basis of adequate samples. When doing so they shall take account of established principles of risk assessment, complaints and other information.  

·      Products presenting a serious risk – Article 20 (1.) Member states shall ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on the market is prohibited, and that the Commission is informed without delay thereof, in accordance with Article 22.  

·      Restrictive measures – Article 21 (1.) Member states shall ensure that any measures taken, pursuant to the relevant Community harmonization legislation, to prohibit or restrict the products being made available on the market, to withdraw it from the market or to recall it, is proportionate and states the exact grounds on which it is based.  

·      Exchange of information – Community Rapid Information System – Article 22 (2.) If a product presenting a serious risk has been made available on the market, Member States shall notify the Commission of any voluntary measures taken and communicated by economic operators.  

·      Controls of products entering the Community market – Article 27 (3.) The authorities in charge of external border controls shall suspend release of a product for free circulation on the Community market when any of the following findings are made in the course of the checks (on the characteristics of products)  

o   The product displays characteristics which give cause to believe that the product, when properly installed, presents a serious risk to health, safety, the environment or any other public interest  

o   The product is not accompanied by written or electronic documentation required by the relevant Community harmonization or is not marked in accordance with that legislation  

o   The CE marking has been affixed to the product in a false or misleading manner  

·      The authorities in charge of external border controls shall immediately notify the market surveillance authorities of any such suspension  

When The EU market authorities find a product that presents a serious risk, they will take measures to prohibit the product from being placed on the market and mark the products documentation with:  

‘Dangerous product – release for free circulation not authorized – Regulation (EC) No 765/2008.   When the product is not in conformity with CE marking requirements the market surveillance authorities shall require the authorities in charge of external border controls not to release the product for free circulation mark it:

‘Product not in conformity – release for free circulation not authorized – Regulation (EC) No 765/2008  

Summary  

In addition to being incredibly lazy and sloppy, I consider the problem of out of date EC Declarations of Conformity and EN harmonized standards to be quite serious. It has safety and liability implications for both the seller and buyer in the EU and US. It also is an area where machinery manufacturers do not expect to receive out of date components.  As of 1 January 2010 only revised Directives and the newest version of EN harmonized standards are to be identified on CE Marking Documents such as the EC Declaration of Conformity.  

When the revised Machinery Directive was adopted 2006, several provisions were inserted to improve market surveillance, such as:  

>Monitor conformity of machines with the relevant Directives  

>Empower authorities to take action necessary to remove non-compliant machines from the EU market  

>Fix rules concerning legal sanctions for non-compliance  

These are just a few of the new rules. I will expand the list in a future blog. If you have any questions concerning compliance and product liability questions concerning 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 #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.  

CE Marking Products for the EU – Product Liability Exposure in the US

I have discussed the topic of product liability exposure in several of my 2009 blogs. Recently, however, as I was helping a client find a company to make new metal plates with a CE Mark, company name and serial numbers for his machines, I came across advertisements from numerous consultants declaring that they could help companies CE Mark their products for modest amounts of money. Of course these claims often are understated only to have the client discover that it will cost a great deal more to finish the work, another form of “bait and switch.” And in other ads, manufacturers pursuing the lowest possible cost discover that they are buying a series of “fill-in-the-blank” templates, which are “one size fits all” for machines ranging from simple to complex. Both approaches could be categorized as a form of fraud.  

Caveat Emptor (Let the Buyer Beware!)

While Americans are suckers for anything cheap, “CE Marking Lite” for machines is a bad idea for several reasons. To comply with the revised Machinery Directive, it is necessary to identify the appropriate conformity assessment procedure for your machine and/or machine product family; it is necessary to construct an Annex I Checklist; identify the relevant EN harmonized standards that will allow the manufacturer to demonstrate a presumption of conformity with the Essential Requirements; it is necessary to conduct a complete ISO 14121-1: 2007 Risk Assessment and Hazards Analysis with documentation; create a Part A Technical File and EC Declaration of Conformity.  

The legal steps taken to comply with the EU revised Machinery Directive and related Directives should be clearly spelled out in your documentation so that the legal rationale and path taken is clearly written in a document for EU member state competent (national) authorities. In addition, this documentation will be vital to a legal defense in the event of a product liability lawsuit in a US Court of Law. This latter point also underscores the liability exposure for any EU based consultants in the UK, Ireland, the Netherlands, France, etc. working directly or via the internet in the EU with EU, US and other third country clients.  

If an EU based consultant or consulting firm accepts money from a US based company for CE Marking Assistance, they are subject to US Law in US Federal and State Courts. The fact that these consultants are physically based in the EU is irrelevant, because they are doing business in the US.  

Issues That Must Be Addressed When Complying with the Machinery Directive and Related Directives  

The primary focus of the Machinery Directive and other new approach Directives is product safety and in the case of machinery, machinery safety. To this end the Annex I Essential Health and Safety Requirements (ESHSR) were designed to address the various aspects of machine safety. This also means that new designs must incorporate the elements of the ESHER into the design of new machines and modify the designs of existing machines accordingly.  

To do this, it is necessary to identify the EN harmonized standards that will allow for a presumption of conformity. Many of these EN harmonized standards have been revised and are now EN ISO standards which means as ISO standards they also are American Standards, since the American National Standards Institute (ANSI) participates in the drafting of ISO standards (the implications of ANSI participation will become more apparent in future product liability litigation, see my July 10, 2009 & March 23, 2009 blogs). In short, ANSI standards are acceptable evidence to establish state-of-the-art in product safety in US Courts of Law.  

I have worked with machines from simple to extremely complex. The number of EN harmonized standards can range from as few as four to 30 or more. It depends on the number of ESHSR that apply to a specific machine. To assert that the certification for simple to complex machines can be handled for US$730.00 is not only absurd, it is wildly misleading. Further, it is necessary for each machine to conduct a hazards analysis and risk assessment for the design of the machine. To suggest that all hazards analyses and risk assessments are equal and can be handled for the same amount of money is equally stupid and misleading. A competent risk assessment can take a significant amount of time to do well. The more complex the machine, the greater amount of time and detail.  

Compliance with ISO 14121-1: 2007 Safety of machinery – Risk assessment – Part 1: Principles. Conducting a thorough risk assessment means that every possible hazard is identified and the reduction of that hazard to an acceptable level of machine safety by designing out all hazards, guarding against those hazards that can’t be designed out or guarded against and creating warnings and instructions for those hazards that can’t be designed out or guarded against.  

Every single question in the risk assessment standard must be answered Yes, No or N/A and the answer must be written in clear English so that it can be understood if a product safety issue arises. In most instances questions will arise several years later after the original writers of the risk assessment have moved on to other positions or retired. Therefore, the answers will have to stand on their own.  

Finally, it is only at the end of this process that a manufacturer can establish warnings and instructions for a machine and to determine how the machine should be marked for machine safety. Failure to issue warnings without conducting a full hazards analysis and risk assessment has resulted in punitive damage awards for plaintiffs against numerous manufacturers in product liability lawsuits in the US.  

Summary  

Product liability exposure will increase with the revised Machinery Directive, related Directives and the revised EN ISO standards. All companies, (domestic and foreign manufacturers, independent consultants and notified body consultants) active in the US marketplace will be subject to product liability exposure (see my July 10, 2009 blog, CE Marking Machinery – Future State-of-the-Art in American Product Liability Lawsuits). CE Marking will assume greater importance as soon as plaintiffs’ attorneys and subsequently defense attorneys begin to understand what is happening.  

While the one case to date that went to trial in Minnesota in 2002 resulting in a $35 million dollar punitive damages judgment involved safety standards, it was understood by the jury as a case where a California machinery manufacturer had been making a safer machine for the EU and a less safe machine for the US resulting in an injury that crushed the skull of a worker requiring 24 hour care for the rest of his life. The attorneys and the jury didn’t know that California machinery manufacturer implemented safety standards created for the EU Machinery Directive. What the jury did know was the fact that the California machinery manufacturer knew how to make a safer machine and had been doing so for 6 years, but chose to make a less safe machine for the US Market.  

How does this affect future product liability litigation in the US? Quite simple, a plaintiff’s attorney hires someone like me to serve as a legal expert to testify about the CE Marking process and how your company failed to meet the Directive’s Essential Health and Safety Requirements resulting in an injury to the attorney’s client or clients. It is similar to my involvement as a legal expert in product liability, design and contract litigation involving ISO 9001.  

Presently I am talking with some attorneys about serving as legal expert concerning accidents involving US manufactured machines. I discovered that two of the manufacturers sell their machines in the EU, which means that their EU machines should be CE Marked. Therefore, the question arises, are the EU machines safer? A perusal of their Technical Files, compliance with EU harmonized standards and hazards analysis/risk assessment will provide valuable information for the lawsuit. If you have product liability and risk assessment concerns vis-à-vis the US market regarding the revised Machinery Safety Directive and related Directives, 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.      

Revisions To EU Medical Devices Directive Come Into Force On 21 March 2010

On 5 June 2009 the European Commission published, “Interpretative Document Of The Commission’s Services”, “Implementation Of Directive 2007/47/EC Amending Directives 90/385/EEC, 93/42/EEC And 98/8/EC”(e.g., Active Implantable Medical Devices, Medical Devices & In Vitro Diagnostic Medical Devices Directives).  

The Implementation Document was published because the new Medical Devices Directive 2007/47/EC did not contain provisions for a transition period to the new Directive. Therefore, the European Commission produced guidance on implementation. The critical date is 21 March 2010.

The application of the new legislation to Medical Device Machines combining the requirements of the new Medical Devices Directive and the new machinery Directive was discussed at length in my October 26, 2009 blog.  

Among the new requirements addressed in the Implementation Document are the following:

Placing on the market – is defined as the first making available in return for payment or free of charge … with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished.  

Putting into service – is defined as the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose”  

While these were never voluntary requirements, manufacturers should anticipate that as of 21 March 2010, they are mandatory. Further, manufacturers should anticipate that that their Declaration of Conformity must state compliance of their Devices with the new Directives on the face of the Declaration by 21 March 2010.  

Evaluation by Notified Bodies According to New Requirements  

Timing – Any decision that a Notified Body takes as of 21 March 2010 regarding the delivery or renewal of a certificate must take account of the new evaluation requirements as amended by the new revised Medical Devices Directive. This means that Notified Bodies must alert manufacturers about:  

·      a new type of medical device  

·      devices that change their class due to the revised device classification rules  

·      devices that undergo changes that are subject to prior assessment by a Notified Body     This means that a manufacturer may have to request that a Notified Body carry out a new conformity assessment to comply with new revised Medical devices Directive by 21 March 2010.   

Device Classification – While the device classification changes are modest, manufacturers should review the classification of their existing devices to determine if any changes might affect them. For example, until the new revised Medical Devices Directive, reusable surgical instruments were classified as Class I non sterile, which meant that manufacturers would not require Notified Body involvement and could self certify. As of 21 March 2010, reusable nonsterile surgical instruments are classified as IIa and will require Notified body approval of their ISO 13485 Quality Management System.  

Crossover with the Personal Protective Equipment – Where it is apparent that personal protective equipment is intended to protect the patient (therefore a medical device) is also designed to protect healthcare workers (therefore personal protective equipment), it will be necessary to CE mark to both directives. Since the requirements of these two directives can be quite different, this will require special attention. The British Medical Device Competent Authority Medicines and Healthcare Products Regulatory Agency (MHRA) stated that it “will take action to ensure that manufacturers indicate clearly what purpose the product can be used for and do not take advantage of the changes by remaining silent in their claims then carrying on activities that indicate an intended PPE or medical device function.”  

Custom-made Medical Devices – For manufacturers of custom made devices, this will implement significant changes. As reported in two previous blogs on orthodontic custom-made medical devices on October 20 & November 9, 2009, most custom-made orthodontic medical devices were placed in the EU market with minimal information on their EC Declaration of Conformity, including a Statement at the bottom of the form that “this device complies with the Essential Requirements of Annex I of the Medical Devices Directive.” It was a form commonly used by all custom-made orthodontic manufacturers.  

When I asked a client if they knew what that meant, they said no. So we promptly created an Annex I Checklist, checked the relevant Essential Requirements, identified the EN harmonized standards that would allow demonstration of compliance with these standards and conducted an ISO 14971 Risk Management Hazards Analysis. At the time I wondered if this was the only custom-made orthodontic medical device manufacturer who truthfully answered the question.  

It should be noted that all manner of medical device manufacturers make custom-made medical devices. The new changes for custom-made medical devices that must be in place by 21 march 2010 are significant:  

·      The custom-made statement required by Annex VIII for Classes IIa, IIb and III medical devices must be made available to the particular patient for whom the device has been made,  

·      The patient may be identified on the statement by name, acronym or numerical code,  

·      The statement must now include the name and address of the manufacturer,  

·      In the documentation that must be kept available for inspection by NCAs (National Competent Authorities), the manufacturer must now include the name and addresses of the manufacturing site(s),  

·      Custom-made devices in the future will be subject to the vigilance requirements applicable to devices in serial production, 

·      Registration of custom-made devices in the European databank (EUDAMED) will no longer be required.  

Summary 

Several other medical device requirements must be in place by 21 March 2010 including Standalone software, Labeling, Access of registration data, Sampling regimes, NBOG Tech File sampling, Design Dossier, Authorized Representatives for all medical device manufacturers outside the EU/EEC and clear identification of medical devices in the Declaration of Conformity.  

I have talked with regulatory officers of some major medical device manufacturers who are complying with these new requirements. I am also aware of other manufacturers who aren’t taking the new deadline seriously. Manufacturers are advised to study these change carefully. As reported in previous blogs, the EU made a significant effort beginning 1 January 2010 to improve market surveillance and take legal action against non-compliant CE Marked products. If you have any questions regarding CE Marking to the revised Medical Devices Directive, 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.  

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  

New Rules For CE Marking Medical Device Machines

On August 21, 2009 the European Commission published an Interpretative Document of the Commission’s Services, “Interpretation of the Relation Between the Revised Directives 90/385/EEC and 93/42/EEc Concerning (Active Implantable) Medical Devices and Directive 2006/42/EC on Machinery. It is an interesting development with significant implications. Since the language is a bit stilted and cloaked in EU legalese, understandable because of their effort to use wording that translates approximately the same message in all of the EU languages, I will attempt to capture the essence of the Document and its implication for manufacturers of Medical Device Machinery.  

Background

1. Medical devices previously were excluded from the scope of the Machinery Directive 98/37/EC. Article 1(3) of the machinery directive stated, “The following are excluded from the scope of this Directive … medical devices”

2. Machinery Directive 98/37/EC has been replaced by Machinery Directive 2006/42/EC which does not contain such an exclusion clause, rather it states a general a “general principle” of demarcation in Article 3 of the Directive which reads:

Where for machinery, the hazards referred to in Annex I are wholly or partly covered more specifically by other Community Directives, this Directive shall not apply or cease to apply, to that machinery in respect of such hazards from the date of implementation of those other Directives.

3. However, in light of the fact that medical devices are no longer explicitly excluded from the revised Directive on machinery, the application of the revised Machinery Directive in relation to Directives concerning Medical Devices was brought into question.

Revision of Article 3, Medical Devices Directive 93/42/EEC and Active Implantable Medical Devices Directive 90/385/EEC

4. To ensure simplification in legislation [their words], both Directive 93/42/EEC and Directive 90/385/EEC have been amended by the new Medical Devices Directive 2007/47/EC which added the following paragraph to their respective Article 3 which sets out the Essential Requirements.

Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) 0f 2006/42/EC [Machinery Directive] of the European Parliament and of the Council of 17 May 2006 on machinery shall also meet the essential health and safety requirements set out in Annex I of that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I of this Directive. (emphasis added)

5. The amendment allows certain essential health and safety requirements of the revised Machinery Directive to become a part of the Directive concerning Medical Devices. According to a linguistic and systematic interpretation of the paragraph of Article 3 of the Active Implantable and Medical Devices Directives, the relevant requirements of the revised Machinery Directive are incorporated into the Medical Devices Directives.

6. Therefore:

·      Only a single conformity assessment is required under the Medical Devices Directives (according to the procedures provided for by these Directives) for medical devices that are also machinery;

·      The risk assessment to be carried out for medical devices that also are machinery is the risk/benefit analysis as set out in the essential requirements of the Directives concerning medical devices. [e.g., ISO 14971: 2007]

7. Harmonized standards for medical devices which also are machinery should cover any requirements of the Machinery Directive that are applicable to the devices in their scope. Such standards will have to be reviewed and amended or revised if necessary.

Illustration

8. In order to demonstrate which essential health and safety requirements of the revised Machinery Directive are part of the Medical Devices Directives, the following example serves as an illustration.

9. Annex 1, section 1.5.4 of the Revised Machinery Directive requires:

Errors likely to be made when fitting or refitting certain parts which could be a source of risk must be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves or their housing. The same information must be given on moving parts and/or their housings where the direction of movement needs to be known to avoid a risk. Where a faulty connection can be the source of risk, incorrect connections must be made impossible by design, or failing this, by information given on the elements to be connected and, where appropriate, on the means of connection.

10. There is no equivalent of such a specific requirement in Annex I of the Medical Devices Directives. For certain medical device machinery, where a fitting error can present a hazard, quite clearly this Machinery Directive essential requirement must also be met under the applicable Medical Devices Directive.

11. The application of these principles will require a case-by-case examination of every individual hazard listed in Annex I of the revised Machinery Directive. If a hazard is relevant for a specific medical device and if the corresponding essential health and safety requirement of the revised Machinery Directive is either not provided for in Annex I of the Medical Devices Directive or the Active Implantable Medical Devices Directive, this essential requirement will have to be met by the medical device concerned.

12. Assessment of compliance to these requirements will be carried out under the conformity assessment procedure for which the device is submitted within the framework of the applicable Medical Devices Directive.

Observations

The preceding account is my effort to make EU Commission legalese more readable, yet respect the substance of the legal points being made. Having worked extensively with both the Medical Devices Directives and the Machinery Directive since their inception, I can attest that this new rule will require a bit of work. Annex I of the Machinery Directive is more extensive and detailed regarding machinery safety than the Medical Devices Directives regarding medical devices. It is a response to the diversity of machines sold in the market place. It also focuses more on the operator and persons working in the vicinity of the machinery, whereas the Medical Devices Directives are more focused on patient safety. Response to the rule will not be a simple task, but it will improve the safety quality of medical machinery.

In addition to the new rule, two other issues will come into play: 

First, on 9 July 2008, EC Regulation No 765/2008 was published “setting out the requirements for accreditation and market surveillance relating to the marketing of products and Repealing Regulation (EEC) No 339/93. It was a response to complaints that the EU and its member states were not doing a good job of policing and regulating their marketplace. The regulation goes into full effect on 1 January 2010.

Second, Guidelines for various revised CE Marking Directives are stating that all products manufactured after the implementation date of the new/revised Directives and EN standards must be in compliance with the requirements of these new/revised Directives and EN standards from that date forward. Therefore, the new rules for medical device machinery should be in place by January 1, 2010.

Finally, one additional issue deserves consideration. New rules for medical device machinery safety will soon become an issue of concern for potential product liability exposure in the United States. Any company designing and manufacturing a CE marked medical device machine should sell this same machine in both the US and EU. Otherwise, they could be accused of manufacturing a less safe machine for the US market, opening the door to potential product liability lawsuits.

Such a lawsuit occurred in Minnesota in 2002. A California manufacturer sold a packaging machine with a laser light curtain in Europe to meet requirements of the EU Machinery Directive while selling a less safe machine in the US, because it wasn’t required. When one of the workers in a Minnesota plant walked into an area where the CE Marked machine would have shut down, the Minnesota machine continued to operate and crushed his skull requiring 24 hour care for the rest of his life. When the jury discovered that the company manufactured a safer machine for Europe and a less safe machine for the US, they gave a punitive damage award of $35 million dollars. Given the litigious history vis-à-vis medical device manufacturers in the US, it would be prudent to move to implement the new EU Commission rule ASAP.

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

CE Marking to the Low Voltage Directive & the GS mark certification scheme: A Postscript

 

In my September 8^th blog, I discussed the pressure that some American companies were experiencing from test labs telling them that they should have the German GS mark in addition to the CE Mark for the new EU Low Voltage Directive 2006/95/EC if they wished to sell their products in the EU. As mentioned, the labs were selling services that weren’t needed to Americans who don’t understand EU CE Marking requirements. In the blog I mentioned writing an e-mail to EICTA the European Trade Association that represents the European digital technology industry concerning their letter objecting to German efforts to peddle a voluntary mark along with the CE Mark. Subsequently, I sent the e-mail again.

To date I haven’t received a response from EICTA, which is a bit unusual for a trade association that purports to represent several companies, among them several American companies such as Apple, Cisco Systems, Corning, Dell, Microsoft, Kodak, Motorola, Qualcomm, Sun Microsystems, Texas Instruments, etc. However, I did e-mail the UK Department of Business Innovation & Skills (BIS) the successor to the UK Department of Trade & Industry (DTI) and received a helpful response.

In August 2007, Luis Montoya, Head of Unit I/4, Directorate General, Enterprise and Industry of the European Commission issued Guidelines On The Application Of Directorate 2006/95/EC. Chapter II of the Guidelines clarifies the legal structure of the Directive.

 II the “Low Voltage” Directive

 5. Directive 2006/95/EC is a codifying Directive which brings together in one text the “Original” Low Voltage Directive 73/23/EEC with its subsequent amendments. Directive 2006/95/EC came into force and repealed Directive 72/23/EEC as from 16 January 2007.

 It should be noted that the content is also identical to the previous Directive (as amended). However the process revealed an inconsistency between different language versions of Directive 93/68/EEC. This has been addressed by issuing a Corrigendum to Directive 93/68/EEC, aligning all language versions. This amended Directive 72/23/EEC which was subsequently replaced by Directive 2006/95/EC.  The clause in the new Directive (Article 14 second paragraph) indicates that references to the old Directive are to be taken to refer to the new Directive. Codification does not change national legislation.  

The aim of the Directive therefore remains the harmonizing the laws of the member states relating to electrical equipment designed for use within certain voltage limits.

 6. The “Low Voltage Directive” is a “Total” harmonization Directive in the sense that it has superseded existing national regulations in the field covered: electrical equipment may only be put on the market if it is in conformity with the requirements of the Directive and, on the other hand, member states may not impede free circulation or the marketing of conforming equipment.

While the language from the Directorate is a bit obtuse to American attorneys, to EU attorneys and EU government officials, paragraph 6 is extremely clear. The German government had no legal authority to refer to the GS mark when it attempted to transpose Directive 2006/95/EC into their national law because the new German transposition was moot (irrelevant). The Corrigendum to Directive 93/68/EEC aligned all language versions. Directive 2006/95/EC simply replaced the amended Directive 72/23/EEC, therefore a new transposition wasn’t required. Finally it also should be remembered that EU legislation attempts to find the most accurate translation between multiple languages. Consequently, the language often does not read as smoothly as it might if it had been written in English for English only readers, as is the case in the United States.

One final point is worth underlining. In a 2004 publication DTI, Product Standards Electrical Equipment (implementing the Low Voltage Directive) DTI (now UK BIS Department of Innovation & Skills) emphasized the following:

It is for the manufacturer to decide on how these objectives (Principal Elements of the Safety Objectives) should be met but it should be remembered that a presumption of conformity with the safety requirements will be afforded to electrical equipment which has been designed and constructed to meet the specifications of a harmonized standard.

Harmonized standards: Electrical equipment which complies with the safety provisions of a harmonized standard, will be presumed to comply with the safety requirements of the Regulations.

In other words, a manufacturer can comply with the provisions of the new Low Voltage Directive 2006/95/EC if they use EN harmonized standards. They do not require any tests from a certified test lab to comply with the Low Voltage Directive, unless they choose to do so on a voluntary basis. I mention this because all you have to do is Google the Low Voltage Directive and all sorts of labs will pop up telling you how important they are and suggesting that they conduct vital risk assessments for you to comply with the Directive. On the contrary, your company can self certify without their help. If you have any questions about legal certification to the Low Voltage Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net

CE Marking to the Low Voltage Directive & the GS mark certification scheme

This blog originated last week when a new client called and asked me about the GS mark. They had been told by a local test lab in Atlanta that they should have the GS mark in addition to the CE mark for their electrical products they wished to sell in the EU. My first thought, the test labs are at it again selling services that aren’t needed to Americans who don’t understand EU CE Marking requirements.

I immediately went to the Internet and Googled the German GS Mark and there they were, several test labs selling their services explaining that only a German accredited lab may confer the GS Mark and that it is recognized by consumers in the EU as a symbol of safety and quality. One of the web sites, however, did mention that it is a voluntary mark. 

Another posting that caught my attention was a letter from EICTA, the European Trade Association that represents the European digital technology industry to The European Commission, Directorate General Enterprise and Industry concerning the German GS mark certification scheme. EICTA sent the letter to Mr. Pedro Ortun Director, Directorate I, New Approach Industries, Tourism and CSR. Their concern was the GS mark certification scheme and EU Test mark because it was initiated by a single member state (Germany) and it challenges the EU New Approach [Safety Directives] opening a window to a gradual fragmentation of the single market.

While the preceding language probably is confusing to most Americans, it is critical to the cohesion and integrity of the EU market, known also as the “single market”. When a member state such as Germany can reference a mark such as the GS Mark while transposing a Directive such as the revised Low Voltage Directive into German law attaching a voluntary national mark to the Directive, it erodes the uniform adoption of EU law into national law. Further, if all 27 EU member states decided to attach voluntary national marks while transposing EU law into national law it would open a window to fragmentation of the single market introducing barriers to trade re-introducing “eurosclerosis” to the EU marketplace.

EICTA recommended the following:

EICTA recommendations.

EICTA has on many occasions stressed the importance of the single market concept for the competitiveness of industry and benefit to consumers. The New Approach directives have played an important role in maintaining harmonised rules for placing products on the EU market. However, the reference to GS Mark in German transposition of EU Directives and the proposed EU test Mark challenge the consistent use and implementation of the EU New Approach, open a window to a gradual fragmentation of the single market for ICT products, and potentially introduce barriers to trade.

As the European Community expands and new member states join, vigilance will be required to sustain the single market. In particular, there is a duty on established member states to demonstrate commitment to the concept.

Based on the above EICTA urges the Commission to complete its analysis of the situation and to take measures which will bring the matter to a quick and satisfactory conclusion. In so doing EICTA recommends that:

>Requirements for safety and health related to ICT equipment must be harmonized throughout the EU market and implemented via harmonized standards where possible,

>National requirements that are not harmonized within the EU shall be avoided,

>Any reference to voluntary certificate in national regulations shall be prohibited because it leads to de facto national legal requirements specific to the country and distorts public's perception of the voluntariness of the certification,

>Any national requirements for placing products on the EU market or putting into service shall be aligned with the EU harmonized requirements,

>If a risk assessment leads to new requirements for safety and health, Authorities and Industry shall forward these items for discussion on EU level as foreseen in the procedures of the EU Directives safeguard clauses. Implementing new requirements in harmonized standards is the consequential and correct way to assure protection of all users within the EU,

> Marks shall remain "voluntary" and in order to avoid any confusion with the CE marking, they shall refer to requirements complementary to the ones covered by CE marking.

I have written to the author of the letter, Tony Graziano, Director of Technical and Regulatory Policy for EICTA asking about the European Commission response to EICTA concerns and will share that response in a future blog. Meanwhile, I have written to some other EU organizations for their take on the issue. As mentioned in two previous blogs, I wrote a letter in March 2004 to Commissioner Liikanen concerning notified body misuse of The Machinery Directive and received a helpful response within three weeks later in April.

Finally, I think it would be helpful for those interested in this topic to understand the purpose of EICTA and its membership. It is a significant trade association.

EICTA MEMBERSHIP

About EICTA:

EICTA, founded in 1999 is the voice of the European digital technology industry, which includes large and small companies in the Information and Communications Technology and Consumer Electronics Industry sectors. It is composed of 55 major multinational companies and 38 national associations from 27 European countries. In all, EICTA represents more than 10,000 companies all over Europe with more than 2 million employees and over EUR 1,000 billion in revenues.

The membership of EICTA:

Company Members:

Adobe, Agilent, Alcatel-Lucent, Apple, Bang & Olufsen, Blaupunkt, Brother, Canon,

Cisco Systems, Corning, Dell, EADS, Elcoteq, Epson, Ericsson, Fujitsu, Hitachi, HP, IBM, Infineon, Intel, JVC, Kenwood, Kodak, Konica Minolta, Lexmark, LG Electronics, Loewe, Micronas, Microsoft, Motorola, NEC, Nokia, Nortel, NXP, Océ, Panasonic, Philips, Pioneer, Qualcomm, Research In Motion, Samsung, Sanyo, SAP, Sharp, Siemens, Sony, Sony Ericsson, Sun Microsystems, Symantec, Texas Instruments, Thales, Thomson, Toshiba, Xerox.

National Trade Associations:

Austria: FEEI; Belgium: AGORIA; Bulgaria: BAIT; Czech Republic: SPIS; Denmark: ITEK, IT-Branchen; Estonia: ITL; Finland: TIF; France: ALLIANCE TICS, SIMAVELEC; Germany: BITKOM, ZVEI; Greece: SEPE; Hungary: IVSZ; Ireland: ICT Ireland; Italy: ANIE, AITech-ASSINFORM; Latvia: LIKTA; Lithuania: INFOBALT; Malta: ITTS; Netherlands: ICT-Office, FIAR; Norway: ABELIA, IKT Norge; Poland: KIGEiT, PIIT; Slovakia: ITAS; Slovenia: GZS; Spain: AETIC, ASIMELEC; Sweden: IT Företagen; Switzerland: SWICO, SWISSMEM; Turkey: ECID, TESID, TUBISAD; Ukraine: IT Ukraine; United Kingdom: INTELLECT

Summary

Last week I also talked with the representative of a US company that supplies CE Marked equipment and components. He said he had just talked with a company that spent $7,000 for GS mark tests. He told them that’s too bad, you could have purchased the same equipment from us already CE Marked, you wasted your money. It brings to mind the old English legal axiom, “Caveat Emptor”, Let the Buyer Beware! Concentrate on CE Marking, not on voluntary national marks!

If you have questions regarding CE Marking to the Low Voltage Directive, Machinery Safety Directive, Medical Devices Directive, other new approach Directives and/or product liability concerns 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

 

High Voltage Power Systems, Risk Assessment & Product Liability Exposure

   

     Two years ago I received a call from a Japanese company representative stating that I had been referred to them by an engineer from Georgia Tech who had attended a training course I had taught on CE Marking. The company was new to the US and had just located their US Manufacturing and Importing facility in suburban Atlanta. For the purposes of this blog, I will label them Company X. The company was concerned about US requirements for safety manuals, safety instructions and safety symbols on their power equipment. When I met with their engineers (all Japanese trained) some located in the US and others from their headquarters in Tokyo, it was clear that the safety issues were considered to be a bother to be dealt with as quickly as possible. Even though Japan adopted a Product Liability law in 1994, concern about product liability litigation and product liability exposure in the US was low to nonexistent in this group.

 For starters I briefly discussed general safety concerns, safety manuals, safety warnings and risk assessment. I then walked them through the list of hazards from ISO 14121:1999 noting that warnings could not be placed on their equipment without a rationale. It had to be the end product of a risk assessment where the first step was to design out hazards, guard against those that couldn’t be designed out and warn against those that couldn’t be designed out or guarded against. Clearly they made electrical equipment that was extremely dangerous. While there were some guards such as doors covering motors that would allow adjusting the equipment to respond to power demands, the doors were not secured by safety interlocks allowing easy access and no warning that a fatal electrical shock could strike anyone who unwittingly opened the door and reached in not realizing the potential consequences.

 Since it was apparent that the company did not want to take any further safety steps, I presented them with Minimum Steps Necessary to Complete the Company X Hazards Analysis & Safety Manual for the US Market. Two reasons motivated the list of steps; (1) I wanted them to fully understand what had to be done at a minimum for the US market, and (2) I didn’t want them to think that I agreed with what they were doing. In my opinion, I thought they were headed for a potential product liability disaster. The steps are listed below:                                                                       

·      The identification of Hazards from ISO 14121:1999, Annex A filled out at Company X’s US office needs to be carefully reviewed to make certain that all of the potential hazards have been identified. Everything must be documented!

·      The judgments made on each hazard from 4 General Principles on page 2 to 8.3 Comparison of Risks on   pages34-39 in the Draft Company X Hazards Analysis/Risk Assessment are my assumptions (I am an attorney, not an electrical engineer) based on our conversation and must be carefully reviewed and edited for each hazard by Company X electrical engineers. Also, the list of hazards should be reviewed to see if additional hazards should be added. Remember, if an accident should happen and Company X is sued in a US court of law, Plaintiff’s attorneys will hire their own electrical engineering experts to study the list and challenge your hazards assumptions.

·      Once this step is completed, it is necessary to determine the best safety approach to address each hazard – first, design out the hazard, second, guard against the hazard if it can’t be designed out and third, warn against the hazard if it can’t be designed out or guarded against. For each hazard identified there must be a solution, whether it is design solution, guarding solution or warning solution and design must be revisited until the risks are judged to be acceptable.

·      The standards used [whether JIS (Japanese Industrial Standards), UL (United Underwriters) US Standards, ISO or IEC Standards or ANSI (American National Standards Institute) Standards] to design and manufacture the power equipment must be identified in the Technical File.

 

·      The Warnings, Cautions and Safety Symbols for use on equipment in the US are found in ANSI Standard Z535.5: 2004, which is the most recent version. Therefore, this is the standard that should be used to mark Company X power equipment.

 

·      The Warnings, Cautions and Safety Symbols should be repeated in the safety manual, along with a clear description of the consequences of what could happen if a person failed to follow the warning or caution, e.g., severe burns, severe electrical shock, electrocution, death.

I also created a Draft Product Safety Checklist Overview for Company X that is listed below:

·      Review files for all existing product containers shipped by Company X to determine the status of safety labels, warnings and instructions to users

 

·      Review customer complaints/concerns in the last 2-3 years to see if they raise any product safety issues

 

·      Determine if there are any specific country requirements for instructions, labeling, warnings that need to be addressed, e.g. US safety requirements, EU Directives, Japan Safety requirements, Brazilian Safety requirements, etc.

·      Determine if risk assessments/ hazards analysis and product safety reviews were conducted to provide a legal basis for existing labels, warnings and instructions. If not, for product liability purposes conduct product safety reviews including risk assessments/hazards analyses

 

·      Determine what new products/product containers are being developed in the future and whether a risk assessment/hazards analysis have been scheduled for labels, warnings and instructions

 

·      If not, schedule product safety reviews including risk assessment/hazards analysis to determine what types of labels, warnings and instructions will be needed

 

·      Determine if there are any international, regional or national safety requirements that must be addressed for the product to enter a market

 

·      Develop a timetable for addressing all new products and product containers with key personnel, including       marketing

·      Create a Technical File for all new Company X products/product containers

·      Identify any insurance requirements that should be addressed regarding product labeling, warnings and instructions for new products

 

·      Develop a recall policy for potential recalls

·      Develop a crisis management plan for a potential disaster, i.e. Tylenol, Pepsi

I also created a sample Technical File and 16 page Company X Hazards Analysis and Procedure. I thought they might be interested in an EU modeled approach, however, I would be amazed if any of these steps were taken. The arrogance of the engineers was substantial and their ignorance of US product liability litigation was even more substantial.

If you have product liability and risk assessment concerns vis-a vis the US market, you can contact me for a free preliminary consultation at theguide1@comcast.net

CE Marking Medical Device Boundary Issues – Is it a Medical Device or Something Else?

Early in the implementation of CE Marking Directives, a Dutch notified body issued a CE Mark under the Medical Devices Directive to a company that manufactured radioactive seeds for use in prostate cancer tumors, only to discover that radioactive seeds were classified as an Active Implantable Medical Device. Since the notified body wasn’t notified to the Active Implantable Medical Devices Directive, they had to apologize, refund the company’s money and direct them to active implantable notified bodies. It was early in the CE Marking process and device classification was evolving.

A few years ago I flew into La Guardia and drove up the Connecticut coast to meet with a small company that manufactured lead aprons for use in dental x-rays. The company had requests from dentists and distributors in the EU and therefore wanted to CE Mark their aprons. Since it was not clear how the aprons should be classified under Annex IX of the Medical Devices Directive, I called the US Director of a medical devices notified body with whom I had worked several times and sent a fax describing the aprons and their use to the UK competent authority, the Medical Devices Agency MDA (now the Medicines and Healthcare Products regulatory Agency MHRA) for guidance. To my astonishment, both the notified body and MDA said they thought it was not a medical device, but instead was Personal Protective Equipment.

While their classification seemed absurd, it was necessary to obtain clarification before proceeding to CE Mark the aprons. The confusion was the assumption by both the notified body and MDA that we were asking about the classification of lead aprons to be worn by dental x-ray technicians, the people who take the x-rays. While it was clear that dental technicians were covered by the Personal Protective Equipment Directive, we were talking about dental patients. The difference in compliance was substantial to a small company. The Personnel Protective Equipment Directive would have required notified body approval and an ISO 9000 Quality Management System. By way of contrast, if the apron was a medical device, it would be a Class I non-measuring/non-sterile device allowing the company to self certify and CE Mark without requiring notified body approval.

After corresponding via fax and e-mail, the notified body and competent authority better understood our question and agreed that the aprons were a non-invasive medical device that allowed us to self certify and CE Mark them for export to the EU.

While this was a clear boundary issue, quite often the distinctions are not clear or are a consequence of different regulations in the EU and US. For example, FDA regulates several health care products as medical devices that are not classified as medical devices in the EU, among those products are feminine sanitary napkins. Not being able to CE mark such products means that the regulations are country by country requiring time, research and patience working your way through 27 national bureaucracies. In pursuit of national regulations for feminine sanitary napkins I found the British had their own system which was most helpful. The French and Germans also were helpful once we navigated the language issues. The Italians, however, were maddening. The officials in charge weren’t interested in answering our questions and wouldn’t return calls.

When it comes to cosmetics, another area governed by FDA (Federal Food, Drug and Cosmetic Act), the EU has a Cosmetics Directive that operates much like new approach directives. There is no CE Mark, but following the Directive concerning Cosmetic Products it is possible to manufacture cosmetics and sell them throughout the EU without going country by country for approval. It has recently been amended by Commission Directive 2009/36/EC of 16 April 2009 amending Council Directive 76/768/EEC, concerning cosmetics products for the purpose of adapting Annex III thereto to technical progress. It may not be a CE Mark, but compared to general health care products it is a blessing.

Finally, other types of boundary issues regarding classification undoubtedly will crop up in the future. Another boundary issue that will continue to materialize is the number of new approach directives that apply to a product. Thus far the greatest number of new approach directives I have worked with to CE Mark a product have been Machines that were subject to the Machinery, EMC, Low Voltage, Pressure Equipment and Explosive Atmospheres Directives.

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

My First Introduction to CE Marking Products for the European Union

In the July 16 blog, I mentioned that my first introduction to CE Marking occurred in 1991 while writing a White Paper to secure foundation support for funding a new Center for International Standards and Quality (CISQ) at Georgia Tech. In the July 16 blog I mentioned that one of the faculty members seeking to create the new center (who was a member of the committee that drafted the original ISO 9001 Series of Standards in 1987) suggested that ISO 9000 was a response to the new European Community Product Liability Directive (it didn’t become the European Union until 1993 after the Maastricht treaty). When asked where I could obtain a copy of the Directive, he said the Georgia Tech Library.

When the library staff was asked for help in finding the Directive, they said that they had no European Community Directives on file and suggested Emory University because it was the Depository for European Community Laws and Publications for the State of Georgia. With the help of a friendly librarian in the Emory University Law Library, where the materials were kept, we found a copy of the Product Liability Directive and some other key new approach Directives. At that time, no one at Emory was teaching European Community Law, so the materials had not been incorporated into their regular shelved collection. After reading the Product Liability Directive, it was clear that it had no influence on the creation of the ISO 9000 Series of Standards.

The next question was, who if anyone, was writing about CE Marking in the United States. I was told that an Associate Dean at the University of Georgia Law School, who was a specialist in European Community Treaty Law, had asked the UGA Law School library staff to begin binding European Community materials and incorporating them into their shelved collection. After reading the few articles written about CE Marking, I discovered a law firm in Minneapolis where the CEO, Mark Whitehead, and his associate, Greg Scott, were writing about CE Marking. I contacted the firm and we discussed some future projects. They asked if I would like to help in preparing materials on the proposed Medical Devices Directives (Active Implantable Medical Devices, (general)Medical Devices & In Vitro Diagnostic Medical Devices) for a presentation to Medtronic, one of their clients.

Using drafts of the proposed Directives we prepared the material for the presentation. Following this effort, Greg and I decided to expand the work into a book, European Community Medical Devices Directives: Certification, Quality Assurance and Liability, CEEM Information Systems, Fairfax, VA, 1992. Greg and I also decided to write a book about the European Community Product Liability, Product Safety and Machinery Safety Directives entitled, European Community Product Liability and Product Safety Directives, CEEM Information Systems, Fairfax, VA, 1992, which included a section on the Machinery Directive. (Both books were discussed briefly in the May 11 blog.) These were the first two books of their kind on the American market.

Because of growing interest in CE marking in the United States, I found myself publishing several articles and giving presentations in 1992: EC Directives and Standards, American Petroleum Institute, Annual Quality Symposium in Tulsa, OK, SAE International in Warrendale, PA, 17th Annual Meeting, National Electrical Manufacturers Association, Diagnostic Imaging and Therapy Systems Division in Tucson, AZ, Kaiser Aluminum and Chemical Corp., ISO 9000/Product Liability Workshop in Dallas, TX   and the ISO 9000 Standards for Quality Management: International Registration of Quality Systems, Georgia Tech, Atlanta, GA.

1993 proved to be even more hectic with more articles and presentations concerning EC Directives, ISO 9000, Product Liability & Product Safety – European Directives and the Automotive Industry, ISO 9000 in the Automotive Industry, Dearborn, MI; EC Directives, Product Liability and Product Safety: Internationalization of US Product Liability Practices/EC Directives, College of Engineering, University of Wisconsin Madison, EC Directives & Standards, Stat-A-Matrix Consultant Training Session, Edison, NJ; EC Directives, Product Liability and Product Safety, Center for International Standards & Quality, Staff Training Seminar, Georgia Tech; The Need for Preventive Law: Product Liability, EC Directives and ISO 9000, ISO 9000 Standards for Quality Management/Center for International Standards & Quality, Georgia Tech; Product Liability and Legal Issues with ISO 9000, College of Commerce and Industry, Clemson University, Charlotte, NC; Environmental Liability: “Product Liability & Product safety in the EC” and “UK British Standard BS 7750 Environmental Management Systems, EC Green Laws Conference – BHS  International, Manhattan Beach, CA; EC Product Liability and Environmental Concerns, Global Telecommunications Certification – BHS International, Minneapolis, MN; EC Product Liability & Safety and the EC Medical Devices Directives – Preparing for Export and  a Global Approach to Liability & Safety: Some New Common Denominators for a Liability Management Strategy – A Comprehensive Workshop, Global Medical Device Regulation – Institute  for International Research, Chicago, IL;  Product Liability in the EC, Medical Device Regulation: Europe and North America – International Business communications, New Orleans, LA; Impact of ISO 9000 on Safety and Liability Issues, 1st Annual International Conference on ISO 9001, Lake Buena Vista, FL. 

The subsequent years were no less hectic, but they underscored the need for the 1996 ASQ Conference in Washington, DC. The early new approach CE Marking Directives were written by different standards groups in Europe at different stages, e.g. the Directive on Non-Automatic Weighing Instruments first began as a collaborative metrics effort in the mid 1930’s written by French Engineers and translated into English Engineers, not the best of writers in either language. When I wrote an abstract of the Directive in 1996, I had to talk out loud repeatedly to make sense of what was written.

The first effort of the European Community to correct some of these issues occurred in 1993.The Low Voltage Directive was converted from an old approach to new approach directive in 1993 with Council Decision (93/465/EEC0 Concerning Modules for the Various Phases of Conformity Assessment Procedures and the Rules for the Affixing and Use of the CE Conformity Marking Which are Intended to Be Used in the Technical harmonization Directives. Also, from that point on numbers could only be affixed to a medical devices CE Mark, denoting a notified body. The new Directives (Medical devices, Machinery, Low Voltage, Electromagnetic Compatibility) emerging in the 21st Century decade are significant improvements over their predecessors.

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

ASQ CE Marking Conference – Washington DC – December 1996

In early 1996 I was contacted by the American Society for Quality (then the American Society for Quality Control) about chairing a CE Marking Seminar in Washington DC. When asked what they wanted to cover in the Seminar, the response was, all of it! My response was that CE marking was far too amorphous a topic for an all inclusive conference, what is required for CE Marking some products is completely different for CE Marking other products. I suggested instead that we concentrate on four areas that were of interest to the greatest number of people. We settled on CE Marking Medical Devices, Machinery, Electromagnetic Compatibility (EMC) & Low Voltage and Telecommunications Terminal Equipment.

ASQ titled it, The CE Mark Seminar: Your Key to Obtaining Unrestricted Trade Throughout the European Union. I agreed to give a Presentation, CE Marking in the U.S.: An Overview for the session. We chose Holly Grell-Lawe, Senior Research Associate and Head of the Center for International Standards and Quality at Georgia Tech to discuss CE Marketing Issues and Charles Ludolph, Ph.D., Director, European Union and Regional Affairs, US Department of Commerce to discuss Mutual Recognition Agreement Between the United States and the European Union.

Following the opening session, we had a panel discussion titled Impact of CE Marking on U.S. Industry with representatives from Semi Conductor Equipment and Materials International, National Electrical Manufacturers Association, National Association of Manufacturers and The Association of Manufacturing Technology. The objective was to learn about the impact of the EU’s CE Marking new approach Directives on members from some of the US manufacturing associations.

The afternoon Concurrent Sessions were designed for repetition so that each Seminar participant could attend two of the four sessions. Session 1, Telecommunications Terminal Equipment was conducted by the US Sales and Marketing Manager for TUV Product Services. Session 2, Electromagnetic Compatibility (EMC) & Low Voltage was conducted by the President, DLS Electronic Systems, Inc. and by a Principal Product Safety Consultant. Session 3 Medical Devices was conducted by the Senior Engineer for Medical Products, TUV Rhineland of North America, Inc. Session 4, Machinery was conducted by the Product Manager, CE Marketing, KEMA Registered Quality Inc.

The following day, began with a Panel Discussion With Notified Bodies, which included a representative from Underwriters Lab., Inc./DEMKO, Director of Finance and Business Development, ITS Intertek Services and the Manager, European Directives, SGS-ICS. The objective of meeting with representatives from the notified bodies  was to give participants a chance question and better understand the role of notified bodies vis-à-vis different EU Directives. At this time (1996), there was a fair amount of confusion about EU directives and the role of the different notified bodies.

Finally, the Seminar concluded with a presentation Implications of CE Marking in the Semiconductor Industry: A Case Study by Paul G. Green, Manager, Product Safety, Cymer Laser Technologies, with whom I had worked on CE Marking lasers at their plant in Rancho Bernardo, California.

My objective for providing an Overview on CE Marking in the US was driven by an acute awareness that the European Union was little understood in the United States at that time, and the rationale for CE Marking in the EU was even less understood at that time (still is, for that matter). Since my PhD is in Political Science, Europe & Latin America, I decided to provide an historical context for the evolution of the European Union. Also, being a lawyer, I wanted to set the historical context for a different type of European administrative legal system (except for the UK & Ireland) driving the new approach safety directives that in turn required CE Marking for placing products on the EU Market.

The CE approach was new to companies in the US convinced that these regulations were restraints of trade, which they weren’t since every company inside and outside of the EU had to comply with the new regulations in order to place safer products on the EU Market.

My introduction to ISO 9001 and CE Marking began in 1991 at Georgia Tech when I was drafting a White Paper to obtain funding for a Center for International Standards and Quality for Georgia Tech.
One of the faculty members promoting the Center told me at the time that he thought that the ISO 9000 series of standards was a response to the EU’s new Directive on Product Liability. Following that lead led to many discoveries that I will address in future blogs. Suffice to say, the ISO 9000 series of standards had their own inception as did the CE Marking new approach safety directives. The Product Liability Directive did not create the ISO 9000 series of standards. The fact that ISO 9001 might be a conformity assessment option for some of the CE Marking new approach directives is a separate issue.

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

CE Marking Machinery – Future State-of-the-Art in American Product Liability Lawsuits

I just completed a Machinery Directive CE Marking project with a client in the Atlanta area this past week. They received an order from the UK for their asphalt pavement analysis machinery and also have received several inquiries from other countries in the EU. I told them that they will do very well. The EU invests billions of euros to buildup the infrastructure (roads, rail, airports) in each of its member states to make transportation more efficient and make the countries more competitive. In addition, several large European construction companies with divisions in the United States are familiar with their machinery. They already have a global presence outside of the EU (e.g. Brazil, Canada, Central America, India).

The project also provided a new opportunity to compare the revised EU Machinery Directive, Low Voltage Directive and Electromagnetic Compatibility Directive with their predecessors as well as compare EN ISO 14121-1:2007 with its predecessors, ISO 14121:1999 & EN 1050:1997. In each instance, the new versions made significant improvements. These improvements coupled with EN ISO 12100-1:2003 & EN ISO 12100-2:2003 have qualitatively upgraded compliance with the three Directives safety objectives.

The redrafted Machinery Directive ANNEX I Essential Health and Safety Requirements Relating to the Design and Construction of Machinery in GENERAL PRINCIPLES places special emphasis on risk assessment underscoring the iterative process of risk assessment and risk reduction, language not contained in earlier versions of the Directive. In addition, the new Machinery Directive pays additional attention to foreseen conditions and foreseeable abnormal conditions vis-à-vis the principles of safety integration referred to in section 1.1.2 & sections 1.7.3 and 1.7.4 regarding instructions. The attention to foreseeable uses and misuses matches closely with Article 6 of the Product Liability Directive:

 A product is defective when it does not provide the safety a person is entitled to expect, taking all
 circumstances into account, including”

(a ) the presentation of the product;

(b ) the use to which it could reasonably be expected that the product would be put;

(c ) the time when the product was put into circulation.

It also matches closely Article 2 of the 2001 revised Product Safety Directive:

(a)’product’ shall mean any product – including in the context of providing a service – which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them, and supplied or made available, whether for consideration or not, in the course of a commercial activity, and whether new, used or reconditioned. 

In addition, Annex VII of the Machinery Directive does a better job of setting forth the requirements for the Technical File for machinery, again underscoring the documentation requirements for risk assessment. As noted in earlier blogs, I have reviewed numerous Technical Files and too often have found risk assessment to be weak or non-existent. It is the reason I decided to write the initial risk assessment for my clients and have them make corrections and edits making certain that all questions are answered Yes, No or N/A and where the answer is yes write the response in clear English. This will serve them well in response to EU competent authorities and future US product liability lawsuits.

This leads to EN ISO 14121-1:2007 Risk Assessment standard which is a considerable improvement over the earlier versions EN 1050:1997 and ISO 14121:1999. Experience with the earlier versions of the standard led the drafters to expand their concepts and application of hazards and connect many of the hazards to subclauses of ISO 12100-1:2003 and ISO 12100-2:2003. In addition, examples of hazardous situations and hazardous events also improves the quality of the risk assessment.

In response to their global marketing and in anticipation of CE Marking their machinery, my client had already taken several steps to improve the safety of their machinery. It was a pleasure working with them on compliance with the Machinery Directive, Electromagnetic Compatibility Directive and Low Voltage Directive, which brings me to the title of this blog.

In my opinion, my client represents the future of machinery safety in the US. EU safety standards written in response to their new approach safety directives are far more thorough than US safety standards, which tend to be sector specific. The EU is the driver with ISO and IEC in drafting new safety standards. The EU member states through their standards’ organizations (BSI, AFNOR, DIN, etc.) along with the European Standards Organizations (CEN, CENELEC, ETSI) approach standards writing as a broad systematic effort. All ISO standards become American National Standards through the participation of ANSI (American National Standards Institute) in the ISO/IEC standards writing process.

Therefore, these new EN ISO safety standards are also American National Standards and thereby become fair game in US product liability lawsuits concerning defective machinery, pressure equipment, personal protective equipment, toy safety, electromagnetic compatibility, explosive atmospheres, etc. How long it will take trial attorneys to grasp this fact is unknown, but it will happen sooner or later and US companies should be prepared.

If you have product liability and risk assessment concerns vis-a vis the US market regarding the Machinery Safety Directive and related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net

Early Impact of CE Marking in the US

In the early 1990’s, a colleague and I were asked to give a presentation on CE Marking and ISO 9001 to the staff of the Society for Automotive Engineering (SAE) at their headquarters in Warrendale PA. This was before the Maastricht Treaty was adopted by the European Community in 1992. I led off with a presentation on CE Marking giving background on the European Commission White Paper, Completing the Internal Market, White paper from the Commission to the European Council which was endorsed by the European Council in 1985 in Milan, and its pledge to eliminate fiscal, technical and physical barriers by:

•    Replacing national standards with the EC wide standards

•    Eliminating national (Member State) regulations that restrict trade (i.e., health, safety and environmental regulations)

•    Agreeing on EC wide testing and certification procedures

I then proceeded to discuss some of the key new approach directives, such as Machinery, Electromagnetic Compatibility, Personal Protective Equipment, Medical Devices, Toy Safety, etc. As I spoke about CE Marking and its rationale, several of the staff in the room became quite agitated. One staff member said that if the Maastricht Treaty isn’t adopted, CE Marking will not occur. I responded by stating that the treaties required to support CE marking already existed and the outcome of the vote on the Maastricht Treaty would have no effect on the future of CE Marking products. (As everyone knows, the treaty was adopted, the European Community became the European Union and the legal groundwork was created for the creation of the Euro.)

When we took a break, I asked our host what was going on? Why so much hostility to CE Marking? He and his colleague grinned and said this was shock therapy.  The minute the staff listened to the presentation on CE Marking, they knew their work agenda for the next several years – to develop SAE standards that would provide a US counterpart to EN harmonized standards.

Their agenda became more salient to me eleven years later when I worked with a US company that manufactured Ground Support Equipment (GSE) for the airline industry, e.g. different types of tractors for hauling planes onto an airport tarmac, conveyor belts for unloading luggage from planes, air conditioning equipment for planes at airport gates, etc. SAE had created several standards for different types of ground support equipment. In this regard, SAE was one of the few organizations that created standards to match their EU equivalents. As standards, however, they tend to be more suggestive in approach, whereas EN harmonized standards tend to be more prescriptive in approach. Also, EN harmonized standards are more extensive in the safety issues covered. With the Machinery Directive, however, the rigor of EN harmonized standards is only as good as the companies that apply them to their products. Unfortunately, I have seen too many instances where the rigor of companies applying EN standards to their products was weak.

Over time the lack of rigor in applying EN standards will make its way into US courtrooms via product liability lawsuits. Although in all candor, I had expected much more litigation by now. The only notable lawsuit to date has been the 2002 Minnesota $34 million dollar punitive damages award discussed in earlier blogs. The failure to seize upon EU new approach safety standards setting higher safety standards and higher safety expectations in the US appears to rest with either the ignorance or lethargy of American trial lawyers vis-à-vis European safety standards and their potential impact in US product liability litigation.

Using ISO 9001 to Win Product Liability Lawsuits

In blogs posted on March 20 & 23 I reviewed problems Case Company had in the courts with its ISO 9001 quality management system. It raises the question whether an ISO 9001 quality management system is a legal burden. The answer is no. In the early 1990’s a number of lawsuits were initiated against companies with no ISO 9001/ISO 9002 quality management system. Examples of such cases were recorded by John R. Broomfield in his article, "Lawyers Wise up to ISO 9000” in the January -- February 1996, Compliance Engineering Volume 13, No. 1. One of the cases resulted when the collapse of a chaise lounge caused the plaintiff to reinjure a knee that was healing from reconstructive surgery. The retailer attempted to pass blame to the manufacturer, asserting that the assembly instructions were incomplete and confusing. Plaintiff’s counsel argued that the manufacturer had ignored The American National Standard for Quality Systems (ANSI/ASQ Q 9001) and the retailer did not document its training or inspections.

In deposition the defendants were questioned by plaintiff’s attorney using clauses from ISO 9001 that addressed design control, training, inspection and testing.  Because the defendants were unable to effectively answer the questions, the case was settled prior to trial with the plaintiff receiving a total of $55,000 from the manufacturer and retailer.

Neither the manufacturer nor retailer was registered to one of the three compliance standards available at that time (ISO 9001/2/3), yet they were challenged for ignoring those quality standards. Since the case did not go to trial we have no way of knowing whether the judge would have permitted plaintiff’s attorney to pursue this line of questioning.  The defendants didn't want to risk the possibility that questions might be allowed using clauses from ISO 9001 concerning design control, training and inspection and testing.

Mr. Broomfield's article discussed similar cases where companies not registered to ISO 9001/2/3 were subjected to questions derived from ISO 9001 and ISO 9004.  All of these companies chose to settle out of court rather than risk possible embarrassment in a trial where their business processes would be compared to processes derived from an international quality management standard. In a conversation with Mr. Broomfield in February 2001, he noted that the forensic engineer and the law firm using ISO 9001 and ISO 9004 to sue companies not registered to an ISO 9000 QMS were 100% successful in litigation over six years.

Parenthetically, at that time I was contacted by a recent engineering graduate from Georgia Tech who said he was working as a forensic engineer for a law firm in Atlanta using ISO 9001 & ISO 9004 in product liability lawsuits.  As a postscript, a few years ago I received a call from a product liability attorney in Las Vegas who said he and a colleague were using the same ISO 9001 approach in Nevada and Texas courts.

What About Guidance Standards

In the United States guidance standards such as ISO 9000 and ISO 9004 are considered components of a series along with ISO 9001. As such, even though these are guidance standards, they can be used to examine issues such as product safety. Further, these guidance standards ask questions that every company should ask itself when establishing a quality management system. In the U.S., guidance documents that are part of a series can be used to establish an organization’s “due diligence” and “duty of care” and can be used by courts to establish evidence of negligence and/or a design defect. A plaintiff’s attorney could argue that the issues raised by ISO 9004 should be considered first by any responsible company before registering to ISO 9001.

This particular issue about the role of guidance standards aggravates a number of consultants who believe that guidance standards are optional and that guidance standard ISO 9004 was designed solely for performance improvements and was not intended to be used to evaluate an organization's ISO 9001 quality management system.  Be that as it may, it is reasonable to expect that plaintiffs’ attorneys will argue that ISO 9004 should be considered before complying with and certifying to ISO 9001. Especially, when there are key issues raised by ISO 9004 relevant to product or services safety and the day-to-day operations of an organization.

Conclusion

Clearly, the 2000 version of the ISO 9000 series of standards represented a new set of expectations and requirements. Returning to the question of whether an ISO 9001 Quality Management System could provide an excellent defense in event of a lawsuit, the answer is yes. It will, however, require a proactive preventive law approach by a company. This could be facilitated by product safety audits, service safety audits, evaluation of safety critical points and safety critical issues, product liability audits and a review of documentation, records and minutes.

For example, quite often design engineers create records that could have powerful implications in future lawsuits. In most instances, these engineers will not be in their same position in ten years, having moved to other positions in the organization, to other companies or retired. Design control records that indicate that product safety was a concern when the product was developed would be extremely helpful to defense attorneys who want to demonstrate that there was a concern for product safety when the product was designed.

An absence of design records means that defense attorneys will have to reconstruct design history through depositions in an effort to prove the same point. It is an extremely expensive way to defend against a liability claim in a lawsuit. Furthermore, the decision concerning historical facts will rest with a jury.  A company with an ISO 9001 quality management system structured to reduce liability exposure would be in a far more powerful position to defend itself in future litigation.  

CE Marking Computer Chip Machinery – A Case Study

Early in my CE Marking experience I worked with a company in Central Ohio that had a contract with Siemens stipulating CE Marking for machines to assemble computer chips in the EU. It was my second experience where a contract with Siemens had stipulated CE Marking for a US company (the first Siemens contract was described in my May 12 blog).

The irony in this case was that the Ohio plant reported to their corporate parent in France. When they called the corporate office in France they were told that none of the French plants at that time had expertise in CE Marking machinery, so the Ohio plant could learn about the process and teach the rest of the corporation. When I checked in with the Ohio plant four months after my visit to see how everything was going, the chief engineer with whom I had worked said he now was traveling to France teaching CE Marking to their engineers.

When I toured their manufacturing facility I learned that the plant had been built to manufacture machines for the assembly of computer chips. The original owner was a quirky sort who had some unusual likes and dislikes, among them a preference for magnetic doors on his machines. He felt that this would make maintenance easier.

The engineer walked over to one of the machines and banged his fist on a magnetic door that swung open and exposed two large electric motors running the robotic machinery that was enclosed in a plexi-glass case on a counter above the motor. He asked if this if this kind of exposure would be acceptable under the Machinery Directive. I asked if the exposed motor was dangerous and he replied, “ if you touch it, you will be electrocuted!” I said that would be unacceptable, the doors would have to be secured by a safety interlock that would shut off the machine if they were opened. He responded, “that’s great, I am a safety engineer and have been bothered by these doors ever since I first saw them.”

These machines were synchronized with other machines, including an oven responsible for baking the final product. Since the company was only responsible for CE Marking their machines under the Siemens’ contract they didn’t have to CE Mark the whole assembly line. I noted, however, that if they received a bid for an assembly line or independently decided to build a chip making assembly line, they would be responsible for CE Marking the final assembly line in addition to CE Marking their own machines. At that time there was a misunderstanding about CE Marking. Several companies argued that you could assemble several CE Marked machines making up an assembly line and then claim “voila” the whole assembly line was therefore CE Marked. I said that wasn’t possible, some manufacturer would have to take CE Marking responsibility for the final assembly line.

We visually inspected the machine for other safety issues that might need to be addressed. In addition to the metal doors meeting safety interlocks, it was clear that the entire space containing the electric motors need to be insulated to prevent electrical shocks to workers running the machines. Following that inspection, we walked through the Annex I Essential Health and Safety requirements to determine which of the requirements applied to the machine. Next, we identified the EN harmonized standards that would address the essential requirements and allow for a presumption of conformity.

Following that, we conducted a risk assessment & hazards analysis to determine what additional steps would be needed concerning the design of the machine, guarding against those hazards that couldn’t be designed out and warning against those hazards that couldn’t be designed out or guarded against, in other words “the “principles of safety integration”, described in Annex I, 1.2.2. From there we constructed a Technical File (parts A&B), containing drawings, ISO 9001 Quality Manual, compliance with the Low Voltage Directive and certification of compliance with the Electromagnetic Compatibility Directive. The Operations Manual and Safety Manual were translated into the language(s) of the countries where the machines were going to the installed. Finally, we drafted an EC Declaration of Conformity and identified the corporate office in Paris as the Authorized Representative.

Since that first CE Marking work by the Ohio plant, the company CE Marks machinery at all of its plants for every market, including the US.  The uniform approach to machinery safety will prevent any disparity that could give rise to a subsequent product liability lawsuit.

If you have product liability and risk assessment concerns vis-a vis the US market regarding the Machinery Safety Directive and related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net

CE Marking Assembly Line Machinery for the EU: Product Liability Exposure in the US

In 2002 I flew from California to Western New York to work with a company asked to design and deliver a CE Marked Assembly Line for manufacturing a radiator for a European automobile manufacturer. They had been chosen because of their considerable experience creating similar assembly lines for US automobile manufacturers. After touring their facility and examining various designs of assembly lines created by the company, I presented an overview of the Machinery, Low Voltage and EMC Directives.

Before beginning work on applying the Machinery Directive to their initial design, I accompanied three of their engineers on a tour of a nearby automobile supplier’s manufacturing plant that had several of their assembly lines installed. It was both a shock and revelation to watch the operation. The plant was large, employing about 5,000 workers.

When we reached the area where four of their assembly lines were operating, I saw workers feeding flat metal sheets into a series of machines which operated continuously, first creating round tubes, welding the tubes, flattening the round tubes into thin tubes, cutting the thin tubes and feeding the finished product into a bin where workers would pick them up and place them in open containers. The tubes would then move to another production line where they would become the internal tubing for circulating automobile radiator coolant.

At one point one of the engineers told me not to get too close to the arc weld, because you could be electrocuted. Also, as we watched the production line, we could have touched the material at any point as it moved along the continuous assembly line. I asked if there were any guards to prevent direct access to the assembly line. They said yes, but all of the safety interlocks they had installed had been defeated because the men didn’t like them. I said this is a product liability lawsuit waiting to happen and both your company and the supplier manufacturer would be named as defendants. They said they knew this and would be working harder in the future to create interlocks that couldn’t be defeated.

As we watched the workers transferring the finished tubes, which were hot, from the bins to open containers, some of the workers wore gloves and a few others feeling macho used their bare hands. I asked where is OSHA (Occupational Safety & Health Administration) in all of this. To which one of the plant managers replied, the union doesn’t want OSHA here, so they don’t come. I didn’t find the explanation persuasive, but if OSHA had ever visited they must have sent a team with white canes and dark glasses.

When we returned to the design facility, I asked an engineer who had recently visited an automobile manufacturing facility in the UK if he had seen similar efforts to defeat safety guards and interlocks. He said no, it wouldn’t happen there, they respected the safety measures. Returning to designing their CE Marked Assembly line for the European automobile manufacturer, I recounted my encounter with the blow moulding plastics machinery manufacturer in Canada (described in my April 3 blog) and their encounter with German authorities.

I also described an earlier encounter of an American automobile manufacturer that didn’t CE Mark their machinery for their plant in Belfast. When one of the workers reported that the machinery wasn’t CE Marked (which they are supposed to do under the EU Workplace Safety Directive) the American company responded that the machines were built by them for their plant in Belfast, it is “us to us”. British authorities responded that may be true, but Belfast is in British sovereign territory and EU/British law applies. They gave the plant manager a six month suspended sentence under the British Criminal Code and said don’t let it happen again.

Returning to design, we walked through the requirements for the Machinery Directive constructing an Annex I Essential Health and Safety Requirements Checklist. The search for EN harmonized safety standards proved to be more daunting because the complexity of the assembly line required a significant number of EN standards to address the essential requirements. We then embarked on the EN 1050/ISO 14121 (now EN ISO 14121-1) Risk Assessment/Hazards Analysis. Next we constructed the Technical File (Parts A&B), Design Drawings, EMC Certification, Quality & Safety Manuals, Language Translation, EC Declaration of Conformity and identified their Authorized Representative.

While the US was not the direct focus of my work with the company, it was a collateral focus because the minute the new CE Marked Assembly Line would be placed in the EU, it would mean that the company knows how to make a safer Assembly line. Making a less safe assembly line for the US would place the company in the same jeopardy as the California Company (described in my February 26 blog) that lost a $35 million dollar lawsuit because it manufactured a safe CE Marked machine for Europe and manufactured a less safe machine for the US that caused a lifetime debilitating injury requiring permanent 24 hour care. The assembly lines I saw at the suppliers’ manufacturing plant provided a vivid demonstration of what could go wrong.

If you have product liability and risk assessment concerns vis-a vis the US market regarding the Machinery Safety Directive and related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net

CE Marking for the Machinery & Medical Devices Directives – A Case Study

A few years ago I received a call from the California Manufacturing Technology Center (CMTC) asking for assistance with a manufacturer of exercise machinery in the San Joaquin Valley. The owners wanted to me to conduct a GAP Analysis to determine what would be needed to CE Mark their exercise machinery to the Machinery Directive. After arriving on site I discovered that they also were interested in the possibility of CE Marking the machinery for medical centers and health care facilities and CE Marking some play equipment to the Toy Safety Directive.

First things first, the exercise machinery was (and continues to be) extremely popular in Exercise, Fitness & Sports Recreation Centers in the US. Because it is pneumatic and electric, the resistance can be calibrated by any user and increased as the person becomes more proficient. The company had been successful in training athletes for sports competitions, including the Olympics, for 20 years. The company also had been working with universities and medical centers for several years to improve the physical performance of older adults to slow the aging process and improve their quality of life.

I indicated that the two CE Marks would be needed to accommodate the different Essential Health and Safety Requirements and Conformity Assessment Requirements of the two directives. In particular, if the company wanted to make medical claims and sell their machines to EU medical centers, it would be necessary to CE Mark their machines to the Medical devices Directive.

I toured their facility, examined the design and production protocols they had in place and then reviewed the separate requirements for the two directives. The company had their own quality system, which would satisfy the Machinery Directive, Annex V, Paragraph 3(b) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with
the provisions of the Directive.

For the Medical Devices Directive, a review of Annex IX indicated that their machines would be classified under the following rules:

Definitions for the Classification Rules

1.5 Active therapeutical device

Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or mediation of an illness, injury or handicap.

 3. Additional rules applicable to active devices

 3.1 Rule 9   

All active therapeutic devices intended to administer or exchange energy are in Class IIa unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are in Class IIb.

To confirm that our classification of their machines under Annex IX of the Medical Devices Directive was correct, we faxed materials about the machines and our tentative IIa classification decision to the Medical Devices Agency (now the Medicines and Healthcare products Regulatory Agency MHRA) in the UK and received confirmation that our classification was accurate. To obtain a CE Mark for a Class IIa medical device, it would be necessary for the company to have an ISO 9001 Quality Management System (exempted from examination of the design) approved by a notified body, that they were not prepared to tackle at that time.

We discussed both paths to CE Certification (Machinery & Medical Devices) and covered the steps necessary to comply with each directive and then focused on compliance with the Machinery Directive. The first step was to sort the various machines into a few product families and then discuss the Low Voltage & EMC Directives, the Machinery Directive Annex I Essential Health & Safety Requirements for each product family, identify the EN harmonized standards that would allow them to demonstrate conformity with the essential requirements, review the application of the EN 1050/ISO 14121 Risk Assessment Standard, the construction of the Technical Files (Parts A & B), the EC Declaration of Conformity and the identification of their Authorized Representative.

The Toy Safety Directive issue was interesting, because most of their equipment didn’t fall under the Toy Safety Directive. Instead some of their equipment was subject to the requirements of old approach EU directives and couldn’t be CE Marked. Fortunately, these were recently adopted old approach directives with fairly clear steps for compliance and directions for the appropriate safety markings.

Postscript: The company successfully CE Marked their exercise and fitness machinery and now have offices in 15 EU member states as well as offices all over the world. They subsequently CE Marked selected machines to the EU Medical Devices Directive and sell those machines through their 15 EU offices. They also participate in Aging and Wellness research in EU universities and medical centers.

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

Product Liability Exposure in the US for EU Machinery Manufacturers

The theme of this blog is the same as several previous blogs, except that the focus is on machinery manufactured in the EU that is not CE Marked. While selling non CE Marked machinery is prohibited in the EU, there is no prohibition against manufacturing non CE Marked machinery in the EU that will be sold in “third countries”, the quaint phrase for all countries outside the EU. This would include the United States. Presumably, EU manufactured machines should be CE Marked. The only reason for not doing so would be that they cannot satisfy the Annex I Essential Health and Safety Requirements. If that is the case then the non CE Marked machines being sold in the US and other “third countries” aren’t as safe as their EU CE Marked counterparts.

This, of course, raises the same question that was raised in the Minnesota case discussed in previous blogs. In a blog posted on February 26, I recounted a 2002 Minnesota trial where an employee was injured by a box-stacking machine that crushed his skull requiring 24-hour care for the rest of his life. When the jury discovered that the same company made a safer version of the same machine (CE Marked) for Europe with a laser light curtain that would have stopped the machine’s operation if it detected the presence of a person, it awarded the plaintiff $35.5 million dollars in punitive damages. Clearly, the manufacturer knew how to make a safer machine, but chose to make a less safe machine for the US market because there was no government requirement.

In the Minnesota case the machine manufacturer was an American Company that created a CE Marked machine that met the EU’s more stringent safety requirements, but made a less safe machine for the US, because there was no US government safety requirement. Their calculation, however, failed to factor in product liability case law which holds a manufacturer liable if they knew how to make a safer machine, but chose to make a less safe machine for the market. In similar fashion, any EU manufactured machine that is less safe than a CE Marked machine will suffer the same fate.

More than once I have counseled an American manufacturer not to purchase a non CE Marked machine from the EU with the admonition that it was being dumped in the US market because it could no longer be sold in he EU. To buy such a machine and have an accident occur could expose the American manufacturer to a product liability lawsuit once the plaintiff’s attorney discovers that safer machines existed. The issue wouldn’t end there, however, because the European machinery manufacturer also could be sued for making a less safe machine. Further, all of their documents describing the safer and less safe machines would be subject to discovery in a US Court of Law. The fact that they are European would not exempt them from US legal procedures. Once they choose to enter the US market they are subject to US legal rules and requirements.

I have worked with American machinery manufacturers who didn’t want to sell CE Marked machines in the US complaining that it would be too expensive and make them non competitive. They asked if I could come up with an alternative. In response I developed an approach using SAE, ASME, IATA, OSHA standards because the machine was being prepared to meet the requirements of the American market. In the EU templates, EN standards would be used because it is being prepared to meet requirements of the EU market and in the US templates US Standards would be used for the US market. I also proposed that a Technical File be created for both markets. It would help to organize the Safety information.

I think it was plausible to take such a position, because the different markets have different types of requirements. The EU tends to address requirements in “shall terminology”, whereas the U.S. tends to identify “standards of practice", but in some instances also uses “shall terminology". The kicker, however, is that the EU standards are more safety oriented and in the end if the EU machine is safer than the US machine, the court and jury might not be persuaded that the US approach is adequate.

I also felt that it was essential that each file contain some type of risk assessment. To this end, I developed a template using the format I developed in the EU for the same machine. It allowed for the identification of standards (again US and EU respectively) that address hazards reduction. It would be necessary to conduct a FMEA or FTA risk assessment for the American market and use the EN 1050/ISO 14121 Risk Assessment standard for the European market. That would require identifying every hazard, the gravity of the threat posed by that hazard and how the hazard can be reduced to a safety level acceptable to the machinery company.

It was an attempt to push the machinery company toward some sort of safety design model for the US that would match the Technical File they created for their EU machines, but it was in vain because they could not be persuaded to develop a safer approach to the US market. They still thought it would be too expensive and make it difficult too compete.

Given their losses in product liability lawsuits, I thought they might consider a new approach. At this point, because of their litigation losses, the deductable on their insurance policy had reached $2 million dollars. The only thing that saved them from greater litigation losses was the ineptitude of the plaintiffs’ attorneys. Instead of delving into design files and learning about CE Marking, plaintiffs’ attorneys made generic assertions with minimum work and had been successful. Had they been more diligent and dug deeper, they would have been more successful and the company’s litigation losses probably would have driven them out of business.

Returning to the theme of this blog:

•    If an EU company manufactures a CE Marked machine for sale in the EU and non-CE Marked less safe machine for sale in the US, they risk losing a product liability lawsuit with a Minnesota punitive damages result. Expect trial attorneys will become a bit more resourceful and determine whether a company makes a CE Marked machine and seek the Technical File and related documents in discovery to compare with US documents.

•    If any company places a machine on the US market, all documents related to that machine are discoverable in a US Court of Law. This includes any third party assessments, certification and surveillance audits.

•    Expect plaintiffs’ attorneys to hire a legal expert, such as myself, to determine if a company did a poor job in self-certification and didn’t fully comply with the safety requirements of the Machinery Directive, thereby creating a less safe or unsafe machine, resulting in an injury.

•    Expect that the safety requirements of the EU Machinery Directive, which your competition is meeting to CE Mark its machines, will become state-of-the-art for safety for manufacturing machinery in the US and therefore will become the standard against which your company will be measured in future product liability lawsuits whether or not your company CE Marks your machines.

As noted earlier and in previous blogs, we live in a global marketplace. Perhaps one unanticipated consequence of this market place is the assimilation of safety standards from outside the US into deliberations within the American legal system. It is here and it is real! In addition to design engineers, CEOs, Corporate Counsel and CFOs need to be aware of these global implications.

If you have product liability and risk assessment concerns vis-a vis the US market regarding the Machinery Safety Directive and related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net
 

CE Marking Machinery to Maximize Market Flexibility

I first learned about CE Marking and market flexibility from a colleague when (with two other colleagues) we presented a two-day course on CE Marking at the University of Wisconsin Madison several years ago. My colleague was product safety manager for a Minnesota Company that manufactured paint sprayers. Because his company had a manufacturing plant in the EU, their European engineers were able to work with their European competitors, National Standards Experts (e.g., BSI, DIN, AFNOR, etc.) and university engineers under the auspices of the European Committee for Standardization (CEN) to establish new EN harmonized paint spray standards for the Machinery Directive. It had several benefits, among them collaborating on standards for paint spray canisters used in explosive atmospheres. Heretofore, each company had worked on company standards that often yielded cumbersome and heavy canisters. Working together they were able to craft standards that reduced the weight, increased the strength and improved the safety of the canisters.

After this experience his company decided to use CE Marking as their approach for all new global products manufactured by the company in the US, EU and Japan. He commented that with the Product Family Technical File, containing an Annex I Checklist, EN harmonized standards to satisfy essential health and safety requirements, design drawings for each sprayer and their ISO 9001 Quality Management System monitoring production quality, for the first time in his professional experience he could find all of the safety information needed to defend the company in the event of a product liability lawsuit. His company decided to place a copy of the EC Declaration of Conformity in each box containing every paint sprayer sold in the world. They thought it attested to the safety of their products and also provided excellent marketing.

Subsequently I worked with a company in the San Diego area that manufactured Eximer Lasers for lithographic etching on computer chips. They wanted to CE Mark all of their machines even though their primary destination was chip manufacturers in the US like Intel. They reasoned that while these lasers would be used for a few generations of lithographic chip manufacturing, eventually a new type of physics would replace them. Since they are robust machines, that would be valuable to other companies wanting to apply lithographic etching to their products, the lasers could be re-sold in the EU if they were CE Marked. It was an excellent business decision and stood in marked contrast to other machinery manufacturers I was working with who worried that the additional safety requirements for CE Marked machines would make them too expensive for the US market.

A similar decision was made by a Connecticut Company I worked with that manufactured plastic and rubber extrusion machinery. They asked for help with CE Marking because CE Marking had been stipulated in an order they had from Siemens. I toured their manufacturing plant, met with the CEO and made a formal presentation on the Machinery Directive to the CEO and key management in their Conference Center. When I finished, he asked, “Do we have to do this to sell our machines in Europe?” I said yes. He then turned to two of his managers and said I want you two to spearhead this effort and see that it is done correctly and as soon as possible.

Following the meeting I worked with the two managers walking through the steps necessary to satisfy the Machinery Directive, Low Voltage and EMC Directives. After CE Marking their machines for Siemens, the company decided that their machines also would have greater initial value and resale value if they were CE Marked. A few years later I was sponsored at an American Law Firm Association meeting in Florida where I gave a talk on ISO 9001 and its legal implications. The senior partner of a Philadelphia Law Firm introduced himself and said that his firm was my sponsor. The Connecticut Company was a client of theirs. He thanked me and said the CEO told him that I had saved his company $150,000 by walking them through requirements of the Directive.

Recently, I worked with a company in Indiana that manufacturers generators and high pressure gas compressors for moving natural gas through pipelines. The compressors are designed so that they can be easily moved to different sites. When I arrived at their plant they informed me that the specific model of compressor we were working on was headed to a company in Colorado, but they wanted the compressor CE Marked so that it subsequently could be moved into the EU. They also wanted to learn how to CE Mark their other products to improve their value. I thought it was a bright business move on their part.

If you have product liability and risk assessment concerns regarding the Machinery Safety Directive and related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net

     

My Adventures With CE Marking

Introduction

By now most everyone knows that CE stands for Conformité Européenne (or European Conformity in English). It is the only EU required safety mark that must be affixed to new approach directive products to travel freely throughout the EU. While most new approach directives require the existence of a Technical File and many require Conformity Assessment (an approved process control quality management assurance system), it is the CE mark and Declaration of Conformity that they all share in common.

Early in the annals of CE Marking I read that some Asian Toy manufacturers accommodated the requirement by stamping CE on their toys. No compliance with the Toy Safety Directive, (the first of the new approach directives), no Technical File, just a stamped CE on each toy. To counter this obvious attempt to circumvent EU law, the EU adopted EU Council Regulation on Product Safety Conformity 339/93 on 17 March 1993.

My Adventures

Shortly after I began to write about CE Marking and work with companies on CE Marking, I received a call from a company in Northern Minnesota who read a book I co-authored with Greg Scott in 1992 entitled, European Community Product Liability and Product safety Directives, which included chapters on the Machinery Safety Directive. The person on the other end said, “Where can I get a box of them CE Marks?” I responded, it doesn’t quite work that way. This was my first and would not be my last encounter with strange CE marking requests. Although the number of strange requests has diminished over time, they continue to this day.

Greg and also wrote another book in 1992 entitled, European Community Medical Devices Directives: Certification, Quality Assurance and Liability. Consequently, I received requests on medical devices including a call one evening from a manufacturer of a pacemaker asking if they had to stamp CE on the pacemaker. The thought of a little CE stamped on an active implantable medical device in someone’s body seemed almost comical, but the caller was quite serious. To his relief, I was able to tell him that on small medical devices the CE marking could be in the instructions and on the package containing the device.

A while later I worked with a medical device manufacturer in Central Connecticut who made dental braces from spring metal that would become limp when placed under cold water, but would tighten when warmed in the mouth, perfect for dental braces. In the US it was common for large medical device companies to buy a small device, such as dental braces, place 20-40 in a plastic container and sell it under their name. One year this company’s dental braces packed by three different distributors was ranked 1st, 2nd and 3rd in the US for the same dental braces.

European distributors also were accustomed to doing the same thing, packaging products such as dental braces under their names. With the CE Mark, however, the rules changed. Only the manufacturer of a product can claim the CE Mark. Distributors can continue to sell the product, but the manufacturer must be identified as the owner of the CE mark. The dental braces manufacturer seemed happy with this solution.

A similar medical device situation was described in an April 9 blog about a California manufacturer of saw blades for hip and knee replacements. In that instance, a German saw manufacturer wanted the California company to CE Mark their blades in the German company’s name. It couldn’t be done

A Machinery Directive situation occurred a few years ago when I was working with a manufacturer of air compressors on the Virginia coast. As we walked through the structure of the Machinery Directive and the steps necessary to CE Mark their equipment, I mentioned that only the manufacturer of a machine can place a CE Mark on their machine. At that point, one of the persons in the room bolted from his chair and left the room. A short while later he returned with a bronze CE Mark plaque with the name of a company in New England. The New England Company asked my client to affix the plaques to compressors manufactured by my client. When they initially agreed to affix the plaques, they were unaware that what they were doing was illegal. They said that the New England company had been rather arrogant and difficult to deal with and were looking forward to terminating the contract.

Last year I received a call from a client in North Georgia who makes orthodontic devices. A Scandinavian dentist, who looked at a component of one of their devices at a Trade Show wrote to tell them that he had CE Marked the component in his name. When informed that they had not agreed to his CE Marking and that it was illegal, the dentist was outraged at their ingratitude. He even threatened to sue my client, an interesting move. It reminded me of Jonathan Swift’s Gulliver’s Travels where Gulliver explains that, “if my neighbor hath a Mind to my cow, he hires a lawyer to prove that he ought to have my cow from me.” Gulliver goes on to explain that he is at disadvantage because it is his cow. He will have to hire a lawyer to defend himself, because it is his cow. Better yet if his lawyer can prove that the cow belongs to his neighbor, which will impress the court. The Scandinavian dentist laid claim to my clients component, who knew how close Gulliver was to the truth today in 1726.

Finally, there are situations where no CE Mark is affixed to products that should be CE Marked. A colleague described the manufacturer of metal baby cribs being shipped to hospitals in the EU by a manufacturer in Western New York. Although he has been told that he needs to CE mark the cribs, he hasn’t done so. In this case the blame falls on the manufacturer, the EU member state’s customs & competent authority and his clients in the EU. Until enforcement improves, these types of abuses will continue.

If you have product liability concerns with CE Marking for the EU's Medical Devices Directives & Machinery Directive you can contact me for a free preliminary consultation at theguide1@comcast.net

CE Marking a Large Machinery Complex – EU Machinery Directive

As noted in earlier blogs, the EU Machinery Directive has developed an excellent approach to Machinery Safety, its biggest weakness being self-certification and weak enforcement. Its Annex I Essential Health and Safety Requirements are comprehensive, beginning with the Principles of Safety Integration (design out, guard against and warn against) the list of essential requirements for basic machinery safety, foodstuffs machinery, machinery mobility, lifting machinery, machinery for underground work and machinery for the safe of movement of persons.

Once the Annex I Essential Requirements Checklist is completed, it is necessary to select those EN harmonized standards that will allow the EU to presume conformity with the essential requirements of the directive. Among the critical standards was EN 1050: 1997/ISO 14121: 1999 Safety of Machinery – Principles for risk assessment, which now has been replaced with ISO 14121-1:2007 Safety of machinery - Risk assessment - Part 1: Principles for risk assessment. We have no comparable comprehensive application of safety standards for machinery in the United States.

A few years ago I worked for some time with a company in West Georgia to CE mark a complex continuous metal rod rolling mill casting system comprised of 12 different machines, all of them large, housed in a very long building. It is a turnkey operation.  Altogether, the complex of machines and the building is delivered on site with eighteen 16-wheel trucks and takes the better part of a year to set up. We had to CE Mark several machines manufactured by my client, buy CE marked machines from other companies and then CE Mark the entire complex. They have built and installed these continuous rod rolling mill casting systems all over the world and they wanted to prepare to enter the EU.

The installation involves several engineers from the West Georgia company working with the personnel of the company that franchised the operation (both at their home office in West Georgia in preparation to operate the complex and subsequently on site), for as long as it takes to make the complex operational. Although it is a larger overall complex in size, it reminded me of CE Marking a turnkey aluminum-smelting complex I worked with ten years earlier with a company in Eastern Washington.

In addition to the Machinery Directive, we had to incorporate the essential requirements and standards of the Low Voltage Directive, EMC Directive, Explosive Atmospheres Directive (ATEX) and the Pressure Directive. For the EMC Directive the final testing of the complex would be “in situ”.

The first step was to create a CE Marking Compliance Protocol for each machine. The first machine we began work on CE Marking was their Furnace Loader. After completing the Annex I Checklist, we tentatively identified 25 EN harmonized standards that would have to be examined by their engineers for the furnace loader. Needless to say, there was no Type C standard for such a machine.

Next we tackled the EN 1050/ISO 14121 Risk Assessment standard, which took a substantial amount of time. By the time we recorded the steps and rationale, we had created a risk assessment portfolio of 185 pages, not including the design calculations and drawings. As with the company that I described working with in an earlier blog, that was building machines to be shipped into Spain and Turkey, I wrote the first draft of the documents, including the risk assessment to make certain that every question was addressed, and an answer of Yes, No or N/A was recorded. Further, the answers were written in clear English for future reference. This was turned over to their engineers for edits and corrections.

I had stressed that a complete document would be needed for each machine and for the complex in case of an inquiry by the country where the complex would be located and for any potential health, safety, environmental and liability issues. Naturally, we expected all of this documentation would be reviewed by their attorneys as well as designated government personnel. We also wanted to create safety documentation for any future product liability lawsuit.

The second machine we worked on was the Furnace Area, including the smelting furnace, which resulted in identifying 51 EN harmonized standards after we completed the Annex I Checklist. Again the list of standards was turned over to their engineers for examination and implementation. The risk assessment portfolio exceeded 200 pages. These steps were taken for each machine manufactured by the company. The purchased CE Marked machines were reviewed to make certain that the same level of attention was given to each those machines.

The CE Marking Compliance Protocol for each machine included all of the elements in paragraph 3 of Annex V including an Annex I Checklist, the list of EN harmonized standards, standards calculations and Risk Assessment for each machine, the Operating Manual, Specifications/Maintenance Manual, Training Manual, language translation protocol, all of which were included in the Technical File. Finally when the individual machines were all CE Marked, the company CE marked the entire continuous metal rod rolling mill casting system complex. It was the biggest CE marking project I have worked on and the company responded diligently to the challenge. In particular we addressed issues concerning product liability avoidance in the US as well as meeting the requirements of the EU and EU member states.

If you have product liability and risk assessment concerns regarding the Machinery Safety Directive and related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net

EU Machinery Directive – EU Regulatory Enforcement vs US Market Enforcement: Addendum

When my wife (the English Major) read my original blog, she thought its length detracted from my point. Realizing that her criticism was valid, I agreed to condense the observations. For the unexpurgated version, please read the April 30 blog.

EU Regulatory Enforcement

The reader will quickly discern that my encounters with notified bodies and the Machinery Directive have been frustrating. Too many times I have watched notified bodies, whose notification to the Directive is limited by law, take advantage of Americans who could self certify. Instead these bodies would present themselves as representatives of the UK, Germany, the Netherlands, Denmark, etc. and propose all manner of services (basically consulting services) and imply that they are required by EU law and only they could perform these services.

The most egregious example was a Dutch notified body that flew a team from the Netherlands to the US that issued bogus EC Type Examination Certificates and other paper at great expense to the company. Worse yet they were even bad consultants who “approved Technical Files” that had no risk assessment for the machines. While I am sure that they were amused by the ignorance of the company, they unwittingly issued false documents that could make them liable in a US product liability lawsuit. As noted in the unexpurgated version of this blog, after no answer from the notified body or the Dutch Government Competent Authority for six months I contacted the European Commissioner in charge of this area and received a response within three weeks copying the Dutch notified body and the Dutch Government Competent Authority stating that I was correct and the certificates were not legitimate.

Unfortunately, the three examples cited in the blog are not the only examples I have encountered of Machinery Directive notified body “smoke and mirrors.” At the same time, I have also dealt with notified bodies that acted in a proper manner vis-à-vis the Machinery Directive. However, if one multiplies the number of notified bodies by the vast number of countries where they work, it quickly becomes apparent that oversight from the member state competent authority is overwhelming. Further, as “for-profit” entities often driven to make money at the lowest possible cost, their behavior can be quite mercenary. A number of former employees of a German notified body in the US have related some horrendous stories of bad management and high pressure that caused them to leave.

This raises a serious problem for the EU outsourcing its external regulatory authority to 27 member state competent authorities and who knows how many notified bodies. My comments here are limited to the Machinery Directive. My experience with the professionalism of Medical Devices notified bodies has been good, not perfect, but good.

Concerning machinery entering the EU, the two major check points are member state customs and member state competent authorities. Unless something is glaring at customs such as no CE Mark or inadequate papers, the volume of traffic makes it exceedingly difficult for non-compliant machinery to be caught. A substantive examination of Technical Files is virtually impossible. Member state competent authority oversight varies according to their experience, budget and expertise. Unless an accident occurs, a competitor complains or an employee blows a whistle, the chance of in-depth oversight is slight. A few years ago I proposed some oversight ideas to the Machinery Committee of the European Commission, but never heard back, not surprisingly.

US Market Enforcement

Except for unsafe machinery called to the attention of the US Consumer Products Safety Commission (CPSC), because of a pattern of injuries reported to the Commission, there is no governmental mechanism in the US to oversee unsafe machines. Perhaps the US Occupational Safety & Health Administration (OSHA) might observe unsafe machinery in the workplace, but is not a central oversight responsibility. Instead the US system of state and federal courts provides a forum for litigating civil cases where persons injured by unsafe machines can sue the manufacturer for damages.

In a blog posted in February, I recounted a 2002 Minnesota trial where an employee was injured by a box-stacking machine that crushed his skull requiring 24-hour care for the rest of his life. When the jury discovered that the same company made a safer version of the same machine with a laser light curtain for the EU that would have stopped the machine’s operation if it detected the presence of a person, it awarded the plaintiff $35.5 million dollars in punitive damages. Clearly, the manufacturer knew how to make a safer machine for the EU, but chose to make a less safe machine for the US market because there was no government requirement in the US.

As observed in the April 30 blog, the product liability implications of the EU machinery Directive are significant for all manufacturers:

•    If a US, EU, Japanese, etc. company manufactures a CE Marked machine for sale in the EU and non-CE Marked less safe machine for sale in the US, they risk losing a product liability lawsuit with a Minnesota punitive damages result. Expect trial attorneys to determine if a company makes a CE Marked machine and seek the Technical File and related documents in discovery to compare with US documents.

•    If any company places a machine on the US market, all documents related to that machine are discoverable in a US Court of Law. This includes any third party assessments, certification and surveillance audits.

•    Expect plaintiffs’ attorneys to hire a legal expert, such as myself, to determine if a company did a poor job in self-certification and didn’t fully comply with the safety requirements of the Machinery Directive, thereby creating a less safe or unsafe machine, resulting in an injury.

•    Expect that the safety requirements of the EU Machinery Directive, which your competition is meeting to CE Mark its machines, will become state-of-the-art for safety for manufacturing machinery in the US and therefore will become the standard against which your company will be measured in future product liability lawsuits whether or not you CE Mark your machines.

As noted earlier and in previous blogs, we live in a global marketplace. Perhaps one unanticipated consequence of this market place is the assimilation of safety standards from outside the US into deliberations within the American legal system. It is here and it is real! In addition to design engineers, CEOs, Corporate Counsel and CFOs need to be aware of these global implications.

If you have product liability and risk assessment concerns regarding the Machinery Safety Directive and related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net

EU Machinery Directive – EU Regulatory Enforcement vs US Market Enforcement

This may seem to be an odd title for a blog, but it is a topic I have discussed in articles, papers and presentations for a number of years. It is a topic that should be of concern to all companies placing CE Marked machinery on the EU market, and all companies placing CE Marked and non CE Marked machinery on the US market.

EU Enforcement

The term “regulatory enforcement” is not the preferred term in the EU, instead they use “market surveillance” to describe their process of enforcement. Whatever the preferred term, my own experience with Machinery Directive enforcement has been mixed. As mentioned in an earlier blog, a few years ago I worked with a manufacturer of machinery that had been visited by a notified body that flew in from the Netherlands to issue EC Type Examination Certificates to two machines that were not classified dangerous under Annex IV (dangerous machines) of the Directive and therefore could not receive such certificates. Further, they issued pronouncements on several other machines declaring that they could not be CE Marked without additional changes.

While the Dutch notified body stated that the company’s two Technical Files were satisfactory and therefore a CE Mark could be affixed to the machines, there was no Risk Assessment in either file. Further, these were machines subject to self-certification. The notified body had no authority to grant CE Marking to the company. Their notification was confined to Annex IV.  Naturally, the notified body collected a good amount of money and depended on the ignorance of Americans and American companies about the new EU CE Marking legislation.

It wasn’t the first time I encountered this sort of shell game. Shortly after completing my second book on the Machinery Directive, I received a telephone call from a machinery manufacturer in South Georgia who asked for a quote from an English EMC test lab in the Atlanta area and was told it would cost $16,000 to CE Mark his machine. When I asked him to review the quote, except for EMC testing, the remainder of the quote covered work that he could have done himself. Further, the EMC testing appeared to be open-ended. I gave him the name of a Chicago EMC lab and they gave him instructions on how to go about testing his existing machinery for electromagnetic compatibility. Following their instructions, he discovered that his existing motor would never satisfy EMC testing. He also realized that the Atlanta lab was going to test him several times before informing him that he would need a new motor. Needless to say, he self certified and found a CE marked motor that would satisfy EMC requirements.

A few years later when working with the California Manufacturing Technology Center (CMTC) in Fresno, we received word from a company that had requested a quote that they were going to sign with a German notified body. When I asked if our quote was high, the CMTC representative said no, in fact their quote was 75% higher than our quote. The owner, however, was led to believe that the German notified body had some official status in regard to the Machinery Directive when in fact they were simply acting as a consultant, but implying they had official sanction from the German government to do this work.

I have recited this rather long description of three notified bodies because it illustrates one aspect of the EU regulatory process in regard to CE marking. Each directive is different and the notification of third parties and their official status is different for each directive. Consequently, unless the American company knows this they are ripe for whatever chicanery or sleight-of-hand is used to obtain their business. Further, the outside of EU behavior of “notified bodies” is not scrutinized well, if at all, by their government competent authorities.

Since each of the 27 EU member states oversees their own 3rd parties and notifies the commission of the approved 3rd parties, it is a big task and a major enforcement failure of the EU regulatory process. Further, while “notified bodies” are approved by a governmental authority they are “for-profit” entities and often quite mercenary in pushing their employees to bring in money quickly and firing those who don’t perform. Not a model of quasi-government integrity.

To return to the Dutch notified body discussed earlier, I contacted the UK Department of Trade and Industry (DTI) and ask for their assistance. After three months, the representative from DTI said he received no response from the Dutch competent authority and suggested that I try to contact them myself. After three months of no response, I contacted the European Commissioner in charge of this area and received a response within three weeks copying both the Dutch government and the Dutch third party stating that I was correct and that the certificates were not legitimate.

The problem for the American machinery company was the assumption that the certificates had some legal status that could be used in an American court of law should it be necessary. In fact, they were bogus. Whether the Dutch notified body knew or cared I can’t say, but they chose to issue paper to an American company and therefore could have found themselves liable in a US Court of Law.

In the EU, “market surveillance” of the Machinery Directive is handled by Member State’s Customs Authority and Member State’s Competent Authority. Customs clearly is overwhelmed by the magnitude of products, such as machinery, entering the country. Only if the proper papers don’t accompany the machinery on entry will it likely be caught if it is improperly CE marked. Likewise, Member State Competent Authorities also have a formidable task policing compliance with the Machinery Directive. A few years ago, when I was touring a winery in Italy, I saw a Japanese manufactured fork-lift that wasn’t CE Marked. It seems that a machine likely won’t get attention, unless an accident occurs and the machine does not comply with the requirements of the Machinery Directive and related Directives.

US Market Enforcement

The US enforcement mechanism is indirect, but it can be very effective. Machinery, like any other product on the US market, is subject to product liability lawsuits. If a person is injured by machine and a court determines in a product liability civil lawsuit that the machine was unsafe, the manufacturer can be held liable in a  US court of law. The EU Machinery Directive adds a new equation to product liability. In a blog posted in February, I recounted a 2002 Minnesota trial where an employee was injured by a box-stacking machine that crushed his skull requiring 24-hour care for the rest of his life. When the jury discovered that the same company made a safer version of the same machine with a laser light curtain that would have stopped the machine’s operation if it detected the presence of a person, it awarded the plaintiff $35.5 million dollars in punitive damages. Clearly, the manufacturer knew how to make a safer machine, but chose to make a less safe machine for the US market because there was no government requirement.

The product liability implications of the EU Machinery Directive are significant for all manufacturers:

•    If a US, EU, Japanese, etc. company manufactures a CE Marked machine for sale in the EU and non-CE Marked less safe machine for sale in the US, they risk losing a product liability lawsuit with a Minnesota punitive damages result. Expect trial attorneys to determine if a company makes a CE Marked machine and seek the Technical File and related documents in discovery.

•    If any company places a machine on the US market, all documents related to that machine are discoverable in a US Court of Law. This includes any third party assessments, certification and surveillance audits.

•    Expect plaintiffs’ attorneys to hire a legal expert, such as myself, to determine if a company did a poor job in self-certification and didn’t fully comply with the safety requirements of the Machinery Directive, thereby creating a less safe or unsafe machine, resulting in an injury.

•    Expect that the safety requirements of the EU Machinery Directive, which your competition is meeting to CE Mark its machines, will become state-of-the-art for safety for manufacturing machinery in the US and therefore will become the standard against which your company will be measured in future product liability lawsuits whether or not you CE Mark your machines.

As noted frequently by economists, scientists and in previous blogs, we live in a global marketplace. Perhaps one unanticipated consequence of this market place is the assimilation of safety standards from outside the US into deliberations within the American legal system. It is here and it is real. In addition to design engineers, CEOs, Corporate Counsel and CFOs need to be aware of these global implications.

If you have product liability and risk assessment concerns regarding the Machinery Safety Directive and related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net