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.