NCHR Comments at CDRH’s Voluntary Medical Device Manufacturing and Product Quality Workshop

Good afternoon.  I’m Jack Mitchell, director of health research for the National Center for Health Research.  We produce unbiased health research to inform public policy, and we advocate for patients and consumers.  NCHR accepts no funding from medical device or pharmaceutical companies, so I have no conflicts to report.

CDRH is to be commended for continuing to follow up on its announced strategic goal of improving medical device quality, and for outlining the innovative and collaborative programs under discussion today.   Patients can certainly benefit from increased device manufacturing quality and data transparency.  Industry deserves less regulatory burden if the criteria outlined can be successfully met and carried out in a uniform fashion going forward.

As a think tank focused on scientific and medical evidence to prove the safety and effectiveness of all medical treatments, we are very concerned about CDRH’s increased emphasis on reducing evidence requirements pre-market.  While the efforts presented today may someday alter that paradigm, it seems that the FDA and industry believe that post-market surveillance will be sufficient for protecting the medical needs of patients and consumers.

But what about the quality of medical products when they are first on the market – and for the next few succeeding years?  A recent HHS Office of the Inspector General report noted that the recall of medical devices almost doubled from the period 2003-2012.  In a six-year period, for example, more than 200 cardiac devices were recalled, according to the report.

Additionally, a continuing failure to adequately track just 7 makes of cardiac implants cost Medicare over $5 billion dollars.  The IG was only able to estimate expenses that are the tip of the iceberg – for example, replacement surgeries for devices that were under warranty — not the actual cost of all Medicare services for all the cardiac implants that had to be removed.  Device failures not only waste huge sums of taxpayer money, but expose patients to risks from additional surgeries, potentially causing irreparable harm or even death.

My point in raising this issue is that if the increased number of recalls reflects better post-market surveillance, that’s a positive outcome.  But regardless of the reason for the increase, the recalls of medical devices reflect, at least to a degree, a failure of pre-market regulations.  Therefore, recalls demonstrate the crucial need for improved medical device quality, and for more clinical testing of such devices before they are put onto the marketplace, as well as improved inspections of manufacturing facilities prior to them going on the market.  It’s a positive sign that this pilot program will address at least some of these inspectional issues.

The agency is coming under increasing pressure, through user fee agreements and the 21st Century Cures Act, to approve medical devices more rapidly.  At the same time, the largely passive FDA post-market surveillance system is not able to keep pace.  These trends also will place more urgency on maintaining high and consistent manufacturing and quality standards for medical devices.

We question whether there is sufficient evidence that a voluntary system, no matter how well-meaning, is sufficient to improve the quality of medical devices enough to improve patient safety.  We’re pleased to hear from CDRH Compliance this morning that positive patient outcomes are a high priority for this pilot program; and that several speakers have emphasized the importance of patient input.  The Patient Engagement meetings later this week may further focus CDRH on patients’ critical role in this process.

Nevertheless, the Center’s laudable efforts to improve and standardize these quality measures must be seen in the larger context of the increasing pressure to ease regulations, CDRH’s lack of resources and funding to make post-market surveillance more proactive and effective, and the critical goal of improving patient outcomes and safety.

Thank you for allowing us to express our views.