Q: What needs to be done to improve the oversight of medical device safety?
A: Post-market surveillance of medical devices should be as effective as possible in order to preserve the fast-track approval process that gets new and innovative medical products on the market for consumers. There’s an opportunity this year to pass legislation to strengthen the ability of the Food and Drug Administration to run a robust post-market surveillance operation and to act quickly when a medical device safety problem is discovered. By September 30, Congress must renew a program that collects fees from the medical device industry to help pay for safety reviews by the Food and Drug Administration. Along with Senators Herb Kohl of Wisconsin and Richard Blumenthal of Connecticut, I introduced a bipartisan bill (S.1995) late last year that would let the Food and Drug Administration require post-market clinical studies for medical devices that pose potential safety risks if those devices were first approved through a fast-track process that’s allowed for moderate risk devices. These changes should be passed along with renewal of the medical device user fee program. Our bill also would allow the Food and Drug Administration to implement a routine assessment of device recalls, develop enhanced procedures and criteria for assessing the effectiveness of recalls, and document the agency’s basis for terminating individual recalls. These changes were recommended in a 2011 report of the Government Accountability Office. The report showed that such gaps in the system today limit the ability of manufacturers and the Food and Drug Administration to make sure recalls are implemented in a timely and effective manner. In addition to requesting the report and seeking legislative reform, Senators Kohl and Blumenthal and I also have asked five companies that have recalled faulty medical devices for detailed information about how they conduct post-market surveillance and how the companies have managed recalls of hip implants, surgical mesh, heart defibrillators, knee replacements, and spinal fusion products.
Q: What about other efforts to track defective medical devices?
A: As part of a law enacted in 2007, a tracking system for medical devices was created to enhance post-market surveillance of medical devices, improve data collection on medical devices, and allow companies and the FDA to track faulty devices when problems occur. This Unique Device Identifier (UDI) system would require implantable devices to carry a unique numerical identifier so products can be tracked through the distribution chain and after they’ve been used with patients. Even so, the UDI system has yet to be implemented. At this point, the plan is stuck at the Office of Management and Budget, which must approve what the Food and Drug Administration submitted last summer. The sooner this system is in place, the better for patients who have received medical devices. Senators Kohl and Blumenthal and I have urged the Office of Management and Budget to act and, this month, I joined Senator Jeff Merkley in introducing a bill (S.2193) that would require a final UDI rule by the end of 2012. The legislation also would add medical devices to a post-market surveillance initiative launched in 2008. This Sentinel system is an integrated electronic system that tracks prescription drug safety nationwide. The post-market surveillance work of the Food and Drug Administration must be empowered to use the valuable information about drugs and devices available when millions of people start using products, compared to what can be known before a drug or device goes on the market.