Recently, four U.S. Senators from both parties came together to introduce Senate bill 2193, Ensuring Safe Medical Devices for Patients Act, in an effort to strengthen the U.S. Food and Drug Administration’s oversight of medical devices. Democrats Merkley, Bennet and Kohl of Oregon, Colorado and Wisconsin, respectively, and Republican Chuck Grassley of Iowa, co-sponsored the legislation and have actively garnered support among advocacy groups to help get it passed.
Senator Jeff Merkley noted on average 700 different medical devices had been recalled every year since 2005. “Faulty medical devices, especially those implanted in the body, can have a disastrous impact on the health of those who use them,”[1] according to Senator Kohl. The Senators also noted in their statements that “harmful or defective devices were associated with the death of almost 5,000 Americans in 2009.”[2]
Following the recent widely publicized recalls of medical devices, such as the Johnson & Johnson DePuy/ASR hip implant, scientific, medical, health and technology-related advocacy groups seem to concur that the FDA requires more oversight of device manufacture to ensure public safety. Concerned groups supporting the bill include: Consumers Union, the National Women's Health Network, the National Research Center for Women & Families, the Health Care Supply Chain Association, the Premier Healthcare Alliance, the Association of American Medical Colleges, the Alliance for Advancing Nonprofit Health Care, and others.
In addition to making a provision for additional FDA oversight to approval of medical devices, the bill “would require unique identifiers for implantable medical devices and ongoing monitoring of the devices for safety issues.”[3] The reason for the unique numerical identifiers is so that problems with faulty devices could be tracked through the distribution chain and corrective actions to benefit patients could be taken expeditiously. The Unique Device Identifier program, according to Sen. Merkley, was created almost five years ago, but the FDA had not implemented it.[4] The bill requires FDA to generate, approve and publish in the Federal Register a final rule by the end of the year “requiring implantable devices to carry a unique numerical identifier”. Presently, FDA’s proposed rule requiring identifiers has been languishing at the Office of Management and Budget since it was submitted eight months ago.
Also, the bill would add medical devices to the FDA’s post-market surveillance system, which currently tracks prescription drug safety. Senator Merkley’s hope is that the “common-sense reforms will not only protect patients, but improve efficiency in the health care system.”[5] Senator Bennet agreed, “the last thing someone should fear is that these devices will harm them.”[6]
This is a good bill, designed to enhance public safety. The fact that is has bipartisan support at the outset is obviously a good sign. Given the incredibly high number of medical device recalls (see, e.g., DePuy/Johnson & Johnson ASR hip implant) in the past ten years, more oversight of the industry is needed. Hopefully, this Bill continues to receive support from both parties and gets signed into law without being substantially gutted.
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[1] “Senators introduce bipartisan medical device bill”, MassDevice Newsletter, March 16, 2012, by Mass Device Staff, http://www.massdevice.com/news/senators-introduce-bi-partisan-medical-device-bill
[2]“Bill would mandate medical device IDs”, Government Information Security, Anderson, Howard. March 20, 2012, http://www.govinfosecurity.com/articles.php?art_id=4598
[3] Op. Cit.
[4] “Senators Introduce Bipartisan Effort to Make Medical Devices Safer”, Merkley, Jeff, March 15, 2012, U.S. Senate Press Release, http://www.merkley.senate.gov/newsroom/press/release/?id=63dd8e2d-bf9a-491c-bfc2-0a33a5096bf7
[5] “Merkley backs bill to make medical devices safer”, March 15, 2012, KTVZ.comhttp://www.ktvz.com/news/30685383/detail.html
[6] Op. Cit.
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