In Support of the Ensuring Safe Medical Devices for Patients Act
March 15, 2012
Your toaster has a unique serial number on it in case it needs to be recalled. Your hip implant doesn’t. Let’s hope that is about to change. Senator Jeff Merkley (D-OR) today joined Senators Chuck Grassley (R-IA), Herb Kohl (D-WI) and Michael Bennet (D-CO) in introducing the bipartisan “Ensuring Safe Medical Devices for Patients Act.” The National Research Center (NRC) for Women & Families strongly supports this bill, which requires the Food and Drug Administration to establish a Unique Device Identifier (UDI) rule by the end of this year. Unique identifiers would make it possible for the first time to track all medical devices and recall defective ones.
The bill also requires FDA to add medical devices to the Sentinel system, its surveillance database. Sentinel is a new national electronic system that includes the medical records of millions of patients and can be used to flag potential safety problems for prescription drugs. If medical devices are included in the Sentinel program, problems caused by all kinds of implants, from hips to heart valves, will be spotted earlier.
NRC for Women & Families has long championed legislation to improve the safety of medical devices, and we sounded the alarm that most high-risk recalled devices received less-than-rigorous review by the FDA.
We testified about the large number of high-risk recalled medical devices that were cleared by FDA’s fast-track process at a Senate hearing of the Special Committee on Aging last year, Chaired by Senator Herb Kohl (D-WI) who is now one of the co-sponsors of the UDI bill. We thank the Senators for their leadership on this important issue and look forward to working with them on this long-overdue identification system.
–Paul Brown, Government Relations Manager, National Research Center for Women & Families
For more information on the bill, please read Senator Jeff Merkley’s press release.