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Washington Highlights

AAMC Commends Senators for Introducing Legislation Improving Medical Device Safety

March 23, 2012—AAMC President and CEO Darrell G. Kirch, M.D., thanked  Sens. Jeff Merkley (D-Ore.), Michael Bennet (D-Colo.), Chuck Grassley (R-Iowa), and Herb Kohl (D-Wis.) for introducing the Ensuring Safe Medical Devices for Patients Act (S. 2193) in a March 19 letter. This legislation, which was referred to the Senate Health, Education, Labor, and Pensions (HELP) Committee, would require the Food and Drug Administration (FDA) to establish a unique device identifier (UDI) final rule by the end of 2012, and adds medical devices to the post-market risk identification and analysis database, Sentinel. 

“The AAMC strongly supports this legislation and believes that implementation of the [UDI] system is a necessary step forward for patient safety that will also provide significant cost savings,” Dr. Kirch stated. He added, “UDI will enable health care providers to track medical devices electronically to improve the speed and accuracy of product recalls, facilitate timely reporting of adverse events, and bring sufficient efficiencies to supply chain management of medical devices.”

The Food and Drug Administration Amendments Act of 2007 [P.L. 110-85], signed into law Sept. 2011, included language related to the establishment of a UDI System. The FDA sent the Office of Management and Budget a UDI proposed rule for review in July 2011, where it awaits approval.


David E. Longnecker, M.D.
Director, Health Care Affairs
Telephone: 202-862-6113

Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559


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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806