Premier Issues Statement on Legislation to Require Medical Device ID System

Members of the Premier alliance applaud recently introduced legislation that would require implementation of a unique device identification system for medical devices to improve medical device safety.

Senators Jeff Merkley (D-Ore.), Chuck Grassley (R-Iowa), Michael Bennet (D-Colo.) and Herb Kohl (D-Wis.) introduced the Ensuring Safe Medical Devices for Patients Act, which would require the FDA to issue a unique device identifier rule by the end of 2012. This rule would establish a unique numerical identifier system that would allow rapid and efficient recalls and mitigate the risk of patient harm. The UDI program was created nearly five years ago but the FDA has not implemented it. This bill would also add medical devices to the sentinel post-marketing surveillance initiative, which was launched in 2008.


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"It is essential that UDI regulations move out of the OMB and into implementation immediately. Electronic tracking systems are commonplace in other industries, and have been in place since the 1970s," Premier said in the news release. "Today we can recall tainted dog food using standardized bar codes faster than we can medical devices, including those that are implanted in patients. It's time for healthcare to join the 21st century with a fully functioning UDI system."

Related Articles on Device Safety:

Legislation Calls for Unique IDs to Improve Device Safety

Proposed Bill Would Tighten FDA Oversight of Medical Devices

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