Coalition Pushes for UDI Ruling

Recently, a number of physician associations, group purchasing organizations, and other groups in the healthcare industry have petitioned Senate and House committees to set defined guidelines to implement a unique device identifier system.

The Advancing Patient Safety Coalition (APS) petitioned a pair of Congressional committees to include in the latest FDA user fee agreements specific deadlines to implement a UDI system to track and monitor devices. The coalition has asked House and Senate committees to mandate a 2-year timeline for launching the UDI system.

“Every day that goes by without such electronic identification of medical devices is a threat to patient safety and increases costs in the healthcare system,” the coalition wrote in a letter to chairmen and ranking members of the Senate Committee on Health, Education, Labor & Pensions and the House Energy & Commerce Committee.

Congress initially approved the UDI program in 2006 to enable tracking of medical implants and to add medical devices to the post-market surveillance program that currently monitors prescription drug safety.

The APS Coalition noted that the tracking system could save about $16 billion each year in costs incurred from inefficiencies in the medical products supply chain.

The FDA has held several workshops to discuss UDI systems, but no final ruling has been made. Because of the lack of ruling, the UDI measure is stuck in the Office of Management and Budget since last year.

In March, the Ensuring Safe Medical Devices for Patients Act was introduced in the Senate, which would force the FDA to issue a final rule before the end 2012. The legislators pointed to the recent medical device recalls to point out the need for FDA oversight in medical devices to ensure public safety.

The APS Coalition hopes that lawmakers will include UDI deadlines in the FDA user fee bill which passed the House and Senate last month. Endorsements for the coalition came from some powerful groups in the health and safety field, including AARP, the American Heart Association, the American Medical Association, and the American Nurses Association.