Clamor for Unique Device Identification Grows Stronger

NEWS TRENDS

A coalition in late March sent a letter to FDA commissioner Andrew von Eschenbach supporting a mandatory unique device identification (UDI) system and asking him to set a timeline to implement one. Under such a system, device manufacturers would be required to put a bar code or some other identifier on each of their devices to better enable safety-related tracking.

The Advancing Patient Safety Coalition is a broad-based organization comprising hospital, physician, nursing, research, quality, and patient advocacy organizations. (See the Sidebar on this page for member companies.) In its letter, the coalition stated that UDI is “a crucial factor to improving patient safety, reducing medical errors, facilitating device recalls, improving device adverse event reporting, and improving postmarket surveillance efforts.”

The letter reminded von Eschenbach that the Food and Drug Amendments Act of 2007 contains language requiring FDA to set up a UDI system and urged the agency to write regulations for it as quickly as possible.

The device industry has had reservations about UDI because of the difficulty of trying to come up with a system that makes sense for each of the vast array of devices on the market.

“A national UDI standard has great potential for our entire healthcare system,” the coalition wrote. “It will improve patient safety while increasing efficiency for manufacturers by reducing the potential for counterfeit products being used on a patient. A UDI standard would also help contribute to the success of [electronic health records] and improve patient care by providing appropriate healthcare providers with accurate information.”

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