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FDA Urged to Issue Identifier System for Medical Devices

The Advancing Patient Safety Coalition, whose members include the American Hospital Association, the American Nurses Association, Premier, and VHA, urged the Food and Drug Administration (FDA) this week to quickly issue a proposed rule creating a unique device identification (UDI) system that supports national and worldwide needs.

In a letter to the agency, the group said a UDI system is "critical to patient safety improvement initiatives, as well as implementing electronic health records and the delivery system reforms included in the recently enacted healthcare reform bill."

They add that the efficiencies gained through UDI could save the healthcare system billions of dollars—"which providers could reinvest in initiatives to improve the quality and safety of care." The FDA Amendments Act of 2007 includes language requiring the FDA to promulgate regulations establishing a national UDI system for medical devices.

"While the coalition recognizes and appreciates the work and interest of the FDA on UDI, it is taking the agency an unreasonable amount of time to publish a proposed rule," the group said.

Unlike medications, medical devices cannot be identified in a "systematic and consistent manner," the letter said. The result is an ad hoc approach resulting in increased clinical risks to patients, it added. These clinical risks include implanting a defective, counterfeit, or recalled product; inability to track the recipient of a faulty product if it is recalled; and inability to appropriately track adverse events.

UDI may be "the missing link" to protect the safety of patients by improving processes for device recalls and corrections. The rapidly rising number of device recalls points to the need for UDI for effective management. More than 700 medical device recalls were issued in 2008—including more than 100 Class 1 recalls (defined as dangerous or defective products that predictably could cause serious health problems or death).

Manufacturers also issued many "device corrections" that can have serious consequences for patients if not handled correctly. Because of the absence of UDI, providers often must use manual and imprecise systems to identify if they have any recalled products.

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