FDA sends device identifier rule to OMB for final review

The U.S. Food and Drug Administration submitted a proposed final rule on unique medical device identifiers to the Office of Management and Budget for review, Health Data Management has reported.

The rule--initially requested  by Congress in 2007--would mandate placement of unique device identifiers (UDIs) on medical devices. The UDIs would have to include information about the type of device, its model number, manufacturer, expiration date, and lot number. UDIs would contain no patient identifying information, and would be recorded in a publicly available database.

A proposed rule was issued by the FDA last summer, one year after the agency originally sent a UDI proposal to OMB. Updates were made last fall that called for implantable devices to bear an identifier as a permanent marking one, three or five years earlier than initially proposed, depending on the class of the device.

Both the American Hospital Association and Charlotte, N.C.-based Premier healthcare alliance--a healthcare purchasing group--urged the FDA to accelerate adoption of the UDI rule in November. In a letter to the FDA, the AHA said that a UDI would "provide an important means for hospitals to better track devices used in patient care, act in the event of safety recalls and manage their supply chains."

In April, the FDA announced updates to its post-market surveillance of medical devices in order to add more input from physicians and patients.

To learn more:
- read the Health Data Management article


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