FDA to Move Ahead With UDI Implementation

The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that a top official with the U.S. Food and Drug Administration (FDA) has promised that his agency will waste no time to promote the widespread adoption of unique device identifiers (UDIs) in the U.S. healthcare system.

The agency unveiled the UDI rule in September 2013 and will require each device to be labeled with a unique number assigned by the manufacturer, along with other identifying information-similar to a barcode.

Likening them to vehicle identification numbers, Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, stressed that UDIs will help make it easier to monitor device safety over time. However, without all clinical actors on board-hospitals, healthcare insurance companies, and others-“UDI will be codes and a database with limited utility to improve patient care or reach its other critical goals,” he wrote in a blog post.

“So while there’s little doubt that UDI can improve patient safety, modernize how we evaluate devices once they are in use, and facilitate future device innovation, these benefits will only become a reality when the UDI system is adopted and integrated into the healthcare system-when hospitals, doctors’ offices, patient registries, heath care insurance companies, and others incorporate UDI as part of their standard electronic health information systems,” he wrote.

He added that the agency is moving “full steam ahead” to promote the use of UDIs.

The FDA’s commitment comes with the release of a roadmap for UDI implementation, prepared by the Brookings Institution, a centrist think tank based in Washington. The report, which was commissioned by the agency, lists 17 UDI-related recommendations grouped into three categories: for provider systems, administrative transactions, and patient-directed tools.

The report also calls for a national “Know Your UDI” campaign to increase awareness of the importance of UDI for patient safety.

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Source: AAMI