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FDA proposes UDI system to track high-risk medical devices

The US Food and Drug Administration (FDA) has proposed a rule to develop a new unique device identification (UDI) system in response to legislation passed by Congress in June 2012.

The FDA has worked closely with industry, the clinical community and patient and consumer groups and conducted four pilot studies in the development of the proposed rule, reports StarTribune.

The UDI system is designed to track high-risk medical devices after they have gone public, giving patients, doctors, regulators and consumer advocates access to information about specific products.

The FDA said every high-risk medical device such as pacemakers and stents will be labeled with a unique identification code to improve patient safety, and a production identifier which includes production information for the device.

The identification code will provide basic information about the name of the manufacturer of the device, type, model and expiration of the device as well as a batch or lot number to help officials better track devices that have been recalled.

Consumer Reports policy and advocacy division and Consumers Union senior policy analyst Lisa Swirsky said, "Once it is fully implemented, this system will enhance the FDA’s ability to identify problem medical devices more quickly and inform patients when their safety is at risk."