FDA proposes unique IDs to track medical device safety

See on Scoop.ithealthcare technology

Bar codes for hip implants and pacemakers? Health regulators are proposing a new rule to improve the tracking of safety problems with medical devices by requiring that each have a unique code.

 

The Food and Drug Administration said under the rule, devicemakers like Boston Scientific Corp and Medtronic Inc would put the special code on most of their products, ranging from hip implants to heart defibrillators.

The unique device identifier (UDI) would allow doctors and regulators to detect safety problems more quickly and to inform patients about flaws or dangers.

Companies and hospitals could pull faulty devices from the market faster — by knowing which products are affected.

Unique codes would also prevent counterfeit or stolen devices from entering the supply chain, the FDA said.

The FDA said people have 120 days to comment on the proposed rule. The agency will consider the comments before it makes the rule final.

See on www.msnbc.msn.com

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