FDA seeks feedback on medical device identifiers
Ambulatory Safety Monitor, August 17, 2006
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The Food and Drug Administration (FDA) is currently accepting comments from the public on a proposal released in the August 11, 2006 Federal Register regarding unique device identifier (UDI) systems for medical devices.
UDIs-including bar code systems or radiofrequency technology-may reduce medical errors, facilitate device recalls, and improve medical device adverse event reporting, according to the FDA. The FDA already requires bar codes on certain human drug and biological products to help verify that the patient receives the correct drug and dose.
A similar system for medical devices could help identify medical devices that are compatible, such as implanted devices that are safe to use with magnetic resonance imaging equipment.
Click here to access the proposal.
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