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7. Headaches around UDI

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Implementing real-time tracking of medical devices is turning into a major challenge in the U.S.

Among the medical device industry professionals helping to implement FDA's Unique Device Identification rule, only 15% say their companies are ready for upcoming compliance deadlines, according to a report released in August by enterprise labeling services company Loftware (Portsmouth, NH) and professional services firm USDM Life Sciences (Santa Barbara, CA).

The UDIs are meant to greatly improve tracking of medical devices, helping FDA to identify problems with devices much faster than the present system that relies on self-reporting from medical device manufacturers and health providers. A U.S. Senate reportearly this year, which examined deadly hospital superbug outbreaks related to a particular type of endoscope, recommended legislation to require and promote unique device identifiers (UDIs) in insurance claims, electronic health records, and device registries for faster FDA identification of problems.

FDA appears to be feeling medical device companies' pain, recently finalizing guidance to allow device manufacturers more time to remove legacy FDA identification on particular device labels.

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[Image, slightly modified, courtesy of DIGITALART/FREEDIGITALPHOTOS.NET]

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