Barbara Strain
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Who's Who in Healthcare?
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Streamlining the medical device recall process with UDIs
From the August 2021 issue of HealthCare Business News magazine By Barbara Strain The U.S. has averaged more than 2,900 medical device recalls annually since 2014 and that number does not appear to be going down. In 2020, only 18% of all medical device recalls included the Unique Device Identifier (UDI) and only 24% of those flagged as implant recalls. The overarching intent by the FDA of the Unique Device Identifier Rule was to provide safety, effectiveness, and traceability of medical devices.
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