For Healthcare Systems and Providers
Webinar: Monday, November 5, 2012 @ 2:00 pm
In response to growing calls for the development of a standardized medical device identification system, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA mandated the U.S. Food and Drug Administration (FDA) to create a unique device identification (UDI) system that would enable tracking and identification of medical devices across the medical device lifecycle (i.e., from production through use in clinical practice). In response to this mandate, on July 10, 2012, the FDA published its Proposed Rule for a Unique Device Identification System in the Federal Register.
While the release of the Proposed Rule is an important step forward, its proposals, if adopted in the Final Rule, only ensure that UDIs will be developed and included on labels for relevant medical devices and that accompanying device information will be available to the public. With the enhanced capabilities that could arise from UDI adoption and implementation, there are a number of opportunities that exist specifically for health care systems and providers, including streamlining internal supply chains, more effective recall management, and increased access to device information to inform point of care decisions.
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