The Unique Device Identification (UDI) System Proposed Rule was published by the U.S. Food and Drug Administration (FDA) on July 10, 2012. The UDI rule sets the foundation for use of UDI across healthcare and establishes a common language for medical devices. The potential benefits of UDI are many, including greater accuracy and efficiency in the procurement process, improved charge capture, a standard for device documentation in clinical care and post-market surveillance, enhancement of post-market surveillance activities, greater efficiency and comprehensiveness in recalls, and the ability to track a device across its lifecycle. Achieving the full value of UDI across healthcare will require implementation and adoption of UDI in multiple areas, including supply chain, clinical care, and post-market surveillance, as well as integration between these areas. Research, key constituent involvement, and education efforts are ongoing to address implementation and adoption of UDI across the healthcare industry.
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