BENEFITS OF UNIQUE DEVICE IDENTIFICATION
When fully implemented, the UDI system may:
- Allow more accurate reporting, reviewing, and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
- Reduce medical errors by enabling healthcare professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
- Enhance our analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources, and registries. A more robust postmarket surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
- Provide a standardized identifier that will allow manufacturers, distributors, and healthcare facilities to more effectively manage medical device recalls.
- Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion, and prepare for medical emergencies.
- Lead to the development of a medical device identification system that is recognized around the world.