The new UDI rule initially impacts the medical device industry. Longer term, though, the whole intent is to benefit patients. Once implemented, it will be much easier for health care delivery organizations to track devices when needed for recalls, adverse incident investigation, product safety alerts, and the like. Set up well in a health care delivery organization, it can be used to document a specific patient device (e.g., an implantable) right in the EHR, and can be tied in with a device inventory management system.



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