The U.S. Food and Drug Administration (FDA) published a final rule in the Federal Register on September 24, requiring that medical device labels and packages contain a unique device identifier (UDI). UDIs are numeric or alphanumeric codes that include a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number, and/or expiration date. UDIs will improve patient safety by “making it possible to rapidly and definitively identify a device,” resulting in improved accuracy in adverse event reporting, reduced medical errors caused by misidentification of a device, more efficient recalls, and more focused FDA-safety communications, according to the ruling.
