The Unique Device Identification (UDI) refers to a system used to mark and identify medical devices within supply chain. Food and Drug Administration (FDA) and International Medical Device Regulator Forum(IMDRF) proposed a harmonized legislation for Unique Device Identification using global standards with an objective of increasing patient safety and improve optimized patient care through harmonized and consistent approach to medical device identification.
A national UDI system will significantly improve patient safety by helping in the identification of medical counterfeits products. It will also improve the ability of staffs to distinguish devices that have a similar appearance but serve different functions. This will improve and facilitate recall process and greatly enhance efficiency within the medical system.
On September 27, 2007, UDI system was signed into law as part of Food and Drug Administration Amendment Act of 2007. The act encompasses language related to the establishment of Unique Device Identification System. When fully implemented, this new system will require medical devices to bear a label with a unique identifier. Doranix has been leading in providing the required label printer-applicators for medical, food, and packaging identification, which will apply to all medical devices in the United States unless FDA makes an exception. The act also requires the unique identifier to be able to identify the device through use and distribution. Moreover, the act calls for the unique identifier to include serial number or lot according to FDA specifications.
Currently, analysis of specific devices involved in adverse events is limited by the fact devices often involved are not known with required degree of specification. However, a national UDI system will create a common vocabulary that will improve reporting and electronic tracking abilities. Consistent and reliable identification of specific medical devices will enable FDA and manufacturers to conduct safety surveillance that could identify device defect and improve patient care.
UID encompass a coded number that will be registered with standard organizations. Further, it will incorporate a variety of information such as the manufacturer of the device, the model, and make of the device, expiry dates, and any other special attributes that may be related to a specific device.