The U.S. Food and Drug Administration (FDA) created unique device identification, often abbreviated UDI, a rule that requires medical device manufacturers to label their products, and in some cases, direct product markings, with both a unique device identifier and production identifiers (such as expiration date and lot or serial number). The FDA has also created a database called the Global UDI Database (GUDID) to which manufacturers upload product data and is searchable by the public.

The FDA’s intent is to reduce medical errors and more quickly identify medical devices in the case of adverse events or recalls, in addition to providing an accessible source of definitive device identification information. Scanning barcodes containing standardized product information not only streamlines recall management but also allows hospitals the opportunity to manage inventory better and integrate standardized product information into their electronic medical records.

The timeline for our implementation of GS1 barcodes on labels is in line with the FDA’s timeline for UDI:

 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm