In 2007, the U.S. Food and Drug Administration’s (FDA) Unique Device Identification (UDI) System was signed into law. Effective Sept. 1, 2014, providers in hospitals, ambulatory surgery centers and nursing homes, along with device manufacturers, were required to report adverse patient events involving such high-risk Class III medical devices (life-support or life-sustaining devices–eg, pacemakers and heart valves), including the UDIs.
The goal is to improve patient safety. The FDA receives about 50,000 reports of adverse events each year, which include about 3,000 deaths. The UDI labeling system will help the FDA and manufacturers identify and track problem products. The coding would help to manage product recalls.
The UDI reporting system should help to reduce medical errors because healthcare personnel could identify a device and get information about it. The UDI system also will provide a secure global distribution network, help to identify counterfeit products and prepare for medical emergencies, according to an article in Dark Daily.