The U.S. Food and Drug Administration, hospitals, manufacturers and patients have lacked the needed information to quickly identify problems with medical devices and quickly remove those products from the market. As a result, the FDA in 2013 issued final regulations that will require medical device labels to bear a distinctive code—called the unique device identifier, or UDI—to help track products used in patient care.
The UDI is an alphanumeric code that identifies the make and model of the product and provides other clinically relevant information, such as an expiration date. Once a device has a UDI, the code can be added to relevant records—such as hospital purchase orders, a patient’s electronic health record, and an insurer’s claim forms—and tracked throughout the healthcare system. This information will help remove recalled products from the market and more quickly identify product failures.
Pew is working to support full implementation of the UDI system, including efforts to incorporate it into patients’ electronic health records and insurance claims forms.