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Patients rely on medical devices to replace failing joints, fix irregular heart rhythms, test blood sugar, unblock clogged arteries, diagnose disease, and improve their health in other ways. Yet for many years these devices have lacked industrywide standard identification numbers, a shortcoming that hinders hospital efforts to track inventory, prevents physicians and patients from having complete information on the products they use, and limits analyses of the real world performance of medical devices.
Now there is a new system, developed by the Food and Drug Administration at the direction of Congress, to provide medical devices with a unique device identifier, or UDI, that corresponds to the product’s manufacturer, model, and other clinically relevant information, such as expiration date. These codes already appear on an increasing number of product packages, allowing doctors, nurses, hospital staff, patients, and others to read the information. They also appear as bar codes—like the ones used in supermarkets—or other electronic depictions so the identifier can be easily scanned and entered into different databases.
This report examines how the UDI works, how it is captured in electronic data systems, and how it can benefit the medical system to: