The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States. It was signed into law on September 27, 2007, as part of the Food and Drug Administration Amendments Act of 2007. This act includes language related to the establishment of a Unique Device Identification System.
When implemented, the new system will require:
- The label of a device to bear a unique identifier, unless an alternative location is specified by the U.S. Food and Drug Administration (FDA) or unless an exception is made for a particular device or group of devices.
- The unique identifier to be able to identify the device through distribution and use
- The unique identifier to include the lot or serial number if specified by FDA
A national UDI system will create a common vocabulary for reporting and enhance electronic tracking abilities. Currently, analysis of adverse event reports is limited by the fact that the specific devices involved in an incident are often not known with the required degree of specificity. Without a common vocabulary for medical devices, meaningful analysis based on data from existing voluntary systems is problematic. Reliable and consistent identification of medical devices would enable safety surveillance so that the FDA and manufacturers could better identify potential problems or device defects, and improve patient care.
The UDI is expected to improve patient safety (in part by helping to identify counterfeit products and by improving the ability of staff to distinguish between devices that are similar in appearance but serve different functions), facilitate and improve the recall process, and create efficiences within the medical system.
In the most basic format, the UDI would be a coded number registered with standards organizations, and would incorporate a variety of information, including (but not limited to) the manufacturer of the device, expiry dates, the make and model of the device, and any special attributes that the device may possess. In a medical sense, “device” refers to any product that is not pharmaceutical in nature, and while the FDA have been given approval to exempt some devices, Jay Crowely (who was responsible for implementing the UDI requirements in the Act), has expressed an intent to apply the UDI to “everything until somebody gives us good reason not to”, (excluding devices which won’t need identification).
Since the passing of the Act, there have been calls for the FDA to publish a timeline for the implementation of the UDI.