The FDA said that the new unique device identification system (UDI) will improve the quality of information in medical device and help it to catch problematic implants earlier. The UDI will be contain two major components, the first being a unique device identifier, a unique number assigned to the version or model of a device by the device manufacturer. This will include product information such as batch number, expiration date, and manufacturing date.
The FDA will also be maintaining a publicly searchable database, known as the Global Unique Device Identification Database (GUDID), which will provide a reference catalogue for every device with an identifier. The agency added that no patient information will be stored on the database.
"UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation. A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development", FDA's director of the FDA's Center for Devices and Radiological Health, Jeffrey Shuren said.