FDA unveils database to track medical devices
The U.S Food and Drug Administration launched an eagerly-anticipated database to allow consumers, healthcare providers and product manufacturers to access information tracked on medical devices.
The online Global Unique Device Identification Database, called AccessGUDID, follows almost three years after Congress mandated that medical devices be marked and tracked with unique identifiers.
FDA’s database uses a unique device identification system to identify devices sold in the U.S., with the capability to track them from manufacturing through distribution to patient use, the FDA said.
When fully implemented, the label of most devices will include a UDI in human- and machine-readable form. Device labelers must also submit certain information about each device to AccessGUDID, where the public can search and download information.
Most devices will be required to have a UDI on their label and packaging, and for certain devices, on the product itself, the FDA said. Device companies must also submit certain information about these devices to the databases. UDIs will be phased in over several years, starting with the highest risk devices, such as heart valves and pacemakers.
The identification system was created in the 2012 Food and Drug Administration Safety and Innovation Act. And in 2013, the FDA issued a final rule describing a schedule for phased implementation.
The identification system established under this rule allows “the FDA, health care providers, and industry to more rapidly extract useful information from adverse event reports, pinpoint the particular device at issue and thereby gain a better understanding of the underlying problems, and take appropriate, better-focused, corrective action,” according to the final rule issued by the FDA and authorizing the system.
The rule also mandates that dates on medical device labels conform to a standard format to ensure those dates are unambiguous and clearly understood by device users.
Most devices will be required to have a UDI on their label and packaging, and for certain devices, on the product itself. Device companies must also submit certain information about these devices to the GUDID. Among the first UDIs to be introduced to the system will be the highest risk devices, such as heart valves and pacemakers.
“The unique device identification system, which will be phased in over several years, offers a number of benefits that will be more fully realized with the adoption and integration of UDIs into the health care delivery system,” the FDA said. “UDI implementation will improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.”