FDA Launches Medical Device Identification Site

Federal regulators launched a new website this week, which is designed to provide the public access to key information about medical devices and help identify products that may contain dangerous defects that pose a risk for consumers.

The FDA’s Global Unique Device Identification Database (GUDID) is a database of key device identification information that is updated daily, which will be run in collaboration with the National Library of Medicine. The information provided by the site is available to the patients, caregivers, industry and the medical community.

The AccessGUDID website was launched on May 4, allowing consumers to search either for information about a specific medical device, or they can download all of the data from the system at once.

The Unique Device Identifiers (UDI) will include a Device Identifier that is a unique numeric or alphanumeric code that is specific to the device version or model, as well as Production Identifiers (PI), which are numeric or alphanumeric codes that identify specific product information, including:

• Lot or batch number
• Serial number
• Expiration date
• Manufacturing date

In addition, there is a distinct identification code for Human Cell, Tissue or Cellular or Tissue-Based Products (HCT/P) that allows the manufacturer to identify the specific donor. However, the PI is not stored in GUDID, only the Device Identifier. The FDA says the GUDID does not collect or contain patient information.

“UDIs will be phased in over several years, starting with the highest risk devices, such as heart valves and pacemakers,” the FDA notes. “Because of this, records for only a fraction of devices currently in use have been submitted to GUDID.”

In July 2014, the FDA finalized guidance on the creation of a Global Unique Device Identification Database (GUDID), following the issuance of a final rule on the unique device identifier (UDI) program issued in September 2013.

The FDA intends to phase in the UDI system, starting with high-risk devices. However, some low-risk medical devices will be partially or fully exempt. The agency first proposed the rule in July 2012.

In the past, the U.S. public often had to wait for problems to be noticed, since adverse event reports were not consistently tracked and the manufacturer was largely responsible for identifying issues after medical devices were introduced. The first warnings about problems with medical devices frequently came from oversees, since Australia and the U.K. have extensive databases for medical devices hip replacement systems and knee implants.