On Monday, May 4, the FDA announced the launch of AccessGUDID, its latest effort towards improving insight into the performance of medical devices on the market. The site contains a vast trove of information on devices sold within the U.S., from the pre-trial stage to distribution figures.
The site was a joint effort between the FDA, the National Institutes of Health (NIH) and the National Library of Medicine (NLM). It is currently open to the public, meaning anyone curious about a device, such as whether a certain model was subject to a recall, will have quick and easy access to the information they seek.
“Through AccessGUDID, anyone can search or download information that labelers have submitted about their medical devices to the GUDID,” FDA explained in a press statement. “Device identification and key safety information, such as whether the device is safe for use while undergoing MRI, will be available for health care providers to search at any time.”
The initiative was originally begun in 2013, when the FDA first finalized its Unique Device Identification Rule after requests from both the industry and public officials for improved visibility into long-term device efficacy. This latest effort should continue to help improve the industry’s ability to react to adverse event reports and identify and track problems that could be associated with a particular device. The FDA estimated that about 50,000 serious adverse events related to medical devices are reported each year.
Moving forward, most medical devices will now be required to have a UDI on their label and packaging, and in select cases, etched on the device itself. UDIs for existing devices will be released over the following few years, with the highest-risk devices being assigned first.
