The FDA launched its Global Unique Device Identification Database (GUDID) website this week, allowing the public to download information about a medical device by entering its unique device identifier (UDI).
AccessGUDID contains a database of all UDI information the FDA has on file and represents the latest step in the agency’s march toward full UDI implementation. Presently, data is only being submitted for what the FDA calls “the highest risk medical devices,” but other devices will be gradually added. By 2020, every applicable medical device is expected to have its own UDI, with information available through the database.
Deborah Kotz, FDA spokesperson, described the importance of this database to RadiologyBusiness.com.
“Incorporating UDIs into electronic health information, especially electronic health records and registries, is a cornerstone of FDA’s strategy to establish a national medical device postmarket surveillance system,” Kotz said. “Because UDIs remain constant throughout the medical device supply chain, they provide a reliable way to clearly identify a device when safety concerns arise.”
Tracking devices when recalls are announced will be a primary function of this UDI system, but FDA says there other advantages as well. For instance, the database will help healthcare professionals reduce errors, and manufacturers will be able to more easily address counterfeiting issues.
The AccessGUDID website is still in its earliest stages, so it could look much different once it houses all applicable medical device UDIs. In the meantime, FDA hopes many individuals affected by the UDI system will peruse the site.
“The FDA encourages users, including large hospital systems, physicians, professional associations, researchers, data aggregators, and industry and patient groups, to share their feedback and suggestions for improving this site,” Kotz said.