The Food and Drug Administration has created a global unique device identification database (GUDID) that contains key device identification information and Unique Device Identifiers (UDIs). Working with the National Library of Medicine, FDA has created a web portal (AccessGUDID) that serves as a reference guide for patients, clinicians, hospitals, and industry. The UDI system can help improve patient safety, offering all involved stakeholders a common vocabulary to help monitor medical device adverse effects.
Authentag LLC has created a mobile medical app called UDI Check that scans Type II medical devices, allowing users to detect the UDI embedded in the label’s barcode. In the United States, as of September 24, 2016, all class II medical devices sold here must contain a UDI, an alphanumeric code that can be read by humans and machines. Authentag says its code reader is “compatible with multiple code formats and UDI’s from all three accredited issuing agencies: GS1, Health Industry Business Communications Council (HIBCC), [and] International Council for Commonality in Blood Banking Automation (ICCBBA).” The mobile app is available for both Apple and Android devices.
Federal law requires device manufacturers to keep the data in the FDA GUDID database up to date. According to Authentag, “Each barcode also has its own identifiers which make it completely unique. This means it can have its own story to tell about who and where it was built, how it shipped all the way to who is using it in a hospital or even patient level. The foundation of this digital life thread is the data that UDI Check stores for you in your personal history.”
Available on iOS (iTunes)