AHRMM LUC Comments to the FDA’s Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
The AHRMM Learning Unique Device Identifier (UDI) Community (LUC) members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. They recommend that information related to all Class I Medical Devices be included in the GUDID without exception.
AHRMM sponsors the Learning UDI Community (LUC). The LUC is comprised of physicians, clinicians, hospital supply chain professionals, manufacturers, distributors, software application providers, health care consultants and representatives from Group Purchasing Organizations (GPOs), GS1, HIBCC, HIDA and the FDA. The mission of the LUC is to enhance patient safety and improve supply chain efficiency by developing recommended practices that speed the adoption and maximize the utilization of the UDI.
To date, there have been 13 LUC workgroups involving over 600 individuals that have addressed a wide range of issues from making the business case for UDI to incorporating the UDI throughout the recall process.