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This week, HSCA President Curtis Rooney released a statement regarding FDA’s release of a proposed rule on a Uniform Device Identifier (UDI) for implantable medical devices; a rule that will improve patient safety by attaching a unique identifier--similar to a barcode--to these devices, helping hospitals track and facilitate device recall processes, if necessary. Rooney stated:
“UDI will help ensure that patients can be quickly located and notified in the event of a device recall and that they do not continue to use devices that may be harmful to their health. HSCA and its member GPOs will continue to monitor the rulemaking process to ensure swift implementation of a robust UDI system that will enhance patient identification, strengthen and improve the recall process for faulty medical devices, ensure the integrity of products through the transportation process, and improve safety for patients and hospitals.”