Inside HSCA: HSCA and Leading Healthcare Groups Urge FDA on Unique Device Identification System Implementation

The Healthcare Supply Chain Association (HSCA), Health Industry Distributors Association (HIDA), Medical Device Supply Chain Counsel (MedSC) and Strategic Marketplace Initiative (SMI), this week sent a letter urging the Food & Drug Administration (FDA) to issue the final rule to establish the long awaited Unique Device Identification (UDI) system for medical devices. The implementation of a UDI system will enhance patient safety and achieve numerous health benefits. The groups write in the letter:

The ability to track and recall faulty medical devices is critical to protecting the health of American patients, many of whom depend on medical devices in their day-to-day lives. Unique device identifiers will help ensure that patients can be quickly located and alerted in the event of a recall, and that patients do not continue to use devices that may be harmful to their health.

The six-month period in which the FDA was required to issue the final regulations for a UDI system has now elapsed.