Healthcare Supply Chain Association (HSCA) President Curtis Rooney today released the following statement regarding FDA’s release of a proposed rule on a Uniform Device Identifier (UDI) for implantable medical devices:
“HSCA applauds the Food and Drug Administration (FDA) for releasing its proposed rule for medical device tracking and beginning the important process of implementing a robust UDI system for implantable medical devices,” said HSCA President Curtis Rooney. “A uniform system for tracking medical devices is critical to the health of American patients. The UDI rule will enhance the ability of the healthcare supply chain to track and recall faulty medical devices by creating a system that attaches a unique identifier – like a barcode – to implantable medical devices that patients rely on for their health and well-being. 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.”