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HSCA Statement on New Legislation to require implementation of Unique Device Identification System for Medical Devices

Healthcare Supply Chain Association (HSCA) President Curtis Rooney today released the following statement on new legislation that would require implementation of a Unique Device Identification (UDI) system for medical devices:

“HSCA and the healthcare group purchasing industry applaud Senators Jeff Merkley (D-OR), Michael Bennett (D-CO), Charles Grassley (R-IA) and Herb Kohl (D-WI) for introducing legislation to implement a Unique Device Identification system for medical devices, which is critical not only for patient safety, but also for reducing healthcare costs.

“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. There have recently been a large number of medical device recalls and the current system does not allow stakeholders to quickly find patients who may be living with those affected devices. 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.

“Hospitals and other healthcare stakeholders remain in the dark about why OMB continues to delay UDI implementation, which Congress originally mandated in statute five years ago with broad support from hospitals, healthcare providers, and patient and consumer advocates.

“The great potential for UDIs to increase safety and lower costs for the American healthcare system means that widespread adoption is sorely needed now. It is essential that the UDI regulations, which are critical for both hospitals and patient care, move into implementation immediately.”
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