Realizing the Benefits of the Unique Device Identifier in Health Care

Article January 15, 2015 Read time:

Projects: Medical Device Initiative

Experts from hospitals, health plans, health technology developers, medical device manufacturers, and other health care stakeholders convened December 9, 2014 to discuss the importance of medical device identification. The result: a clear message that a new tool to track medical devices can improve patient safety and the quality of care, but changes in health data systems must occur for this to happen.

Steve Posnack, left, director of the Office of Standards and Technology at the Office of the National Coordinator for Health Information Technology, and Jamie Ferguson, vice president of health information technology strategy and policy at Kaiser Permanente.

The event—hosted by The Pew Charitable Trusts in partnership with the U.S. Food and Drug Administration and the Office of the National Coordinator for Health Information Technology (ONC)—identified key benefits, challenges, and next steps for implementing unique device identifiers (UDI). Under this system, all medical devices, such as cardiac stents and implanted hips, will be assigned codes corresponding to their manufacturers and model types.

Speaking at the conference, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said that additional data are needed to better understand how medical devices perform and that adoption of UDI in patients’ health records could help provide that information.

Jeff Shuren, director of the Center for Devices and Radiological Health, at the Food and Drug Administration.

Allan Coukell, senior director of health programs at The Pew Charitable Trusts, said the UDI system has the potential to help hospitals, doctors, and manufacturers quickly locate recalled products, reduce the costs of health care, and improve patient outcomes.

Speakers from the Mayo Clinic, Aetna, Brigham and Women’s Hospital, the National Quality Forum, FDA, ONC, and other leading health care organizations identified the next steps to achieve the UDI system’s potential. These steps include its adoption as part of electronic health record standards, insurance claims submitted by hospitals to health plans, and materials management systems used to track inventory in hospitals.