Pew Commends FDA for Releasing Final Medical Device Identifier Rules, Outlines Next Steps

WASHINGTON—The Pew Charitable Trusts today commended the U.S. Food and Drug Administration for issuing final regulations establishing a unique device identifier (UDI) system to mark medical devices or their labels with a code corresponding to the products' make, model and other clinically relevant information.

"This new rule will help improve the safety and quality of care for patients that rely on medical devices, from artificial hips to cardiac stents," said Josh Rising, director of Pew's medical devices initiative. "Unique device identifiers will enable faster identification of product failures and more comprehensive recalls. But the FDA's rule is just the first step. To fully realize the new system's benefits, hospitals, health plans and physicians must integrate these codes into patients' health records and insurance billing transactions."

More information on Pew's work to encourage UDI adoption by health care professionals and advance medical device safety and innovation is available at www.pewhealth.org.

The Pew Charitable Trusts is driven by the power of knowledge to solve today's most challenging problems. Pew applies a rigorous, analytical approach to improve public policy, inform the public and stimulate civic life.