FDA Presses Forward with Unique Device Identifier System

The U.S. Food and Drug Administration is moving ahead with the Unique Device Identifier (UDI) system to identify medical devices. Yet, the question remains: If FDA builds the system, will the healthcare industry adopt it?

The agency is working with manufacturers to launch the UDI system, which will be phased in over several years. When fully implemented, the label of most medical devices will include a unique device identifier in human- and machine-readable form. As part of the implementation, device labelers will also submit certain information about each device to FDA’s Global Unique Device Identification Database, which the public will be able to search and download information.

Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, says that UDIs are “intended to streamline the monitoring of devices, improve safety tracking and recall efficiency, and even make it easier to evaluate device performance over time.” However, writing in a recent blog, Shuren acknowledges that these benefits “will only become a reality when the UDI system is adopted and integrated into the healthcare system—when hospitals, doctors’ offices, patient registries, heathcare insurance companies, and others incorporate UDI as part of their standard electronic health information systems.”

He adds that “the goal is to have the UDI system not only up and running—but actually used as the key to unlock important data that can help patients” but “without the practical implementation on the clinical side, UDI will be codes and a database with limited utility to improve patient care or reach its other critical goals.”

In an effort to drive industry adoption, FDA commissioned the Brookings Institution to create a “roadmap” for stakeholders to adopt and use UDIs. Released on Dec. 5, the report provides 17 recommendations for adopting UDIs across three major intersections of the healthcare system—providers (electronic health records, hospital inventory management, billing records); administrative transactions (claims data and payment information); and patient-directed tools (mobile apps and public awareness campaigns).

“As the standard for communicating specific device information across major healthcare sectors, UDIs can unlock important information about devices at critical points in the delivery of care and facilitate optimization of device safety and effectiveness,” according to a team of Brookings Institution analysts. “For example, recording UDIs at the point-of-care in electronic health records and in claims data could significantly enhance the nation’s ability to conduct medical device safety surveillance and manage recalls.”

The Brookings team also recommended that “relatively straightforward steps” could be undertaken now to realize some of the benefits of UDI implementation. “For example, two high priority steps that can be taken in the near term include enabling providers to scan and record UDIs into EHRs at the POC and motivating patients who receive device implants or use other major devices to demand the UDIs from their providers. A national ‘Know Your UDI’ campaign can be an effective way to increase awareness of the importance of UDIs to patients and consumers.”

The Brookings report, which focuses on high-risk implantable devices, is available here.