FDA Moves Forward On UDI System Initiative
By Christine Kern, contributing writer
A Brookings Institution report provides a roadmap for effective implementation.
The FDA is moving forward on its initiative to establish guidelines and requirements for inclusion of Unique Device Identifiers (UDI) on all medical devices, and a recently-release Brookings Institution report has provided a roadmap for effective UDI implementation.
The FDA website explains the agency is in the process of creating a unique device identification system to adequately identify medical devices through their distribution and use. In accordance with this system, most device labels will include a unique device identifier (UDI) in human- and machine-readable form, and device labelers will be required to submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). The public will be able to search and download information from the GUDID.
The unique device identification system will be phased in over several years, and offers a number of benefits as a result of the adoption and integration of UDIs into the health care delivery system. The FDA asserts that “UDI implementation will improve patient safety, modernize device post market surveillance, and facilitate medical device innovation.”
In a blog post, Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, explained 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.”
But Shuren also 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, healthcare 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.”
Which is why, Shuren explained, in an effort to drive industry adoption, the FDA commissioned the Brookings Institution to create a “roadmap” for stakeholders to adopt and use UDIs. 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.”
Additional strategies include integrating UDIs into hospital inventory management and billing systems, and incorporating UDIs into administrative transactions,” according to the study. “Further, integrating UDIs into easily accessible patient and consumer tools, such as personal health records (PHRs) and mobile applications, would enable patients to receive safety alerts, obtain information about their devices, and potentially communicate patient experiences with devices,” and thus improve patient experiences and outcomes within the healthcare system.