FDA Touts UDI Benefits in New England Journal of Medicine Commentary
Writing in The New England Journal of Medicine two officials with the U.S. Food and Drug Administration (FDA) say the agency’s proposed unique device identifier (UDI) system “is of critical importance” to improving postmarket device surveillance and enhancing patient safety.
“The new UDI system will provide most medical devices with a consistent, standardized, and unambiguous identifier,” reads the commentary, “Unique Device Identification in the Service of Public Health.” It was written by Jay Crowley, senior advisor for patient safety in the FDA’s Center for Devices and Radiological Health (CDRH), and Thomas P. Gross, MD, deputy director in the Office of Surveillance and Biometrics at CDRH, and appears in the prestigious journal’s Oct. 25 edition.
The proposed rule was issued last July. If approved, it would overhaul how devices are labeled.
Manufacturers would be required to place a numeric or alphanumeric code on certain devices. It would contain identifying information such as batch number, serial number, and expiration date. Over-the-counter and certain low-risk devices are exempt from the requirement.
The authors argue the UDI system will improve medical device tracking.
“It will permit more accurate and timely reporting and analysis of adverse events, which will help the device industry, healthcare facilities, and regulators to more quickly identify and address problems relating to a particular device,” they write.
This will allow manufacturers, distributors, healthcare facilities, clinicians, and patients find a recalled device faster, according to Gross and Crowley.
The FDA is engaged in various activities to speed up the adoption of the UDI system. For example, the authors say that the agency is working with the Brookings Institution, a think tank based in Washington, DC, to “develop an overall road map of tasks and potential hurdles for the adoption and implementation of UDIs in various aspects of the healthcare system.”
The agency and the Office of the National Coordinator for Health Information Technology (ONC) are also exploring how the UDI system can work in collaboration with the ONC’s “meaningful use” program. Hospitals and physician offices can receive funding if they prove they are “meaningful users” of electronic health records (EHRs). The ONC creates the criteria that hospitals and physician offices must meet.
The agency is developing a pilot program that will demonstrate “how a device safety report (including the device’s UDI) can be triggered from within an electronic health record and submitted electronically to the FDA.”
The comment period for the proposed rule ends on Nov. 7. In their commentary, Gross and Crowley emphasized that the agency wants to hear from clinicians about the proposal. For more information on the rule, click here.
Posted: November 5, 2012