The U.S. Food and Drug Administration is pressing "full steam ahead" to develop a unique device identifier (UDI) system for medical devices, according to Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health.
Shuren, in a post to FDAVoice this week, stressed the importance of UDIs for safety improvement and efficiency, comparing them to vehicle identification numbers for cars. Hospitals, doctors' offices, patient registries and insurance companies, he said, must adopt and integrate UDIs into their standard electronic health information systems, in order for safety to be maximized.
"Without the practical implementation on the clinical side, UDI will be codes and a database with limited utility to improve care or reach its other critical goals," Shuren said. "We are doing everything we can to promote the widespread adoption of UDI in the U.S. healthcare system."
Last week, the Brookings Institution, commissioned by the FDA, developed a roadmap for implementing UDIs. The report urges healthcare executives to develop an implementation strategy, to automate the process as much as possible, and to integrate the flow of UDIs across supply chain, clinical and revenue-cycle management systems.
The FDA this summer issued guidance to manufacturers for submissions to its Global Unique Device Identification Database, which began in September. It also announced a collaboration the National Health Information Sharing and Analysis Center on cybersecurity of medical device information.
Also in September, a report from the Pew Charitable Trusts, the Blue Cross Blue Shield Association and the Medical Device Epidemiological Network Science Infrastructure Center at Weill Cornell Medical College called for a national system of registries to track safety and effectiveness in medical devices. Josh Rising, director of the medical device initiative at Pew, called registries a "powerful tool for healthcare professionals, patients and manufacturers" in search of reliable device performance.
A final UDI rule was issued by the FDA in September 2013.
To learn more:
- read Shuren's post