What's taking so long? That's what four members of the U.S. House asked in a recent letter to the Office of Management and Budget about releasing the Unique Device Identifier (UDI) final rule.
In response to slow progress, Congress last year set a June 19 deadline for the Food and Drug Administration to develop regulations for a medical device tracking system. The FDA's proposed rule has been under review with the OMB--the final step--for nearly a full year.
"The UDI system will significantly advance the safety and quality of care for Americans who rely on medical devices," said the four, who identified themselves as members of the New Democrat Coalition, in asking for a status update. "With each passing day, delays [in] implementing and adopting the UDI system throughout healthcare delivery only prolong the realization of these essential benefits for patients across the county."
Separately, executives from Geisinger Health System, Intermountain Healthcare, Kaiser Permanente, Mayo Clinic and Mercy--collaborating as the Healthcare Transformation Group--also sent a letter urging the UDI rule be released as soon as possible.
"The HTG Research and Development Team will be working to establish a standard language and network of data sets within our healthcare systems," they wrote. "The project, which is an expansion of a UDI demonstration project currently underway with the FDA, will eventually provide a pathway to integrate UDI into each HTG healthcare system's clinical processes."
They added: "Through UDI implementation and incorporation into electronic health information, the UDI system will enable the tracking of medical devices through their distribution and use; create data sets for research and safety surveillance; support comparative effectiveness research; facilitate better management of product recalls; and help generate health system savings. The UDI rule's finalization is the first step to achieving these benefits and must promptly occur in time for the next updates to electronic health records standards and policies."
The letters are just the latest urging the rule's release. In a letter to OMB Director Sylvia Mathews Burwell in July, 18 patient advocacy groups noted that owners of recalled cars have more information than patients with dangerously defective pacemakers.
The Advancing Patient Safety Coalition sent a similar letter back in 2008.
To learn more:
- read the lawmakers' letter (.pdf)
- find the hospitals' letter (.pdf)