On Monday, a coalition of health care industry groups called the Advancing Patient Safety Coalition sent a letter urging members of Congress to add language to this year's FDA user-fee reauthorization bill to set a firm deadline for FDA to develop a unique device identification system, The Hill's "Healthwatch" reports (Baker, "Healthwatch," The Hill, 6/4).
The coalition sent the letter to ranking members of the Senate Health, Energy, Labor & Pensions Committee and the House Energy and Commerce Committee (Norman, "Pulse," Politico, 6/5).
Coalition members include:
- The American Medical Association; and
- The Federation of American Hospitals ("Healthwatch," The Hill, 6/4).
Background on UDI System
There currently is no uniform labeling system for medical devices, making it difficult to track down problematic equipment used by hospitals and patients.
In 2007, Congress voted to support FDA's plan to create a UDI system for medical devices. Such a system would allow FDA officials to electronically track medical tools and promptly recall any devices that could jeopardize patient safety.
In July 2011, FDA sent its proposal to Office of Management and Budget for review, but OMB has yet to release a proposed rule based on FDA's plan.
In February, Sens. Charles Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.) sent a letter urging OMB to release the delayed rule.
In April, Sens. Tom Harkin (D-Iowa) and Michael Enzi (R.-Wyo.) added language to a proposed FDA user-fee bill that would require HHS to issue a final rule establishing a UDI system for medical devices by the end of 2012 (iHealthBeat, 4/19).
A House and Senate conference committee currently is working out the details of the final FDA user-fee legislation.
Details of the Letter
The letter calls for the final user-fee bill to require FDA to release a final rule on the UDI system within six months after the proposed rule is published. It also calls for the UDI system to be in place no later than two years after the final rule comes out ("Pulse," Politico, 6/5).
The coalition wrote, "We believe a UDI system is essential to help protect the safety of patients, reduce medical errors and strengthen the ability of the FDA and manufacturers to monitor adverse events."
The letter continued, "Every day that goes by without such electronic identification of medical devices is a threat to patient safety and increases costs in the health care system" ("Healthwatch," The Hill, 6/4).