A group of high-profile organizations representing hospitals, physicians, nurses, medical researchers and patient advocacy is imploring two Congressional committees to set deadlines that would help bring to fruition the unique medical device identifier (UDI) system that has been in the making for several years now.
The Advancing Patient Safety Coalition, whose 30-odd members include the American Medical Association, the Association of American Medical Colleges and Premier, wrote the chairs and ranking members of the House Energy & Commerce Committee and the Senate Committee on Health, Education, Labor and Pensions about the UDI on June 4.
“We strongly urge you to ensure the inclusion of critical language in the final medical device and user fee reauthorization bill to finalize regulations within six months after the close of the comment period, and to implement a national UDI system within two years after the final regulation is issued,” the group wrote.
The signatories reiterated points they made in a 2008 letter to the FDA stating their belief that 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.
“Every day that goes by without such electronic identification of medical devices is a threat to patient safety and increases costs in the healthcare system. UDI is the missing link to better ensuring patient safety,” wrote the group to Congress in their June 4 letter. “Implementing a national UDI system will not only reduce clinical risks to patients, but will also save an estimated $16 billion in costs annually which are incurred due to inefficiencies in the medical products supply chain.”