APS coalition calls for Congress to set UDI program implementation deadline


Prestigious organizations from various realms of the healthcare industry are demanding that a pair of Congressional committees set deadlines for the implementation of the FDA’s promised system of unique medical device identification (UDI).

On June 4, the Advancing Patient Safety Coalition (APS) — a unit whose membership consists of the AARP, the American Medical Association and the Federation of American Hospitals — sent a letter to members of Congress insisting that the language in the FDA’s user-fee authorization bill be altered to cement a 2-year timeline for UDI introduction.

The UDI program was originally approved by Congress in 2006, but disregard has permitted the motion little progress since it reached the Office of Management & Budget in July 2011, the APS coalition stated.

The UDI concept originated when the FDA recognized the need for a system with the ability to track medical implants as well as accommodate the addition of more devices to the Sentinel post-market surveillance program, which monitors prescription drug safety. Although the FDA has conducted workshops on the UDI system recently, the 5-year delay has caused many physicians and other healthcare personnel to become exasperated.

The APS coalition’s letter heralds sentiments similar to another written correspondence the group made to the FDA in 2008 articulating the essentiality of a UDI system for the well-being of both patient and practice. “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 APS coalition wrote.

The APS coalition isn’t the only organization mandating urgency in the matter; a quartet of senators presented the bipartisan Ensuring Safe Medical Devices for Patients Act in March, a piece of legislation that would compel the FDA to issue a final rule regarding UDI before the end of 2012.

The introduction of the UDI system is not only “the missing link to better ensuring patient safety,” according to the APS coalition; it’s also purported to save an estimated $16 billion in costs annually by eliminating blemishes in the medical products supply chain. "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," the APS coalition wrote in their June 4 letter.

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