The Food and Drug Administration is taking far too long to announce a proposed rule and concrete timeline for setting up a mandatory unique identification system for medical devices, according to a March 26 letter from the Advanced Patient Safety Coalition to the FDA’s commissioner.
In the letter, the coalition – made up of hospitals, patient advocacy groups, and clinicians – called unique device identification “a crucial factor” in improving patient safety and reducing the frequency of medical errors.
“We need to be able to track medical devices like we can track any other product,” Blair Childs, senior vice president at Premier Inc., of Charlotte, N. C., and a member of the coalition, said in an interview. “We can track spinach that has E. coli back to the field where it was grown, but we can’t track a recalled medical device because there is no unique numbering system.”
Having that unique numbering system will mean quicker and more reliable recalls and better tracking of outcomes in patients who have implanted devices, Childs said. Once the FDA creates the requirement, it will ultimately be administered by a single organization such as GS1 – a New Jersey-based company that designs and implements standards – and the data will be stored in a central warehouse, he added.
The Food and Drug Administration Amendments Act of 2007, which passed in October, included legislation requiring the implementation of a unique identification system for devices but did not specify a time frame, Childs said.
“There’s a growing sense of urgency that we need to keep the fire lit under the FDA because they have given no indication of when this will come about,” Childs said. “Our letter follows other letters by members of Congress and Secretary Leavitt. Everyone realizes this is something that needs to get done.”
Once the proposed rule appears in the Federal Register, it must go through a 60-day comment period and potential FDA adjustments. That multistep process takes time and needs to begin as soon as possible, Childs said.
He acknowledged that the FDA is underfunded and pointed to a recent statement by Dr. Daniel Schultz, FDA’s director of the Center for Devices and Radiological Health, in which Schultz said the agency is lagging behind on guidance documents. Still, unique device identification needs to be at the top of the list, Childs said.
“It’s amazing that a device that is implanted in a human body is less able to be tracked than peanut butter or dog food,” Childs said. “Hospitals do their best in a recall, but it’s very difficult.”
From the battlefield to the home front: Managing medical data
Government Health IT presents Col. Claude Hines Jr., program manager for the Defense Health Information Management System, in this recent InSight eSeminar. Col. Hines discusses the health information technology and tactical challenges faced by the military medical community in Iraq, Afghanistan and other areas of conflict. In doing so, he describes the current information technology solutions for transferring clinical data between battlefield care givers to health care personnel at military treatment facilities worldwide.
