Unique medical device identifier proposed
■ Some are calling for the FDA to shorten the timeline for implementing the system to adhere to recent federal legislation.
By Jennifer Lubell — Posted July 12, 2012
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Washington The Food and Drug Administration on July 3 issued a proposed rule long anticipated by physician and hospital groups to establish a unique identification system for medical devices. While stakeholders said they were pleased with the development, some are hoping that the FDA will put the new system in place well before 2019.
“A UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety,” the agency said in a July 3 statement. With certain exceptions, such a system would include a device identifier consisting of a numeric or alphanumeric code specific to a device model, and a production identifier, which would include the current production information for a device.
“Those who have been advocating for patient safety have reasons to cheer,” Blair Childs, senior vice president of public affairs with the Premier health care alliance, said in a statement. “With this rule, we are one step closer to a UDI system that will enhance adverse event reporting, a safety gap that the Institute of Medicine said made it impossible to draw conclusions about the safety of medical devices. Moreover, UDI will dramatically improve the recall process.”
Once a uniform number exists for every device that’s made, the ability to track devices electronically and identify them reliably in electronic medical records will be simplified greatly, Childs said. From a physician’s and hospital’s vantage point, “this is going to make for a much more efficient, safer, faster system for managing both cost, quality and safety for patients,” he said.
The FDA proposed rule, however, would phase in the implementation of UDI for lifesaving and implantable devices over seven years. That’s too long, Childs said. “Patients can’t wait until 2019 to have confidence that the devices implanted in their bodies are safe and effective.”
Legislation to reauthorize the Prescription Drug User Fee Act, which President Obama signed into law on July 9, contained similar provisions to establish an identifier system, except that it included a requirement to implement the system within two years. Childs said the FDA recently indicated in a conference call with stakeholders that the agency might have to change its timeline to be more in sync with the PDUFA reauthorization law.
Medical and health care organizations had been waiting for this rulemaking for some time. James L. Madara, MD, executive vice president and CEO of the American Medical Association, underscored this concern in a recent letter to lawmakers on the PDUFA legislation.
“Although the Food and Drug Administration Amendments Act of 2007 required the FDA to implement a mandatory national UDI system,” the agency had not released implementing regulations, Dr. Madara wrote in a June 7 letter. He said a national UDI system would improve clinical care and lead to an estimated $16 billion reduction in medical supply chain costs.
During a July 3 conference call, Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said the comment period on the proposed rule would be open for 120 days from its July 10 publication in the Federal Register (link).
As stipulated in the PDUFA legislation, the final rule should be issued within six months after the comment period closes, Dr. Shuren said.