The number of safety recalls of medical devices nearly doubled from 2003 to 2012, according to a report released Friday by the U.S. Food and Drug Administration. The FDA attributes the increase, in part, to greater vigilance on the part of the industry and the agency to respond more quickly and decisively to problems with medical devices.
Out of the nearly 1,200 recalls recorded by the FDA in 2012, 57 were Class I recalls — considered by the FDA to involve problems most likely to cause injury or death. That compared with just seven Class I recalls in 2003. Class I recalls represented 1 percent of recalls in 2003, but comprised nearly 5 percent in 2012.
"The annual number of Class I recalls increased in part due to CDRH [the FDA's Center for Devices and Radiological Health] and industry efforts to improve performance of devices historically associated with high numbers of device problems, such as ventilators, infusion pumps, and external defibrillators," the FDA report said.
Medtronic Inc. issued a statement, saying it is diligent in monitoring the safety of its technology and alerting the FDA to problems. "When we have new information that can help reduce the risk of use of our therapy and improve patient outcomes, we share it proactively with health care professionals and regulatory agencies," the Fridley-based company said.
Sometimes that leads to recalls.
Officials at AdvaMed, the trade association for the medical device industry, cautioned against just comparing the number of recalls from one year to the next. There are many more — and more complex — devices on the market now than a decade ago, said Janet Trunzo, AdvaMed senior executive vice president for technology and regulatory affairs. "But without a denominator, it is difficult to truly know the significance of the agency's raw recall numbers."
In fact, according to the report, the increased complexity of newer devices has not resulted in more of those devices failing. The proportion of recalled devices in their first year on the market was about the same as recalled devices that had been on the market for more than 15 years — about 10 percent. That share stayed about the same for all 10 years studied, the report said.
"The medical technology industry is committed to patient safety, and FDA's report underscores that commitment. It is important to note that nowhere in its report does FDA indicate that the increase in recalls correlates to increased risk for patients," Trunzo said. "As the agency notes in its report, industry and FDA are working together more and more to improve the quality and safety of medical devices, and this partnership will continue."
