The FDA’s concerns over the facility that manufactures the Durata defibrillator has led to a warning letter to St. Jude.
., St. Jude Medical
FDA report shows medical device recalls climbing
- Article by: James Walsh
- Star Tribune
- March 21, 2014 - 8:58 PM
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.”
But Dr. Robert Hauser, a local cardiologist and device industry watchdog who has helped highlight safety concerns associated with defibrillator leads, questions the report’s conclusion that increased recalls signals improved safety. Hauser has long criticized the FDA’s review process and how well it tracks devices after they are approved.
“The FDA suggests that the rise in the number of recalls reflects favorably on the regulatory process. I disagree,” he said in an e-mail to the Star Tribune. “A truly effective regulatory system would have prevented most recalled devices from being approved for use in the United States. The report also fails to measure the harm to patients and the cost to the health system.”
According to the report:
• The annual number of medical device recalls increased by 97 percent from fiscal year 2003 to fiscal year 2012.
• In the last 3 years, CDRH reduced the average classification times for high risk Class I recalls by 9 days and Class II by 26 days, significantly reducing the time it takes to process recalls and assuring “that medical device problems are effectively addressed and underlying problems resolved.”
• The most frequent causes for recalls are related to device design, software, and nonconforming material or component issues. “If industry and CDRH can address these problems jointly, we may be able to prevent as many as 400 recalls each year.”
“The increase in recalls reflected in the data can be attributed primarily to companies taking a more, aggressive, pro-active, patient-centric approach to quality, safety and reporting of events to FDA,” Trunzo said, agreeing with the report’s conclusion. “The overwhelming majority of devices perform as intended to save and improve lives, and our members are committed to improving that remarkable record of safety and reliability.”
James Walsh • 612-673-7428
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