Most medical devices recalled in the U.S. in recent years for causing serious injury or death had been approved for market through a fast-track program that doesn’t require clinical testing on patients, a study published Monday in the Archives of Internal Medicine reports.
Specifically, the study found that about 70 percent (80 of 113) of the “Class I” (the most urgent) medical devices that were recalled from 2005 through 2009 had originally entered the market through the U.S. Food and Drug Administration’s speedy 510(k) process, which allows devices to be used without human testing as long as the devices are considered similar to ones already in use.
Only 19 percent (21) of those Class I recalled devices had gone through the FDA’s more stringent premarket approval (PMA) process, which requires clinical testing and inspections. Another 7 percent (8) of the devices were exempt from any FDA regulation.
Cardiovascular devices (mostly automated external defibrillators used to resuscitate patients whose hearts have stopped beating) made up the most-likely-to-be-recalled category. According to the study, the FDA recalled more than 20 percent of the 1 million or so external defibrillators sold during the period under review in the study. Hundreds of people died during that time due to the malfunctioning of these devices.
Other high-risk devices that got recalled included insulin pumps, intravenous infusion devices, mechanical ventilators used to administer anesthesia during surgery, neurologic shunts and a contact-lens solution (that caused blindness in some users).
“The findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices,” wrote the study’s authors, Diana M. Zuckerman and Paul Brown of the National Research Center for Women & Families, and cardiologist Dr. Steven E. Nissen of the Cleveland Clinic.
According to background information in the study, the speedier 510(k) process was expanded by Congress (and signed into law by President Bush) in 2002. The Obama administration looked as if it was going to tighten the rules after a 2009 government report said that the fast-track program was being overused. But last month, the FDA announced that the 510(k) process would remain essentially in place — or, at least, that’s how many outside observers interpreted the announcement.
The medical device industry praised that decision.
As the new study points out, “One reason that the FDA has relied heavily on the 510(k) process is because it is less expensive and enables the relatively small Center for Devices and Radiological Health (CDRH) to review thousands of devices each year. For example, in 2005, the average cost for the FDA to review a 510(k) submission was estimated at $18,200, while a PMA submission cost the agency $870,000 to review. The Congress has not appropriate sufficient funds to the CDRH to use the more expensive PMA process for most devices, and this large cost differential creates an incentive for CDRH to rely heavily on the 510(k) process.”
Doing the right thing
Medical device companies responded to the study quickly on Monday, claiming its findings were, as one chief executive told the LA Times, “fundamentally flawed” because the study “focuses on the total number of recalls and ignores the fact that there are over 50,000 devices on the market.” Other studies, he also told the Times, show that less than half of 1 percentage point of medical products are recalled for serious health problems.
One of the authors of the new study responded that the public would never accept that level of risk in other aspects of daily life, like air travel. “We can do better,” he told the Times reporter.
“Doing the right thing will require withstanding the pressure of industry lobbyists,” wrote Drs. Rita Redberg and Sanket Dhruva of the University of California (San Francisco) in an editorial accompanying the study. (These two published a study last year that criticized the FDA for being too lenient with its approval of cardiovascular devices.) The process must begin, they added, “by appropriately classifying high-risk devices according to their risk for adverse events and by requiring high-quality clinical trial data of safety and effectiveness so that the FDA will get it right the first time.”
“Consumers are justifiable upset when their cars, toasters, and baby food bottles are recalled,” Redberg and Dhruva pointed out. “Recalls make us all question the safety of the products we take for granted. But what about the products permanently implanted inside our bodies? Surely they have been sufficiently tested to ensure that no one will need to bring their thorax to the shop for removal and replacement. It is sad and troubling to learn that we cannot count on this assurance for some medical devices.”