Of 113 medical devices recalled by the FDA between 2005 and 2009 because they were dangerous, 81% had been cleared under a lenient process reserved for devices deemed "substantially equivalent" to others already approved, revealing "critical flaws" in the federal review system.
That's the conclusion of a report in Tuesday's Archives of Internal Medicine that evaluated each medical device. The researchers discovered that these recalled cardiac and other devices were approved without clinical trials or higher levels of scrutiny under 510(k) protocols in which they were deemed similar enough to an already approved device and a few were exempt from the approval process entirely.
"These devices did not undergo clinical testing or premarket inspections, nor were postmarket studies required to determine safety and efficacy," as they would have under the U.S. Food and Drug Administration's higher level "premarket approval" or PMA process that requires clinical testing and inspections, wrote Diana Zuckerman of the National Center for Women & Families.
Zuckerman co-authored the report with Paul Brown of the Center and Steve Nissen, MD, chair of the Department of Cardiovascular Medicine at the Cleveland Clinic.
Additionally, the researchers discovered, 12% of the recalled devices that were approved under the 510(k) process were originally marketed for "risky or life-sustaining Class III (defined as implantable or life-sustaining) indications, which are required by law to undergo a full PMA regulatory review."
These 510(k) approved devices that were recalled "were used by tens of millions of patients, exposing them to potential harm and adding substantial costs to medical care," the authors wrote.
Also, the concept of "substantially equivalent" has been modified over the years to allow that classification even for devices made from different materials and which use a different mechanism of action.
The FDA did not respond to a request for comment on the report.
Zuckerman, Brown and Nissen noted that the resource-challenged FDA uses the 501(k) process "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, 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," they wrote.
Of these recalls, the largest group were for cardiovascular use and 35 – involving 31 separate devices – and most were automated external defibrillators (AEDs) approved for resuscitation of patients in cardiac arrest. About one in five of the one million AEDs in circulation have been recalled, "and hundreds of people died due to AED malfunction," the researchers wrote. Of these 35, 23 were cleared through the 510(k) process.
The second largest high-risk recall category involved 27 general hospital devices, such as insulin pumps, intravenous infusion devices and patient lifts. Of these, 20 (74%) were cleared through the 510(k) process.
The third largest high-risk recall category involved devices used in anesthesia, including mechanical ventilators. All were cleared by the 510(k) process or were exempt.
Other high-risk recalls involved clinical chemical analysis and neurological devices, such as glucose meters and other diagnostic equipment.
"The problem is that the FDA is relying on anecdotal experience," says Nissen. "The answer is to have these devices adequately tested in the first place. If you have to wait until they're out in widespread use, then we have a problem that needs to be fixed."
"The biggest take-home message is we find out if devices are safe or not by using them on people after they are approved for market, and that's just not good public policy."
In an August, 2010 report, the FDA's 510(k) Working Group addressed the concerns about this process, and suggested that "clinical trials should be require din more 510(k) reviews and that safety would be enhanced if the FDA had expanded authority to require premarket inspections and postmarket studies as a condition of clearance," the researchers wrote.
However, they wrote, "AdvaMed, the largest association representing medical device manufacturers, opposes these changes."
Contacted for response, AdvaMed issued statements calling the Zuckerman study "flawed and inconsistent with three previous analyses of the same data set by respected researchers" and said she was guilty of an "elementary error in data analysis," "a large number of factual errors" and "misleading references."
"The 510(k) process does an excellent job of protecting patient safety and (the) FDA is already taking actions to address problems with specific device types, where they exist," the association said.
In an accompanying invited commentary, Rita Redberg, MD, a member of the FDA circulatory System Devices Panel who is affiliated with the University of California San Francisco, says some solutions the FDA has proposed miss the mark. "The FDA's plan places implantable devices, life-sustaining devices and life-supporting devices in the lower-risk category to skirt this critical requirement.
"The FDA is already taking steps to strength its 510(k) review through an internal review, for which it has solicited public comment," she wrote. "Unfortunately, the FDA backed down from several essential safeguards when it released its implementation plan in January 2011. It has asked the Institute of Medicine to perform a review, due in mid-2011."
Zuckerman and co-authors said that correcting the problem "will require either congressional action or major changes in regulatory policy," but that the number of high-risk recalls and the number of patients harmed could be decreased with these four actions:
1. The FDA implements current law that subjects life-saving and life-sustaining devices to the PMA, rather than the 510(k) process.
2. The FDA's definition of a high-risk device takes into account the potential risks if the device fails.
3. The FDA expands the use of their authority to inspect the manufacturing of 5019k) devices just like they do for PMA devices.
4. The FDA strengthens authority to use special controls for 501(k) devices, such as postmarket surveillance, performance standards and product-specific and general guidance documents.