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.