点击显示 收起
Feb. 14, 2011 -- More than three-quarters of medical devices involved in high-risk recalls in the last five years because they could cause serious harm or death to patients did not undergo FDA premarket approval, which requires clinical testing and inspections, a study shows.
Instead, these devices were cleared through an alternative FDA regulatory review, called a 510(k), which allows manufacturers to market devices as long as they can demonstrate that their products are similar enough to other products already on the market.
Some of the devices cleared this way that were later recalled as high risk include automated external defibrillators (AEDs), insulin pumps, intravenous infusion devices, and glucose meters.
Researchers point out that more than 20% of almost 1 million AEDs -- which are supposed to help resuscitate patients who are having life-threatening abnormal heart rhythms -- have been recalled and that some people may have died because of AED malfunctions.
“It was a surprise,” says study researcher Diana M. Zuckerman PhD, an epidemiologist at the National Research Center for Women and Families, a nonprofit think tank in Washington, D.C. “I knew, of course, that there would be some high-risk recalls of 510(k) devices, but I really didn’t expect that it would be the overwhelming majority.”
“Devices that are cleared through the 510(k) process are supposed to be moderate risk or low risk, with that definition that the FDA has. They shouldn’t be high risk when they’re recalled,” Zuckerman says.
The study, which is published in the Archives of Internal Medicine, comes as the FDA is weighing changes to how it approves medical devices. It drew sharp criticism from the medical device industry, which countered that the percentages of class I (highest-risk) recalls involving products given 510(k) reviews is small compared to the absolute number of products approved under that program each year.
“There are more than 3,000 devices and diagnostics cleared through the 510(k) process every year compared to 20-40 products cleared through the PMA [premarket approval] process. To conclude that the safety profile of the 510(k) process is inferior because a larger number of 510(k) products are recalled is like concluding that the United States’ system of cancer care is inferior to Monaco’s because more people die of cancer in the U.S. each year than in Monaco without considering the population differences,” says AdvaMed, a group that lobbies for the medical device industry, in a statement.
The researchers, however, stand by their analysis, saying that they were focused on patient safety.
“Our decision to focus on the numberof high-risk recalls that were cleared through the less stringent 510(k) process, rather than the percentageof 510(k) clearances that were later recalled, is not an error in data analysis,” Zuckerman says.?“It represents the public health approach to the problem, rather than the industry approach.”?