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.
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.
Medical Device Industry Responds
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.”
Medical Devices and the FDA
The FDA classifies medical devices into three categories, based on their potential to cause harm to patients.
Class I devices are the least risky and include things like tongue depressors, bandages, and crutches. Class II devices involve intermediate risk, and these include things like hearing aids, contact lens solutions, hip and knee implants, and powered wheelchairs. Class III devices pose the most risk to patients and include things like pacemakers, heart stents, and HIV diagnostic tests.
Class III devices are intended by law to undergo premarket approval, a process that requires extensive testing, including “valid scientific evidence” to assure that a device is safe and effective for its intended use. Most class I and some class II devices are exempt from premarket approval but are cleared for market through the 510(k) process.
In recent years, the researchers note an increasing number of class III devices that should have gone through premarket approval instead went through the 510(k) process.
When a product has been shown to have substantial safety concerns, either because it is defective, dangerous, or both, it is recalled.
The FDA has three levels of recalls, I through III. Class I is considered the highest risk recall, indicating that there’s potential for a product to cause serious harm or death.
Investigating Device Recalls
For the current study, researchers analyzed class I recalls from January 2005 through December 2009.
Of 113 Class I recalls during that time, only 21 of those products, or 19%, were found to have been approved through the more stringent premarket approval process. Eighty products were given 510(k) clearance. Eight were exempt from regulation or were merely registered with the FDA.
“Simply put, this means that more often than not, the highest-risk medical devices are being approved, marketed, and used in patients without any clinical trial data,” says Rita F. Redberg, MD, a cardiologist and professor of medicine at the University of California, San Francisco, who wrote a commentary that accompanied the study.
“Undoubtedly, we need more clinical trials of high-risk devices,” Redberg says.