You'd think medical devices that get implanted in the body or are used to keep someone alive would have gone through studies in actual humans before being allowed on the market.
But that's usually not the case. A study in the Archives of Internal Medicine notes that many of the most critical medical devices are allowed on the market without their makers being required to submit results of clinical studies before approval.
And, the analysis finds, most of the Food and Drug Administration's most urgent recalls in recent years have involved "high-risk" devices that had gone to market that way.
"We found to our surprise that the vast majority of devices later recalled as high-risk and potentially deadly had never gone through clinical trials or inspections," study author Diana Zuckerman tells Shots.
Of the 113 recalls of "high-risk" devices between 2005 and 2009, Zuckerman and her colleagues found that 80 had been approved through a process called 510(k) that doesn't specifically require any human trials. The largest percentage of these recalls, around a third, involved cardiovascular devices such as defibrillators and stents.
And another eight of the urgently recalled devices went on the market without any FDA oversight at all, because the agency considered them to pose no risk.
The Stabilet Infant Warmer was one of devices cleared for marketing through the 510(k) process without human studies or safety inspections, Zuckerman says.
It was marketed to "provide a controlled environment for the care and protection of infants." In 2009, the FDA told the manufacturer to pull back 6,000 such devices under a Class I recall – the most serious kind — because the faulty device could cause serious injury or death. At least one infant was seriously injured after the device caught on fire.
The new study paid particular attention to recalls of Class III devices — those that "support or sustain human life, are of substantial importance in preventing impairment of human health, or…present a potential, unreasonable risk of illness or injury."
By law, Class III devices are supposed to go through a process called pre-market approval that requires good clinical trials, just as the drug process does. But in the 20 years that the law has been on the books, only one percent of all medical devices has gone through this stringent process, write Dr. Rita Redberg, the journal's editor, and Dr. Sanket Dhruva of the University of California San Francisco, in an accompanying editorial.
The reason so many devices get waved through the 510(k) process is clear enough. The FDA doesn't have the staff or budget to do pre-market reviews on the vast majority of new devices submitted each year.
FDA charges companies a "user fee" of just over $200,000 to do a thorough review — less than a quarter of the $870,000 it costs the agency, on average, to do a pre-market approval. By contrast, pharmaceutical companies pay up to $1.4 million for pre-market approval of a drug.
The price tag for a 510(k) review: only $4,007.
The medical device industry trade group AdvaMed got out ahead of Zuckerman's study last fall with its own evaluation of device recalls. It noted that of nearly 50,000 devices approved under the loose 510(k) process since 1998, only 77 types have been subject to Class I, or highest-risk, recalls.
"It's hard to imagine any other regulatory process with as good a record as this," David Nexon of AdvaMed told the Minneapolis Star-Tribune after the group released that report, which it commissioned from the Battelle Memorial Institute.
Asked how she squares her study with AdvaMed's, Zuckerman says she agrees most devices haven't been recalled. "But I'm taking the public health perspective," she says. "How many people have been harmed by these products? We know that 112.6 million devices have been recalled in the last five years. That's a lot of products. We know thousands of people have died. And those are deaths that did not have to happen."
The backdrop to this back-and-forth is a big-deal revamping of medical device regulation that the FDA has proposed.
Zuckerman, who heads a nonprofit consumer advocacy group called the National Research Center for Women and Families, applauds some of the FDA's proposed reforms. But she says they were watered down from the original form last summer.
Meanwhile, the Institute of Medicine is working on a comprehensive report, commissioned by the FDA, on what's wrong with medical device regulation. That's due later this year.