Nearly three-quarters of medical device recalls that could have caused injury or death from 2005-2009 went through the 510(k) pre-market notification process at the Food & Drug Administration, according to a new report from the Archives of Internal Medicine.
The report’s authors say the study findings are proof that high-risk devices should not be cleared for market using the quicker and less stringent 510(k) process and should instead be reviewed in the more thorough — and costly — pre-market approval or PMA program.
“The standards used to determine whether a medical device is a high-risk or life-sustaining product prior to approval are clearly very different from the standards used to recall a medical device as life threatening,” the author’s wrote. “Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy.”
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The study reported that 80 of the 113 medical devices recalled during the period studied went through the 510(k) process, versus just 21 recalled devices that were brought to market through the PMA process. Cardiovascular devices comprised the largest recall category, with 35 percent, two-thirds of which were cleared by the 510(k) process. Fifty-one percent of the recalls classified as high-risk by the FDA represented five other device categories: general hospital, anesthesiology, clinical chemistry, neurology or ophthalmology, according to the study.
The report’s lead author, Diana Zuckerman – a public health advocate and president of the National Research Center for Women & Families – has long advocated for implantable devices to be disqualified from the 510(k) process, along with diagnostic tests to determine whether a patient suffers from a life-threatening illness.
Last year, she was one of the lone public health advocates to speak during a public meeting on the 510(k) program. She told MassDevice afterward that the lack of concern for public safety at those meetings was a major concern for her.
“Public health has to be bottom-line here and I did not see one word expressed in terms of concern about public health, not one word,” she said. “It’s not like people in that room didn’t know that defibrillators didn’t work and people died. People in the room know it very well.”
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Zuckerman added that she has been surprised by the differing attitudes between medical device company reps and their counterparts in the pharmaceutical industry, who she said will at least admit that some ineffective products can slip through the regulatory cracks.
“The device company people talk about how great their products are and how great the 510(k) process used to be until it got slower,” she said, adding that while she didn’t think the entire program needed to be scrapped, it does need a major overhaul.
“The 510(k) program is based on substantial equivalence to a product approved before 1976. That whole concept seems very strange for an industry that seems to pride itself on being innovative,” she said.
The Advanced Medical Technology Assn. (AdvaMed) quickly responded to the study by calling it “flawed,” because it only looked at recalls alone, rather than versus the overall safety of the 510(k) program. The industry group has strongly advocated for the program to remain relatively unchanged and has released several of its own studies to highlight the need for less stringent regulation.
AdvaMed president Stephen Ubl said in a statement that making radical changes to the program in light of “remarkably low recall rates” would “harm patient access to medical technology.”
More than 3,000 medical devices are cleared for market using the 510(k) program every year. It is the most common regulatory pathway for medical devices.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
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