Nearly three-quarters of Class I medical device recalls went through the Food & Drug Administration’s 510(k) pre-market notification process from 2005 to 2009, according to a report in the Archives of Internal Medicine.
That’s proof that high-risk devices should not be cleared for market using the quicker and less stringent 510(k) process, the authors claim, arguing that the devices should instead be reviewed via the more rigorous — and costly — pre-market approval program. Class I recalls, the most serious level, are issued for devices that could cause serious injury or death.
“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,” according to the report‘s examination of FDA approval and recall records. “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.”
Eighty of the 113 medical devices recalled during the study period were 510(k)-cleared, compared with 21 recalls of PMA devices. Cardiovascular devices were the largest recall category, at 35 percent; two-thirds of those were cleared by the 510(k) process. Fifty-one percent of the recalls were for devices in five other categories (general hospital, anesthesiology, clinical chemistry, neurology or ophthalmology).
The Advanced Medical Technology Assn. 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. AdvaMed, the device industry’;s national lobbying arm, has strongly advocated for keeping the 510(k) protocol relatively unchanged, funding several 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’s the most common regulatory pathway for medical devices.
Lead author Diana Zuckerman — a public health advocate and president of the National Research Center for Women & Families — has long advocated that implantable devices 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 the sole public health advocate 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.”
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.