How the FDA’s approval process puts the safety of heart patients at risk
High-risk medical devices are much more likely to be recalled if the U.S. Food and Drug Administration (FDA) accepts modifications to their original approval, according to new data published in JAMA Network Open.[1] It’s a trend that impacts cardiology more than any other specialty.
Class III medical devices such as pacemakers and automated external defibrillators go through a longer, more comprehensive approval process than other devices due to the significant risks associated with their use. Once the devices go through that process and receive premarket approval (PMA), however, manufacturers can modify that approval by simply submitting a supplement for approval by the FDA.
These supplements come in many forms, the study’s authors explained, and a majority of them do not require clinical data of any kind.
“Two brands of cardiac defibrillator were recalled after being approved by supplements due to high rates of lead failures,” wrote lead author Jonathan R. Dubin, MD, an orthopedic surgeon with the University of Missouri Kansas City, and colleagues. “Similar regulatory failures have been reported in otolaryngology, with a cochlear implant being recalled due to otogenic meningitis linked to an electrode positioner approved via supplements, along with additional examples in orthopedics. To date, no prior studies have examined the association between PMA supplements and patient safety.”
Dubin et al. examined data from 373 high-risk medical devices that gained PMA from the FDA from 2008 to 2019. Those devices were linked to a whopping 10,766 supplements. Thirty-seven percent of supplements were granted to cardiovascular devices, a higher percentage than any other specialty. Microbiology devices made up 12.1% of all supplements included in the study, and no other specialty surpassed 10%.
Overall, PMA supplements were directly associated with a heightened risk of high-risk medical devices being recalled. Also, the risk of recall continues to increase as more and more supplements are approved by the FDA.
In addition, the authors added, cardiovascular devices were found to be 3.5 times more likely to be associated with a class 1 recall than other devices.
“An estimated 10% of U.S. residents will have medical devices implanted during their lifetime, and physicians should be aware of this association because many devices undergo extensive postapproval modifications,” the authors wrote.
Dubin and colleagues also noted that PMA supplements have created the possibility that many modern devices may “bear little resemblance” to the device the FDA actually approved. They detailed two examples of devices that were approved in the mid-1990s and then went through at least 80 supplements through 2012.
“These devices were linked to multiple patient deaths and were recalled in 2007 and 2011, respectively, after implantation in hundreds of thousands of patients worldwide,” the group wrote.
Another key takeaway from their research was that just 1.2% of supplements submitted to the FDA actually required the manufacturer to submit updated data. These supplements did not appear to increase the risk of recall or class 1 recall, “implying that … the clinical data may provide some protective effect.”
“The findings of this cohort study suggest that postmarket modifications to high-risk medical devices may increase their risk of recall and class 1 recall,” the authors concluded. “Physician awareness, improved preapproval testing, and postmarket surveillance strategies should be used to mitigate risks to patient safety and public health.”
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Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.