The FDA approves or clears thousands of new medical devices each year. This highly complex process of review has garnered criticism in recent years. In this series of articles, General Surgery News navigates different aspects of the FDA medical device approval process to better understand the various pathways and help unravel the current debates and concerns. This final article in the series explores medical device recalls. […]
In 2014, the FDA’s Center for Devices and Radiological Health (CDRH) published an in-depth analysis of medical device recalls over the past 10 years. What the FDA discovered suggests that there may be cause for concern: Between 2003 and 2012, the annual number of medical device recalls had increased by 97%. Recalls almost doubled over the 10-year study period, increasing from 604 to 1,190, while the total number of products recalled in that time increased from 1,044 to 2,475. […]
So what might account for this rise in recalls? Although the evidence is limited, some experts have voiced concern that the lack of premarket clinical testing may increase our uncertainty about device safety, which may in turn lead to recalls after devices reach the market. […]
As a result, most medical devices do not undergo any safety testing before reaching the market (Milbank Q 2014;92:114-150). The majority of medical devices are cleared through the 510(k) pathway, which typically requires companies to show a device is “substantially equivalent” to an already approved device. Thus, 510(k)-cleared devices often bypass clinical testing, even when the predicate device was recalled or never assessed for safety and effectiveness,explained Rita Redberg, MD, MSc, a cardiologist in the Department of Medicine at the University of California, San Francisco.
Overall, less than 2% of approved medical devices go through the most rigorous FDA regulatory pathway, premarket approval (PMA), which requires companies to perform clinical tests. But even PMA-approved medical devices may not be examined rigorously enough. […]
Inconsistencies in the quality of clinical trials and lack of testing altogether may increase the likelihood that unsafe or subpar devices are approved. In a 2011 study, Diana Zuckerman, MD, and her colleagues evaluated recalls of high-risk medical devices between 2005 and 2009 (Arch Intern Med 2011;171:1006-1011). In that period, the FDA recalled 113 high-risk devices, 80 (71%) of which had been cleared through 510(k) and 21 (19%) of which had been approved via PMA. An additional eight (7%) were exempt from FDA review. According to the authors, 13 of the 80 510(k) recalled devices should have gone through PMA, given the severe risk they posed to patients if a malfunction occurred.
Overall, Dr. Zuckerman and her colleagues found that most medical devices recalled for life-threatening or serious hazards were cleared through 510(k), and concluded that the 510(k) pathway poses greater dangers to patients because it is less likely to uncover design or manufacturing flaws. […]
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