High-risk recalled devices categorized by medical specialty designated by the US Food and Drug Administration.
Source: Archives of Internal Medicine
San Francisco — Most of the medical devices recalled in recent years because of serious or life-threatening hazards were initially cleared through an abbreviated approval system that doesn’t require testing on patients, according to a study in the medical journal Archives of Internal Medicine.
The study, from the Washington, DC-based National Research Center for Women & Families and the Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, shows that of 113 medical devices that were subject to recalls between 2005 and 2009, 80 were allowed on the market through the 510(k) program, the study found. About a third of the recalled devices were cardiovascular products, including several brands of external defibrillators. More than half of the high-risk recalls were in five other device categories: general hospital, anesthesiology, clinical chemistry, neurology, or ophthalmology.
"Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%). These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices," conclude the authors, led by Diana Zuckerman, PhD, of the National Research Center for Women & Families.
The Advanced Medical Technology Association, or AdvaMed, dispute the findings, telling The Wall Street Journal (WSJ) the study is flawed because it looks at the number of recalls without comparing that to the number of devices that didn’t have problems. AdvaMed-supported studies say that more than 99% of the devices cleared through 510(k) don’t face recalls.
"Adoption of the paper’s recommendations would actually harm American patients by further delaying access to safe and effective treatments," said AdvaMed’s president Stephen Ubl in the WSJ article.
Study co-author Stephen Nissen, MD, of the Cleveland Clinic, dismissed the criticism, saying the withdrawn products are used on millions of Americans. "We are looking at the recalls that the FDA deemed serious, potentially life-threatening … We found—to my surprise—that more than 70% of them got through the FDA on the fast-track 510(k)," he told the WSJ.
A 510(k) costs the FDA an average of about $20,000 per application compared to more than $800,000 for a full device review by the agency, according to the report. A full review includes evaluation of safety-and-efficacy clinical trials.
The full text of the study can be found on the Archives of Internal Medicine Web site.