Study finds unsafe medical devices gain FDA approval through legal loophole

Jan. 24, 2023

Manufacturers, through a loophole in federal law, can use unsafe medical devices as a basis for authorization by the U.S. Food and Drug Administration (FDA) to bring new, related products to market. New Yale research, published Jan. 10 in JAMA, finds that many medical devices subject to recall had received FDA approval based, in part, on the products’ similarities to earlier devices which had also been subject to recalls.

FDA authorization for most medical devices is based on the products' similarity to devices already on the market, and manufacturers are often allowed to bypass clinical testing by building on previous FDA approvals. However, the new study found that some medical devices reach the market based on their similarity to devices that have been recalled, including products that were subject to what is known as a Class 1 recall, an FDA designation that warns that use of the device may cause patients harm or death. Previous research has identified examples of significant patient harm from devices that were authorized using flawed devices.

For the study, investigators from Yale, Harvard, and the University of California-San Francisco, reconstructed the regulatory history of all medical devices that were subject to Class 1 recalls from 2017 through 2021 and found that safety issues were pervasive. Notably, they found that 44% of recalled devices were related to older devices that had been subject to earlier Class 1 recalls, and approximately one in four of these earlier devices were recalled before the FDA approved the next generation of devices.

Furthermore, these new devices often supported the authorization of additional devices which also were later recalled.

Some recalled devices that had received authorization based, in part, on previously recalled products include an infusion pump used to control the delivery of IV fluids and medication for hospital patients; an artificial shoulder device, used in shoulder replacements, that cited seven previous devices that have been subject to some kind of recall; and an intra-aortic balloon pump, used temporarily in patients hospitalized for heart failure, that was related to an earlier product which was subject to multiple recalls — including a Class 1 recall just two months before the new model was approved.

“While regulators have been aware of this loophole for years, our study is the first to systematically characterize the harms to patient safety,” said Dr. Harlan Krumholz, the Harold H. Hines Jr. Professor of Medicine (Cardiology), and director of the Yale Center for Outcomes Research and Evaluation (CORE) at Yale School of Medicine (YSM). “To be clear, this is not an FDA issue, but is about the law that governs FDA actions.”

To illustrate the effect of previous recalls on future recalls, the team compared the recall rates among devices related to recalled devices with recall rates among devices related to products that were recall-free. They found that devices approved using recalled devices were more than six times as likely to be subject to a Class I recall.

Yale University release