Loophole enables FDA approval of unsafe medical devices, Yale study finds

Manufacturers, through a loophole in the law, can use unsafe medical devices as a basis for bringing new, related products to market.
An EKG monitor

New Yale research 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. (© stock.adobe.com)

Manufacturers, through a loophole in federal law, can use an unsafe medical device as a basis for authorization by the U.S. Food and Drug Administration (FDA) to bring new, related products to market, a Yale-led study finds.

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, a 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.

The study was published Jan. 10 in JAMA.

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 1 in 4 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.

Many patients and clinicians may be unaware that FDA regulations permit new devices to use recalled predicates. This loophole has serious consequences,” said Harvard Medical School’s Kushal Kadakia. “Our results show how using unsafe devices as the basis for a new approval increases future risks to patient safety.”

Closing this loophole, which requires Congressional action, would improve medical device safety and reduce the risk of future recalls,” said Dr. Joseph S. Ross, professor of medicine (general medicine) at Yale School of Medicine and of public health (health policy and management) at Yale School of Public Health.

Other study authors included Dr. Sanket Dhruva from the University of California-San Francisco and Dr. César Caraballo-Cordovez, a postdoctoral associate (cardiovascular medicine) at Yale.

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Media Contact

Fred Mamoun: fred.mamoun@yale.edu, 203-436-2643