When the Department of Agriculture issued a recall of chicken nuggets that may be contaminated and ordered consumers to return them or throw them away.
When the Consumer Product Safety Commission announced that poorly designed baby loungers could suffocate infants and warned consumers to stop using them immediately.
But when it comes to medical devices, the Food and Drug Administration And manufacturers routinely allow doctors and hospitals to continue using equipment that the government says could harm or kill the patients they are supposed to help. KFF Health News recently highlighted the problem of unrecalled product recalls in an analysis of Miter clipa heart implant.
In 2016, the medical device giant Abbot The FDA issued a notice to remove the device from the market — “a Class I recall, the most serious type,” the FDA said. “Use of this device may cause serious injury or death,” an FDA notice said.
But neither the manufacturer nor the FDA removed the device from the market or stopped its use, instead allowing doctors to continue implanting the clips into leaky heart valves.
In a notice, Abbott revised its instructions for use and required that doctors who implant the clips undergo training.
The company told KFF Health News that the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.
Medical device recalls can include “disposals,” where the device is removed from the location where it is used or sold, and “corrections,” which address the problem in the field, for example by repairing, adjusting, relabeling, or inspecting a device.
“It’s very contradictory,” he said. Rita Redbergcardiologist of the University of California, San Francisco and former editor-in-chief of the magazine JAMA Internal Medicine“A recall sounds like a recall, but that’s not what it actually means.”
From 2019 to 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, the FDA spokesman said. Amanda Hills saying.
Some products are subject to multiple recalls while still on the market. MitraClip line products have been subject to three rounds of recalls, none of which have stopped use.
“In deciding whether a recall warrants removal of the device from the market, the FDA considers the frequency and severity of adverse events, the effectiveness of corrective actions that have been taken, and the benefits and risks of preserving patient access to the device,” the FDA spokesperson said. Audra Harrison saying.
In some cases, a medical device that is the subject of a recall can safely remain on the market with a simple fix, he said. Sanket Dhruvacardiologist and associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove the devices can provide unwarranted reassurance and leave the public at risk, Dhruva said.
“Depending on the risks and benefits of the device compared to alternatives, it may be best to remove the recalled device from the market and from clinical use,” Redberg said.
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