TUESDAY, April 23, 2024 (HealthDay News) -- The U.S. Food and Drug Administration is advising people to use the Heimlich maneuver to aid a choking victim and not rely on over-the-counter anti-choking devices.
"The safety and effectiveness of over-the-counter anti-choking devices have not been established; they are not FDA approved or cleared," the agency said in a safety communication issued Monday.
The FDA admitted that it is "not aware of any serious injuries reported with the use of these devices, and no deaths have been associated with the use of anti-choking devices." However, the agency is concerned that fumbling with these one-use-only devices could cost precious time in an emergency.
The leading device, the $70 LifeVac, comes with a mask that fits over a person's nose or mouth and attaches to a plunger-like bellows. Pushing the bellows down and then quickly up creates a vacuum to clear the airway.
The LifeVac website contains a "Hall of Saves" presenting thousands of cases in which the device has saved a child or adult from choking, as well as a page devoted to medical journal articles about the gadget.
The company informs consumers that the LifeVac is "FDA registered as a Class II medical device," adding that "it is exempt from premarket clearance. The FDA does not require a premarket review of the LifeVac device. Currently, in the United States, all portable suction devices are required to be registered with the FDA, not approved."
Still, the FDA says people should not rely on these devices because established choking rescue protocols, which rely on the Heimlich, "have a high rate of success and can be carried out immediately without devices, saving valuable time."
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