Unpacking and figuring out how to use an anti-choking device can waste valuable time, the agency said<\/p>\n<\/h3>\n
By Physician\u2019s Briefing Staff HealthDay Reporter<\/b><\/p>\n
<\/b><\/p>\n
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.<\/p>\n
“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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
The LifeVac website<\/a> 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.<\/p>\n 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.”<\/p>\n 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.”<\/p>\n