FDA Warns of Problems with Anti-Choking Devices

Federal regulators are warning consumers that new anti-choking devices or choking rescue kits may be ineffective, urging the public to instead rely on proven methods like the Heimlich maneuver.

The U.S. Food and Drug Administration (FDA) issued a safety warning on April 22, encouraging the public to avoid using anti-choking devices advertised as a way to stop a person from choking, because the devices are not approved by top health organizations and are not proven to be safe or effective.

Over the counter (OTC) anti-choking devices include a face mask that is fitted over the mouth with a valve attached. They are designed to suction an airway obstruction in emergencies.

Instead of relying on these devices, the FDA recommends consumers use established and well-known choking rescue protocols, such as the Heimlich maneuver and abdominal thrusts. These established protocols are approved by the American Red Cross and the American Heart Association, which provide step-by-step instructions for relieving airway blockages in choking victims.

The FDA emphasizes these approved choking rescue protocols have a high success rate compared to anti-choking devices, which do not.

Anti-Choking Device Delays Could be Fatal

According to the agency, using anti-choking devices could delay life-saving actions, like the Heimlich maneuver. In many cases, when consumers want to use the devices, they have to remove them from the packaging, assemble them, and follow instructions. This can cause a significant delay in choking relief.

So far, no deaths have been linked to the use of these devices. However, the FDA is aware of reports involving minor problems, including bruising around the face, lips, and mouth, as well as scratches to the back of the throat. No serious injuries have been reported.

The FDA is working with anti-choking device manufacturers to bring the devices into compliance with medical device requirements so they can be approved by the agency in the future.

The agency understands the devices may already be in consumers’ homes, but offers the following recommendations:

• Follow established choking rescue protocols approved by the Red Cross and the American Heart Association before considering other devices.
• Choking rescue protocols should only be used when there is a complete airway block or the person is unable to cough.
• Interventions, like back blows, may turn a partial airway block into a full airway block.
• If you choose to use an anti-choking device, only use it after established choking rescue protocols have failed.

The FDA urges consumers who have experienced problems with an anti-choking device to submit a report the agency’s MedWatch adverse event reporting program.