FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication
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Date Issued: April 22, 2024
The U.S. Food and Drug Administration (FDA) encourages the public to follow established choking rescue protocols, which are step-by-step guides, approved by the American Red Cross and the American Heart Association to relieve the airway obstruction in choking victims.
These rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults. These protocols do not include anti-choking devices. The safety and effectiveness of anti-choking devices that are being sold over-the-counter have not been established; they are not FDA approved or cleared. Consumers should be aware that using anti-choking devices first could delay action, as consumers usually have to take them out of packaging, assemble them, and follow device instructions, which may delay the use of established rescue protocols.
Recommendations for Consumers, Parents and Caregivers
- Always follow established choking rescue protocols approved by the American Red Cross and the American Heart Association before considering other interventions, as these protocols have a high rate of success and can be carried out immediately without devices, saving valuable time.
- Choking rescue protocols should only be used when there is complete airway block or the person is unable to cough, because interventions (such as back blows) could convert a partial airway block (which choking victims are usually able to clear on their own) to a complete airway block.
- If you choose to use an anti-choking device, only use it after established choking rescue protocols have failed. The safety and effectiveness of over-the counter anti-choking devices have not been established.
Recommendations for Health Care Providers
- Educate your patients on how to follow established choking rescue protocols.
- Talk to your patients about the potential risks of using unauthorized anti-choking devices.
- Talk to your patients about what they can do to potentially avoid choking incidents.
Potential Problems with Anti-Choking Devices
The FDA recognizes that anti-choking devices may already be in consumers’ homes. Our recommendations are intended to help avoid delaying use of the established rescue protocols listed above if people choose to use these devices.
The FDA is aware of reports describing problems with the use of anti-choking devices, including failure to resolve a choking incident due to lack of suction, bruising around the face, lips, and mouth, and scratches in the back of the throat.
Established choking rescue protocols, such as the American Red Cross and the American Heart Association, have a high success rate. Anti-choking devices typically require removal from packaging and assembly and could delay using established rescue protocols.
FDA Actions
The FDA is working with manufacturers of anti-choking products to bring their products into compliance with the FDA’s medical device requirements. The FDA will keep the public informed if significant new information becomes available.
Reporting Problems with Your Device
If you think you have had a problem with your anti-choking device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Questions?
If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.