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A. Federal

FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication, 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.

IDPH has received requests for the use of suction anti-choking devices by EMS Provides thru their EMS System to be included as new pieces of equipment on their EMS vehicles.

In an effort to consistently provide safe, evidence-based, and data driven care to the people of Illinois, we rely on equipment that have stood the rigors of research and proven benefit including equipment approved by the FDA.

At this time, these devices (ex. LifeVac, DeCHOKER, etc.) are not approved for use by the FDA or by IDPH and if used, could delay treatments that have been shown to be effective. In addition, this device may cause serious injuries. We strive to operate based upon evidence, and not anecdote, and any such device shall not be stocked, deployed, or utilized on any emergency service vehicles licensed and operating with IDPH approved protocols.

Over the past few months, many school districts have been contacted about the use of the LifeVac device during an acute choking episode. At this time, unbiased, peer reviewed data to support its use is lacking. The device is not approved by the FDA and has not been endorsed by the American Red Cross or the American Heart Association. The American Academy of Pediatrics, in 2021, published a statement warranting further research of use of LifeVac in resuscitation of pediatric choking victims if established protocols fail. Current Basic Life Support training provides the universally accepted choking guidelines for both the pediatric and adult populations.

Please also note that the LifeVac website states the device is "FDA Registered", which is not the same as FDA Approved. Please see the following link for an explanation of the difference: Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?

The New Jersey Department of Health (Department) Office of Emergency Medical Services (OEMS) recognizes that there are several devices marketed to be used in the case of a foreign body airway obstruction (choking) in the community setting. Such devices include but are not limited to, Lifevac and Dechoker.

...OEMS does not endorse, nor approve of the utilization of these devices by pre-hospital health care providers (EMTs, paramedics, etc.) in pre-hospital settings or during non-emergency medical transports. As such, OEMS continues to endorse that pre-hospital providers follow AHA guidelines and the National EMS Scope of Practice for the management of foreign body airway obstruction appropriate to their level of training.

The Office of Child Development and Early Learning (OCDEL) received questions on the use of manual Airway Clearance Devices (ACD). OCDEL’s current regulation is that all child care staff employed in a child care facility are required to have training in pediatric first-aid and pediatric cardiopulmonary resuscitation (CPR). OCDEL recommends child care providers continued use of approved pediatric first-aid and CPR training.

Child care providers may wish to consult with their own legal counsel and insurance company before deciding whether to use an ACD in their facility. It is best practice for the child care provider to have policies and procedures in place to address parental consent.

Per the child care regulations, signed written parental consent is required prior to administration of minor first-aid procedures by facility staff and must be kept current. (55 Pa. Code §3270.181(b), §3270.182(5), §3280.181(b), §3280.182(5), §3290.181(b), §3290.182(5)).

If an ACD is used on a child, but the parent/guardian consent is absent from the child’s file, this will result in violation of the regulations at 55 Pa. Code §3270.181(b), §3270.182(5), §3280.181(b), §3280.182(5), §3290.181(b), §3290.182(5).

Parent/guardian are not required to provide consent if they don’t want this device used on their child while in care at the facility.

 

II. MEDICAL ORGANIZATIONS 

A. United States

a) American Academy of Pediatrics (Wisonsin chapter): July 20, 2023 letter in opposition to proposed legislation to supplying Anti-Choking Devices in Schools

Given there are no specialty societies (including The American Heart Association, The American Red Cross, and the 2022 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care) that support the use of anti-choking devices, and that the American Academy of Pediatrics does not have a policy in place, we cannot advocate in favor of the use of these.

B. EUROPEClip from ABC7 Sarasota, FL, April 7, 2016 story by investigative reporter Kate Flexner, Sarasota Police Department using LifeVac anti-choking device