FDA Communication on anti-choking devices
Positives:
- Ease of Use: The LifeVac is designed to be simple to use, even for individuals without medical training. It can be applied quickly in emergencies.
- Portable: The device is compact and can be easily stored or carried, making it accessible in various settings, such as homes, restaurants, and schools.
- Non-Invasive: Unlike some other choking relief methods, the LifeVac does not require invasive procedures, making it safer for users.
- Single-Use Design: The device can be used once and then disposed of, ensuring hygiene and reducing the risk of infection.
- Clinical Backing: Some studies and testimonials suggest that the LifeVac can be effective in removing obstructions when traditional methods fail.
Negatives:
- Limited Evidence: While there are positive testimonials, comprehensive clinical studies validating its effectiveness in all situations are limited.
- Cost: The LifeVac can be more expensive compared to traditional methods like the Heimlich maneuver or CPR training, which may deter some individuals from purchasing it.
- Not a Replacement for Training: While the device is easy to use, it does not replace the need for first aid training. Knowing how to perform CPR or the Heimlich maneuver is still crucial.
- Potential for Misuse: If not used correctly, there may be a risk of injury or further obstruction. Proper training on how to use it is essential.
Want to know more? Keep reading to help sort through the online research regarding this controversial device. These opinions reflect my individual perspective.
Likely you have done some online research regarding the LifeVac anti-choking system. Here are some of the most popular searches regarding this device.
- Does the LifeVac actually work?
- What is the controversy with the LifeVac device?
- Why isn’t LifeVac FDA approved?
- Is the LifeVac a good product?
As an instructor for American Heart Association (AHA), American Red Cross (ARC) and Emergency Care and Safety Institute, I have been wondering IF and WHEN one of these entities would speak up and either support or reject the claims of the LifeVac device. At the time of this article, none of them have.
Does that mean, you shouldn’t purchase the device? No, but there are some things to consider before spending your money.
Is this better than what I learned at my American Heart or Red Cross training?
Have you had training with a nationally recognized training provider such as the American Heart Association (AHA) or American Red Cross (ARC)? If so, you’ve been given a set of instructions to follow if you or your family is choking.
First, determine if the patient is choking and if an adult patient, get permission to help. Implied consent applies to children and infants. Then, depending on the guidelines and the age of the patient, administer 5 back blows, then 5 abdominal thrusts (chest thrust for infants), or repeated abdominal thrusts. You would repeat the sequence until the object comes out or the patient goes unresponsive. If the patient goes unresponsive and you haven’t already called 911, do that immediately and start CPR beginning with compressions. Initiate the 30:2 sequence (30 compressions/2 breaths). When you go to give breaths, look in the mouth for the object and pull it out if you see it.
Below is an excerpt from the LifeVac website that suggests straying from the algorithm provided by the top training curriculums.
Your friend did not respond to back blows and abdominal thrusts, now what? The ambulance has not arrived yet what do you do? She is now lying on the floor and unconscious. The algorithms state to use CPR but chest compressions and rescue breaths will not work if the airway is blocked. This is where the algorithm ends!!
Until the AHA or ARC complete the research and sciences regarding changing the algorithm, is this best practice? Will the Good Samaritan Law protect you if you stray from your certified training?
A CPR class is less expensive than this device. The LifeVac starting at roughly $70 and a CPR class tops out at about $65.
What about the federal Food and Drug Administration (FDA)?
The FDA requires approval of many life-saving devices including Automated External Defibrillators, but although the LifeVac is registered with the FDA as a Class II medical device, it is not approved. The FDA does not require a pre-market review of the LifeVac device.
But they did issue this directive in April 2024 cautioning people who want to jump on the LifeVac bandwagon.
FDA Communication on anti-choking devices
What about using the LifeVac with babies?
Choking is a top cause of death in children and infants, but how does the LifeVac help children and infants.
This excerpt comes straight from the LifeVac website.
LifeVac is equipped to be used on persons starting at 22 pounds utilizing the pediatric mask. Per our mask manufacturer’s recommended guidelines 22 pounds is the minimum weight for the pediatric mask to fit properly. Manufacturers must create specifications where their tests show the product functions optimally. We have verified testimonials that the rescue device was used successfully under that weight recommendation saving infants’ lives. After all other choking rescue measures were unsuccessful the parent used the rescue device at their discretion as a last resort to save their child. LifeVac has safely saved children ranging from 3 weeks old to 13 years old.
Most babies under the age of 1, are 22 lbs or less. The recommendations are for 22 pounds or less.
Documented effectiveness and limitations
Positives:
- Ease of Use: The LifeVac is designed to be simple to use, even for individuals without medical training. It can be applied quickly in emergencies.
- Portable: The device is compact and can be easily stored or carried, making it accessible in various settings, such as homes, restaurants, and schools.
- Non-Invasive: Unlike some other choking relief methods, the LifeVac does not require invasive procedures, making it safer for users.
- Single-Use Design: The device can be used once and then disposed of, ensuring hygiene and reducing the risk of infection.
- Clinical Backing: Some studies and testimonials suggest that the LifeVac can be effective in removing obstructions when traditional methods fail.
Negatives:
- Limited Evidence: While there are positive testimonials, comprehensive clinical studies validating its effectiveness in all situations are limited.
- Cost: The LifeVac can be more expensive compared to traditional methods like the Heimlich maneuver or CPR training, which may deter some individuals from purchasing it.
- Not a Replacement for Training: While the device is easy to use, it does not replace the need for first aid training. Knowing how to perform CPR or the Heimlich maneuver is still crucial.
- Potential for Misuse: If not used correctly, there may be a risk of injury or further obstruction. Proper training on how to use it is essential.
Now that you have some additional information, it’s up to you to decide if this is right for you.