LifeVac Controversy: The Story Behind The Dubious Device

When Arthur Lih heard that a child died from choking as a result of the Heimlich maneuver failing, he wanted to find a solution.

In 2012, he created LifeVac, an anti-choking device designed for use in a choking emergency. However, there was a lack of scientific evidence on the device’s safety and effectiveness, which led health authorities to be wary about recommending the device, creating a LifeVac controversy that is still a hot topic today.

At Business2Community, we looked at scientific papers, independent studies, LifeVac’s website, and news articles to shed light on the LifeVac controversy.

Here, you’ll find a comprehensive rundown of all aspects of the scandal and how it has affected the company and the public to hopefully learn how to best avoid similar issues in the future.

Latest News & Updates

The LifeVac controversy continues to evolve in 2024, particularly with discussions surrounding its efficacy, safety, and legislative impact. A few key developments have emerged recently:

1. Legislative Efforts: In New Jersey, lawmakers are considering a bill that would mandate schools to have anti-choking devices like LifeVac. LifeVac has hired lobbying firms to support these efforts, which would require the state to reimburse schools for purchasing the devices. This proposal has drawn concern from some medical professionals, who argue that the devices lack sufficient clinical evidence to replace standard life-saving techniques like abdominal thrusts and back blows​.
2. Medical Community’s Concerns: While LifeVac claims to have saved over 2,000 lives, many in the medical field remain skeptical due to the lack of rigorous real-world testing. Experts highlight the difficulty in conducting clinical trials for such devices because inducing choking for research purposes is unethical. Although there have been manikin and cadaver studies, many healthcare professionals believe more independent research is needed​.
3. Global Usage and Regulations: Restrictions on LifeVac were lifted in the UK in 2023 after initial concerns about its effectiveness, aligning its availability with countries like the U.S., Australia, and the EU. However, concerns remain, especially with counterfeit versions of the device appearing on e-commerce platforms, potentially undermining safety​.

The Story of the LifeVac Controversy

It’s extremely difficult, if not essentially impossible, to make sure LifeVac and similar devices are safe and effective because of their unique use case. Choking is an extremely urgent emergency that must be treated immediately, making it impossible to run regular clinical studies with anti-choking devices.

Obviously, you can’t intentionally induce choking in someone just to test if it works either because of the tenet of “do no harm.”

So, constructive studies testing LifeVac’s effectiveness can only be performed on manikins and cadavers though case studies (though retrospective studies are possible). The lack of live real-life testing has led to reservations from some healthcare professionals and authorities. For example, the UK’s Medicines and Healthcare Products Regulatory Agency limited the device’s use in 2017.

Safety and Effectiveness of LifeVac and Dechoker

Both LifeVac and its competitor, Dechoker, are single-use devices for anti-choking emergencies.

They operate on a similar principle – creating suction to dislodge an obstruction from a person’s airway. Founded in 2012, LifeVac claims to have saved over 2,000 lives. On its website, it documents the stories of the people it has saved from choking.

According to LifeVac, the duration of the suction is minimal, which makes the anti-choking device safe. The company’s FAQs state that the device can be used on persons weighing above 22 pounds, as a last resort if all other choking rescue methods fail.

However, there are mixed opinions on anti-choking devices’ safety. According to Dr. Darria, an ER doctor who shares medical content on TikTok, anti-choking devices are only effective when the responder gets a good seal around the victim’s mouth. She said in a TikTok video:

One study found that over 40% of parents couldn’t do this. I couldn’t get them to work every time. When that happens, they [anti-choking devices] are useless, and you’re wasting precious seconds

@babycenter

As a parent, you may wonder if choking devices work as well as traditional techniques like the Heimlich maneuver. Here, ER doctor, mom, and BabyCenter Medical Advisor @therealdrdarria gives us her honest opinion on the LifeVac and DeCHOKER. Spoiler alert: They’re hard to use, and it’s best to use the Heimlich and back blows. #parentsoftiktok #lifewithababy #firsttimeparent #newparent #babysafety #choking #chokingtechnique #chokingprevention #chokingawareness #babysafetytips

♬ original sound – babycenter

Restrictions in the UK

Anti-choking devices like LifeVac and Dechoker first appeared in the UK market in 2015.

In choking incidents, the Resuscitation Council UK recommends back blows and abdominal thrusts. Since anti-choking devices do not follow these Basic Life Support protocols, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) decided to review LifeVac and Dechoker’s quality, safety, and effectiveness in 2017.

As a result, both LifeVac and Dechoker implemented voluntary restrictions in the UK that same year. With the restrictions in place, only trained healthcare professionals would be able to use anti-choking devices in the following cases:

• When a patient in a molded wheelchair needs help
• When the emergency services are unable to respond

The restrictions also aimed to improve clinical data and scientific studies related to such devices. In 2022, the MHRA reviewed LifeVac and Dechoker’s progress and clinical data. With the approval of the Devices Expert Advisory Committee, the agency agreed on an action plan to lift the restrictions.

By June 2023, the restrictions on the LifeVac device were lifted, allowing it to be sold more broadly in the UK. This aligned the UK market with the USA, Australia, and the EU, where the devices never had restrictions. As of 2024, Dechoker UK still has restrictions.

Medical Studies on LifeVac

A key reason why LifeVac experienced restrictions in the UK was the lack of pre-market data, such as clinical trials and studies. There have been several studies since, mainly comparing LifeVac with Dechoker and chest thrusts. Most of these studies simulated choking incidents on manikins and cadavers.

Here is a summary of five of these studies and their findings:

• A systematic review on the effectiveness of anti-choking suction devices and identification of research gaps, Dunne et al (2020): This study searched Ovid MEDLINE, Embase, PubMed, The Cochrane Library, SCOPUS, Web of Science, and CINAHL Plus databases to assess the success rate of anti-choking devices. LifeVac was the most studied device, showing a success rate of 94.3% on the first attempt.
• The efficacy and usability of suction-based airway clearance devices for foreign body airway obstruction. A manikin randomized crossover trial, Patterson et al (2021): In this study, medical students were asked to remove a foreign body airway obstruction from a manikin. The study analyzed three techniques: abdominal thrusts, LifeVac, and Dechoker. Compared to abdominal thrusts, LifeVac demonstrated a higher success rate. Dechoker had a lower success rate.
• Anti-choking suction devices use. A pilot simulated study with parents and kindergarten teachers, Carballo-Fazanes et al (2022): Parents and kindergarten teachers were asked to use LifeVac and Dechoker in simulated choking scenarios, with the help of the manufacturer’s leaflet instructions. Participants were able to follow the steps correctly, without significant differences between LifeVac and Dechoker. However, participants had difficulty fitting the mask to the victim’s airway. 43.1% of participants failed to keep the mask fixed with LifeVac, and 33.3% with Dechoker.
• Would anti-choking devices be correctly and quickly managed by health science students? A manikin crossover trial, Cardalda-Serantes et al (2023): Conducted by authors working closely with the Health Research Institute and Intensive Care Research Unit of Santiago de Compostela, this study tested untrained medical students’ ability to use LifeVac and Dechoker. The students found it easier to use LifeVac and Dechoker than to the recommended foreign body airway obstruction protocols.
• The efficacy of two commercially available devices for airway foreign body relief: A cadaver study, Ramaswamy et al (2023): This study used a fresh cadaver to test the removal of commonly aspirated objects (saltines, grapes, cashews) using LifeVac and Dechoker. Three participants conducted trials and found that both devices failed to remove the cashews and grapes. LifeVac successfully removed barium-moistened saltines, but Dechoker failed in all three categories.

Current Situation of Anti-Choking Devices

LifeVac’s restrictions have been lifted in the UK. However, there is another worldwide problem regarding anti-choking devices. In 2022 and 2023, LifeVac noticed counterfeit anti-choking devices available on ecommerce platforms like Amazon, Aliexpress, eBay, and Alibaba. Although they look like LifeVac, these devices are not regulated, meaning that they do not meet the necessary safety requirements.

Both the MHRA and LifeVac warned consumers against the counterfeit devices, saying they should check the “LifeVac” or “LifeVac – Made in the USA” signs or call the company if they are unsure.

The Consequences of the LifeVac Controversy

With the lack of evidence and real-world testing, the FDA, MHRA, and healthcare authorities cannot recommend LifeVac as an official Basic Life Support protocol. However, despite the controversies, some consumers and healthcare professionals see its potential as a backup measure.

Recommendation From Health Authorities

To treat choking children and adults, the UK’s MHRA still recommends that users follow the Basic Life Support protocols, which include back blows and abdominal thrusts. Responders should only turn to anti-choking devices if the Basic Life Support protocols fail.

Similarly, the FDA recommends the American Heart Association and American Red Cross rescue protocols, which are back blows and abdominal thrusts. Besides high success rates, these protocols reduce the time spent on rescuing the choking victims.

For anti-choking devices, consumers would need to unpack and assemble the devices, which would make them lose time. In time-sensitive choking emergencies, these should only be the last resort.

Need for More Research

Medical experts express caution regarding anti-choking devices, due to the lack of sufficient evidence related to their effectiveness and safety.

Marc Cohen, Executive Director of the Wisconsin Emergency Medical Services Association, emphasized the need for more testing. “Without data to know if it is something that would save a life or won’t, you can’t make any valid decisions,” he said to a local Milwaukee newspaper.

Similarly, pediatric nurse Sarah Hunstead said anti-choking devices should not replace first aid, and consumers must be up-to-date with their first aid training.

Overall, the LifeVac is mostly doomed to never be entirely validated (or invalidated) as an effective medical device due to the limitations of its indication. Because it can only be sufficiently tested on mannikins and cadavers (so far), there will always be doubts that it may not be very effective.  “A cadaver is certainly a good start, in terms of testing, but it doesn’t have any response,” said Marc Cohen.

Consumer Reactions

On the Subreddit Science-Based Parenting, Redditors discussed whether LifeVac was worth having or not. Many parents agreed that it was good to have as a last resort, in case the Heimlich maneuver and Red Cross-recommended protocols fail.

Other users were skeptical of the company’s marketing strategies and use of targeted ads across social platforms.

Legal Action Against Counterfeit Devices

The counterfeit devices on the market not only damage LifeVac’s credibility, but also put lives in danger.

LifeVac announced that it took legal action against these companies for patent infringement, intellectual property, and design right infringement. It also warned its customers to report counterfeit devices to regulatory bodies such as the FDA or MHRA.

Never buy counterfeit medical devices, even if they seem identical to the real thing. It simply isn’t worth the risk.

Do Doctors Recommend LifeVac?

The medical community remains divided on whether or not to recommend LifeVac as a go-to solution in choking emergencies. Here are some key perspectives:

1. Skepticism Due to Lack of Clinical Evidence: Many doctors and healthcare professionals are hesitant to fully endorse LifeVac due to the limited clinical evidence supporting its effectiveness in real-world situations. Because ethical concerns prevent controlled studies where actual choking events are simulated, much of the data comes from manikin and cadaver studies, which, while useful, don’t fully replicate live scenarios. Several medical experts, such as ER doctors, have voiced concerns about the challenges in using the device effectively, like securing a proper seal around the victim’s mouth​.
2. Endorsements as a Last Resort: Some healthcare professionals and organizations believe that LifeVac could be a useful last resort after traditional methods like abdominal thrusts (the Heimlich maneuver) and back blows have failed. In emergencies where these methods are unsuccessful, LifeVac may offer another option to dislodge an obstruction from the airway.
3. Regulatory Perspectives: While LifeVac has faced regulatory challenges, such as restrictions in the UK that were lifted in 2023, regulatory bodies like the FDA have classified it as a Class II medical device. This classification means the device is considered safe for use but does not require the rigorous pre-market testing required for other medical interventions​.
4. Limited Formal Recommendations: Major medical organizations such as the American Heart Association and American Red Cross have not included LifeVac in their official protocols for choking interventions. They continue to recommend well-established methods like abdominal thrusts and back blows, which are proven to be highly effective.

What Can We Learn From the LifeVac Controversy?

Despite the controversies around LifeVac and mixed consumer reactions, the company believes in its product.

It sells a wide range of LifeVac kits, for home, travel, EMS, and school. Active across many social media platforms, LifeVac has been constantly sharing how it helps save lives as well as the partnerships it has formed with schools and healthcare institutions.

@lifevac

Changing the world! Visit link in bio. #psa #fyp #savealife #chokinghazard #chokingprevention

♬ Sky Aesthetic – Tollan Kim

More research and upcoming independent studies will be key to the future of LifeVac, whether it will be an official FDA and MHRA recommendation or not.

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