Is the LifeVac device for choking too good to be true? Why the product is causing so much controversy

Saving lives really shouldn’t be controversial. But the brouhaha over an anti-choking device in Australia engulfing local councils and child and aged-care providers has seen it become just that. Most of the noise is being generated by Simon Gould, the director and owner of Medics for Life Group, which has the rights to sell the LifeVac in this country. The LifeVac is a handheld suction device being marketed as a game changer in clearing the throats of choking victims when first aid fails. Despite Mr Gould’s urging, some medical organisations that governments pay attention to warn against using it. Mr Gould has fights afoot on multiple fronts to get his product into schools, creches, residential aged care homes and other community facilities. Death rates from choking are set to rise further as the nation’s retirement-age population grows. Choking and suffocation claimed 1427 lives in 2022-23 — the most recent data available — or nearly 10 per cent of all injury deaths. The highest death rate by far was for those aged 65 and above. Several WA councils have in recent months voted to buy the devices. But others haven’t, and Mr Gould has threatened legal action against St John WA and Royal Life Saving WA over their alleged advice to hesitant councils. He accused St John WA of a “misinformation campaign” and putting “lives at risk for sociopolitical purposes”. He suspected it was motivated, in part, to protect St John’s “training income”. St John strongly rejects the claims. In NSW, Mr Gould is at war with the Education Department in trying to get LifeVac into all schools, and has complained to the State’s Ombudsman, alleging officials misled the Education Minister there. And he’s got into online stoushes with popular organisations like Tiny Hearts Education, which offers courses and resources to help Australian parents learn first aid. To supporters, Mr Gould is simply passionate about preventing deaths and doesn’t care about ruffling feathers to achieve that end. To detractors, he’s prickly and aggressive in defending his product. They say he needs more proof of its efficacy for them to support it. But the public and parents of young children, in particular, just want to know if will it help or hinder them in a sudden, harrowing life-and-death scenario. Sarah Giltrow, a mum from NSW, says the LifeVac saved her daughter’s life in March. Maddie, 2, had choked on vomit and was turning blue. “Despite carrying out all the appropriate first aid . . . everything failed,” she posted on Facebook. “Thankfully the LifeVac removed the blockage in just two quick plunges.” Ms Giltrow said she still believed long-established first aid measures — back-slaps and abdominal thrusts — should be tried first, but she was “so grateful” to have an extra tool on hand. The jury is out Scientific studies on the LifeVac to date have been mixed, with some relying on data supplied from the company’s own database of “lives saved”. Others used mannequins and human cadavers to test the device and also a rival product, DeChoker, which has also been approved for sale in Australia by the Therapeutic Goods Administration. For obvious reasons, it’s untenable to test these devices in a laboratory setting on real choking children and adults. LifeVac originated in the US States, with Mr Gould’s American counterpart Arthur Lih claiming the US company is on pace to “do a $100 million (in sales this year), maybe $200m”. The company there has endured similar frustrations with regulators and medical bodies. It says the product’s validation is the growing number of people still walking around today because it worked on them. That number of saved lives is approaching 5000 globally, it claims. Owners who use it in an emergency are invited to complete an online questionnaire on their experience. ‘“The LifeVac has saved over 2400 children, all without harm or failure, and all after first aid has failed. These are all documented reports, not customer reviews,” Mr Gould’s company claims. Yet several expert bodies that provide advice on best resuscitation practices remain sceptical. The International Liaison Committee on Resuscitation has acknowledged “some data . . . demonstrating the efficacy of suction-based airway clearance devices . . . (but our) task force felt that there was insufficient evidence to make a treatment recommendation in relation to these devices”. “The task force has outlined recommendations for further research in relation to these devices.” The committee’s position is shared by the the Resuscitation Council UK, the European Resuscitation Council and the Australian Resuscitation Council, which represents all major groups involved in the teaching and practice of resuscitation in this country and is sponsored by the Royal Australasian College of Surgeons and the Australian and New Zealand College of Anaesthetists. The calls for more research are a clear source of irritation for Mr Gould and Mr Lih, who invented LifeVac in 2012 and began selling it two years later. The company makes the assertion its device has never failed. US regulator the Food and Drug Administration last year issued a warning about anti-choking devices. “The safety and effectiveness of anti-choking devices that are being sold have not been established; they are not FDA approved or cleared,” it said. “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. “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. “Always follow established choking rescue protocols . . . before considering other interventions, as these protocols have a high rate of success and can be carried out immediately without devices, saving valuable time.” Confusingly for consumers, LifeVac (the company) is registered with the FDA, but registration doesn’t denote approval for the company or its products. Not all American States have been put off by the FDA’s warnings. Texas has just made it a requirement for all its public schools to be equipped with airway clearance devices. In Australia, the Queensland Government is using LifeVac in its independent living homes for people with intellectual and other disabilities. “Since its introduction (in mid-2024), LifeVac has been used by trained staff to help participants in choking emergencies. Feedback from staff has been positive to date,” a spokesperson for the Department of Families, Seniors, Disability Services and Child Safety said. Heartache at home The City of Joondalup in Perth’s north became the first local government in Australia to embrace LifeVac, rolling out kits across 36 sporting and community venues in April. The move was born out of tragedy — 22-month-old Zaire Bwoga, or ZaZa, choked on a grape at Iluka Foreshore Park in January last year and couldn’t be saved despite his father’s frantic efforts. Brian Bwoga has been on a mission ever since to save other children and spare their parents his pain. After learning about the LifeVac device, he made a heart-rending address to councillors a year ago, imploring them to get it. “My son passed away in my arms after five minutes. After doing first aid, mouth-to-mouth and CPR, I couldn’t save him,” he told councillors. Since then, Mr Bwoga has attended nearly 20 council meetings across WA advocating for the devices. His actions mirror those of other grief-stricken families on the east coast and overseas who have become de facto ambassadors for LifeVac. In the UK, the Oliver Steeper Foundation has raised funds and provided more than 1200 devices to childcare and early learning facilities. Several other WA councils have followed Joondalup’s lead in buying LifeVacs. These include the cities of Stirling, Vincent, Rockingham and Wanneroo and the shires of Harvey and Jerramungup. After hearing from Mr Bwoga, Wanneroo councillors unanimously voted to buy them — against the recommendation of staff. Councillors at the City of Melville and the Town of Bassendean have voted against buying the devices at this stage, while the cities of Cockburn, Swan, Canning and Bayswater and the Town of Cambridge are still considering it. “In May 2025 the City of Melville completed a thorough review of the LifeVac device and the broader issue of choking response measures,” chief executive Gail Bowman said. “Based on expert advice and available evidence, the decision has been made not to support the installation of these devices in city-managed facilities at this time.” Town of Bassendean officers, who contacted a variety of organisations for advice, reported Perth Children’s Hospital, the Australian Resuscitation Council and St John WA did not endorse use of the device. “Should they be endorsed by the State Government and St John Ambulance (in future), the town could then consider installing devices at some community facilities,” they reported. Mr Gould was particularly angry at what he described as “false and misleading advice” to local governments by St John and Royal Life Saving WA. In a Facebook post, he indicated he was contemplating legal action against the organisations and members of the ARC — which he also attacked. “We are happy to debate in any forum with these organisations. However, so far they have refused to do so and prefer more subversive means,” he said. The ARC told The West Australian: “The council does not currently recommend or endorse the use of suction-based airway clearance devices. “The council supports (the International Liaison Committee on Resuscitation’s) call for high-quality clinical research focused on the efficacy of these types of devices.” Mr Gould argues the demand for more robust research makes no sense. “Why does LifeVac need strong evidence if it is not seeking to replace a poorly evidenced first aid measure?” he said in a recent video, which used an AI avatar to speak for the company. Mr Gould said the opinions of St John or Royal Life Saving were based on “historical rhetoric”. “Unlike medical devices, where all failure and harm is reported to the regulators, first aid has no surveillance or reporting of failures and harm,” he said in another video, voiced by a different avatar. “Ineffective measures can therefore be used for many years, with users falsely thinking they are using best practice.” He suggested members of the ARC provide their loved ones for a live trial of the LifeVac or “stop demanding this level of more evidence that is ethically unobtainable”. St John WA said it was aware of LifeVac’s video. “We reject the claims made in the video, which misrepresent our evidence-based approach to first aid,” a spokeswoman said. “Our guidance remains aligned with the Australian Resuscitation Council and Australian Skills Quality Authority standards.” Deluge of counterfeits LifeVac maintains lumping anti-choking devices together is unfair because they aren’t all the same, and it claims there has been an explosion of dangerous imitation devices being sold online, manufactured by scammers looking to exploit LifeVac’s commercial success. The imitation devices sell for as little as $2 each, whereas the cheapest LifeVac kit starts at $125. The American company has filed court actions and urged Amazon to rid its site of “knock-offs”, claiming blatant cases of patent violation. In Australia, Mr Gould has mauled the TGA for not coming down hard enough on counterfeiters. Mr Gould, a former paramedic, said the fake devices could result in death. He said his company had been buying them back from customers at “our own expense to safeguard the public”. He’s taken his battle with the TGA on the matter to Federal Health Minister Mark Butler and the Commonwealth Ombudsman among others. He also filed a compensation claim against the regulator which was denied. The TGA rejected LifeVac’s claim it was waiting for someone to die before it would consider cracking down on fakes. “The TGA actively monitors digital platforms and social media for unlawful advertising and counterfeit therapeutic goods. We work closely with platforms such as eBay, Meta, and Amazon to deter and remove non-compliant content,” a spokesman said. “When breaches are identified, platforms are notified and, in many cases, platforms act swiftly in accordance with their user policies when alerted to breaches. In the 2024–25 financial year, the TGA requested the removal of over 13,700 online advertisements.” The TGA also said LifeVac and DeChoker’s inclusion in the Australian Register of Therapeutic Goods must not be presented as TGA endorsement. “All medical devices included in the ARTG are subject to ongoing monitoring by the TGA following approval. This includes ensuring the device performs as intended and continues to be safe. “Importantly, advertising should not take advantage of people’s concern for their health by using fearmongering in advertisements. Advertisers should avoid words or images that would give the impression that the safety and efficacy of the advertised goods is guaranteed or remarkable.” Nothing is foolproof It is universally accepted that back-slaps and abdominal thrusts don’t always work, and those with first aid training are more likely to succeed — but there are no guarantees. Sadly, no method or product is foolproof. Despite disparaging the quality of evidence behind the established first aid protocols, Mr Gould and Mr Lih don’t advocate their device should be used as a first response in choking emergencies. Their advice is to use it when back-slaps and abdominal thrusts fail to dislodge an obstruction — as a last resort. In a Facebook post, Tiny Hearts Education recently updated its own advice to parents, stating that anti-choking devices had a role, but “first aid will always be the gold standard”. “Anti-choking devices should never replace training, but they may provide an extra chance when every second counts,” it wrote. “The industry around anti-choking devices will continue to grow. Our hope is that as it does, it becomes more ethical, more transparent, and always centred on what truly matters: saving lives, not selling products.” The comment prompted a terse exchange on social media. “Our lawyers will be in touch with Tiny Hearts,” Mr Gould wrote. “Saving lives is our only goal. To be accused of unethical conduct and greed erodes our reputation and is a baseless allegation.” Tiny Hearts said it had ceased all communication with LifeVac. “This isn’t the first aggressive interaction I’ve had with LifeVac,” it replied on Facebook. “The only thing reckless here is the way you think it’s acceptable to speak to others. The market will soon be flooded with airway clearance devices, many of them on track for TGA listing. I’ve spoken with five companies just in the last week who are in the process.” Mr Gould, who is trying to get more LifeVac kits into aged care homes, also has a dispute with the Aged Care Quality Safety Commission and has escalated it to the Inspector-General of Aged Care and the minister for aged care and seniors. The commission said it did not recommend or endorse commercial products. “Providers must have measures in place to support safe chewing and swallowing,” a spokesman said. “The commission expects that the first aid capabilities are consistent with those determined by the Australian Resuscitation Council.” Mr Gould claims the LifeVac has saved 60 people in disability and aged care in Australia. His website cites a long list of aged care providers that use the product. One of them, RSL LifeCare, replied to The West Australian, saying it wasn’t correct. “We’re in the process of getting our details removed from their website,” a spokesperson said. Science falls short Some of the scientific research referred to by LifeVac hasn’t helped its cause. Some supportive studies were co-authored by Lisa Lih-Brody, a gastroenterologist who is Mr Lih’s sister. Another positive study cited on LifeVac’s US website was published in the International Journal of Clinical Skills, which belongs to OMICS International, which has been described as the world’s biggest publisher of fake science journals. India-based OMICS was fined $US50.1 million by the US Federal Trade Commission in 2019 for deceiving thousands of authors who published in its journals. According to Science magazine it promised rigorous peer review overseen by editorial boards. Instead, its journals approved many articles for publication in a matter of days with no substantive feedback to authors. “Predatory” journals have been accused of publishing anything, even gibberish, for a fee. The latest study of LifeVac, published last week, gave it a thumbs down. Across 21 trials performed on three fresh cadavers, only one successful extraction occurred, involving a piece of hot dog, the researchers from Oakland, California, reported in the journal Resuscitation Plus. Neither of the other two food items, grapes and steak pieces, were successfully extracted inside four minutes, the duration before brain damage, quickly followed by death, occurs. Mr Gould complained the journal was biased against LifeVac. He said it had refused to publish a response he’d written, in which he argued cadavers “cannot replicate . . . airway recoil, secretions and reflexive coughing, which may influence device effectiveness in living subjects”. “This is the second time (the journal) has refused the opportunity to respond to the facts and conclusions of studies involving LifeVac,” he said. The other study that provoked him was led by laryngologist Dr Apoorva Ramaswamy, the wife of American politician and entrepreneur Vivek Ramaswamy. In 2023, Dr Ramaswamy and colleagues from the universities of California and Ohio tested LifeVac and the DeChoker. Saltine crackers, grapes and cashews were placed in the vocal folds of a fresh cadaver. “The DeChoker resulted in gross injury to the tongue and failed to remove the obstruction in all trials,” the authors reported. “LifeVac was successful in removing the saltines, but failed to remove all foreign bodies. Both devices applied significant pressure to the tongue.” Dr Ramaswamy and her co-authors warned “both devices may cause significant pressure and injury to the oral cavity in a clinical setting”. “We conclude bystanders should continue to follow ILCOR guidelines on resuscitation to aid with relieving foreign body aspiration,” they wrote. A recent study by researchers in Brazil compared LifeVac and abdominal thrusts (also known as the Heimlich manoeuvre). Using a special mannequin, they found both techniques successfully relieved airway obstruction in all 200 tests. The authors cautioned the tests were performed by specialists in a simulated environment. They also remarked on the pressure variances generated by different operators suggested a need for greater training. The American Red Cross Scientific Advisory Council claims there is considerable bias in much of the research to date, but now recognises LifeVac as an option if standard treatment doesn’t work or isn’t feasible. It said it would continue “to follow the literature as evidence evolves but the preponderance of history and expert opinion is with traditional anti-choking treatments”. Dr Cody Dunne, a University of Calgary lead researcher in the field, claims larger studies are required, while noting evidence for abdominal thrusts and back-slaps is still evolving as well. “We’re only now getting good evidence on the old choking techniques, let alone these new ones,” he told Associated Press. LifeVac has prominently marketed its products as “made in the USA”, but the American company had to remove the claims from all its materials, including social media, after the US Federal Trade Commission took it to task, stating its products contained significant imported content. The imported components were from Taiwan.