The Truth about LifeVac®
The following video addresses some of the myths and misinformation surrounding LifeVac®
Statement Regarding LifeVac Devices in Child Care and Education Settings in Australia.
We are aware that LifeVac is discussed across several forums and social media groups in relation to its use in the childcare and education settings. We recognise that inaccurate or incomplete information can sometimes circulate, especially advice from organisations and institutions that lacks legislative or evidential support. In situations involving choking emergencies, hesitation caused by uncertainty can have serious consequences. It is therefore essential that providers, caregivers and teachers have access to clear, accurate, informed and evidence-based information.This statement sets out verified facts regarding the legislative and regulatory status, liability as well as the safety, training, and appropriate use of LifeVac devices.
Liability
We always recommend that any setting receiving a donated device or purchasing one, notifies its insurer as a matter of good governance and record-keeping.
To date we have not received a single report of an insurance provider refusing cover where the device is used appropriately namely, after standard first aid procedures have been attempted in accordance with recognised protocols.
Under Australian law, there is not automatic liability for using a medical device not specifically mentioned in a first aid guideline. The law in an emergency has “good Samaritan” type legislation that protects the individual and organisation. To be liable the threshold in an emergency is that the person acted recklessly or with malice. Neither of these can be applied to a medical device, reviewed for safety and risk and listed by the TGA for use without restriction. Additionally, there is no legal protection automatically granted for strict adherence to set of first aid guidelines, liability is again determined by proving recklessness or malice, not adherence to procedures.
In the recent case of Bridie Gilligan [Reference Number: 2021/1923], handed down by the Queensland Coroner in February 2026, after choking and dying while in the care of a first aid trained care worker; the worker attempted abdominal thrusts (formally known as Heimlich Manoeuvre) on direction by a non-clinical ambulance call-taker without any authority. Despite this failing, this technique is not recommended in the ANZCOR guidelines that were the basis of the first aid training the worker received. However, there was no liability found, no negligence and no personal liability for using a technique outside the recommended guidelines in an emergency. The reason for this is that there is no legal or legislative requirement for these guidelines to be followed in an emergency; they are unenforceable.
Under education department policies, teachers, staff and schools are protected from vicarious liability by the State provided the actions are lawful. In addition, LifeVac, as a medical device manufacturer, maintains full product liability and public liability insurance that extends protection to end users when the device is used in accordance with instructions.
Requirement for “endorsement” by an organisation other than the TGA
There is no requirement under any legislation or law in Australia for the endorsement by any other organisation or authority for the safe and legal use of TGA listed medical device. This incudes Ambulance Services, Training Providers (RTOs), The Australian Resuscitation Council (ARC) and State Health or State Education Departments. Not of these entities have legislated authority over the Department of Health (the TGA) and most have no jurisdiction outside their own internal policies. This myth although common, has no basis in legislation or law. Since the ARC (a non-government voluntary body with no legislated authority) last reviewed the use of the LifeVac (5 years ago), an additional 3,510 lives saved worldwide and the publication of 13 additional peer-reviewed medical studies examining safety, usability, effectiveness, and outcomes; with no reported harm or delay to any regulator.
Requirement to be specifically listed in the SafeWork – First Aid Code of Practice
SafeWork has formally advised that there is no requirement for the specific listing of a medical device in the Code of Practice for it to be legally used in an Australian workplace. In fact, the advice from SafeWork is that the First Aid Code of Practice actually encourages the implementation of additional equipment if a risk is identified i.e. that any organisation suggesting that the Code of Practice limits the equipment available in a workplace in an emergency is advice contrary to the WHS Act.
Requirement to be in the first aid minimum contents list to be legally used in schools
The reality is that there is no “approved” list of first aid equipment in a school. There are recommended minimum standards that vary by state e.g. In WA AED’s are mandatory in all schools, while in NSW schools they are seen as “not necessary”. These minimum lists, are based on the TGA minimum list for first aid kit contents that are listed in the Workplace – First Aid Code of Practice, but they are not designed to be finite and there is no legal or legislative support for this assumption.
The LifeVac must be in the ASQA Units of Competency and training to be legally used in Australia
Under Australian law and legislation there is no requirement for a medical device to be specifically mentioned in the ASQA Units of Competency to be legally and safely used in a workplace. All Units of Competency are minimum standards based on unenforceable and non-legislated first aid guidelines that provide no legal protection in an emergency. The ASQA framework for industry workplace training is carried out by Register Training Organisations (RTO’s) who deliver both “accredited” and “unaccredited modules”. Accredited modules are transferable to be used in gaining another qualification and unaccredited modules provide additional skills and training that cannot be used in attaining another qualification. This does not however reflect either their legal status, safety or the liability of the participants. Although The TGA determined through review of risks, that the LifeVac did not require specific training, LifeVac has developed a range of training options, including:
• Free self-directed online training • A free non-accredited training module for RTO’s to add to their scope on using the LifeVac
It should be stated clearly, any training organisation that does not include LifeVac training (or advises against it on the basis of not being in the Units of Competency) is acting purely out of adherence to internal policy and not from any legal or legislative requirement.
Regulatory Status and Classification
LifeVac is not a substitute for first aid. It is a medical device intended for use only when established choking protocols have failed or cannot be performed. As such it has been determined by the regulator after a 2-year long review to be a low-risk Class I Medical Device. Class 1 medical devices in Australia are referred to as listed on the Australian Register of Therapeutic Goods [# 285082] where they are continuously surveyed for safety, efficacy and risk. Class 1 (low-risk) medical devices in Australia cannot be “approved” this description is only used for pharmaceutical and moderate to high risk medical devices. The LifeVac device is manufactured in the US under strict ISO and FDA regulations.
Types of Obstructions Removed in Recorded Cases
Reported use cases show that when deployed appropriately as a last-resort intervention, LifeVac devices have successfully removed a wide range of airway obstructions, most commonly food items such as grapes, sausages, sweets, bread, and pieces of meat, which are among the leading causes of choking incidents in both children and adults.Documented incident reports also describe removal of non-food objects including small toys, beads, coins, and medication tablets, particularly in paediatric or vulnerable-adult settings where accidental ingestion risk is higher.These outcomes were after first aid failed and reflect the device’s negative-pressure suction mechanism, which is designed to extract rather than push an obstruction, and reinforce its intended role as a secondary emergency tool used only after established choking first-aid techniques have failed or cannot be performed.LifeVac is used within the NHS in the UK. During 2023, Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust (CNTW), one of the largest mental health and learning disability trusts within the NHS, undertook clinical evaluation and governance review of LifeVac for use within its services. Following structured assessment, the Trust approved deployment of the device across relevant inpatient and specialist settings as an additional safeguard in choking emergencies. Since full rollout in December 2024, the Trust has reported multiple successful uses of the LifeVac device, reinforcing its role as a secondary airway clearance option within a regulated healthcare environment. Several Australian medical institutions are undertaking trials of the LifeVac to the view of widespread adoption in emergency and allied health areas.
Device Design and Safety Mechanism
LifeVac is a non-invasive airway clearance device designed to remove obstructions without inserting anything into the airway.Key safety features include:
• A patented one-way valve, preventing air from being forced into the airway.
• No internal tubing, eliminating risk of pushing an obstruction further down.
• Non-invasive, reducing risk of internal injury.
Counterfeit Devices
Counterfeit anti-choking devices should never be purchased or used under any circumstances. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued formal safety alerts and recalls warning that numerous imitation devices are being sold online which do not comply with UK medical device regulations and may pose a serious risk to life [DSI/2024/003]. These copies often resemble genuine products but lack valid TGA markings, appropriate instructions, and verified safety mechanisms, meaning they may fail during an emergency or even worsen a choking incident by pushing an obstruction further into the airway due to the one-way valve being nothing more than a rubber grommet.These are the same devices being exported to Australia from the same illegal factories in China, however despite reporting the danger to the TGA, our regulator has refused to react until there is a death in Australia using a counterfeit device.Counterfeit devices must not be used and should be safely disposed of, and LifeVac is working to police online marketplaces to remove such listings from sale. For safety and legal compliance, devices should only ever be obtained from authorised suppliers whose details are listed on the LifeVac Australia website www.lifevac.net.au , and any suspected counterfeit products should be reported to the TGA.
Conclusion
LifeVac is a regulated medical device designed to be used only after first aid has been attempted and proven unsuccessful, or when such techniques cannot be performed. It does not replace established first aid procedures and should always be considered a secondary intervention.When used in accordance with instructions:
1. It is lawful in Australia to use once first aid has been attempted and deemed unsuccessful or cannot be performed. There is no contrary legislation or automatic liability.
2. It is supported by manufacturer liability cover.
3. It has documented evidence of effectiveness (without harm or delay) and saved thousands of lives.
4. There is no other authority than the TGA that is required to “endorse” the LifeVac prior to its legal and safe use in Australia.With more than 5,500 recorded and documented lives saved worldwide, including approximately 3,350 paediatric cases, LifeVac represents a significant additional safeguard in choking emergencies.
We are not sure who convinced YouTube (without providing any evidence) that they were being “defamed” by the original video below we published on the situation in Western Australia. Whoever it was did not contact LifeVac, but again acted anonymously and subversively.
It may have been St John, the same people, who when one of their representatives told a national television audience that direct vigorous, upward strikes to the solar-plexus (rendering the patient unable to cough for up to 20 minutes) was a technique that was “wholly in line with the ANZCOR guidelines” for choking; or it could have been the ARC who attempted to force the TGA to restrict the LifeVac for use solely on deceased patients. If successful, this would have directly this would have directly resulted in over 80 deaths.
However, once again, these organisations have used their influence to attempt to bully and impugn LifeVac to ensure that they don’t have to provide legislative, legal or regulatory evidence to either support the poor advice they have provided to councils and others, outside their scope; nor have they produced this evidence to justify why a claim of “defamation” is valid as all our claims are provably true. As a company that has been subjected to injurious falsehood being spread by these organisations, it is the common playbook that they work clandestinely to ensure that no questioning is allowed of their actions or opinions, simply based on an appeal to their own self-determined authority, but devoid of facts. And yes, we have the receipts.
A hollow appeal to authority is not evidence. "Error does not become Truth because it is widely accepted; Truth does not become error, even when it stands alone!” - John MacArthur