On receipt of correspondence from the NSW Education Department (on behalf of the Minister for Education Prue Car MP) and also ratified by the NSW Health Minister (Ryan Park MP) in correspondence to the Orange Council, LifeVac Australia has conducted a detailed examination of the statements made and the source and integrity of the evidence used in the decision-making not to make the LifeVac available in NSW Schools. Our findings show that both the advice from the NSW Education Department to the Minister and NSW Health to their Minister was at least poor and in the case of advice provided by the NSW Education Department, was deliberately false and misleading. This conduct has now been referred to the NSW Ombudsman (by the Education Minister) for investigation. The specific false assumptions and mistruths concocted by officers of the NSW Education Department and NSW Health in this matter included:
1. The claim that the LifeVac is a “new” device
LifeVac Australia was established in 2016 (8 years ago) and has been around for approximately 15 years worldwide. In that time LifeVac has been responsible for over 3200 documented saves (including over 2000 children) worldwide (including Australia) all without harm or failure, and all after first aid methods failed. This claim, made by NSW Health Minister is an attempt to undermine the credibility and depth of data and evidence of the device by erroneously suggesting that there has “not been time to assess the device”.
2. Claim that there are “limited” studies on the LifeVac
There are many peer-reviewed studies concerning the LifeVac airway clearance device. This statement is a throw-away line that does not reflect the current quantum of academic literature. Some 15 years ago this may have been a reasonable conclusion but as of today, there is ample, independent, and definitive research supporting the wide adoption of the LifeVac into regular first-aid practice, based on its proven safety and efficacy. This statement represents a degree of laziness and/or malfeasance on the part of those providing advice to departmental ministers or departments and suspiciously the origin of such unqualified statements may be from those who lack contemporary knowledge or have other agendas e.g. resuscitation bodies.
Regardless, the term “limited” is a completely subjective opinion designed to discredit without proof i.e. if there are 10 studies does there need to be 20, if there are 20 does there need to be 30 to reach a yet unspecified “threshold”? Is the “requirement for acceptance” that LifeVac needs to perform random control trials on real live volunteer children to prove efficacy, despite the ethical issues?! Despite studies proving ease of use, effectiveness, and safety, the outcome data from LifeVac has been studied and published in internationally peer-reviewed literature, concluding it is safe, effective, and “should be part of regular first aid measures”. In contrast, not one single peer-reviewed study has even been published to support the Australian Resuscitation Council's bespoke “chest thrusts” techniques relied upon as “evidenced-based and effective”, that are divergent from the worldwide consensus of evidence. A recent review of the safety and efficacy of first aid measures recommended for choking around the world (published in a peer-reviewed journal) showed that the was no evidence to support the ANZCOR (ARC) bespoke, recommended “chest thrusts” or even a rationale for their effectiveness. Measures that are touted as effective recommendations without any clinical evidence, research, or proof of efficacy. If science was the benchmark for recommendations it is abundantly clear the recommendations would be much different.
3. Claim that trials of the LifeVac are biased studies i.e. suggestive that they are “not credible”
The notion of “biased” and “unbiased trials” is a misuse of the GRADE evidence review methodology. In accessing academic literature, all studies have the potential for bias from a variety of reasons (including editorial and bias). This does not however mean the results are “biased”. If this is what is being claimed by those advising the Minister from the department, this represents libel and slander and is a legally actionable claim. This is essentially gaslighting and a deliberate misrepresentation of academic literature assessment processes.
4. Claim that LifeVac is attempting to replace first aid measures and therefore requires “very strong evidence”.
LifeVac does (and never has) sought to replace first aid measures but is recommended (and TGA approved) for use after first aid measures fail, as in the recent case of Decklan Haywood. This is a position that is accepted and recommended by the world’s pre-eminent first aid body, the American Red Cross after a clinical review of the science and literature and the TGA. The LifeVac has undergone post-market review (including clinical, evidence, and risk review by the regulator, the TGA. The surveillance and risk management processes for device regulation are more rigorous that those used to create and perpetuate first-aid recommendations.
5. Claim that the NSW Education Department received “strong advice” from NSW Health against the use of the LifeVac in NSW schools.
In particular during this period, Ms Kim Hoskin R/Director of the Department of Education Strategy Governance and Staff Wellbeing Unit, and Dianne Van Berlo, Executive Director, Health Safety and Staff Wellbeing have repeatedly claimed in responses to LifeVac Australia (and their advice to the Minister and Premier) that they have received “strong formal advice from NSW Health” that they should not consider the LifeVac device in NSW schools after the death of Decklan Haywood. Under FOI, LifeVac Australia obtained this “strong, formal advice from NSW Health” which these officers relied upon and used to misinform the Minister and Premier. The “formal advice” obtained from NSW Health was not in fact “formal advice” at all, but a single informal email from one individual with no knowledge of the device, or authority, that cited a newspaper tabloid as the basis of “evidence” for their personal opinion. If there were “formal advice” and it was not supplied under FOI and not disclosed as “denied”, it is a breach of the FOI (GIPA) legislation. For the DoE to continue to assert therefore that this represents “formal” or “strong advice” is not only disingenuous but amounts to deceptive conduct. This conduct is now in the hands of the NSW Ombudsman at the request of the NSW education Minister. The TGA (the only regulator of such devices) is under the DoHA i.e. the governing authority in Australia under the Health Minister and they have determined otherwise. Regardless, for the DoE to continue to claim that the assessment of DoHA, the published scientific research, and outcome evidence is supplanted by the opinion of an unqualified individual from NSW Health is quite absurd and disingenuous.
6. Claim that the LifeVac must be specifically listed in the SafeWork, First Aid – Code of Practice to be used in schools.
LifeVac Australia has been in contact directly with SafeWork NSW to verify these claims. Firstly, to establish if the NSW Department of Education has accurately interpreted the legislation, and secondly to confirm if the NSW Department of Education actually sought and received any advice from SafeWork or simply chose to fabricate their own interpretation of the legislation to support their own opinions. SafeWork NSW has confirmed that:
a. The NSW Education Department has never requested or been sent any advice from SafeWork NSW in regard to the use of the LifeVac device in NSW schools.
b. The statements made by the NSW DoE regarding the necessity of a medical device to be “specifically listed in the Code of Practice before it can be legally used by teachers in schools”, are wholly false. In fact, SafeWork NSW has affirmed that they would never provide such advice as it is contrary to the legislation. Legislation that specifically encouraged the inclusion of additional equipment when a risk is identified e.g. choking. The legislation (and Code of Practice) does not prohibit the use of LifeVac or any medical device.
c. Any statements made by the NSW DoE are purely based on their own misinterpretation of the legislation and codes.
7. Claim that LifeVac must be specifically mentioned in the ANZCOR (ARC) guidelines to be used in NSW schools
The reality is that (ANZCOR) ARC is not a regulator nor a scientific body, but merely a voluntary, non-government, member-representative organisation with no legislated authority. Choking guidelines in Australia are simply “good practice statements” i.e. do not rise to the level of an evidenced-based guideline and are divergent from the worldwide consensus of evidence. Medical devices (unlike first-aid measures) are regulated and monitored for safety and efficacy. LifeVac has over 3200 documented case reports of success. If the those advising the Minister’s wish to prove their speculative opinions they should produce the associated reports held by government regulators that show failure and/or harm related to those over 3200 reports. By comparison, there is no government regulation or monitoring of safety, failure, or harm of the application of first aid measures, any failure is simply inappropriately written-off to be simply “back-luck” or “poor technique”. Medical devices are accountable for any failure or harm and no regulator in any country has received any reports to this effect. The TGA is the only regulator of medical devices in Australia and the ARC has no role in the “approval” or “endorsement” of medical devices, particularly one only used after their recommendations fail. There is also no legal prohibition or protection from strict adherence to non-enforceable first-aid guidelines under Australian law.
The TGA is under the Department of Health and Aging, the Federal Health Department that has cleared the LifeVac to be sold and used (without any restriction or requirement for specific training) in Australia based on a review of clinical evidence, risk assessment, and safety review. The speculative and highly biased “advice” from a voluntary non-government association or the representative but poor-researched “opinions” of NSW Health (a state-based organisation) in some way superseded the Commonwealth medical device regulator; I would suggest this is not a position that is accepted by the DoHA.
8. Claim that LifeVac must be part of the current “accredited” first-aid training e.g. HLTAID012 Provide First Aid in an Education and Care Setting, to be used by teachers in NSW schools.
The use of medical devices is not regulated by the Australian Skills Quality Authority or the ARC. The TGA (the regulator) has determined that specific training is not required for the use of the LifeVac device as it is determined to be a Class 1 (low-risk) device that can be supplied to anyone without a prescription. LifeVac also has available online learning that has been used thousands of times. The NSW DoE is being disingenuous, given that teachers are considered “competent” in emergency care by undertaking a self-guided, unaccredited online module without any practical component. (e-Emergency Care).
9. Assumption that there is more legal liability for the NSW Department of Education to allow LifeVac to be used in schools than the situation where another child dies in front of teachers as long as they do not breach policy.
There has never been any legal advice sought by the NSW Education Department in this matter. All assumptions made by officers of the DoE are based on the false belief that strict staff adherence to policy is the ultimate defence from liability (vicarious, or otherwise) under the law. This same false assumption restricted the use of an available adrenaline auto-injector on a child in life-threatening anaphylaxis if the adrenaline auto-injector was not held for the use of that specific child. The theory (untested in law) was that as long as teachers adhered to policy in refusing to use the medical to save a child’s life; this liability (even if death resulted) was minimal compared to the unlikely scenario where the auto-injector was then not available for the specified student. Under WHS legislation, this policy position failed the test of a duty of care and saw a change in NSW DoE policy to see schools holding additional adrenaline auto-injectors. If the position (established by the same group within the NSW DoE) was defensible in law there would have been no need for a change. The scenario of choking and teachers being prohibited by policy to save a life using the LifeVac device is similar. In other jurisdictions parents have successfully sued education authorities in instances where children have suffered permanent brain injury or death resulting from a choking incident and where the school refused to implement the LifeVac (even without cost).
10. The assumption that WHS legislation allows unilateral decisions on the implementation or refusal to implement mitigation strategies can be made without consultation with the affected workforce or addressing the specific considerations listed under the Act.
LifeVac Australia in advice received from SafeWork NSW has established that the NSW DoE is in breach of the legislation on several grounds.
· NSW DoE has not considered matters under 2.2 and 2.3 of the Act in its considerations of the LifeVac. Specifically, the consideration of the safety of children under their care in a DoE workplace is a responsibility of the PCUB (person conducting a business or undertaking) i.e. NSW Department of Education. Also, no consideration was undertaken of the…
“The distance of the workplace from ambulance services, hospital and medical centres should be taken into account when determining your first aid requirements. For example, if life-threatening injuries or illnesses could occur and timely access to emergency services cannot be assured, a person trained in more advanced first aid techniques, for example providing oxygen, should be considered.”
This analysis of local Orange resources and response times was conducted by LifeVac in its submission to the DoE but was not considered in the decision by the NSW DoE. The isolation of schools (given a 4-minute window in severe upper airway obstruction until likely brain injury) is a factor that is not mitigated by reliance on the existing policy of performing unsuccessful and unevidenced first aid measures. The belief that doing the same thing over and over but expecting a different result is the definition of insanity and not good governance.
· The NSW Education Department has ignored the requirements under the Act in Section 3.5 First Aiders (Types of First Aid Training) specifically states that identified risks e.g. death of a child, may require additional training and/or equipment i.e. not prohibitive but rather supporting risk mitigation measures. “For example, additional training may be required where: - work is remote or isolated - there are risks from dangerous substances such as cyanide or arsenic - specialist first aid equipment or first aid room is installed in the workplace - children are present in the workplace - you have identified psychological risks, or - workers have existing medical conditions which may require first aid. Where workers or others at the workplace have known existing medical conditions, first aiders should be trained to respond to these conditions if the topic has not been covered in previous first aid training.”
· NSW DoE has breached the NSW Health and Safety Act 2011, which requires consultation with workers in the workplace where a hazard has been identified or a serious incident has occurred including with those who carry out the business, including first aid provision. This is specifically in the case where mitigation strategies are to be (or not to be) implemented to protect staff and others from harm (including psychological harm). Before a unilateral decision by DoE not to implement mitigation strategies following the death of Decklan Haywood, no such consultation has taken place with the affected staff.
If the NSW Education Minister and her Department and the NSW Health Minister and his Department want to make a case for not making the LifeVac airway clearance device available to NSW schools despite the death of Decklan Haywood, then they need to base this on credible and properly researched advice. The argument needs to be consistent with actual formal advice and the relevant legislation and cannot be the opinion of individuals who are merely interpreting the legislation and legal matters using their own limited understanding and agendas. Nor can this advice provided to the Ministers cannot be falsely elevated to “strong” advice without due diligence, an understanding of regulatory practice and the scientific evidence. Lastly, the advice cannot merely appeal to authority (a logical fallacy) as its only argument, especially from those with no authority or legal standing in this matter.
There is little doubt that the position taken by the NSW DoE in failing not only Decklan Haywood and his family but the teachers and pupils of NSW schools, is not defensible in law, given the poor advice, lack of evidence, and deliberate and unqualified misrepresentations of the legislation. The false and misleading statements made by the DoE and the Health Minister to LifeVac Australia and the Orange Council will be used in future legal action and legal proceedings, including coronial investigations.