The Defibrillator Guidelines
The Defibrillator Guidelines (the Guidelines)
Compliance with these Guidelines is voluntary.
Aimed at saving lives, the Guidelines follow recent research which recommends that organisations adopt a ‘service-based’ approach to heart safety, by clearly defining who has responsibility for monitoring and maintaining AEDs and the training of rescuers.
The first Guidelines were developed by Dr Donald Dingsdag and Dr Graeme Peel in 2012 and launched at Parliament House, Canberra in November 2012. Following consultation with SafeWork Australia, Therapeutic Goods Association, defibrillator users, defibrillator manufacturers and other interested parties, a second edition of the Guidelines was released in October 2014.
In assembling this edition of the Guidelines, Dr Dingsdag examined current trends and practices in the deployment of AEDs, and reviewed research into use of AEDs in workplaces and public spaces. Broad consultation was undertaken with government, business and professional groups and subject matter experts, and careful consideration given to relevant legislation and regulations.
The Guidelines provide technical specifications for defibrillators, where and how they are to be installed, and instructions for their monitoring and maintenance, as well as stipulation of training standards. Also provided are minimum standards for what should happen during an emergency response, for post-incident support and record keeping, and a process for those wishing to voluntarily register an AED System.
Registering defibrillators within a national database will help to improve access to defibrillators by first responders and emergency service personnel, which in turn will improve the survival rate.
About the Defibrillator Guidelines
The Defibrillator Guidelines were created to improve the standards of AED deployment and use by providing guidance on the selection, location, monitoring and maintenance of AED Systems in workplaces and public spaces, and the inclusion of a voluntary registration program.
Whereas the Australian Therapeutic Goods Administration (TGA) recognises that, ‘…some AEDs have been associated with manufacturing problems and some devices have been recalled’ and ‘…in Australia, AEDs are currently classified as Class IIb (medium-high risk) devices.’[1] A limited European Union (EU) pre-market approval model has also been adopted by the TGA along with an extended transitional period.[2] In the USA, under the auspices of the Food and Drug Administration (FDA), AEDs are classified as Class III high risk medical devices owing to the vital role they have in diagnosis and applying therapy, i.e., delivery of a life-saving shock. Accordingly, for conformation with the Guidelines and optimal performance, it is strongly recommended that defibrillators deployed in public places and workplaces in Australia have been fully FDA approved for a minimum of two years. In addition, AEDs that are already designated Class IIb classification, or subject to an application for marketing approval that has not been finally determined, when these amendments commence, will have the benefit of a long transitional period (principally, until 1 November 2024) before the new rule begins to apply to them.[3]
Even though the FDA pre-market approval process is demanding, the EU post-market quality management system is also relevant to the post-selection elements of the Guidelines. For example:
The manufacturer shall establish, document and implement a quality management system as described in Article 10(9) and maintain its effectiveness throughout the life cycle of the devices concerned. The manufacturer shall ensure the application of the quality management system as specified in Section 2 and shall be subject to audit, as laid down in Sections 2.3 and 2.4, and to surveillance as specified in Section 3.[4]
Development of these Defibrillator Guidelines has involved a comprehensive examination of current trends and practices of AED deployment together with extensive research into AED use in the workplace and in public spaces by qualified and experienced people with backgrounds in public health, workplace relations, occupational health and safety, emergency and rescue, quality control and management systems.
[1] Australian Government, Department of Health, Therapeutic Goods Administration, ‘Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy.’, January 2019, pp. 8, 9.
[2] Australian Government, Department of Health, Therapeutic Goods Administration, Explanatory Statement, Therapeutic Goods Act 1989, Therapeutic Goods (Charges) Act 1989, Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019, p. 12
[3] Ibid. p.12
[4] REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017, on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, Official Journal of the European Union, p. 146
Authors
Dr Don Dingsdag
Since 2006 Don Dingsdag has been instrumental in conducting research into out of hospital sudden cardiac arrest (OHSCA) and providing public and workplace access to defibrillation to improve survival chances of SCA sufferers. He is also Chair and principal researcher of the Cardiac Arrest Survival Foundation (CASF). Throughout his professional life as an academic, researcher and consultant, Don has also been passionate about occupational health and safety (OHS). He was first struck for the need of robust OHS legislation during his BA Honors thesis in 1979 while he researched the Bulli Mining Disaster of 1887, when 81 men and boys died owing to weak mines safety legislation (the 1876 Coal Mines Regulation Act, NSW). This legislation was not properly observed by the Department of Mines inspectorate, the management of the Old Bulli mine, the Miners’ Union, nor the miners. The methane gas explosion that caused this needless calamity was catastrophic to the surrounding small mining community as it diminished its male population by about 20%.
Dr Graeme Peel
Dr Graeme Peel is a physician who is a specialist in occupational, environmental, public health and aerospace medicine. He has interests in illness and injury prevention and health promotion, including the efficient and effective deployment of AEDs for public safety. His qualifications are M.B.,B.S; MPH; DAvMed; FAFOEM; FAFPHM; FACAsM.
Graeme served full-time in the Royal Australian Air Force from 1974-2000, primarily in aviation medicine roles in Australia, Malaysia, the United Kingdom and the USA. During this period, he also investigated twelve aircraft accidents and deployed on humanitarian relief and peace monitoring duties.
Graeme was a senior executive with Qantas Airways from 2000-2008, where he firstly developed and then managed the Group’s OHS and occupational medicine programs. He concurrently continued his military service as a Group Captain in the Air Force Specialist Reserve, deploying to Sri Lanka following the 2004 Boxing Day tsunami and subsequently to the Middle East.
Graeme is involved in a diverse range of activities, comprising clinical practice, consulting with industries on OHS, advising on fitness for remote deployments, lecturing in aviation medicine at Griffith University, and Air Force Reserve duties. He was an independent member of the NSW Government Mine Safety Advisory Council for eleven years and chaired the Department of Veterans’ Affairs Human Research Ethics Committee.
Comments
The Defibrillator Guidelines are authored by Dr Don Dingsdag and Dr Graeme Peel and are subject to review from time to time in response to regulatory developments, changing needs and user feedback.
For any feedback or distribution enquiries please contact Dr Don Dingsdag board@cardiacarrest.org.au
COPYRIGHT
© 2022 Dr Don Dingsdag and Dr Graeme Peel
The Defibrillator Guidelines are subject to copyright. Except for the purposes permitted by and subject to the conditions prescribed under the Copyright Act, reproduction by any means (including electronic, mechanical, photocopying, micro-copying or otherwise) is prohibited without prior written permission of the authors. Enquiries regarding such permission should be directed to Dr Don Dingsdag ddingsdag@cardiacarrest.org.au
DISCLAIMER
The Defibrillator Guidelines have been created for use in the deployment, maintenance and operation of AED Systems. Where the Defibrillator Guidelines are used for other purposes, the authors give no warranties as to the completeness, accuracy or adequacy of this publication or any parts thereof. The authors accept no responsibility or liability upon any basis whatsoever for anything contained in, or omitted from, this publication or for the consequences of the use or misuse of the whole, or part, of this publication.