Welcome back to our blogs for 2025. I hope our readers that managed a holiday are feeling well rested and ready for another exciting year. We have been busy planning 2025 and can't wait to share some of our new initiatives with you all.
Last month, Tillys blog looked at how ISO performance metrics can assist in clinical decision making when identifying potential cushion options. (ISO Standards – a tool to overcome prescribing your “favourite” cushion) We often get asked about what standards our equipment meets and if it is regulated, in fact some funding bodies require this information within the application process. Whilst it may seem like more of an administrative task for prescribing therapists there are very valid reasons for funders to ensure that users are adequately protected and safe. If you require these specific standards as part of the application, you can find the Permobil equipment’s relation standards here (Compliance with Australian Standards). Even if the question is not part of the justification process it is important that you understand the regulatory standards of your country and any AT you recommend has met local or international standards.
Recently there has been a lot of publicity in Australia around a devastating scenario that played out last year. A grandmother had purchased a glow in the dark hoodie through an overseas website for her 8 yr old granddaughter's birthday. It was reported to be a favorite piece of clothing and worn frequently. Unfortunately, the clothing was flammable, highly flammable with no warning labels and the child sustained significant burns when the clothing ignited from a bonfire spark. The child has had to undergo multiple surgical procedures and is scheduled for ongoing medical intervention as a result of the serious injuries sustained. The item has now been recalled due to it not meeting Australian Standards and labelling warnings and legal aid has been retained by the family. I really feel for this family and doubt there are many reading this blog who have not at least been tempted by the continuous array of discounted products available in a time where cost of living is having an impact on most households. Like with most things in life we need to do an internal risk assessment before purchasing items, will they arrive, will my Creditcard details be safe, and will the product be of the quality I expect it to be.
Wheelchairs fall under medical devices and as such for them to be sold in New Zealand and Australia they are regulated. The government regulatory body for NZ is Medsafe and for Australia it is the TGA (Therapeutic goods association) Therapeutic Goods Administration (TGA) | Australian Government Department of Health . These are government agencies and are responsible for the evaluation, assessment and ongoing monitoring of medical devices and medications. They ensure equipment and medicines are safe for users. There are specific obligations on the manufacturer or importer of wheelchairs to the regulatory bodies which include evidence that standards have been met.
ANZ standards are developed to meet the specific needs of Australia and New Zealand, addressing local conditions and regulatory requirements. These standards ensure that products and services are safe, reliable, and of high quality. ISO standards, on the other hand, are internationally recognized and provide a global framework for quality and safety.
Following World War 2, the question “what’s the best way to do something” and a goal for global collaboration was the foundation beginning of the development of ISO standards. Since then, 163 countries have membership and over 20,000 standards have been developed. There are standards written for everything that affects our daily lives from quality of Wi-Fi, purity of foods and drinks, to identifying potential risks such as flammability thresholds and how to identify risks to consumers.
Standards are developed by global volunteers through technical committees. A working group may include technical experts, clinicians, regulators, and end users in standards relating to Assistive Technology. All the standards are created to share those best practices, create common language, about how we talk about products, and ensure safety, quality, and reliability of products, and in the case of medical devices, there is also a need to ensure clinical effectiveness. Manufacturers need to meet these standards in order to be allowed to sell them as medical devices. This ensures ongoing safety.
If you are recommending AT to users, it’s important that you know the recommended equipment will do what it claims it will do and that risk has been mitigated or managed. One way to do this is to ensure you are only recommending regulated solutions that have been tested to meet minimum ANZ / ISO standards. It is also important that we are providing users with appropriate training on the care and maintenance of the equipment. Users should also be provided with a user manual on delivery of the equipment and the process made clear of who to contact if there are any issues with the equipment. If you are interested in learning more about standards and safety we do have a range of workshops that you can reach out to the team to discuss. Our Educator from Taiwan Rainy Wu and myself (International Seating Symposium) will also be presenting on batteries and regulations at International Seating Symposium in March 2025 so if you're attending, we would love to see you there. If you aren’t able to make it to ISS, this year – The Oceania Seating Symposium is back on in New Zealand in November, (Welcome - Oceania Seating Symposium) Both events are a definite highlight of the 2025 Calander for those passionate about wheelchairs and seating!
Author
Tracee-Lee Maginnity BHSc (OT)
Clinical Services Specialist
Tracee-Lee Maginnity joined Permobil Australia in July 2019, as a clinical education specialist. Originally from New Zealand, she graduated Auckland University of Technology with a BHSc (Occupational Therapy) in 2003 and has since worked in various roles related to seating and mobility including assessing, prescribing and educating. After gaining experience as an assessor and prescriber at Seating To Go / Wheelchair Solutions in prescribing for both disability and injury, she moved to Australia in 2011 to take on the Senior Occupational Therapist role in a custom moulded seating service. She then worked in clinical consulting and education roles until joining Permobil. Tracee-Lee is passionate about maximising functional outcomes with end users and the importance of education within the industry. She has mentored many therapists interested in AT. Her experience includes working with complex postures to achieve custom outcomes. Tracee-Lee is also an international wheelchair rugby classifier where she enjoys the task analysis of wheelchair propulsion and functional capacity identification of athletes.