Agenda
The Medical Devices Consumer Working Group (MDCWG) met on 19 October 2023.
Members discussed how we regulate software and artificial intelligence (AI), electronic access to medical device instructions for use (IFUs), and noted updates on our:
- digital transformation program
- progress on implementing the Australian unique device identification (UDI) system
- 2022-23 public awareness campaigns, and
- results of the 2023 Stakeholder Survey.
Key points
Members welcomed recent improvements to our website, and noted:
- the ability to present web content that is tailored to a user’s search history or preferences
- improved access to information on recalls and medicine shortages, and
- tailoring newsletters to consumers, health professionals and industry, with real-time alerts when safety alerts and recalls are released, additional to monthly newsletters.
Stakeholders can subscribe to newsletters and alerts by emailing TGASubscriptions@health.gov.au.
We relayed the Department of Home Affairs’ recommendations for individuals travelling with medical devices to facilitate airport security screening:
- notify airport security screening officers about any medical device travellers have before the screening process commences. If available, provide the airport security screening officers with a doctor’s letter, or your medical device patient implant card. This allows officers to choose the most appropriate screening method
- travellers are able to provide feedback on their airport security screening experience. They can talk directly to the screening officers, their supervisors, or write to the Australian Airport Association, as the peak body within the airport industry, and
- refer to information on the Department of Home Affair’s TravelSecure, and our travelling with medicines and medical devices webpage, before travelling.
The MDCWG expressed interest in testing access to electronic versions of patient information leaflets (for some medical implants) and device IFUs in the Australian UDI database, when it is available.
Electronic access to IFUs is normally restricted to devices used by health professionals. During COVID-19, we published the IFUs for COVID-19 rapid antigen self-testing kits. This was a significant step for consumer medical devices and well received.
Expanding electronic access to IFUs for other medical devices would add a means for consumers to access this information on their device.
Members welcomed the progress in consumer engagement across 2022-23. 22.7 million people engaged in our nine public awareness/social media campaigns, which included:
- travelling with medicines and medical devices
- Five questions to ask your health professional before you get a medical implant, and
- beware of buying medicines and medical devices online.
Members discussed:
- the growing reliance on AI by healthcare professionals in clinical practice, and the need to strike a balance between leveraging new technologies that significantly reduce administrative burden, and ensuring safe and accurate use, and
- transmission and protection of patient data included in software/AI components, particularly when transmitted to overseas manufacturers.
Members noted the regulation of software and AI and that digital mental health tools or apps that track an individual’s exercise - i.e., lifestyle apps are not regulated as medical devices. We advised that, consumer-facing medical devices with software/AI components are subject to stricter regulations compared to similar devices directed at health care professionals.
We are working collaboratively with the Australian Health Practitioner Regulation Agency, peak medical bodies, and other regulators, to develop appropriate regulation for new emerging technology.
The next meeting is proposed for March 2024.