Medical device reforms: Consumer Working Group meeting statement, Meeting 15, 8 November 2024

Agenda

The Medical Devices Consumer Working Group (MDCWG) met on 8 November 2024. 

Members received updates and discussed:

• the MDCWG being nominated as a finalist in the national IPAA awards 
• the TGA’s public awareness campaigns,
•  progress of the MDCWG 2024 workplan,
• the outcomes of the TGA’s consultation and webinars on assistive technologies,
• consumer information about metal toxicity in tampons,
• the Government’s work on the safe use of Artificial Intelligence (AI), and
• proposed changes to the regulation of exempt medical devices and other therapeutic goods.

Key points

The TGA updated members on recent and upcoming consumer engagement initiatives and the 2024 TGA Stakeholder survey. There were 11 public awareness campaigns across 2023-24 which reached over 71 million people including:

• phase 2 of the travelling with medicines and medical devices campaign, and
• reporting adverse events.

The TGA informed members of the recent consultation - external site and webinars on assistive technologies. Members discussed how the TGA can use alternative and accessible methods of seeking feedback from consumers to engage specific groups. Suggestions included targeted consultations, lived experience discussions, and the use of easy-read documents. 

Members noted a study into metal toxicity in tampons and discussed processes regarding exposure levels of concern, and the role of Standards Australia. They noted there was an Australian Standard that already includes a requirement for tampons to be free from toxic or irritant effects. The TGA undertook to discuss with sponsors, manufacturers and standards Australia to see if further revisions to the standard were required.

The TGA presented the outcomes of a consultation - external site on the provision of medical device instructions for use (IFUs) and the availability of more flexible formats. Members discussed the benefits of electronic IFUs (eIFUs) being available, but noted an ongoing need for accessing paper IFUs for:

• people with limited or no internet access, such as those in regional and remote communities, and
• people who may not be comfortable using digital technologies.

The TGA provided an update on the Government’s Artificial Intelligence (AI) review - external site and outcomes of the TGA’s stakeholder consultation. Members noted that the consultation outcomes indicated that stakeholders:

• want increased transparency around whether a therapeutic good is approved by the TGA
• want to be able to identify where an AI model or system has been used.

Members suggested that it would be beneficial to have short videos on particular issues or case studies to better understand how regulations may apply.

The TGA presented on the proposed changes to the regulation of exempt medical devices and Other Therapeutic Goods (OTGs). The consultation - external site considered three proposals to increase the TGA’s visibility of exempt products. Members noted that manufacturers would notify the TGA of type of good supplied, rather than each supply instance.

The next meeting is proposed for February/March 2025.