Medical device reforms: Consumer Working Group meeting statement, Meeting 9, 9 December 2022

Agenda

The Medical Devices Consumer Working Group (MDCWG) met via videoconference on 9 December 2022 and:

• discussed progress made by the TGA on medical device reforms
• considered work by the Australian Commission on Safety and Quality in Health Care on urogynaecological mesh guidelines, and
• agreed to MDCWG’s activities for 2023, based on the forward planning workshop held 26 August 2022.

Key points

The MDCWG noted TGA’s reform consultations on Proposed regulatory changes to clinical trials of medical devices, Unique Device Identification (UDI) consultation paper 3, the potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia and the yet to be published Recalls Reforms discussion paper. Members also noted the finalisation of the translation of the consumer fact sheet - Five things to ask your health professional before you get a medical implant into a number of languages and development of the Patient Information Materials - a fact sheet for healthcare professionals.

Members noted that: 

• changes that increase the safety and monitoring of clinical trials, particularly in the growing field of medical devices, noted in the consultation, are welcomed
• there is a need for an ongoing, multi-pronged approach to promote the awareness, understanding of the patient information materials across health professionals, hospitals, state and territories, private health industry, and consumers
• whilst there has been an increase in the awareness of the TGA, there are still gaps and misunderstandings in the general public’s knowledge of the role of TGA and the scope of TGA’s regulatory role and legislative responsibilities, and  
• as self-testing kits continue to rise in prominence, the TGA should consider undertaking an analysis of the use and experience of other self-tests, such as HIV self-test kits. The MDCWG noted the questions and feedback in the recent TGA annual Stakeholder Survey about rapid antigen test kits. Such feedback may inform strategies to educate and provide information to consumers to promote best practice use.

The Australian Commission on Safety and Quality in Health Care presented its work on urogynaecological mesh, including developing and maintaining of resources for hospitals, health practitioners and consumers. The Commission described its activities in relevant working and steering groups. Members encouraged developing similar resources and guidelines to hernia mesh devices and procedures.

Informed by recommendations and priority areas previously identified by members in the August 2022 forward planning workshop, the MDCWG agreed to progress a range of activities, including:

• co-revising adverse event reporting and TGA web content, focusing on improving consumer experience and increasing awareness and understanding of these topics
• co-developing fact sheets to support consumer understanding of patient information materials and how to report adverse events to the TGA, and
• engaging with the TGA through briefing sessions on medical-device related consultation papers of consumer interest, and on-sharing TGA-created content on key consumer-centric information, like safety alerts and recall notices.

The MDCWG will continue to provide advice to the TGA on medical device reform activities and associated resources throughout the year.

The next meeting is proposed for March 2023.

Further information

Meeting statements are made publicly available after each meeting.

For further information on MDCWG, please visit the  Medical Devices reforms: Consumer Working Group page or contact dwg.tga@health.gov.au.