Medical devices reforms: Consumer Working Group meeting statement, Meeting 5, 15 December 2021

Agenda

The Medical Devices Action Plan Consumer Working Group (MDCWG) met via teleconference on 15 December 2021. The agenda included:

• an overview of the Action Plan for Medical Devices (released in 2019) and the work progressed to date by the TGA and consumers / consumer groups;
• the refreshed Terms of Reference (ToR) for the Consumer Working Group; and
• the TGA’s proposal to amend the medical devices adverse event reporting exemption rules.

Key points

Members discussed the draft Terms of Reference, which built on the scope, practice and achievements of the Action Plan for Medical Devices Consumer Working Group (2019-20) to include:

• an expanded membership of more than 20 consumer groups across the health sector;
• proactive involvement of the MDCWG in the TGA’s medical devices reform projects; and
• opportunities to engage with authorities involved with the regulation of medical devices, like the TGA, to improve patients’ engagement with and understanding of the medical devices regulatory processes.

The MDCWG ToR will be published on the TGA website once endorsed by members. The full MDCWG membership list can be found on the MDCWG homepage.

The progress of proposal one, Changes to current adverse event reporting exemptions, from the 2020 consultation paper; Proposed enhancements to adverse event reporting were presented.

The 2020 consultation paper sought feedback on five proposals to enhance adverse event reporting:

1. Make changes to the current adverse event reporting exemptions
2. Strengthen reporting requirements for medical device adverse event
3. Implement a program of TGA inspections and audits of sponsor activities and premises to validate how they conduct their post market surveillance obligations
4. Review post-market definitions in the Medical Device Regulations
5. Find ways to enhance communication between the TGA and the consumers of medical devices.

Proposal one was to amend the eight exemption rules that currently allow sponsors and manufacturers to not report certain adverse events suspected to be caused by a medical device.

Three options were proposed:

• remove all adverse event reporting exemption rules; or
• remove some of the exemption rules that have been misinterpreted in the past; and/or
• reword some of the exemption rules and simplify jargon, along with provide examples to illustrate the application of the exemption rule.

MDCWG views were sought on the changes which were developed after considering the feedback from the public consultation. Respondents to the public consultation supported the removal and rewording of the exemption rules.

The MDCWG noted:

• Activities that increase consumer protection, as seen through the proposed changes, are always welcomed.
• Consumers and consumer groups support the changes to the exemption rules as proposed by the TGA and are willing to work with the TGA, where required and appropriate, to implement the changes, after Government consideration.
• The importance of continuing work on communicating key issues and topics relating to medical device adverse events to consumers, in particular activities that can improve the communities understanding of the issues, regulation, and health literacy.
• Improved access to information using both digital and non-digital communication pathways is important.

Members were also updated on progress under the Action Plan for Medical Devices and the eight focus areas established by the Action Plan Consumer Workshop in August 2019.

The eight focus areas were:

1. Publishing consumer-friendly information about the responsibilities of the TGA, suppliers and health professionals.
2. Strengthening awareness through new consumer communication and education programs.
3. Publishing information on how regulatory decisions are reached for individual high-risk devices.
4. Publishing additional information such as clinical evidence, searchable incident reports, inspection reports, regulatory actions.
5. Identifying easier mechanisms for reporting adverse events.
6. Reporting on assessment timeframes for new products.
7. Establishing expert working groups with consumer representation on devices of concern and establishing a women’s health products group.
8. Translating technical regulatory language into plain English.

Progress reports on the Action Plan for Medical Devices are available on the TGA website. These progress reports show the broad range of TGA activities that have been undertaken to address the three strategies set out in the Action Plan.

Notably, the TGA has progressed the following activities (not exhaustively):

• Publishing consumer-focused information, for example:
  • The Five questions to ask your health practitioner before you get a medical implant;
  • Material (factsheets and webpages) on COVID-19 devices and key topics - test kits, most notably Rapid Antigen Tests (RATs); vaccines; ventilators.
• Mandating the provision of patient information materials (patient information cards / leaflets) to patients that receive an implantable medical device.
• Establishing consumer-centred webpages for medical devices, including dedicated hubs for key devices of interest like breast implants and urogyanaecological mesh devices.
• Ensuring consumers are represented on expert working groups considering medical devices:
  • Breast Implant Expert Working Group
  • Surgical Mesh Expert Working Group
  • Ventilator Expert Working Group

Further information

Meeting statements are made publicly available after each meeting.

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

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