Medical devices reforms: Consumer Working Group meeting statement, Meeting 4, 27 November 2020

Agenda

The working group met via teleconference on 27 November 2020 to discuss:

• Action Area 3 of the priorities agreed by the working group at their meeting on 19 November 2019;
• Benefits realisation
• Consumer fact sheet for personalised medical devices;
• The Reforms website; and
• The Action Plan for Medical Devices Report Card.

Key points

Key points discussed at the meeting included:

• The disruption to day-to-day business at the TGA as a result of the COVID-19 pandemic has resulted in delays to reform work planned during 2020, including work to be addressed by the working group.
• June communique: Members asked that a list of attendees be included in communiques. Otherwise, communique 3 from the June session of the Working Group is accepted and can now be finalised.
• Benefits realisation: TGA will be conducting a benefits realisation consumer survey to ascertain the impact of reforms work on consumers and their perception of the TGA’s work. A draft of the survey will be circulated out of session.
• Consumer fact sheet for personalised medical devices: The consumer fact sheet should be more general, with less focus on the framework. Information about including device details in MyHealth record should be incorporated, along with a link to the "5 questions to ask…" implantable devices fact sheet. A revised version of the fact sheet should be circulated.
• Reforms website: The reforms website is not well structured for consumers. There should be a lot more graphics and visually pleasing, user-friendly content. The current content is appropriate for users with a high education level and should be adjusted to accommodate varying levels of literacy. Links between the consumer and industry content should be made readily available allowing users to easily link and compare the two.
• Action Area 3: Consumers would like to see:
  • a general overview of the assessment process for medical devices;
  • the specific recommendations and advice provided by the Advisory Committee on Medical Devices (ACMD);
  • how the advice and recommendations of the ACMD are utilised by the TGA;
  • more information about the assessments conducted by the TGA;
  • target advisory groups such as an advisory committee focused on women; and
  • clear examples demonstrating how the impact of devices on specific cohorts of patients has been addressed.

Action items

TGA action items arising from this meeting are:

1. Circulate the draft benefits realisation consumer survey;
2. Revise and circulate the personalised medical devices fact sheet for consumers;
3. Provide members who were unable to attend the meeting with an opportunity to provide their comments;
4. Circulate the consumer-friendly reforms website information when it becomes available; and
5. Explore which information about assessments of devices could be published.