Medical devices reforms: Consumer Working Group meeting statement, Meeting 1, 19 November 2019

Agenda

Over 40 consumer representative groups were invited to participate in a workshop convened by the Therapeutic Goods Administration (TGA) on 20 August 2019 to discuss strategies and action items detailed in An Action Plan for Medical Devices.

Following the workshop, a number of the representative groups met on 19 November 2019 to establish a Consumer Medical Device Action Plan Working Group (Working Group) that will work closely with the TGA over the next 12 months, providing input, advice and feedback on specific Action Plan strategies with the aim of improving information available to consumers about medical devices.

Key points

Key points discussed at the November meeting included:

• the function and frequency of meetings;
• the voluntary nature of the group;
• ways to communicate the group’s work to the public; and
• possible ways for the group to assist the TGA on specific Action Plan strategies and actions.

It is envisaged that the group will act as a 'sounding board' for ideas and approaches, providing feedback from both their organisation and their organisation’s networks throughout the community.

Working Group members reviewed and discussed the eight actions / areas of focus arising from the 20 August workshop to identify and agree on the top priorities. The following eight areas were identified:

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.

Actions / areas (1), (2), (5) and (8) will form the priority focus for the Working Group.

It was agreed that (2) and (5) should be considered together and that this would be the subject of the first teleconference to be convened in early 2020.

Actions / areas (1) and (8) will be discussed at subsequent teleconferences.

The Working Group encouraged the TGA to progress with establishing relevant expert working groups and the women’s health products group (7).

Working Group members discussed that wider engagement with 'everyday' consumers and engaging consumers on broader topics could be discussed at a face-to-face meeting. The Working Group noted that a face-to-face meeting may be convened in March/April 2020.