Medical device reforms: Consumer Working Group meeting statement, Meeting 8, 26 August 2022

Agenda

The Medical Devices Consumer Working Group (MDCWG) met on 26 August 2022 and discussed the MDCWG’s forward workplan and:

• adverse event reporting
• the way TGA communicates
• Patient Information Leaflets (PILs) and Patient Implant Cards (PICs), and
• product recalls.

The MDCWG noted TGA actions and improvements to date and discussed consumer impacts and suggested areas for additional change.

Key points

Adverse event reporting

The TGA presented on the current adverse event reporting process and recent changes that aimed to improve consumer access and ease of reporting.

Members noted:

• consumers can report medicine adverse events to the TGA through phone, email or online
• consumer reports contribute to broader datasets to indicate any safety concerns, so reports are not investigated individually, and
• recent updates to the Adverse Event Management System and Database for Adverse Event Notification (DAEN) – Medicines increase consumer access and availability of information, and enable easier reporting processes.

The MDCWG discussed consumer experiences with the adverse event reporting process and suggested opportunities to improve reporting processes and information such as:

• improving information and instructions about medical devices adverse event reporting on the website landing pages, reporting forms and standardised acknowledgements
• considering the terminology of ‘adverse event’ with other, more familiar terminology (‘adverse reaction’, ‘side effect’, ‘undesirable effect’), and
• improving the DAEN – Medical Devices to increase search and access to reports, such as those in place for medicine adverse events.

The MDCWG agreed to work with the TGA on improvements to enhance consumer awareness and also to promote the importance of reporting adverse events.

Changing the way TGA communicates

The MDCWG noted recent changes to the TGA website in an effort to simplify and promote consumer access, such as:

• removing sector-specific hubs
• revising content to align with the Australian year eight level reading standards, and
• leveraging social media and non-digital-based communication to improve outreach, particularly to areas with lower levels of health literacy and culturally and linguistically diverse communities.

Members confirmed that consumers will benefit from the improvements and noted the importance of:

• having recognisable and trusted community members as alternate spokespeople
• engaging broadly with consumer communities to identify and co-develop future TGA website content that is of consumer interest, and
• using existing networks and communities to disseminate content to areas that may not be previously or easily reached.

The MDCWG agreed to collaborate with the TGA to progress these suggestions.

Patient Information Leaflets (PILs) and Patient Implant Cards (PICs)

The MDCWG discussed examples of patient information leaflets (PILs) and patient implant cards (PICs) provided, and lived experiences gathered from members.

Suggestions to improve consumer awareness, access and understanding of materials included:

• leveraging digital technologies (electronic wallets, unique device identifiers) and the government’s My Health Record initiative
• undertaking targeted education to increase awareness and promote confidence for consumers to ask for patient information materials from their health professionals, and
• TGA writing to healthcare professional associations and groups to promote awareness of the resources, which are useful to support informed consent.

The MDCWG agreed to continue to work with the TGA to promote consumer awareness of the patient information materials and advise on any guidance developed.

Recalls

The MDCWG was provided with an overview of the current Australian therapeutic goods recall process, highlighting recent targeted stakeholder feedback on potential improvements and change. Members noted that a discussion paper on recall reforms was being drafted with a view to publishing during late 2022 to seek broader public feedback.

The MDCWG acknowledged the efforts to improve the recalls process, its framework and guidance. Members indicated:

• an interest to participate in the consultation on the reforms
• opportunities the MDCWG could play in raising awareness of medical devices related recalls and its processes with consumers and networks to increase reach of recall notices, and
• opportunities for TGA to engage more with health professionals, particularly general practitioners and pharmacists, to enhance patient follow up in the event of a recall safety alert.

Forward workplan and priorities

The MDCWG identified three priorities for its 12-month forward workplan:

1. regular engagement sessions on upcoming TGA discussion and consultation papers that are of interest to consumers and consumer groups.
2. co-revising content for adverse event reporting with the TGA, ensuring a consumer-centric focus.
3. identifying and advising on content changes for the TGA website that is of highest priority and interest to consumers.

The next meeting is proposed for December 2022.

• Summary from the Medical Devices Consumer Working Group workshop (pdf,86kb)