Medical device reforms: Consumer Working Group meeting statement, Meeting 7, 4 May 2022

Agenda

The Medical Devices Action Plan Consumer Working Group (MDCWG) met via videoconference on 4 May 2022. The agenda included:

• Discussion on the MDCWG Forward Work Plan; and
• Updates on the TGA Digital Transformation Project and Unique Device Identification (UDI) system.

Key points

The MDCWG noted the eight focus areas previously identified at the Action Plan Consumer Workshop in August 2019 and received a presentation from the TGA on the work undertaken on four of the action areas that had been identified as priorities to progress (italicised below) and how consumer input had contributed to the work items:

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

Examples of consumer input into improving TGA website content, a range of information and fact sheets and new consumer membership on working groups and committees was noted.

The MDCWG noted:

• the importance of patient-based material being available in languages other than English;
• future opportunities to discuss and define areas of focus for the MDCWG through a workshop; and how consumers can be better engaged to inform the group's Forward Work Plan.

The MDCWG discussed:

• the TGA's limited media presence and whilst COVID has highlighted the role of the TGA, there still remains a general lack of knowledge and understanding by consumers of the TGA;
• the need to improve the dissemination of consumer-focused information, such as medical device recalls, and suggested greater collaboration with consumer organisations and specialist consumer advocacy groups to help dissemination strategies;
• using different mediums, language, formats, and social media platforms to ensure that information is disseminated widely and to different audiences; and
• the proactive role that the MDCWG can play in this.

The TGA presented an update on the TGA Digital Transformation Project and demonstrated its new website, including the benefits of the new TGA website and ARTG database search to make information more accessible for consumers and health professionals.

The MDCWG was also provided with an update on the Unique Device Identification (UDI) project. The update included the benefits and importance of UDIs, including on how the UDI can improve consumer safety by improving the accuracy and tracking of medical devices and work to include UDIs in digital health records.

The next meeting is proposed for August 2022.

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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