Medical device reforms: Consumer Working Group meeting statement, Meeting 14, 2 July 2024

Agenda

The Medical Devices Consumer Working Group (MDCWG) met on 2 July 2024. Members discussed:

• declaration of interests,
• travelling with medicines and medical devices, and
• the purpose and design of patient information leaflets.

Members received updates on:

• the TGA’s regulation of clinical decision support software (CDSS) and
• the National Clinical Trials Governance Framework.

Key points

The importance of declaring interests and managing potential conflicts of interest from a personal and an organisational perspective were discussed. Members recommended the current declaration of interest forms be reviewed to ensure clarity and completeness. 

The Australian Commission on Safety and Quality in Health Care presented on the implementation of the National Clinical Trials Governance Framework. Members noted the framework is based on five core principles, including:

• patient centred and meeting the needs of the community,
• a safe environment, 
• quality,
• risk and proportionality, and 
• accountability and transparency. 

Members discussed:

• the provision of support to consumers who had been injured during clinical trials,
• the procedures in place for reporting and collecting data clinical trial injuries, and
• increasing the involvement and engagement of people living in residential aged care in clinical trials for interventions that would benefit older people with cognitive impairments.

On the TGA’s web content on travelling with medicines and medical devices, members made further suggestions to inform the TGA’s discussions with the Australian Airports Association, Department of Home Affairs and Melbourne Airport. 

The TGA informed members of the recent Clinical Decision Support System (CDSS) software consultation and the proposals to provide clarity around its regulation. Members:

• noted the regulation of CDSS as exempt software, and the challenges faced by healthcare professionals using CDSS,
• discussed the regulation of computer-generated decision software used for determining eligibility for aged care services, and
• looked forward to participating in future consultations about the use of Artificial Intelligence.

Members agreed that the information provided in patient information leaflets, regarding possible lifestyle adaptations when living with the aid of medical devices, as it is currently presented, is sufficient as providing consumers with additional information could be overwhelming.

The next meeting is proposed for October/November 2024.