Medical device reforms: Consumer Working Group meeting statement, Meeting 11, 22 June 2023

Agenda

The Medical Devices Consumer Working Group (MDCWG) met on 22 June 2023 and discussed:

• real-world evidence and its use in clinical and regulatory settings, in conversation with the TGA’s Chief Medical Adviser, Adjunct Professor Robyn Langham AM
• updates provided on the TGA’s medical device-related reform activities and consultations, including the TGA’s promotion campaigns, the Digital Transformation Program, and the Unique Device Identification (UDI) system.

Key points

The MDCWG welcomed the 2023-24 Australian Government - external site funding including $61 million to the TGA across four years, for public good activities such as:

• expanding compliance activities
• enhancing capabilities to manage medicine and medical device shortages, and
• increasing education for small to medium enterprises, health professionals and consumers

Members noted the preliminary outcomes of the Recalls reforms discussion paper and the Medical Devices Point of Care Manufacturing National Symposium held in mid June 2023.

Members supported the TGA’s consumer-focused promotion campaigns, which ran from 11 June to 30 June 2023:

• travelling with medicines and medical devices
• Five questions to ask your health professional before you get a medical implant (Five questions), and
• beware of buying medicines and medical devices online

Members offered to promote the campaigns across their organisational networks, recognising that this information was important and useful for consumers. They suggested the TGA should look to expand the travelling with medicines and medical devices content to:

• link with other popular and reputable sites with travel information, for example, Smartraveller, and
• broaden the information to consumers, on what to expect when going through airport security and the rights of the individual.

Members recommended:

• future iterations of the Five questions could include information about the broader implications on an individual’s lifestyle after a medical device is implanted, additional to information about possible adverse events, and
• culturally and linguistically diverse (CALD) appropriate content. Translated material should be based on content that is written in plain, simple English and concepts should be readily understandable.

Members agreed that TGA’s work on the UDI will help consumers and health professionals identify their medical devices faster and more accurately. This will be useful when there is an adverse event or recall. With the information readily available in the Australian UDI database (AusUDID), consumers will know more about their medical device. It will help increase consumers’ awareness of any software components associated (or a part of) the device.

The MDCWG appreciated the TGA’s Chief Medical Adviser discussion on the use of real-world evidence in clinical and regulatory settings, and its future in driving healthcare decision-making. Members noted that CALD communities continue to have minimal engagement in clinical trials, and ethnicity is often treated as ancestry, rather than a risk factor for disease. Members encouraged a mindset change when designing and using real-world evidence more broadly to ensure representativeness.

The next meeting is proposed for October 2023.