Medical device reforms: Consumer Working Group meeting statement, Meeting 13, 27 February 2024

Agenda

The Medical Devices Consumer Working Group (MDCWG) met on 27 February 2024 and discussed the TGA’s medical device reform activities. This included the regulation of:

• in-vitro fertilisation (IVF) media and cell/tissue/organ storage solutions, and 
• medical devices manufactured at the point of care (PoC manufacturing). 

Members discussed the: 

• updated MDCWG Terms of Reference (ToR)
• results of a member survey about the work undertaken by the MDCWG in 2023, and 
• MDCWG’s 2024 workplan. 

Key points

Members noted and welcomed the progress of activities outlined in their 2022-23 workplan, including: 

• commenting on and supporting the revision of the TGA’s consumer-facing content for adverse event reporting and travelling with medicines and medical devices, and
• speaking on behalf of consumers living with medical devices and raising awareness about the challenges faced during airport security screenings. 

1. Members agreed to the revised MDCWG ToR, which has incorporated principles that focus on: 

• empowering consumers to make informed decision by being able to ask, find and use important and credible information, for example using TGA developed information and resources 
• considering the needs of consumers and impacts with the use of emerging technologies, particularly in culturally and linguistically diverse, rural and remote, aged care and other communities, and 
• co-designing consumer-facing information and resources with the TGA. 

The ToR and 2024 workplan were informed by responses to the member survey. 

Members agreed to these focus areas for the 2024 workplan:

• increasing consumer awareness of adverse event reporting 
• providing ongoing views on TGA’s medical device regulatory reform work, and 
• reviewing the information provided in the patient information leaflets and instructions for use for consumer goods. 

1. On the IVF media and cell/tissue/organ storage solutions 2019 public consultation, and PoC manufacturing, the MDCWG advised:

• broader impacts on supply and, consequently, consumer access should be considered prior to any changes to how devices are classified or aligned with international regulators 
• healthcare facilities need to be more involved with adverse event reporting, to ensure the TGA receives reports about device use and any problems 
• regulatory processes for health professionals involved with POC manufacturing, need to be robust, to ensure that the trust a consumer puts into their practitioner is retained 
• more information about the safeguards that are in place for POC manufacturing hubs need to be available to provide assurance on the safety and quality of devices produced, and
• early consumer involvement in these considerations is crucial, to ensure a patient-centric approach to any proposed regulatory changes.

The next meeting is proposed for July 2024.