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.
- 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.
- 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.
Outcome of