Medical device reforms: Consumer Working Group meeting statement, Meeting 10, 14 March 2023

Agenda

The Medical Devices Consumer Working Group (MDCWG) met on 14 March 2023 and discussed:

• the progress of the MDCWG’s forward workplan and the TGA’s medical device reforms
• the TGA’s proposed changes to electronic Instructions for Use (e-IFU) for medical devices and point-of-care (POC) manufacturing of medical devices, and
• how consumers/patients’ perspectives contribute to medical device regulation.

Cancer Council Australia and Health Issues Centre presented to the MDCWG the work of their organisations and forward priorities for 2023.

Key points

The MDCWG noted and welcomed the TGA’s proposal to transition the regulation of Class I (low risk) assistive technologies and prescription lenses / spectacles as excluded devices (having no TGA regulation) to exempt devices. The change will enable the TGA have increased regulatory oversight over these low-risk assistive devices.

Members noted the publication of the Action Plan for Medical Devices Progress Report Card – December 2022, and acknowledged work and achievements over the period, including the consumer voice on all the medical devices expert working groups. Consumers are also well represented in TGA’s Women’s Health Products and Medical Devices Consumer Working Groups.

Forward priorities in medical device reforms, include a focus on post-market surveillance activities including:

• piloting the Medical Devices Vigilance Program (sponsor desktop audits and onsite inspections)
• developing new regulations to implement mandatory reporting of medical device adverse events by healthcare facilities, and
• implementing compliance to medical device unique device identifiers.

The MDCWG were provided with an update on the activities agreed to in the MDCWG forward workplan including:

• holding a consumer/user discovery workshop on the travelling with medicines and medical devices content
• providing feedback on revised adverse event reporting web content, report acknowledgement text, and a fact sheet for health professionals on patient information materials
• advising on improving health practitioners’ awareness of and engagement with patient information materials, suggesting that the TGA continuously engage with the Australian Health Practitioner Regulation Agency (Ahpra) and the Australian Medical Association, and
• publishing a patient information materials fact sheet for health professionals, following review by Ahpra.

The TGA presented overviews on e-IFU for medical devices and how POC manufacturing of medical devices was increasing. Consumer views were sought on proposals to:

• expand the access to e-IFU to consumers goods, and
• clarify regulatory oversight of medical devices manufactured at the POC.

The MDCWG advised that:

• having access to both electronic and paper IFUs is important since digital literacy varies across the population
• IFUs should be provided in different communication forms – written instructions, visual flowcharts and videos. The different mediums cater to different consumer preferences. Using different forms was effective with COVID-19 rapid antigen test kits IFUs
• The TGA informed members that manufacturers are responsible for developing IFUs, however the TGA can require consumer testing and include members’ feedback in best practice guidance for industry, and
• consumers should be engaged as early as possible to ensure lived experiences are considered alongside other stakeholder feedback as policy is being developed. Members noted early engagement is important as consumers may not have been aware that their device was a custom-made or patient-matched device. Safeguards on the design and manufacture to ensure devices are safe, and obtaining informed consent, is important.

Members noted the discussion on incorporating the consumer/patients’ perspectives in its regulatory activities and decisions.  Consumer/patient touchpoints included:

• consumer participation in the Advisory Committee on Medical Devices and device-specific expert working groups on surgical mesh, breast implants and ventilators. These groups provide expert advice to the TGA on device applications or devices of concern, and
• gathering and considering the consumer experience through clinical trials data, adverse event reporting and device registries data. Registries can capture real world evidence and patient reported outcomes datasets. Device registries, notably the Australian Breast Device Registry and the Australian Orthopaedic Association’s National Joint Replacement Registry, continue to look at ways to capture the full picture of a patient’s journey.

The next meeting is proposed for June 2023.

Further information

Meeting statements are made publicly available after each meeting.

For further information on MDCWG, please visit the  Medical Devices reforms: Consumer Working Group page or contact dwg.tga@health.gov.au.