Medical devices reforms: Consumer Working Group meeting statement, Meeting 3, 18 June 2020

Agenda

The working group met via teleconference on 18 June 2020 to discuss:

• Action Areas 1 and 8 of the priorities agreed by the working group at their meeting on 19 November 2019; and
• The Action Plan for Medical Devices Report Card.

Key points

Key points discussed at the meeting included:

• Communique 2 from the February session of the Working Group has been accepted and can now be finalised.
• The "five questions" document for implantable medical devices has been finalised and is with the TGA Communications team for publication.
• Minister Hunt has decided to delay the implementation of some medical device reforms due to the impact of COVID-19. This decision reflects the decision of the European Parliament to delay their own medical device reforms due to COVID-19.
• Some members raised concerns about the quality of masks included in the ARTG and available in Australia. The TGA provided information about the actions taken to ensure masks included in the Australian Register of Therapeutic Goods (ARTG) are safe and fit for their intended purpose.
• The suggestion from members that all medical devices should have a patient information leaflet is a government decision. It is likely that the roll out of the current initiative for patient implant cards and information leaflets will be assessed at a later date and expanded if it is found to be effective. There are stumbling blocks in place that make this kind of initiative difficult to introduce.
• Members agreed that the information provided by the TGA is appropriate for the intended audience but the dissemination of information could be improved through partnership with consumer-focused organisations that have established newsletters and social media platforms.
• The Action Plan for Medical Devices infographic is not useful or informative. The information is already contained in the Plan itself and the information that is needed is information about the work that has been done and the work ahead.
• The Action Plan for Medical Devices report card is better laid out and provides more information that would be useful to stakeholders. The squares should be changed to traffic light colours (green, amber and red). The small pictures should also be removed and then it should be published.

Action items

TGA action items arising from this meeting are:

1. Provide members with a copy of the information about masks that is being circulated to healthcare providers.
2. Consider drafting information for dissemination through consumer organisations when preparing new information for publication.
3. Amend the Action Plan Report Card in line with the recommendations made by the Working Group and publish.
4. Notify members of the Working Group when the "five questions" document for implantable medical devices has been published on the TGA’s website.

At the next teleconference the working group will discuss action areas 3 and 4 of An Action Plan for Medical Devices.

3. Publishing information on how regulatory decisions are reached for individual high risk devices.

4. Publishing additional information such as clinical evidence, searchable incident reports, inspection reports, regulatory actions.

Further information

Meeting statements are made publicly available after each meeting.

For further information on the APMDCWG, please visit the Action Plan For Medical Devices Consumer Working Group page or contact devicereforms@tga.gov.au.

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