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Medical devices reforms: Consumer Working Group meeting statement, Meeting 2, 20 February 2020

Action Plan For Medical Devices Consumer Working Group

17 February 2021

Agenda

The working group met via teleconference on 20 February 2020 to finalise the terms of reference for the group and discuss Action Areas 2 and 5 of the priorities agreed by the working group at their meeting on 19 November 2019.

Key points

The majority of members were unable to attend the meeting and therefore the Chair closed the meeting and sought comments via email. A response template was emailed to working group members seeking comments on:

  • the finalisation of the Consumer Working Group Terms of Reference;
  • preferences between two versions of a document for consumers containing five questions they should ask their treating medical practitioner before being implanted with a medical device;
  • three examples of different patient implant information leaflets; and
  • consumer-specific adverse event reporting pages, and possible ways of improving the process for consumers to report adverse events to the TGA.

Reponses were received from five working group members as follows:

  1. Agree that the Terms of Reference can be finalised.
  2. Provided feedback indicating a preference for the question structure used in Attachment 2c and the readability of Attachment 2d as strengths of the '5 questions' documents.
  3. Suggested design elements to improve readability for Attachments 3b, 3c and 3d.
  4. Queried whether Attachment 3b meets the requirements of a patient information leaflet (PIL) as outlined on the TGA website.
  5. Suggested several bodies that the TGA should explore partnerships with for the purposes of strengthening messages around provision of PILs and associated information including Health Direct, NPS MedicineWise, medical colleges and professional bodies.
  6. Proposed that patient information leaflets (PILs) should be available for most, if not all, medical devices to be supplied in Australia (noting that implanted and high-risk devices are the most important devices).
  7. Suggested that the TGA consider developing an online database for PILs for devices included on the Australian Register of Therapeutic Goods (ARTG) for ease of access.
  8. Strongly encouraged the TGA to explore the development of a mobile app for adverse event reporting.
  9. Found that the online adverse event reporting form was difficult to navigate and use.
  10. The small pictures should also be removed and then it should be published.

Action items

TGA action items arising from this meeting are:

  1. The TGA will align Attachment 2c with the design elements that aid readability and proactive consumer voice of Attachment 2d.
  2. The TGA will look to discuss collaborations with the bodies suggested by the members, many of which have other collaborative work ongoing.
  3. The TGA will consider ways to ensure PILs are available online.
  4. The TGA will further explore ways to encourage adverse event reporting, particularly the idea of a mobile app.

At the next teleconference the working group will discuss action areas 1 and 8 of An Action Plan for Medical Devices.

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.

Keep up to date

Please contact the TGA at devices@health.gov.au if you have any queries or comments.

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For more information about other reforms visit Medical devices reforms.