Medical device reforms: Improving consumer/patient information
The TGA publishes consumer-centred information to increase awareness and understanding of devices of public interest or concern.
Consumer information hubs
The TGA has information hubs on devices of interest. Consumers can easily find safety information and, resources on managing their device or condition. This helps to ensure devices continue to be safe and perform as intended.
Breast implant hub
The breast implant hub has information on breast implants. The hub provides information risks, benefits and breast implant associated anaplastic large cell lymphoma (BIA-ALCL). There is also information on where to report problems or get help. Consumer information available on the hub includes:
- information about breast implant associated cancer BIA-ALCL, how it is diagnosed and treated, key symptoms, and how to seek help
- a fact sheet on the recall of Allergan Biocell breast implants in 2019 and what consumers should do and watch for if they have these devices
- questions consumers can ask their health professionals as they consider breast implants (Things to consider before having the procedure).
Urogynaecological (transvaginal) surgical mesh hub
The urogynaecological (transvaginal) surgical mesh hub hosts information on mesh devices, what the TGA has done in response to the 2016 Senate Inquiry, how to seek help, and how to report any problems experienced.
Information available on the hub includes:
- See our other resources for consumers page for fact sheets, videos and other resources about urogynaecological (transvaginal) surgical mesh.
- Support services for women affected by urogynaecological mesh.
Other consumer resources
Other resources on devices or topics (that relate to medical devices) of public interest developed by the TGA have included:
- TGA advice for consumers on purchasing COVID-19 rapid antigen tests, encouraging consumers to only purchase COVID-19 rapid antigen tests (RATs) that are approved for use in Australia by the TGA from reputable sources.
- A consumer fact sheet on correct use of COVID-19 self-testing kits, following reports of inaccurate results because kits may not have been used correctly and/or the instructions for use were not followed properly.
- information on medical device cyber security, addressing the increase in medical devices that connect to the internet or mobile devices, or that can transfer information remotely to health professionals or manufacturers.
Improving industry guidance on devices of public interest
The TGA develops and updates industry guidance on devices of public interest. This guidance encourages industry to ensure that the device is patient centred and mindful of potential risks. Examples include:
- A fact sheet on general requirements for advertising personalised medical devices to consumers, providing an overview of medical device advertising standards and examples of compliant and non-compliant advertisements.
- A fact sheet on digital mental health: software based medical devices, providing information on when a software is considered a medical device and how the TGA regulates these types of devices.
- Medical device cyber security guidance for industry, provides strategies to risk assess and manage cyber security in devices.
- Advertising COVID-19 rapid antigen point-of-care tests and self-tests (home use tests), reinforcing the requirements for self-testing kits that are widely accessed by consumers
The TGA develops information for industry on a as needs basis and consults with stakeholders, including consumers through the Medical Devices Consumer Working Group.