Medical device reforms: improving consumer/patient information

Project overview

To increase public awareness of devices of interest or concerns, we publish consumer focus information.

Consumer information hubs

We have information hubs on devices of interest.

Safety information and resources on managing a device or condition are easy to find on these hubs. 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).

Consumer information includes:

• information about breast implant associated cancer BIA-ALCL
• a fact sheet on the recall of Allergan Biocell breast implants
• Things to consider before having the procedure
• Where to report problems or get help

Urogynaecological (transvaginal) surgical mesh hub

The urogynaecological (transvaginal) surgical mesh hub hosts information on mesh devices.

Information available includes:

• Resources for consumers such as fact sheets, videos.
• Support services for women affected by urogynaecological mesh.
• How to report problems experienced.

Other consumer resources

Other resources on devices or topics (that relate to medical devices) of public interest include:

• TGA advice for consumers on purchasing COVID-19 rapid antigen tests,
• A consumer fact sheet on correct use of COVID-19 self-testing kits
• information on medical device cyber security

Improving industry guidance on devices of public interest

We develop and update industry guidance on devices of public interest. 

This encourages industry to make sure devices are patient-centric and risk-aware.

Examples include:

• General requirements for advertising personalised medical devices to consumers
• Digital mental health: software based medical devices
• Medical device cyber security guidance for industry
• Advertising COVID-19 rapid antigen point-of-care tests and self-tests (home use tests)