To improve the patient safety in the application of medical devices, Therapeutic Goods Administration (TGA) has announced to establish an Australian Unique Device Identification (UDI) system in October 2020. Through the system, tracking and tracing of medical devices are available, and it allows for a quick response from the doctor to notify the patient if safety issues with a medical device become apparent. The system can particularly enhance the strength of the system of adverse events for medical devices during the post-market surveillance.
During the development stage, TGA has involved health professionals, healthcare organisations, consumers and industry manufacturers, and has undertaken consultations to ensure that various different perspectives of the system have been taken into consideration.
TGA has set up several webinars for the UDI system and published the corresponding presentation slides and recordings to provide relevant information and Q&As to the public. TGA has furthermore launched the latest 10th webinar for the unique device identification in June 2022, and the 'Sandpit' version of the Australian UDI Database (AusUDID), which is used to gather the user’s feedback on the usability and design of AusUDID. That is, in order to improve the operation of the system, which was launched on 4 July 2022.
The 'Sandpit' version of the Australian UDI Database (AusUDID) introduces functions, such as user registration and accounts creation; create, read, update, search, view, and export UDI Data; attaching documents to UDI record; scan barcodes and device labels; and managing device lifecycle, etc.
For more information related to the Australian UDI Database (AusUDID), you can check the presentation slides for each Unique Device Identification webinar with the abstract as follows:
- - 1st Webinar (15 June 2021): An Introduction to the Australian Unique Device Identification System;
- - 2nd Webinar (20 July 2021): Worldwide Considerations for the Australian UDI;
- - 3rd Webinar (17 August 2021): Challenges and Considerations of the Establishment for the Australian UDI System;
- - 4th Webinar (21 September 2021): The Introduction of a UDI Issuing Agency;
- - 5th Webinar (19 October 2021): The Introduction of a UDI Issuing Agency and Progress of the Establishment for the Australian UDI System;
- - 6th Webinar (16 November 2021): The Progress of the Establishment for the Australian UDI System;
- - 7th Webinar (22 March 2022): Global Manufacturer UDI Learnings;
- - 8th Webinar (19 April 2022): Information Related to Experiences from Arthrex;
- - 9th Webinar (17 May 2022): Experiences Sharing about Software Solutions to Improve Unique Device Identification;
- - 10th Webinar (21 June 2022): Information Related to the AusUDID Sandpit;