TGA is committed keeping on Australians healthy and safe and the updated legislations include the availability of prescription medicine, protect Australians from intentionally prohibited therapeutic goods. Most importantly, this is to strengthen Australia’s post-market monitoring of medical devices to improve the traceability and monitoring of medical devices.
Establishing the Unique Device (UDI) System will also bring TGA’s operations in line with its international counterparts, including the European Union, the United States and Japan who are also undergoing various stages of implementing this system.
There were some recent unfortunate cases of defective mesh devices and recall of breast implants in Australia. These incidents have shone the lights on the inability to trace a medical device after it has been implanted and pose undesirable post market incident. Introduction of this new UDI will mean people who have implanted medical devices can be identified immediately and recalled, if required.
Currently there is limitation on data collection of implanted devices in patients. UDI system will provide crucial data, including the specific version or model of a device, and potentially, additional information such as a batch number, serial number or manufacturing date. This will enable the identification of a faulty batch/lot in case of an AE incident and correct procedures can be taken within a minimal time. It also means that patients who have implanted devices such as pacemakers, cardiac valves can be easily tracked and followed up.
The information collected from the UDI database are stored within the Australia Medicare System. The regulation’s Section (5) stated that, the whole or a part of the database to be made available to specified persons, authorities or bodies; or publicly available. This database is not a legislative instrument and is required to be compliant under Privacy Act 1988.
In conclusion, implementing this new UDI system will improve TGA’s post market surveillance by unambiguously identifying devices involved with AE and SAE, reduced time and better procedures in regards to the devices for recalls.
- International Medical Device Regulators Forum
- Breast implants and anaplastic large cell lymphoma
- Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
- Therapeutic Goods Amendment (2020 Measures No. 2) Act 2021