NEW measures introduced by the Australian Government will enhance the identification and management of safety concerns related to medical devices, from consumer level devices such as CPAP machines and blood glucose monitors, to hospital equipment and medical implants.
The Therapeutic Goods Administration (TGA) will now receive clearer identification and more detailed information about devices, allowing it to respond more quickly as and when issues are found.
Starting 21 Mar 2026, mandatory reporting of medical device-related injuries or suspected injuries will be in place for all public, private and day hospitals.
These reports will help the TGA to detect safety issues quickly and prioritise patient safety.
Another measure is the mandatory requirement from Jul 2026 for manufacturers supplying medical devices in Australia to use barcodes to identify their products on all packaging and labelling, and submit this data to the TGA.
When used by healthcare organisations, UDI information can be integrated into hospital systems and patient records, including MyHealth Record, to accurately identify the specific medical device used.
The TGA will also maintain a public database of UDI information, giving patients access to details about their medical device.
Finally, a stronger and more transparent process for recalling therapeutic goods in Australia has commenced, making it easier for suppliers and users to initiate and report product safety actions, and assisting the TGA in responding quickly and appropriately.
Key improvements include new and simplified terminology, streamlined processes, enhanced legislative recall powers for the TGA and clearer communication of recall information for patients, healthcare professionals and users. KB
The above article was sent to subscribers in Pharmacy Daily's issue from 01 Jul 25
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