TGA boosts medical device safety

The safety of Australians who rely on medical devices has been boosted with a suite of new regulations announced this week by the Therapeutic Goods Administration (TGA).
 
The measures will allow devices to be clearly and quickly identified by the TGA, enabling quicker responses from the authority if issues arise.
 
In a move to help both GPs and patients, the TGA is introducing a unique device identification (UDI) system for all medical devices.
 
Manufacturers will be required to use barcodes on all product packaging and labelling and submit the data to the TGA. 
 
The UDI data can then be integrated into hospital and patient records to enable identification of specific devices.
 
The information will also be available on a public database for patients to access details about their devices.
 
For implanted devices, compliance with the UDI system will be mandatory from July 2026.
 
TGA Chief Medical Advisor Professor Robyn Langham is encouraging ‘all healthcare facilities, surgeons and GPs to explore the powerful capabilities of UDI’, saying it offers opportunities for improved patient care and clinical data systems.
 
‘UDI is set to play a vital role in empowering patients with full transparency regarding their medical devices, ultimately supporting safer and more informed healthcare decisions,’ she said. 
 
From 2026, mandatory reporting by hospitals of injuries, or suspected injuries, related to medical devices will also come into effect.
 
TGA Chief Medical Officer Professor Anthony Lawler said the additional data provided by hospitals will play a ‘critical role’ in identifying potential safety risks sooner, enabling a quicker response from authorities when needed.
 
For the recall of therapeutic goods, the TGA has already introduced new and simplified terminology, streamlined processes and clearer communication of recall information for patients, healthcare professionals and users.
 
Aided by strengthened legal recall powers for the TGA, the changes are designed to make it easier for both suppliers and device users to make reports on product safety, enabling a quicker response from the authority.
 
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