The Commission, in collaboration with the Therapeutic Goods Administration, Queensland Health and the Australian Government Department of Health is undertaking a project to develop and pilot of the Australian Unique Device Identifier Framework (UDI Framework) for Australian Health Service Organisations.
Adoption of the UDI Framework aims to improve patient safety by enhancing Australia’s post-market medical device adverse event, surveillance and recall systems – at the national and jurisdictional levels, and enable action to reduce potential harm. Adoption of the UDI Framework is consistent with, and supports, the important goal of improving how medical device safety issues are identified, monitored and managed.
Implementation of the UDI Framework will support the response to the Senate Inquiry into transvaginal mesh implants for more efficient regulatory responses by the Therapeutic Goods Administration in relation to safety issues. It will also improve efforts by jurisdictions, and the private sector, to identify safety or performance concerns, enhance their capability to effectively respond to adverse events, support recalls, and build consumer confidence in Australia’s system for post-market surveillance.
In October 2020, the Australian Government announced that it would strengthen patient safety through the establishment of an Australian UDI system for medical devices. In February 2021, changes were made to the Therapeutic Goods Act to provide for the collection of the UDI data in an Australian UDI database, the creation of regulations to support the collection of data, and the changes required to device labels. The Therapeutic Goods Administration will establish and maintain the supporting infrastructure (the database and data collection, and regulations around labelling requirements).
The potential benefits of adopting the UDIs for patients, healthcare providers, hospitals, industry and regulators include:
- Easier identification of medical device models
- More accurate recording and analysis of adverse events
- Faster and more accurate identification of device problems and more effective management of device recalls
- Standardised recording of devices in electronic health records, clinical information systems, registries, supply chains and reimbursement processes
- Better international device information sharing and management of global distribution chains.