Progress update: Mandatory reporting of adverse events by healthcare facilities

The TGA is working with the Australian Commission on Safety and Quality in Health Care and Australian hospitals, peak bodies, and state, and territory governments to improve and increase rapid information sharing about medical device safety and effectiveness.

Increased reporting of medical device adverse events by healthcare facilities will enable the TGA to rapidly identify and respond to significant issues associated with medical devices that impact upon the quality and safety of care and life experienced by Australian consumers.

In 2021, we sought feedback on the potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia in a discussion paper, Potential for Mandatory Reporting of medical device adverse events by healthcare facilities in Australia. The Discussion Paper explored the following areas of interest:

• the feasibility of mandatory reporting of medical device adverse events by Australian healthcare facilities
• the healthcare facilities and types of medical devices which should be included or excluded
• potential issues in enabling adverse event reporting and avoiding data duplication, and
• accountability.

Stakeholder feedback was considered in the drafting of the Therapeutic Goods Amendment (2022 Measures No.1) Bill 2022. On 21 March 2023, the legislation passed making it mandatory for Australian public and private hospitals and any other health facilities (prescribed by regulations) to report medical devices related adverse events to the TGA. Regulations to support implementation is due by 22 March 2025.