Announcement date
25 March 2025
Link to announcement
https://www.legislation.gov.au/F2025L00414/asmade/text
Problem being addressed
Longer-term safety issues with medical devices (such as urogynaecological mesh and breast implants) are more likely to have serious clinical impacts some years after the device implantation. These may present in a different healthcare setting to the original procedure.
Adverse events are often not reported to the Therapeutic Goods Administration (TGA) by consumers, health practitioners or healthcare facilities due to lack of awareness, perceived complexity of reporting process, or concerns about reputational impact. Manufacturers and sponsors of medical devices are required to report adverse events where known, but clinical impacts can take several years to present. Healthcare facilities are often providing treatments before the TGA is made aware of an issue, which does not support the early identification of emerging safety and performance issues.
Proposal
The Impact Analysis (IA) considers four options to address underreporting.
- Option 1: (status quo): Retain current voluntary reporting requirements for healthcare facilities.
- Option 2: Public and private hospitals (including day hospitals) would be required to report adverse events relating to high-risk medical devices. Reporting could occur in batch (for example monthly or every two months, Option 2A) or on occurrence (Option 2B).
- Option 3: Public and private hospitals (including day hospitals) would be required to report on adverse events relating to medium and high-risk medical devices, with reporting occurring in batch (Option 3A) or on occurrence (Option 3B).
- Option 4: Public and private hospitals and approved Residential Aged Care facilities (excluding Multi-Purpose Services facilities) would be required to report adverse events relating to medium and high-risk medical devices, with reporting occurring in batch (Option 4A) or on occurrence (Option 4B).
Based on the assessment outlined in the IA, Option 3A is the preferred option as it considered to provide the best balance between addressing the policy objectives and regulatory burden placed on the reporting population.
Assessed Impact Analysis outcome
Good Practice
Assessment comments
The IA addresses the seven IA questions and follows an appropriate policy development process commensurate with the significance of the problem and magnitude of the proposed intervention. To be considered ‘Exemplary’ as per the Australian Government Guide to Policy Impact Analysis, the IA would have benefitted from a more detailed quantification of the likely costs and benefits and a more detailed evaluation plan.
Regulatory burden
The Department of Health, Disability and Ageing estimates the preferred Option 3A will increase the average regulatory costs by $1.62 million per year, over ten years. In addition, the average regulatory costs are estimated to increase by $1.66 million per year for public hospitals, over ten years.