Potential for Mandatory Reporting of Medical Device Adverse Events by Healthcare Facilities in Australia

Closes 13 Dec 2021

Opened 18 Oct 2021

Overview

The Australian Government is undertaking a significant program of reform to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates medical devices, and is responsible for implementing the Government’s reforms. We have released this Discussion Paper seeking feedback on potential changes to mandatory reporting of medical device adverse events – as part of the reform program.

Following the Senate Inquiry into the Number of women in Australia who have had transvaginal mesh implants and related matters which highlighted that the number, range, and complexity of medical devices will increase over time, the Australian Government supported working closely with healthcare facilities and state and territory health departments to find ways to increase rapid information sharing about medical device safety and effectiveness. An Action Plan for Medical Devices: Improving Australia’s medical device regulatory framework, 2019 endorsed the TGA exploring whether it should be mandatory for healthcare facilities to report adverse events/safety problems with medical devices to the TGA.

Targeted discussions with a range of Australian hospitals, peak bodies, state and territory governments and the Australian Commission on Safety and Quality in Health Care, along with a number of international regulators occurred in early 2021. These discussions explored the potential benefits and limitations of mandatory reporting for adverse events related to medical devices. Their feedback and insights have informed this discussion paper, now being released for public feedback.

Stakeholders are invited to review the Discussion Paper and provide their feedback regarding the following areas of interest:

  • Feasibility of mandatory reporting of medical device adverse events in healthcare facilities
  • Included or excluded facilities
  • Included or excluded device types
  • Reporting logistics and avoiding data duplication
  • Quality assurance of systems used
  • Accountability

A guidance document to assist in completing the survey can be found below, in the related section.

Give us your views - Potential for Mandatory Reporting

Audiences

  • Non-government organisations
  • State government agencies
  • Health professionals
  • Health workforce
  • Community groups
  • Contracted Service Providers
  • Aged care service providers
  • Aged care workforce
  • Aged care professionals

Interests

  • Hospitals
  • Health technology
  • Regulatory policy