The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue 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 therapeutic goods, and is responsible for implementing the Government’s reforms. The TGA conducted this consultation as part of the reform program. This consultation related to proposed enhancements to post-market adverse event reporting and improving communication with the consumers of medical devices.

The aim of a post-market monitoring and vigilance system for medical devices is to maintain the safety of patients and, through the collection, analysis, and action taken in response to adverse event reports, reduce the likelihood of adverse events recurring. Adverse event reporting allows the TGA to monitor medical device performance in the real world and identify emerging safety and performance issues. A number of reviews and inquiries have highlighted the safety of medical devices and the process for monitoring them once supplied on the market. While Australian regulatory practices are comparable to other regulators around the world, this consultation seeks feedback on proposals to strengthen them further. Improving Australia’s adverse event reporting system will more promptly address threats to patient safety and to take quicker action.

The focus of this consultation was to seek feedback on five proposals. The proposals aim to improve access to information about medical device safety. In addition to making it easier to report problems with a medical device, information about known or suspected problems with devices must be accessible and be understood by consumers, their families and their health professionals.

The Consumers Health Forum of Australia (CHF) is the national peak body representing the interests of Australian healthcare consumers and those with an interest in health consumer affairs, including health-based research. We have over 250 members reflecting a broad spectrum of organisations including state-based consumer peaks, condition-specific groups, volunteer patient groups, professional associations, Primary Health Networks (PHNs) and the research community.

We work in collaboration with our members, national partners and research collaborators to influence policy, programs and services to ensure they are in the consumer and community interest. CHF is pleased to make this submission in response to this TGA Consultation on enhancing medical device adverse event reporting.

Note that this consultation was administered as an online survey and this document has been adapted from the CHF submission to that survey.