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Every year we receive about 5,500 incident reports relating to the one million medical devices in use across Australia.
Out of those incident reports, about one in five is followed up with an investigation.
In recent years, members of the public have raised concerns about how we identify and assess problems occurring with medical devices across Australia.
This has resulted in a number of different inquiries and independent reviews around post-market surveillance and monitoring, recommending that the TGA:
- improve the level of data capture relating to adverse events associated with the use of medical devices
- adopt a more systematic and transparent approach to risk assessment of adverse events reported to the regulator
- enhance methods of identifying cases that require further investigation of adverse events;
- strengthen methods of prioritising cases that need more timely investigation
- identify and document key issues underlying decisions made by the regulator to improve the quality and safety of medical devices in Australia.
In the past 12-18 months, we have implemented a number of changes in an effort to increase and improve post-market monitoring and surveillance activities.
Forensic analysis of post market processes
In 2019, we commenced a forensic analysis of our internal assessment practices and tools that are used in monitoring adverse events.
This analysis involved consultation with state and territory health departments, and other stakeholders such as consumer groups, to guide how we could address issues around monitoring and investigating medical devices in the marketplace.
Our analysis was supplemented by external expertise who considered relevant documents, including legislation, regulation, guidance, international standards and previous recommendations.
Current data systems and processes were reviewed for improvements, including incident notification processes, data systems and analytic platforms.
It also examined current assessment and investigation requirements and compared current and alternative approaches to how our TGA teams conduct risk assessments and prioritise cases.
Although post-market monitoring has been working well, the analysis revealed that there was room for improvement. Recommendations from the analysis focused on possible changes that could be implemented to improve post-market processes.
Post-market enhancements
The TGA post-market enhancement activities deliver six key outcomes, and each of our completed enhancements can be aligned to one of those outcomes:
| Outcome | Post market enhancements | |
|---|---|---|
| 1 | Improved information available to consumers and patients | Increase reporting to consumers Increase consulting and assessing impacts upon stakeholders |
| 2 | More timely actions by the TGA relating to post-market assessments and actions (such as recalls) | Enhance investigation processes Upgrade information technology systems |
| 3 | Earlier identification of adverse events | Improve data collection and sharing of information |
| 4 | Reduced burden on industry through increased alignment with other regulators and the EU | Harmonise data collection with other regulators |
| 5 | Improved, consistent and more transparent TGA internal processes (including risk assessments, investigations and prioritisation) | Enhance risk assessment processes |
| 6 | Improved use, analysis, and sharing of data | Harmonise data collection with other regulators Increase reporting to jurisdictions |
Completed post-market monitoring enhancements
Our teams have focused on making sure the post-market enhancements outlined in the TGA's forensic analysis are implemented. To date we have completed a number of these enhancements to post-market monitoring including:
Outcome 1 - Improved information available to consumers and patients
Enhancement: Increase reporting to consumers and jurisdictions
In an effort to increase reporting to consumers and jurisdictions, we recently launched a series of new website information "hubs" that provide a central point to access information about specific devices of concern. These include the breast implant hub and the transvaginal (urogynaecological) surgical mesh hub.
As part of increased reporting we now provide stakeholders, specifically those who manage recalls at local levels such as hospitals or state health departments, with information from the System for Australian Recall Actions (SARA), including sorting functions and data downloading, to allow them to undertake further analysis of particular devices of concern/interest.
The new regulatory requirement for manufacturers to provide patient information leaflets and patient implant cards with higher risk medical devices ensures patients receive the relevant information about implantable devices prior to and following surgery. Consumer focus group feedback was used to help inform what information was used in these materials.
This enhancement also applies to Outcome 6 - Improved use, analysis, and sharing of data
Enhancement: Increase consulting and assessing impacts upon stakeholders
A new consumer working group was established to help progress "An Action Plan for Medical Devices" strategies. The strategies include adverse event reporting and access to information in appropriate formats about medical devices.
Along with the consumer-working group, we also established consumer and expert working groups for specific medical device issues to provide both targeted and broader advice from a range of stakeholders.
These working groups work alongside our ongoing collaboration with state and territory health departments and the Australian Commission on Safety and Quality in Health Care. These collaborations involve discussing improvements and identifying ways for even greater collaboration and information sharing.
Outcome 2 - More timely actions by the TGA relating to post-market assessments and actions
Enhancement: Enhance investigation process
Our teams have revised the classifications for three levels of investigation reflecting the different levels of work involved in the initial risk assessment and following up information on an individual event or cluster of adverse events.
Enhancement: Upgrade information technology systems
A new database is now in place that improves how we conduct post-market reviews, by providing a secure, efficient and effective way for sponsors to respond to post-market reviews. The TGA has also increased analysis capabilities by making changes to an existing database to allow for further enhancements to the investigation processes.
Outcome 3 - Earlier identification of adverse events
Enhancement: Improve data collection and sharing of information
We improved the online web forms and guidance materials for reporting adverse events in medical devices to make it easier for consumers, health professionals and sponsors/manufacturers to submit a report. The changes simplify the reporting process and clarify what information we expect in a report, which in turn improves our data analysis capability as we now have more targeted information.
We continue to consult and seek feedback to inform on improving adverse event data collection.
Outcome 4 - Reduced burden on industry through increased alignment with other regulators and the EU
We continue to participate in international medical device regulator forums to harmonise adverse event coding and data collection fields in adverse event report forms.
We continue to consult and seek feedback to inform on aligning with other regulators and the EU on post-market requirements.
Outcome 5 - Improved, consistent and more transparent TGA internal processes
Enhancement: Enhance risk assessment process
The risk analysis tool used in the reporting of adverse event reports and post-market reviews has been updated with an improved data analytics tool that will enhance analysis capability and improve signal detection.
Outcome 6 - Improved use, analysis, and sharing of data
Enhancement: Harmonising data collection with other regulators
We continue to participate in international medical device regulator forums to harmonise adverse event coding and data collection fields in adverse event report forms.
We continue to consult and seek feedback to inform the establishment of an Australian Unique Device Identification database (AusUDID).
Ongoing post-market monitoring improvements
Along with our completed activities we are also making progress on a range of on-going improvements and projects.
We are improving the flow of TGA information to jurisdictions and other stakeholders. This is being achieved through:
- providing regular notifications of major device reviews we have already undertaken or scheduled for commencement.
- identifying current and/or potential issues of interest, which are summarised and provided to jurisdictions as periodic "radar reports" to assist in state/territory monitoring and collection of targeted information.
- providing flexible data searching, sorting and downloading functions in the Database of Adverse Event Notifications (DAEN) (similar to that implemented for SARA) to allow jurisdictions and other stakeholders to undertake further analysis and develop summary reports of particular devices of concern/interest.
- exploring other opportunities for increased data sharing from jurisdictions.
- seeking public feedback on a discussion paper on the potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia.
As the projects continue, these activities promote improved safety, performance and quality of medical devices, and as a result aim to enhance and improve health outcomes for patients who require these devices. These changes and improvements also strive to increase public confidence in the regulation of medical devices by the TGA.