Results updated 22 Jun 2021

Introduction

The TGA thanks respondents who provided a submission to the public consultation paper, Proposed Enhancements to Adverse Event Reporting for Medical Devices, which closed on 24 December 2020.

One hundred and twelve responses were received with 71% of submissions from medical device manufacturers and/or sponsors. The remaining 29% submissions received were from non-industry respondents representing most other sections of Australia’s health system.

Summary of responses and Analysis of submissions received

The analysis suggests strong support for enhancing the current medical device post-market monitoring and vigilance programs in Australia; although, there were mixed views on some of the proposals. There was, however, very low engagement by consumers and health professionals for some of the proposals.

Overall

Respondents were strongly in favour of:       

• Implementing a mandatory timeframe for submission of a final adverse event report and the provision of additional information, including supply and similar event data, with the adverse event report to aid in assessment of incident trends.
• Developing a pilot program of inspecting medical device sponsor premises and auditing their post-market records, similar to the medicine Pharmacovigilance Inspection Program.
• Aligning post-market related definitions with the European Union’s (EU) new Regulations on Medical Devices.

Proposal 1: Changes to current adverse event reporting exemptions

The majority of industry respondents did not support the removal of all eight of the exemption rules to reporting adverse events, with many concerned about a potential increase in administrative burden. However, industry were generally in favour of removal of some of the exemptions or rewording the exemptions to reduce misinterpretation.

The response rate by non-industry was low, with half of these respondents in favour of the removal of all the exemption rules. Respondents further suggested that all adverse events should be notified to the TGA, to support potential early signal detection and mitigate the risk of reoccurrence of harm.

The feedback for this proposal was skewed due to high number of medical device industry responses and very limited feedback from non-industry stakeholders.

Proposal 2: Strengthen reporting requirements for medical device adverse events

Most industry respondents supported the implementation of a mandatory timeframe to submit the final adverse event report of up to 120 days from the time of submission of the initial report. Respondents also suggested there should be provision for the TGA to approve an extension or an interim report, if a final report cannot be submitted within the stated timeframe.

Feedback indicated the need to enhance the current communication strategies, to ensure consumers are aware about the role of the TGA as a regulatory body, and that adverse event reporting is an option available to them.

Proposal 3: Implement TGA audits of sponsor activities and premises to validate how they conduct post market surveillance obligations

There was overall support for the implementation of a pilot program by both industry and non-industry respondents. Further, the majority of the industry respondents felt there was a need to educate and promote better regulatory compliance among sponsors. Respondents suggested this program would reinforce the requirement to hold timely and accurate data and ensure the sponsors are complying with their regulatory requirements, whilst identifying any areas for improvement.

Proposal 4: Review post-market definitions in the Medical Device Regulations

There was majority support from both industry and non-industry for adopting the definitions in the EU Medical Device Regulations, as many of these terms are not currently defined, but are referred to, within the Australian legislation. Respondents suggested that post-market definition alignment with the EU would reduce the risk of ambiguity and subjectivity by sponsors, and ensure consistency at an international level, thereby enhancing adverse event information sharing.

Proposal 5: Find ways to enhance communication between the TGA and the consumers of medical devices

While the majority of industry respondents reported they were adequately informed about issues related to medical devices, healthcare services and consumers reported they were not. Similar to the other proposals, the overall feedback received was skewed due to the greater industry response and limited feedback from non-industry respondents.

Further to this, the feedback also indicated that:

• During an adverse event investigation process, it is preferable for the TGA to either start communicating with the incident reporter after the cause of the event is verified, or after a decision on the necessary action to be take has been made.
• The process of searching information through the Database of Adverse Event Notifications (DAEN), the System for Australian Recall Action (SARA) database, and the TGA website for device safety information can be further improved by enhancing functionality and layout, including more search fields to refine the search results and making the resources more user friendly and easy to understand by removing jargon words.

Next steps

We have analysed all responses and the findings have indicated that some follow-up discussions should occur on a number of the proposed options. The feedback will be provided to the Minister for Health and as appropriate, inform Australian Government policy and regulatory drafting decisions. The TGA will continue to work closely with stakeholders, including scheduling further targeted discussions, specifically seeking additional feedback from consumers, consumer representative groups, health professionals and healthcare services. 

Published responses

View submitted responses where consent has been given to publish the response.