Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia

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 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.

This paper was informed by targeted discussions, in early 2021, 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.

Stakeholders were invited to review the Discussion Paper and provide their feedback using an online survey via the TGA Consultation Hub.

A guidance document to assist in completing the survey was also provided.

Timetable

The online survey for feedback on the Discussion Paper opened on 18 October 2021 and closed on 13 December 2021.

Summary of feedback

Almost three quarters of respondents were in favour of introducing mandatory reporting of medical device related adverse events by healthcare facilities in Australia, providing a range of comments about to implementation, with safety and accountability as key drivers. Some respondents felt mandatory reporting by healthcare facilities was long overdue and that without it, the current underreporting of medical device adverse events does not support the early identification of emerging safety and performance issues. Those not in favour of introducing mandatory reporting raised valid concerns and issues, including data duplication and integrity, and the burden that would fall to staff. These concerns require further discussion. Most respondents indicated that if mandatory reporting was introduced, all healthcare facilities should be included, however a small number raised concerns about smaller facilities, such as general practices, being included due to limited resources to manage additional administrative requirements.

Data integrity was a key concern of stakeholders, both for and against the introduction of mandatory reporting, with an overall desire expressed by all stakeholders for a better understanding of the risk-benefit profile of medical devices generally. Stakeholders also raised concerns that additional reporting requirements may be burdensome, duplicative, and of little benefit to patient outcomes.

Based on feedback received, it is evident that if mandatory reporting were to be introduced, work would need to be undertaken within healthcare facilities, their existing systems, and information collection points to facilitate accurate and timely reporting. Additional work would also be needed to increase awareness of the scope of benefits of mandatory reporting, including through education and communication materials. This outcome would need to be supported by significant effort to change clinical practice to incorporate mandatory reporting requirements.

The Australian Commission on Safety and Quality in Health Care (ACSQHC) indicated their willingness to take a leadership role in working with the TGA and other stakeholders to incorporate mandatory reporting within the existing frameworks for hospital quality assurance and accreditation processes thus minimising any additional regulatory burden. 

They highlighted those other activities, including further education, encouragement and support given to patients and practitioners to report adverse events are complementary, but do not replace the importance of mandatory reporting.

The TGA will work closely with the Australian Commission on Safety and Quality in Health Care (ACSQHC), state and territory health departments, and private and day hospitals to progress this project.

Submissions received

We received 56 responses from stakeholders across the healthcare sector, industry sector, and consumers. 

The TGA sought consent to publish respondents' submissions and, where provided, submissions are published on the TGA Consultation Hub.

Related

Discussion Paper on potential changes to mandatory reporting of medical device adverse events.

Enquiries

Any questions relating to the Discussion Paper should be emailed to devicereforms@tga.gov.au.