New mandatory reporting of adverse events for medical devices gains motion

MedTech News: An amended Bill was introduced in Parliament yesterday that supports the implementation of a scheme for the mandatory reporting of adverse events associated with medical devices by hospitals.

Following the 2017 Senate inquiry into the number of women in Australia who have had transvaginal mesh implants and related matters, the inquiry made a number of recommendations designed to improve patient safety and better ensure the early detection of safety signals.

Recommendation 1 from the inquiry noted the vital role of adverse event reporting in post-market surveillance.

The Hon Ged Kearney MP, Assistant Minister for Health and Aged Care, said “The Therapeutic Goods Amendment Bill 2022 introduces the legislative framework for a scheme involving the mandatory reporting of adverse events associated with medical devices by hospitals, reflecting that for many patients the hospital setting is where adverse events involving medical devices occur or are recognised. This measure supports the improved monitoring of safety concerns associated with medical devices through access to information held by hospitals that identifies serious adverse events, and facilitates the earlier detection of safety signals that may raise concerns about particular devices.”

The TGA consultation on mandatory reporting of medical device adverse events ran into opposition from key stakeholders earlier this year.

Healthscope, operating 42 hospitals across Australia, also did not support the introduction of mandatory reporting for healthcare facilities on device-related adverse events.

“Mandatory reporting by healthcare facilities is not commonly required around the world and is not necessarily best practice. It is not the most efficient way to address adverse events caused by medical devices and will add unnecessary administrative and financial burden to healthcare facilities,” Healthscope said.

The Medical Technology Association of Australia (MTAA) said “We do not support mandatory reporting by healthcare facilities to TGA. Mandatory reporting by healthcare facilities will lead to unintended impacts and consequences. Multiple sources of AE reporting will pose a challenge to match cases with those already reported directly to sponsors. This is especially difficult when there is insufficient information provided in the report and/or when reporter details are marked as confidential.”

The Royal Australasian College of Surgeons’ (RACS) view was that healthcare facilities should be required to report certain pre-determined serious device-related adverse events. This is because in many cases, only the users of medical devices will be aware of adverse events, particularly non-fatal adverse events. However, RACS was clear that the threshold for reporting and the administrative activities needed to make a report should not make reporting burdensome upon practice.

RACS also argued that funding or other support should be provided to ensure facilities have the capacity to fulfil reporting requirements and that practitioners, in the absence of gross negligence should be indemnified to encourage disclosure of all relevant adverse medical device events.

Russell Broadbent MP, Federal Member for Monash, supported the amended Bill. He said “This legislation is really important because the mesh implants caused untold harm and damage to thousands of women across Australia. This legislation goes right to the heart of many people in this nation that are dealing with issues that are ongoing; they don’t end. The legislation being brought forward by the government today is crucially important so that the tragedy that happened with these mesh implants will never happen again – ever, ever again.”

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