FEBRUARY 2026
EDITION 42
Mandatory Reporting of Medical Device Adverse Events
These changes ensure consistent reporting and a clearer understanding of how high ‑ risk medical devices perform in real ‑ world care. They also help build safer systems by identifying trends earlier and supporting improvements across NSW Health. To make it easier for staff to enter a Medical Device Adverse Event in ims+, eHealth NSW and the Clinical Excellence Commission (CEC) have released a set of step ‑ by ‑ step instruction sheets covering each incident type. Notifying a Patient Incident Related to Medical Devices Notifying Worker Incidents Related to Medical Devices Notifying a No Person Incident Related to Medical Devices Notifying Relative/Visitor Incidents Related to Medical Devices Once entered into ims+, reports will be shared by the CEC with the Therapeutic Goods Administration (TGA) to support national monitoring and regulatory action when needed. If your team uses, manages, or supports high ‑ risk medical devices, please familiarise yourself with the new reporting requirements and the available guidance materials from the CEC website
From 21 March 2026, all NSW Health services will be required to report serious adverse events involving high ‑ risk medical devices. This change aims to strengthen patient safety, improve device monitoring, and ensure faster identification of potential risks. The new requirement applies to incidents involving Class III non ‑ IVD devices (such as implantable pacemakers, defibrillators, nerve stimulators, breast implants, neurosurgical tools, vascular catheters, and valve prostheses) and Class 4 IVDs, which include high ‑ risk blood grouping tests across the ABO, Rhesus, Kell, Kidd, and Duffy systems. These devices and tests play critical roles in patient care, and any issue can have a significant clinical impact. Under the updated process, staff must complete an incident notification in ims+ for any death, serious injury, or serious deterioration associated with these devices, using the category Devices, Gases and Consumables .
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This applies to incidents involving patients, workers, visitors/relatives, or situations where no person was directly harmed but a device fault was identified.
This infographic outlines responsibilities of all NSW Health workers in notifying, monitoring, reporting and responding to medical device related incidents.
Clinical Governance Standard
Fo r more information please contact the NSLHD PRMs Team via nslhd-prms@health.nsw.gov.au.
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