National Safety and Quality Health Service Standards (Third Edition) – Initial Draft

The Australian Commission on Safety and Quality in Health Care (ACSQHC) has released the initial draft of the NSQHS Standards (third edition) for public consultation, and MTAA members are encouraged to review and respond.

What’s changing?
The third edition streamlines the current eight Standards into three integrated Standards:

• Clinical Governance Standard – board, executive and leadership accountability for high-quality care
• Person-Centred Practice Standard – systems that support clinicians to deliver person-centred, safe and effective care
• Safe Clinical Systems Standard – priority systems (infection control, medicines, medical devices, blood management, patient identification and digital systems) that keep people safe

The draft also embeds cultural safety, equity and digitally enabled care as cross-cutting elements throughout, and shifts the emphasis from compliance towards outcomes and continuous improvement, including specific new requirements on digital health governance, cybersecurity, environmental sustainability and clinical research quality.

Why it matters for MedTech
The Safe Clinical Systems Standard includes dedicated requirements on medical devices, covering selection, traceability (Unique Device Identification), reprocessing of reusable devices, Point of Care Testing devices, and incident/recall reporting. This is a direct touchpoint for our sector, and is worth reviewing closely against current TGA obligations and existing member practice.

The consultation is open for response till 25 September. Please provide input to be considered by 18 September so we can consolidate feedback, via the comments below or by directly emailing lwaheed@mtaa.org.au. As for next steps, the plan is to further refine the draft → pilot in 2027 → final release 2028 → assessment from 2030.