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Before a reusable instrument can be used again, it has to be cleaned, inspected, packed, sterilised, stored and tracked. AS 5369:2023 sets out how, and asks for more planning, records and checks than the standards it replaced. Sterile single-use instruments sit outside that cycle.
What's changing
In December 2023 Standards Australia published AS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities. It replaced AS/NZS 4187:2014 and AS/NZS 4815:2006, so one standard now covers hospitals, day procedure services and office-based practices such as medical, dental and podiatry clinics. In January 2026 it was reissued as AS/NZS 5369:2023; its Preface says the two names can be used interchangeably.
The Australian Commission on Safety and Quality in Health Care (the Commission) lists what's new in its transition guides, from AS/NZS 4187 and from AS/NZS 4815. The changes include a risk-based approach, dedicated reprocessing areas with a one-way flow from dirty to clean, more detailed records and traceability, and a recommendation for annual staff training. Office-based practices also face stricter water quality requirements and more detailed validation requirements. The Commission notes that several changes “have resource implications”.
AS 5369 doesn't include timeframes for compliance, as the Commission points out in Advisory AS24/01. The timing comes through accreditation instead.
Key dates
- 15 Dec 2023AS 5369 publishedSupersedes AS/NZS 4187:2014 and AS/NZS 4815:2006.
- 11 Nov 2024Commission advisoriesAS24/01 for health services, PCHS24/01 for primary and community healthcare.
- 30 Jun 2025Gap analysis date (passed)Health service organisations were to update their gap analysis under AS24/01.
- 1 Jan 2028General practiceThe RACGP's updated reprocessing guidelines apply (end of the transition period).
- Health service organisations: Advisory AS24/01 asked them to update their gap analysis against AS 5369 by 30 June 2025, then implement a compliance plan with timeframes. It sets no date for full compliance.
- Primary and community healthcare services: Advisory PCHS24/01 asks for a gap analysis by the start of the second assessment cycle. Its rating rules also cite July 2025, so check with your accrediting agency.
- General practice: the RACGP's updated reprocessing guidelines, aligned with AS 5369, apply from 1 January 2028 (end of the transition period). They include a washer-disinfector, a documented risk assessment, traceability records and yearly validation of reprocessing equipment.
- States and territories may have their own requirements, so check with your health department too.
Benefits of single-use instruments
Sterile single-use instruments, like most of the DTR Medical range we supply, arrive sterile and ready to use and are discarded after the procedure. For the facility, that means:
- No reprocessing for those items. No cleaning, inspection, packing, sterilising or cycle records.
- Less to process and record. Each instrument moved to single-use is one fewer to process, record and trace through a reprocessing system that AS 5369 asks you to validate and document. That matters most for clinics that reprocess on site without a sterilising department.
- A new instrument each time. Each procedure uses a new instrument from sterile packaging, with no reprocessing history to check.
- Simpler records. No reprocessing cycle or batch records to link to the patient; as for any labelled device, the user attaches the label to the patient's notes.
- No repairs or sharpening. There are no reusable sets to maintain, repair or top up when items go missing, and the purchase cost per procedure is known in advance, which makes it easy to budget.
- Ready when needed. There's no wait for a sterilising cycle or for instruments to come back from an off-site service. That can suit rooms that use an instrument only occasionally, and outreach clinics.
When single-use makes sense
It's an instrument-by-instrument decision. Single-use can suit instruments that are used occasionally, take time to clean and inspect (hinges, fine tips, lumens), need frequent repair, or are used away from a sterilising service. Reusable may suit high-volume instruments that reprocess easily, and those without a single-use equivalent.
There are trade-offs. Single-use instruments add to clinical waste, and the RACGP says “reprocessing is often more environmentally sustainable than relying on single-use instruments”, though the impact varies with the device, local waste systems and the alternatives available. Single-use stock needs shelf space and expiry management, and its cost per use should be compared with the full cost of reprocessing, repair and replacement.
Single-use also means used once. The Australian Guidelines for the Prevention and Control of Infection in Healthcare say single-use devices must not be reprocessed. In a COVID-19 pandemic article on reusing masks and gowns, the TGA said anyone who reprocesses a single-use device and supplies it to another organisation becomes a manufacturer, with conformity assessment and ARTG obligations.
Comparing single-use and reusable? Free evaluation packs are available for selected DTR Medical instruments. Each includes sterile sample instruments and a cost worksheet comparing single-use with reusable, including reprocessing and repairs.
Recap
| Setting | Framework | Key date |
|---|---|---|
| Health service organisations, such as hospitals and day procedure services | NSQHS Standards; Advisory AS24/01 | Gap analysis by 30 June 2025 (passed); no set date for full compliance |
| Primary and community healthcare services | Primary and Community Healthcare Standards; Advisory PCHS24/01 | Gap analysis by the start of the second assessment cycle (the rating rules also cite July 2025) |
| General practices | RACGP infection prevention and control guidelines, section 10 | Updated guidelines apply from 1 January 2028 (end of the transition period) |
Sources
All sources were accessed on 30 October 2026.
- Standards Australia, AS/NZS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities (incorporating Amendment No. 1), published 15 December 2023, reissued 16 January 2026.
- Standards Australia and Standards New Zealand, AS/NZS 5369:2023 (incorporating Amendment No. 1), free preview: publication details and Preface, 2026.
- Australian Commission on Safety and Quality in Health Care, Advisory AS24/01: Requirements for reprocessing of reusable medical devices in health service organisations, 11 November 2024.
- Australian Commission on Safety and Quality in Health Care, Advisory PCHS24/01: Requirements for reprocessing of reusable medical devices in practices, 11 November 2024.
- Australian Commission on Safety and Quality in Health Care, Transitioning from AS/NZS 4187:2014 to AS 5369:2023, August 2024.
- Australian Commission on Safety and Quality in Health Care, Transitioning from AS/NZS 4815:2006 to AS 5369:2023, August 2024.
- NHMRC and the Australian Commission on Safety and Quality in Health Care, Australian Guidelines for the Prevention and Control of Infection in Healthcare, section 3.1.4 Reprocessing of reusable medical devices, 2019, as amended to April 2026.
- RACGP, Infection prevention and control guidelines, section 10: Reprocessing of reusable medical devices and other devices in general practice, last revised 12 June 2026.
- Therapeutic Goods Administration, Reuse of face masks and gowns during the COVID-19 pandemic, 28 January 2021.
This guide is general information, not regulatory or infection prevention advice. Standards, advisories and guidelines change, so check the current versions with Standards Australia, the Commission, the RACGP, the TGA and your state or territory health department.