White Paper

Implementing NSQHS Infection Control Standards for Sterilisers and Washer-Disinfectors in Australian Healthcare

October 2026

Disclaimer

This content is provided for information only. The authors make no representation or warranty regarding the accuracy, completeness or currency of the content. No information in this whitepaper should be construed as medical advice. Readers should seek appropriate professional guidance before acting on any information contained in this document. The authors expressly disclaim all liability for any direct or indirect loss or damage arising from the use of or reliance on this information.

Executive Summary

This paper sets out how to meet the reprocessing requirements of the National Safety and Quality Health Service (NSQHS) Standards for steam sterilisers, instrument washer-disinfectors (WDs) and bedpan WDs, using the requirements of AS 5369:2023.

Standards: NSQHS Action 3.17 requires reprocessing consistent with national and international standards and manufacturers' guidelines, traceability of critical and semi-critical devices to the patient and procedure, and processes for novel and emerging infections. AS 5369:2023 is the applicable national standard.

Records: Keep the records listed in AS 5369:2023, check the process record at the end of every cycle, and retain records for the period set by the relevant authority or, in its absence, facility policy.

Maintenance: Plan preventive maintenance from the equipment's documented procedures, perform it by a competent person, specify a maximum permitted delay, perform an annual electrical safety check, and record each activity with the details AS 5369:2023 requires.

Validation: Perform installation, operational and performance qualification (IQ, OQ and PQ), repeat OQ on the specified triggers, requalify annually, and apply the routine monitoring frequencies of AS 5369:2023.

Improvement: Audit regularly, control nonconforming product, investigate failures to root cause, and maintain a business continuity plan.

Introduction

Sterilisers and WDs deliver the cleaning, disinfection and sterilisation steps of reprocessing. NSQHS accreditation assesses whether these processes conform to current standards and whether the organisation can prove it through records. This paper converts the requirements into record templates, maintenance and validation regimes and monitoring frequencies for technical, sterilising services and infection prevention staff.

Overview of NSQHS Infection Control Standards

Action 3.17: The Preventing and Controlling Infections Standard requires that, when reusable equipment and devices are used, the health service organisation has:

• Processes for reprocessing that are consistent with relevant national and international standards, in conjunction with manufacturers' guidelines.
• A traceability process for critical and semi-critical equipment, instruments and devices that is capable of identifying the patient, the procedure, and the reusable equipment, instruments and devices used for the procedure.
• Processes to plan and manage reprocessing requirements, and additional controls for novel and emerging infections.

AS 5369:2023: Published 15 December 2023, superseding AS/NZS 4187:2014 and AS/NZS 4815:2006. It applies wherever reusable medical devices are reprocessed and requires equipment to conform to ISO 15883 for WDs, EN 285 for large and EN 13060 for small steam sterilisers, and ISO/TS 22421.

Advisory AS24/01: The Australian Commission on Safety and Quality in Health Care (ACSQHC) required a gap analysis against AS 5369:2023 by 30 June 2025 and a compliance plan with timeframes aligned with national or international standards, manufacturers' guidelines, the current Australian Guidelines for the Prevention and Control of Infection in Healthcare and state and territory requirements. AS 5369:2023 sets no compliance deadline. Assessors check evidence that the plan is being implemented.

Novel and emerging infections: Define in advance the controls to apply, e.g. single-use devices, dedicated equipment or modified processes, and validate any modified process before use. For bedpan WDs, thermal disinfection does not inactivate bacterial spores, including Clostridioides difficile, so outbreak controls for spore-forming organisms must address cleaning efficacy, not disinfection temperature.

Governance: Assign responsibility for reprocessing to a competent person, report audit results, failures and corrective actions to the infection prevention and quality committee, and integrate equipment risks into the organisation's risk register.

Compliant Record Keeping Practices for Sterilisation and Disinfection

Required records: AS 5369:2023 requires records of at least: purchasing of devices and equipment, equipment monitoring, cleaning, sterilisation and high-level disinfection processes, microbiological surveillance where applicable, cleaning of equipment and the facility, staff training and competency, rosters, maintenance, IQ, OQ and PQ, process deviations with corrective and preventive actions, and recalls. Records must be controlled, retrievable and retained for not less than the period set by the relevant authority or, in its absence, facility policy.

Steriliser cycle records: Check the process record at the end of each cycle against the validated specification. Record the steriliser, cycle number, programme, date, operator, load contents, physical parameters, indicator results, BI results where used, release decision and the person releasing the load.

WD cycle records: Check the process record at the end of each cycle. Confirm water pressure, flow and spray action, cleaning agent dosage, and the temperature and time at disinfection temperature, or the A0 value, against the validated limits. Record the WD, programme, load, operator and outcome.

Traceability: AS 5369:2023 requires critical devices to be traceable at least to the individual cycle of a specified steriliser, and semi-critical devices undergoing high-level disinfection to the individual disinfection cycle. To meet Action 3.17, link those cycle records to the patient and procedure through load labels in the patient record or a scanned tracking system. Test the link with tracer audits.

Nonconformance records: Record every failed cycle, failed test, wet or damaged pack and recall, with the investigation, corrective action and effectiveness check.

Training records: Record training, competency assessment and reassessment for every person who operates, maintains or validates reprocessing equipment.

Template: Steriliser Cycle Log (Example)

Example steriliser cycle log. Each row is one cycle. Adapt the fields to the tracking system in use.

Preventative Maintenance of Sterilisers and Washer-Disinfectors

Planned maintenance: AS 5369:2023 requires preventive maintenance of all equipment to be planned and carried out by a competent person in accordance with the documented procedures provided with the equipment, with the procedure and frequency of each activity specified. All reprocessing equipment requires an annual electrical safety check. Base maintenance and recalibration intervals on maintenance and calibration history, with no more than 12 months between recalibrations.

Return to use: Do not reprocess devices on equipment until the specified maintenance has been completed and documented. Specify the maximum permitted delay for any scheduled maintenance.

Daily user checks: Perform the checks in the IFU before first use: chamber and door seal condition, strainers and spray arms, cleaning agent levels, printer or data record function, and the daily air removal test on vacuum sterilisers.

Calibration: Calibrate timers, gauges and temperature monitoring devices at specified intervals with test instruments whose calibration is traceable to national standards.

Pressure equipment: Steam sterilisers and steam generators are pressure equipment. Confirm the AS 4343 hazard level, whether item registration applies under Schedule 5 of the WHS Regulations, and the in-service inspection regime to AS/NZS 3788. File inspection certificates with the maintenance records.

Repairs: Withdraw faulty equipment, label it out of service and record the fault. After repair, perform OQ before return to use. AS 5369:2023 allows OQ after repair to consist of performance tests, e.g. leak rate, air removal and thermometric tests for a steriliser.

Bedpan WDs: Include strainers, spray nozzles, steam generator, door seal, dosing system and water supply in each planned visit. Verify the thermal disinfection A0 value with independent sensors at requalification.

Template: Preventative Maintenance Record

The fields follow the minimum maintenance record content of AS 5369:2023.

Example maintenance record covering planned services and an unplanned repair.

Validation Protocols and Ongoing Performance Monitoring

Qualification

• IQ: Confirm installation and services against the IFU. Test the water supply before installation, and test steam quality on large sterilisers at installation, relocation and any change to the steam supply.
• OQ: Perform after installation or relocation, when a service is changed, when equipment is modified to deliver a new process, when new devices or loading configurations are introduced, and after repair.
• PQ of WDs: Perform to the relevant part of ISO 15883, with an objective test of cleaning efficacy in addition to visual inspection, e.g. protein residue testing.
• PQ of sterilisers: Use a load representative of routine loads and based on the most challenging load, with total mass documented and devices packaged as in routine use. Perform physical and microbiological PQ concurrently for moist heat, with BIs to ISO 11138 at the positions where sterilising conditions are most difficult to achieve. Demonstrate at least three consecutive successful exposures, and add the equilibration time to the holding time. PQ must demonstrate a sterility assurance level of one in a million.
• Requalification: Requalify each process annually. Have the validation report approved by a competent person.

Routine Monitoring

Routine monitoring frequencies from AS 5369:2023. Monthly TVC testing may be reduced to a minimum of annually after 12 months of results within specification.

BI frequency for steam: AS 5369:2023 leaves BI frequency for moist heat to the facility. Its informative example process uses a BI in a process challenge device at least weekly, preferably daily, and in every implant load, with implant loads quarantined until the BI result is known.

Chemical indicators: Select indicators to ISO 11140-1 by type: Type 1 process indicators on each pack, Type 2 for air removal tests, and Types 4 to 6 for internal monitoring where facility policy requires it.

Bedpan WDs: ISO 15883-3 requires the thermal disinfection stage to deliver an A0 value of at least 60, equivalent to 80 deg C [176 deg F] for 1 min. Program a higher A0 value, e.g. A0 600, equivalent to 90 deg C [194 deg F] for 1 min, where the infection prevention risk assessment requires it. Confirm the A0 value or temperature and time on the process record every cycle.

Protocol Example: Annual Requalification of a Steam Steriliser

1. Preconditions: Confirm planned maintenance and calibration are complete, and that test sensors and recorders hold current calibration traceable to national standards.
2. Function tests: Perform the leak rate test and the air removal and steam penetration test, and confirm air detector performance where fitted.
3. Thermal penetration: Load the reference loads established at PQ, including the most challenging load. Place sensors at the slowest-heating positions. Confirm that every position reaches the sterilising temperature within the established equilibration time and holds it for at least the holding time, e.g. 3 min at 134 deg C [273 deg F] plus the equilibration time added at PQ.
4. Microbiological challenge: Where the requalification program requires it, place BIs at the same positions and confirm no growth after the BI's validated incubation.
5. Steam and drying: Test steam purity on large sterilisers and drying effectiveness on all steam sterilisers. Test steam quality where the facility's risk assessment requires it.
6. Deviations: Investigate any result outside tolerance, correct the cause and repeat the affected tests.
7. Report: Record test conditions, instrument identification and calibration, sensor positions, results and conclusions. Have the report approved by a competent person and schedule the next requalification within 12 months.

Compliance Best Practices for Risk Mitigation and Continuous Quality Improvement

• Policies and procedures: Document every reprocessing step from point of use to storage, including load release, indicator use, traceability, nonconformance, recall and contingency. Review them at the defined interval and have them approved by a competent person.
• Competency: Induct new staff, assess competency objectively after training, reassess at defined intervals and retrain where necessary.
• Audit: Audit regularly against AS 5369:2023 and record findings. Include tracer audits that follow a device from patient record to cycle record, BI result and maintenance status of the steriliser.
• Nonconformance and corrective action: Quarantine nonconforming devices, determine root cause, implement corrective action, and review it for effectiveness. Recall devices from failed loads and notify affected clinical areas.
• Trend analysis: Trend air removal test failures, leak rate results, aborted cycles, wet packs, positive BIs, maintenance delays and repair frequency for each machine. Act on adverse trends before they cause failures.
• Business continuity: Maintain backup procedures for loss of a steriliser, WD, water or steam supply: redundant equipment, mutual aid agreements, additional instrument sets, and single-use bedpans or liners for bedpan WD outages. Test the plan by exercise.
• Assessment of change: Assess the need for revalidation before changing packaging, equipment, processes, load contents beyond the validated worst case, or transport routes.
• Standards currency: Track new editions, e.g. ISO 15883-1:2024 and ISO 15883-3:2024, and ACSQHC advisories, and update the gap analysis and compliance plan.

Conclusion

NSQHS Action 3.17 is met for sterilisers and WDs by operating them to AS 5369:2023 and proving it through records. Keep the required records and check every cycle record. Maintain equipment to documented procedures with a specified maximum delay and annual electrical safety checks. Qualify, monitor and requalify at the AS 5369:2023 frequencies. Link cycle records to patients for critical and semi-critical devices. Use audits, nonconformance control and trend analysis to correct failures, and keep the gap analysis and compliance plan required by Advisory AS24/01 current.

Sources

1. Standards Australia. AS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities.
2. Australian Commission on Safety and Quality in Health Care. National Safety and Quality Health Service Standards, second edition (2021), Action 3.17.
3. Australian Commission on Safety and Quality in Health Care. Advisory AS24/01 Requirements for reprocessing of reusable medical devices in health service organisations, November 2024.
4. ISO 15883-1:2024 and ISO 15883-3:2024 Washer-disinfectors.
5. ISO 17665 series, EN 285 and EN 13060 Steam sterilisation and steam sterilizers.
6. ISO 11140-1 Chemical indicators and ISO 11138 series Biological indicators.
7. Safe Work Australia. Model Work Health and Safety Regulations, Schedule 5. AS 4343 Pressure equipment, Hazard levels. AS/NZS 3788 Pressure equipment, In-service inspection.