White Paper

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

August 2025

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 whitepaper provides a comprehensive guide for Australian healthcare facilities on aligning National Safety and Quality Health Service (NSQHS) Standards Preventing and Controlling Infections Standard (2021 edition) with the management of sterilisation equipment, autoclaves and bedpan washer-disinfectors. It offers brand-agnostic guidance targeted at healthcare administrators, compliance officers, and clinical engineering teams. Key points include:

• NSQHS Standards Overview: NSQHS Standard 3 (Preventing and Controlling Infections Standard) mandates that reprocessing of reusable medical devices, for example instruments, sterilisers, and washer-disinfectors meet current best practices and comply with national standards. Health service organizations must ensure equipment is well-maintained and systems are in place to mitigate infection risks. A traceability system linking reprocessed items to patients and procedures is required for critical and semi-critical devices.

Record Keeping and Traceability: Comprehensive documentation is critical for compliance and patient safety. Facilities should maintain detailed records of each sterilisation cycle, washer-disinfector cycle, maintenance activity, validation test, and staff training. NSQHS-aligned practices and AS/NZS 4187:2014 standards call for full traceability of reprocessed items to patients. Record retention for at least 5 years, or as required by jurisdiction and readiness for audits are essential.

Preventative Maintenance: Regular preventative maintenance of sterilisers and washer-disinfectors is both a safety and compliance requirement. A documented maintenance schedule such as daily checks, monthly servicing, annual inspections should be in place. Australian guidelines and WHS regulations require that sterilisers be inspected by competent persons, typically annually, with calibration of gauges and safety valves. Bedpan washers similarly should be serviced at least annually with biannual servicing recommended for optimal performance. Proper maintenance logs provide evidence of compliance during accreditation surveys or inspections.

Validation and Performance Monitoring: Ongoing validation protocols ensure that sterilisers and washer-disinfectors achieve the required disinfection/sterilisation efficacy. Initial installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) must be completed on new or repaired equipment. Routine monitoring includes physical cycle parameters, chemical indicator results, and biological indicator tests for sterilisers, as well as cleaning/disinfection efficacy tests for washer-disinfectors. Annual re-validation e.g. annual PQ test cycles is required to demonstrate continued performance. Traceability systems are considered part of validation, they confirm that each load’s contents, cycle parameters, and outcome can be traced back in the event of an infection control investigation.

Continuous Improvement and Risk Mitigation: Compliance is not a one-time task but an ongoing process of quality improvement. Best practices include regular staff training and competency assessments, periodic internal audits against standards, incident reporting and root cause analysis for any sterilisation failures, and contingency planning e.g. backup equipment or agreements for outsourced reprocessing if primary equipment fails. Facilities should leverage these activities to reduce infection risks and drive continuous improvement in reprocessing quality.

This document includes sample templates for maintenance records and validation logs, and outlines protocols aligned with Australian standards (NSQHS 2021 and AS/NZS 4187). By following this guidance, healthcare organisations can enhance compliance, ensure patient safety through effective infection prevention, and be well-prepared for NSQHS accreditation assessments.

Introduction

Effective infection prevention in healthcare relies heavily on the proper reprocessing of reusable medical devices and patient care equipment. Sterilisers (steam autoclaves and other sterilisation devices) and bedpan washer-disinfectors are critical pieces of equipment for eliminating pathogenic organisms from surgical instruments, utensils, and human waste containers. Any failure in their performance or in adhering to reprocessing protocols can lead to healthcare-associated infections, posing risks to patients and staff. In recognition of this, the NSQHS Preventing and Controlling Infections Standard provides a framework for healthcare facilities to manage infection control risks, including those related to equipment reprocessing.

In Australia, NSQHS Standards (second edition, updated 2021) set national benchmarks for quality and safety in health service organisations. Standard 3, Preventing and Controlling Infections, specifically requires organisations to implement systems that prevent and manage infections and ensure reprocessing of equipment is performed safely and according to current best practices. This standard intersects with technical standards such as AS/NZS 4187:2014 Reprocessing of Reusable Medical Devices in Health Service Organisations, which provides detailed requirements for cleaning, disinfection, sterilisation, and associated documentation. Compliance officers and clinical engineering teams must work together with infection prevention and control professionals to operationalise these requirements through policies, procedures, and routine practices.

This whitepaper will first outline the relevant NSQHS infection control standards and expectations. It will then delve into specific guidance for record keeping, preventative maintenance schedules, validation protocols with templates, and best practices for ongoing compliance and improvement. The aim is to translate the high-level standards into actionable strategies and example documents that health administrators and technical staff can use to ensure their sterilisation departments and soiled utility rooms meet both regulatory and quality requirements. All recommendations are brand-agnostic and aligned with Australian guidelines and the 2021 NSQHS Standards, making them broadly applicable across public and private healthcare settings.

Overview of NSQHS Infection Control Standards

NSQHS Standard 3: Preventing and Controlling Infections. The NSQHS Standards (2021 update) outline that health service leaders must implement systems to prevent and control infections, including those acquired in healthcare, and ensure a safe environment for patients and staff. Key intentions of Standard 3 are to reduce the risk of preventable infections and to embed infection control into the organisation’s clinical governance and quality improvement systems. Several criteria and actions under Standard 3 are directly relevant to managing sterilisation and disinfection equipment:

Reprocessing of Reusable Equipment and Devices: Action 3.17 of the NSQHS Preventing and Controlling Infections Standard explicitly 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 and manufacturers’ guidelines. In practice, this means adherence to standards such as AS/NZS 4187:2014, which was the prevailing national standard in 2021 for sterilising practices, as well as any applicable ISO standards e.g. ISO 15883 series for washer-disinfectors in conjunction with device-specific guidance from manufacturers. Action 3.17 also requires that reprocessing practices reflect current best practice, for example, using evidence-based methods for cleaning, appropriate sterilisation cycle parameters (time, temperature, pressure), and validated disinfection processes.

Traceability of Reprocessed Items: NSQHS Standard 3 mandates a traceability system for critical and semi-critical items as part of reprocessing requirements. Specifically, Action 3.17(b) states that the organisation must have a traceability process capable of identifying the patient, procedure, and the reusable equipment/instruments used for that procedure. This implies that for each sterilisation cycle or disinfection cycle, there should be a link between instrument sets or items processed and the individual patient on whom they are used. In practical terms, this can be achieved through tracking systems (manual logbooks or digital tracking solutions that record batch/load numbers and corresponding patient case details). Traceability is crucial for patient safety, in the event of a sterilisation failure or infection outbreak, the facility can identify which patients might have been exposed to improperly processed instruments.

Clean and Well-Maintained Environment: The standard emphasizes that the healthcare environment including equipment and engineering systems must be clean, hygienic, and well-maintained. This broad requirement underscores the importance of preventive maintenance and regular servicing of sterilisation and disinfection equipment as part of infection control. Equipment that is not maintained e.g. a malfunctioning steriliser that fails to reach sterilising temperature, or a washer-disinfector with clogged jets, could lead to inadequately processed instruments and increased infection risk. Thus, NSQHS Standard 3 intersects with engineering and facilities management: ensuring sterilisers and washer-disinfectors are functioning optimally is part of providing a safe care environment.

Consistent with National Guidelines: The NSQHS Standards append or reference the Australian Guidelines for the Prevention and Control of Infection in Healthcare (2019) as a principal resource. These guidelines developed by NHMRC and the Australian Commission on Safety and Quality in Health Care include recommendations for cleaning, disinfection, and sterilisation in healthcare settings. Health service organisations are expected to align their infection control policies with such national guidance. For sterilisation services, this means following practices recommended by national bodies e.g. use of standard precautions in reprocessing, proper design of reprocessing areas, etc. and any jurisdictional requirements, for instance, some states have directives or licensing requirements around sterilising services.

Risk Management and Novel Infections: Another aspect of Standard 3 relevant to equipment reprocessing is the need for processes to plan and manage reprocessing requirements for novel or emerging infections. For example, during outbreaks or pandemics, additional controls or disinfection steps might be required for equipment e.g. higher disinfection standards or special handling of waste. Health services should be prepared to adjust reprocessing protocols in line with public health advisories such as ensuring appropriate disinfection of bedpans during a Clostridioides difficile outbreak, possibly requiring higher A_0 values or use of sporicidal agents. This ties into having flexible policies and the capacity to validate new processes if needed.

Alignment with AS/NZS 4187:2014 (and Updates): NSQHS Standard 3’s requirement for consistency with “current national standards” essentially points to AS/NZS 4187:2014 for hospital sterilisation departments and AS/NZS 4815:2006 for office-based practices. AS/NZS 4187:2014 which was current through 2021 is a comprehensive standard detailing every aspect of reprocessing reusable medical devices, from facility design and staff training to equipment performance and documentation. Notably, AS/NZS 4187 requires that all stages of the sterilization process be validated and documented, and emphasizes quality management principles like traceability, routine monitoring, and preventive maintenance. For instance, AS/NZS 4187 mandates full “patient-to-process” tracking of critical instruments, meaning the facility must be able to trace which autoclave load a given instrument went through and link that to patient use, precisely reflecting NSQHS Action 3.17(b). Furthermore, AS/NZS 4187 outlines requirements for routine testing of steriliser function e.g. Bowie-Dick tests, chemical indicators, biological indicators and periodic validation e.g. annual performance qualification for each steriliser. In 2023, AS/NZS 4187:2014 began transition to a new standard (AS 5369:2023); however, during 2021 the expectation for NSQHS accreditation was compliance with AS/NZS 4187. Health service organisations should monitor these developments and ensure their practices remain aligned with the latest standards.

Governance and Multidisciplinary Responsibility: Adherence to NSQHS infection control standards requires a coordinated effort. Clinical governance structures should have oversight of sterilisation practices, for example, an Infection Prevention and Control Committee or a Reprocessing Committee might review sterilisation audit results and policies. Standard 3 is closely linked with Standard 1 (Clinical Governance), which calls for policies and procedures to comply with legislation and standards and for risk management systems to reduce safety risks. Thus, hospital administrators must ensure that robust procedures for equipment reprocessing are in place, regularly reviewed, and integrated into the hospital’s overall risk management. Compliance officers should verify that documentation and practice meet NSQHS and AS/NZS requirements, and clinical engineering (Biomedical Engineering) teams must ensure technical maintenance and validation activities are carried out properly. By understanding the NSQHS framework and its application to sterilisation and disinfection equipment, these stakeholders can better collaborate to maintain a safe environment and achieve accreditation standards.

Compliant Record Keeping Practices for Sterilisation and Disinfection

One of the pillars of both NSQHS compliance and effective infection control is meticulous record keeping. Proper documentation not only demonstrates adherence to standards during audits, but also supports patient safety by enabling traceability and accountability. Below is an overview of record-keeping practices that align with NSQHS requirements and best practices:

Sterilisation Cycle Records: For each steriliser (or autoclave) cycle, records should capture key details of the run. Modern sterilisers typically generate printouts or electronic cycle logs that include date/time, cycle number, load identification, cycle parameters e.g. sterilisation temperature, pressure and hold time, and whether the cycle was successful or had alarms. These records should be retained and reviewed. If a steriliser does not automatically record all details, a manual logbook is required. The log entry should include: the date, cycle or load number, operator’s name, contents of the load e.g. tray or instrument set identifiers, verification that cycle parameters were achieved, often by attaching the autoclave printout or noting the readings, and the results of chemical or biological indicators for that load. Each cycle’s record must be linked to the items processed, for example, by noting the instrument set or tray number, which in turn can be traced to a patient or procedure. Table 1 below provides an example template for a Steriliser Cycle Log.

Washer-Disinfector Cycle Records: Bedpan washer-disinfectors and other washer-disinfectors for instruments likewise should have cycle records. These machines may have digital logging, but if not, staff should record cycles in a log sheet. Important details include: date/time, machine ID (if multiple washers), cycle type (if the machine has different programs), items processed (e.g. number of bedpans, urinals, etc.), operator, and confirmation that the cycle reached the required disinfection parameters. For thermal disinfection, typically the A_0 value or temperature hold value achieved. If the washer-disinfector has a printer, the printout with temperature profiles can be attached to the record. Any chemical indicator or test if used in that cycle should be noted. These records ensure that in the event of an infection issue e.g. spread of C. difficile, the facility can confirm that the washer was operating within specs for those cycles.

Maintenance and Calibration Records: Every preventive maintenance or repair intervention on a steriliser or washer-disinfector must be documented. A maintenance record entry should include: date of service, details of work performed (e.g. replaced door gasket, calibrated temperature probe, ran validation test cycles), the name and company of the service technician, and results of any post-maintenance testing. Maintaining a maintenance log supports NSQHS’s requirement for well-maintained equipment and provides evidence during accreditation that the facility proactively manages equipment safety. Calibration certificates for instruments (e.g. temperature sensors, pressure gauges, data loggers) should also be kept on file. An example Preventative Maintenance Record template is presented later in this document (Table 2).

Validation and Test Records: As part of ongoing performance validation, certain tests are done daily, weekly, or periodically (detailed in the next section). The outcomes of these tests must be recorded. Examples include daily Bowie-Dick test results for vacuum sterilisers (indicating air removal efficacy), biological indicator results (e.g. weekly spore tests or for loads containing implants), chemical indicator challenge pack results, and any soil tests or protein residue tests for washer-disinfectors. Each test record should note the date, the test performed, test results (e.g. “pass” with indicator strip initialed, or any quantitative reading), and the person who performed it. If a test fails (e.g. a Bowie-Dick test shows an air leak), the record should indicate the corrective actions taken (machine taken out of service, engineering called, etc.). Keeping these records is vital for continuous quality improvement, as they allow trends to be monitored e.g. repeated near-failures can signal equipment drift and ensure no test is skipped. NSQHS assessors often review sterilisation test logs to confirm the facility’s compliance with routine monitoring protocols.

Traceability Logs: In addition to cycle logs, a dedicated traceability log or system might be used especially in surgical instrument reprocessing. This could be an electronic tracking system or manual records (e.g. a logbook or using sterilisation record labels). Traceability records link specific instrument sets or items to the steriliser or washer cycle they underwent and to the patient/procedure. Often this is achieved by using load stickers: each sterilised package has a lot label that is also placed in the patient’s file or the operating room record. Alternatively, some systems use barcode scanning where each instrument set is scanned out to a patient after use, and the system can retrieve which cycle that set was sterilised in. The NSQHS requirement is that such a system is in place for critical items that enter sterile body sites and semi-critical items. For example, an endoscope (semi-critical device) reprocessed in an Automated Endoscope Reprocessor (AER) should have a record linking it to the patient procedure in case a contamination issue arises. During NSQHS audits, surveyors may ask to demonstrate traceability by picking a surgical instrument and asking the staff to trace it back to a sterilisation cycle and patient. Robust record systems make this possible.

Incident and Non-conformance Records: If any reprocessing failures or incidents occur, such as a positive biological indicator indicating a sterilisation failure, a malfunction of a washer causing a batch of instruments to be not disinfected, or a recall of instruments due to sterility breach, these should be documented through the organisation’s incident management system. From an infection control perspective, NSQHS expects that failures are investigated and corrective actions are taken to prevent recurrence. Maintaining records of these incidents, along with subsequent corrective and preventive actions (CAPA), is part of compliance and quality improvement. These records should tie into risk management, for instance, records of a steriliser failing its cycle can prompt a risk assessment for surgical schedule impact and mitigation measures, like using a backup steriliser or loaning instruments from elsewhere.

Training and Competency Records: Although not a direct “equipment record,” documentation of staff training and competency in operating sterilisers and washer-disinfectors is an important component of compliance. NSQHS Standard 3 and Standard 1 require that staff are appropriately trained and that education is provided e.g. action 3.1 and 3.2 cover infection control education for workforce. Records should show that all staff who use the steriliser or work in Central Sterile Supply Department (CSSD) have been trained on the procedures, understand the logs and indicators, and undergo periodic competency assessments. Additionally, any personnel performing maintenance or validation should have evidence of qualifications or training. Training logs (dates of training, topics, attendees) may be reviewed during audits to ensure personnel managing these critical processes are competent.

It is essential that all these records are well-organised, readily accessible, and retained for the period required by local policy or regulation (often several years). Many facilities are moving toward digital record-keeping systems or sterile services management software, which can simplify storage and retrieval. However, paper-based logbooks are still common and acceptable, provided they are filled out consistently and stored securely. A general rule is “if it isn’t documented, it didn’t happen.” Not only do thorough records demonstrate compliance, they are invaluable for internal monitoring and tracing issues in the event of an infection control concern. As noted in one guidance, auditors may arrive without warning and ask for proof of sterilisation and maintenance records; failure to produce them can lead to penalties or service shutdowns. Thus, diligent record keeping is both a regulatory necessity and a cornerstone of safe patient care.

Template: Steriliser Cycle Log (Example)

The following is an example of a steriliser cycle log template, illustrating the type of information that should be captured for each sterilisation cycle. This template can be adapted for either paper logbooks or electronic records. (Table 1)

Table 1. Example template for a steriliser cycle log. Each row represents one steriliser cycle/load. The log captures traceability (which load, which items), accountability (who ran it), verification of cycle parameters and indicators, and outcome. In the third example, a failure is recorded with actions taken.

In practice, if using paper logs, additional columns or fields might be included e.g. a space to attach the cycle printout or to note the steriliser cycle program type, etc. Electronic systems may automatically record more granular data. The key is that all critical information is recorded and retained.

Preventative Maintenance of Sterilisers and Washer-Disinfectors

Preventative maintenance ensures that reprocessing equipment operates reliably and within specification, directly impacting infection control efficacy. NSQHS standards implicitly require a maintenance program as part of providing a safe environment and well-functioning equipment. Moreover, AS/NZS 4187 explicitly calls for a documented program of preventative maintenance for all reprocessing equipment and documented records of maintenance activities. This section outlines maintenance requirements and provides example templates for record-keeping.

Routine Maintenance Schedule and Requirements

1. Daily and Weekly Checks: Frontline staff e.g. sterilisation technicians or nurses in a sterilising department should perform basic daily checks on equipment. For sterilisers, this may include verifying the chamber is clean, door gaskets are intact and lubricated, checking the water level (if applicable), and running a warm-up or Bowie-Dick test cycle at the start of the day. Any daily safety or functionality test results, such as Bowie-Dick test outcome for vacuum steriliser leak detection must be logged. For bedpan washers, daily checks could involve cleaning strainers or filters, checking spray arms for clogs, and confirming chemical detergent levels if the unit uses chemicals. Weekly maintenance might include more thorough cleaning, e.g. washer-disinfector jets cleaned of scale, steriliser chamber drain cleaned and calibration verification of displays. Some sterilisers have weekly auto-calibration or require an operator check of gauges. These routine tasks are often outlined in the manufacturer’s user manual and should be included in standard operating procedures. A checklist can be used for daily/weekly tasks for consistency.

2. Scheduled Preventative Maintenance by Technicians: In addition to routine user checks, a qualified technician such as a biomedical engineer or authorised service contractor should perform in-depth preventative maintenance at regular intervals. Typically, annual servicing is considered a minimum for sterilisers, aligning with both manufacturer recommendations and safety regulations, since sterilisers are pressure vessels requiring periodic inspection. Many facilities opt for more frequent servicing, e.g. biannual (twice-yearly) maintenance for heavily used autoclaves or high-risk settings. The same logic applies to bedpan washer-disinfectors: manufacturers and service providers often recommend servicing at least once per year, with twice-yearly service being optimal for continuous reliability. During each service, the technician will typically:

   • Verify and calibrate temperature and pressure sensors using certified test equipment, as required by standards to use NATA-accredited calibration tools in Australia.
   • Inspect and replace worn mechanical parts e.g. door seals, valves, heating elements, spray nozzles in washers, etc.
   • Test the safety features e.g. door interlock, pressure relief valves.
   • Run test cycles (empty chamber and full load) to ensure the machine meets performance criteria. This overlaps with validation, often the service includes an operational performance qualification.
   • Apply any necessary software updates or modifications.
   • Document all findings and actions.

   For bedpan washers, preventative maintenance is crucial to ensure effective thermal disinfection. Components like heating elements (for maintaining hot water temperature to achieve the required A_0 disinfection value), flush mechanisms, and dosing pumps for detergents must be checked. Scale build-up is a known issue that can impede performance; hence descaling or replacing filters may be part of routine maintenance, especially in hard water areas.

3. Statutory Inspections: Beyond routine service, some equipment may be subject to statutory inspections. For example, steam sterilisers might be classified as pressure vessels under local laws (AS 3788 Pressure equipment in-service inspection). This could require an authorised inspector to check the vessel integrity periodically e.g. every one to three years depending on the category. Healthcare facilities should be aware of state Work Health and Safety (WHS) regulations e.g. SafeWork NSW, WorkSafe Victoria, etc. that may mandate such inspections. Typically, compliance with these laws is managed via the engineering department and records (certificates of inspection) are kept with the maintenance logs.

4. Unplanned Maintenance and Repairs: When a steriliser or washer-disinfector malfunctions or fails a test, prompt corrective maintenance is required. All such events and the repair actions should be recorded in the maintenance log, including date/time of failure, nature of problem, who was notified, repair performed, parts replaced. NSQHS standards expect that faulty equipment is identified, removed from service, and repaired in a controlled manner, with records of these actions. For example, if a steriliser fails to reach temperature, staff should stop using it, tag it as out-of-service, and notify clinical engineering; after repair, a validation test e.g. Bowie-Dick and biological indicator cycle should be done before returning to use, and all steps documented.

5. Documentation of Maintenance: Every maintenance activity, whether routine or corrective, must be documented. This not only provides evidence for compliance but also helps in tracking equipment history, useful for end-of-life decisions or recurring problem analysis. Documentation can be in the form of a logbook, a service report filed by an external contractor, or entries in a computerized maintenance management system (CMMS). Key fields to record include: date, type of service (routine PM or repair), tasks performed, results of checks (e.g. “replaced gasket; leak tested, passed”), any parts replaced, person/company performing service, and confirmation that the equipment was tested and is safe to use. According to an audit tool based on AS/NZS 4187, facilities should have both a preventative maintenance schedule and maintenance records for all reprocessing equipment, surveyors may ask to see evidence of this schedule and recent maintenance reports.

Below, Table 2 provides a template for documenting preventative maintenance of a steriliser or washer-disinfector, which can be adapted to suit an organisation’s needs.

Template: Preventative Maintenance Record

Table 2. Example preventative maintenance and repair log for sterilisation and disinfection equipment. This log captures routine scheduled services (annual, semiannual) and an example of an unplanned repair, along with details and outcomes.

Interpretation of Maintenance Records: The records in the template above illustrate how maintenance data is recorded. Each entry clearly states what was done and the outcome, which is important for auditing. For example, the entry on 2025-07-10 shows an Annual Service for Steriliser #1: multiple tasks are listed (some preventive replacements, calibration, and testing), and the outcome is that the steriliser is operational with the next service due in one year. This aligns with best practice to annually validate and service sterilisers. The bedpan washer entry demonstrates semiannual maintenance focusing on descaling and verifying the thermal disinfection A_0 value (600 is a commonly referenced minimum A_0 for bedpan disinfectors per standards like AS/NZS 4187/ISO 15883), confirming it meets disinfection efficacy. The unplanned repair entry highlights that after fixing a component, the technician performed validation (BI tests) before declaring the unit operational, a critical step to ensure effectiveness after a major fix.

Maintenance Program Best Practices:

• Maintain a master schedule of all reprocessing equipment with their next service due dates, and ensure services are done on time. A lapse could risk non-compliance and equipment failure.
• Use only qualified personnel or authorised service agents for maintenance, especially for complex repairs or calibration. This not only is safer but provides credible documentation e.g. service reports from an authorised company.
• If external contractors are used, ensure they follow relevant standards e.g. using NATA-certified calibration tools as required.
• Have spare parts on hand for common wear-and-tear items such as gaskets or filters to minimise downtime.
• Integrate maintenance with validation: after servicing, always do a cycle with biological and chemical indicators to confirm the steriliser/washer is performing correctly before using for patient items.
• Keep copies of all service reports and certificates e.g. calibration certificates, pressure vessel inspection reports. These may be needed for audits or insurance, and are part of the compliance evidence.
• Monitor maintenance trends: if a particular steriliser has frequent issues, that might trigger a capital replacement plan. Continuous quality improvement by upgrading equipment.

By rigorously implementing preventative maintenance, healthcare facilities reduce the risk of unexpected breakdowns that could compromise infection control. In addition, demonstrating a solid maintenance record fulfills the expectations of NSQHS Standard 3 and gives confidence to surveyors and the facility’s leadership that reprocessing systems are safe and reliable.

Validation Protocols and Ongoing Performance Monitoring

Validation and routine monitoring of sterilisation and disinfection processes are essential to ensure that equipment is not just functioning, but truly achieving the microbial kill or removal required for patient safety. NSQHS Standard 3’s focus on evidence-based systems and risk mitigation is embodied by robust validation protocols. This section discusses initial and ongoing validation for sterilisers and washer-disinfectors, including traceability and efficacy checks, and provides template protocols for these activities.

Initial Qualification and Commissioning

Whenever a new steriliser or washer-disinfector is installed or after major repairs/upgrades, or relocation, it must undergo formal validation before being put into routine use. According to AS/NZS 4187 and relevant ISO standards such as ISO 17665 for sterilisation and ISO 15883 for washer-disinfectors, validation is typically divided into:

• Installation Qualification (IQ): Documenting that the equipment is installed correctly per manufacturer’s requirements (e.g. correct utilities, physical setup, software installed). IQ often involves checking that the machine’s specifications such as electrical supply, water quality connections, steam supply, etc. meet required standards.
• Operational Qualification (OQ): Testing that the equipment operates correctly across its intended range. For a steriliser, OQ might involve running empty chamber cycles at various settings to verify the unit achieves the set temperature and pressure, alarms function, and controls are accurate. For a washer-disinfector, OQ might test cycles with test soils or temperature probes to ensure it meets parameters like water temperature, flow rate, detergent dosing.
• Performance Qualification (PQ): Demonstrating that in actual operational conditions, the equipment consistently produces the desired result (sterile or disinfected items). PQ is often the most involved phase: for a steriliser, it includes running cycles with typical loads (full loads, maximum instrument sets, challenging loads) and using biological indicators (BIs) and thermocouples placed in the load to ensure all locations reach sterilisation conditions. For a washer, PQ may involve processing standardized test loads contaminated with a test soil or microbial markers to verify cleaning and disinfection efficacy, for example, using blood protein test strips or microbiological swabs to ensure the washer disinfector attains an A_0 value of ≥600 or as required.

The outcome of IQ/OQ/PQ should be a validation report for each piece of equipment. NSQHS expects organisations to have these reports on file. The validation report will state that the steriliser/washer complies with performance requirements, often referencing standards like ISO 17665-1 or ISO 15883, and listing all tests performed. For instance, an audit criterion for AS/NZS 4187 compliance is that “There is a copy of the validation report in the department for each sterilizer and each washer-disinfector, indicating it has passed IQ, OQ & PQ”. If a major repair occurs e.g. replacing a steriliser’s control system or a washer’s heating element, requalification (partial OQ/PQ) should be done and documented to ensure the repair did not compromise performance.

Routine Ongoing Validation (Monitoring)

Once equipment is in use, an ongoing validation and monitoring program is critical. This consists of routine cycle monitoring and periodic performance requalification:

Routine Cycle Monitoring: Every sterilisation or disinfection cycle is monitored by a combination of physical, chemical, and sometimes biological indicators:

• Physical Monitors: These are the built-in gauges and digital records of the machine (time, temperature, pressure). Operators should check that each cycle’s printout or display confirms that parameters were within acceptable range e.g. 134°C ±1°C for 4 minutes for a standard steam steriliser cycle. Any deviation or alarm is cause for rejecting the load and investigating. Many sterilisers will alarm and abort automatically if parameters deviate; however, it’s good practice for staff to review the cycle chart. For washer-disinfectors, the key physical parameter is typically temperature/time or the calculated A_0 value. Some advanced machines directly report A_0 achieved each cycle. Staff should verify these readings meet the minimum (e.g. A_0 600) and record that verification.
• Chemical Indicators (CIs): These are dyes or chemical strips that change color when exposed to certain conditions e.g. specific temperature for a certain time or presence of steam. There are different classes of CIs (per ISO 11140 standards). Common practice in sterilisation:

• Class 1 (Process Indicators): e.g. autoclave tape on the outside of packs, simply indicates it went through a process (changes color if heat exposure). Ensures item has been processed, but not proof of full sterilisation parameters.
• Class 4-6 (Multi-variable or Emulating Indicators): Internal chemical strips that react when proper conditions are met. For example, a Class 5 integrator might be placed inside a pack and designed to have a chemical reaction equivalent to biological kill conditions. Staff check these after the cycle; a complete color change indicates the inside of pack likely saw adequate conditions.
• Bowie-Dick Test Pack: A specific chemical indicator test, often a paper pack or electronic device used daily in vacuum-assisted steam sterilisers to check for effective air removal and steam penetration. A uniform color change pattern indicates the vacuum pump and steam penetration are effective (no air pockets). This test is done at least daily, typically in an empty steriliser at the start of the day before processing any loads.
• Washer-Disinfector Indicators: There are color-change indicators to verify washer function too e.g. test strips that indicate proper water temperature or presence of disinfectant. Some facilities use a TOSI test or similar soil test device weekly to verify that the washer-disinfector is actually getting instruments clean (these devices are soil-coated plates placed in a load to see if soil is removed).

Staff should document the results of these chemical indicators for each load or each day as applicable. For instance, “Load 5 Class 5 integrator PASSED” can be noted on the cycle record, or Bowie-Dick test result logged daily (often a logbook just for Bowie-Dick is kept, with the test sheet attached).

• Biological Indicators (BIs): These are the highest level of assurance, using spores of a hardy microorganism (e.g. Geobacillus stearothermophilus for steam sterilisers) to test sterilisation efficacy. The standard use of BIs in steam sterilisation in hospitals often includes:

• A weekly BI test in an empty chamber or a test pack, unless every load is biologically monitored which is rare except in certain cases.
• Every load containing implantable devices must be monitored with a BI as per many policies: the load is quarantined until the BI is confirmed negative (no growth), or a rapid-read BI e.g. 1-hour readout is used.
• For new equipment validation or major changes, multiple BIs are used in various locations to confirm even the hardest-to-sterilise locations reach sterility.

BI results whether using traditional incubated spore strips or self-contained rapid indicators must be recorded. If any BI is positive (shows growth), it is a serious non-conformance: the load is considered non-sterile, items must be recalled if already distributed, the steriliser is taken out of service for investigation, and the incident reported. Records of all these actions and resolution are critical and would be examined in an accreditation or regulatory investigation. Fortunately, BI failures are rare if all maintenance and monitoring steps are effective.

Dose/Exposure Monitors for Disinfectors: While steam sterilisers have clear biological end-points, washer-disinfectors aim for high-level disinfection. There isn’t a routine “spore test” for a disinfection cycle, but facilities rely on physical parameters, like the A_0 concept, which is a formula combining temperature and time of exposure, where A_0 600 is a common benchmark for disinfecting non-critical items. Some washers may output an A_0 value per cycle. If chemical disinfectants are used (less common for bedpan washers, more so for endoscope reprocessors), test strips to measure concentration or efficacy might be used regularly. Additionally, surface ATP or microbe testing can be done on sample items post-wash periodically as part of quality assurance.

Table 3 below summarises key routine monitoring activities for sterilisers and bedpan washer-disinfectors, along with their purpose and typical frequency:

Table 3. Key routine monitoring and validation activities for sterilisers and washer-disinfectors, aligned with standard practices and frequencies. These measures collectively ensure ongoing efficacy of reprocessing equipment.

The above table highlights that multiple layers of monitoring are employed to guarantee sterility/disinfection. NSQHS expects that such systems are in place and used consistently. During accreditation, a facility might be asked to show, for example, a week’s worth of steriliser logs including Bowie-Dick test results and how they responded to any abnormal result.

Periodic Revalidation

In addition to day-to-day monitoring, periodic revalidation, also called periodic performance requalification is recommended and often required by standards. This typically occurs annually for each steriliser and washer-disinfector. Essentially, it is a mini version of the initial PQ:

• For a steam steriliser, annual revalidation might involve running a full range of empty and loaded cycles with calibrated data loggers to map temperatures across the chamber, biological indicator challenges in hardest locations, and ensuring all passes. Many healthcare facilities contract this out to specialists who produce a comprehensive report. AS/NZS 4187 indicated that annual performance qualification (PQ) for each steriliser and washer is required (not met if >12 months since last PQ).
• For a washer-disinfector, annual validation will test cleaning efficacy, possibly with test soil on instruments or microbiological testing and thermal disinfection efficacy, using loggers to verify temperature and hold time meets A_0 target. The service engineer or validation specialist might also verify spray arm coverage with flow verification tests and that dosing of detergents/disinfectants is accurate.

After such periodic revalidation, a revalidation report is issued. Any deficiencies noted must result in corrective actions, e.g. if a particular load type did not consistently reach temperature, the loading configuration might need to change or the machine adjusted.

Traceability and Efficacy: Closing the Loop

Traceability, as mentioned earlier, is an integral part of validation in a broader sense, it ensures that if a problem is found, say a batch failed BI after the fact, or months later a patient develops an infection traced to a surgical instrument, the facility can identify all other items processed in the same cycle or the same period and take appropriate action. A robust traceability system is, in effect, a risk control measure. It also allows targeted quality checks, e.g. if one particular washer-disinfector is found to have an issue, traceability can show which items went through that machine for a targeted recall. NSQHS’s requirement for traceability acknowledges that without this, you cannot fully protect patients in the event of reprocessing failures.

Efficacy validation refers to demonstrating that the equipment achieves the intended microbiological outcomes. This is achieved through the combination of routine monitors and periodic biological testing described. Additionally, efficacy is maintained through adherence to manufacturers’ guidelines, for example, loading configurations (do not overload or cover instruments improperly) are a part of ensuring the sterilant or hot water can contact all surfaces. Staff training in correct loading/unloading and wrapping of instruments is an often overlooked part of validation, a steriliser might be working perfectly, but if a set is wrapped too tightly or a bedpan washer is overloaded beyond its design, the efficacy drops. Thus, ongoing staff competency checks to make sure protocols are followed are part of the validation continuum.

Protocol Example: Annual Performance Requalification of a Steam Steriliser

To illustrate how a validation protocol might be structured, here is a condensed example of steps for an annual performance requalification (PQ) of a steam steriliser to be conducted after routine maintenance:

1. Preparation: Ensure steriliser maintenance is up to date e.g. calibration of sensors done. Gather required tools: calibrated thermocouple data loggers (NATA certified), biological indicators e.g. 10^6 spore strips, Bowie-Dick test pack, and chemical integrators. Verify the steriliser’s empty chamber thermometric performance first.
2. Empty Chamber Heat Distribution Test: Place thermocouples at various points in the empty chamber (corners, center). Run an empty cycle at the standard setpoint (e.g. 134°C/4min). Record temperature and pressure throughout. Acceptance: all thermocouple readings reach ≥134°C for the full 4 min and within a narrow range (e.g. max 2°C spread). Also run a Bowie-Dick test in the empty chamber to confirm air removal; it should pass.
3. Maximum Load Validation: Choose a “challenge load” e.g. the largest load or the load with the most metal mass that is routinely processed. Pack the chamber as per routine use (use test packs if actual instruments are not used). Place biological indicators and thermocouples inside representative items or at worst-case locations, for example, center of dense packs, trays on bottom shelf, etc. Run a cycle with this maximum load. After cycle, retrieve thermocouple data and BI samples.
4. Acceptance for thermometry: all probe readings must meet time/temp requirements (no cold spots).
5. Acceptance for BIs: no growth from any indicator after incubation (usually 48 hours for steam BI unless rapid BIs are used).
6. Acceptance for chemical integrators: all show pass.
7. Varied Load or Hard-to-Sterilise Item Validation: If the hospital has specific complex instruments e.g. long lumen devices that are known challenges, include a test cycle for those. For instance, a cycle with a lumened device with a biological indicator in its lumen to ensure the sterilant penetrates. Alternatively, perform multiple cycles: e.g. one full of textile packs and another full of metal instruments, depending on the load types used.
8. Analysis: Compare all results to criteria. If any cycle fails criteria, investigate causes (equipment issue or operator/loading issue) and repeat the test after correction. For example, if a BI in one position grew bacteria, that indicates a failure at that spot, perhaps an overcrowded pack or an area where steam isn’t reaching; one might re-run with fewer items or check the steriliser’s airflow.
9. Documentation: Compile a report detailing the test conditions, equipment used (serial numbers of loggers, BI lot numbers), results data (graphs of temperature vs. time for each probe, BI outcomes), and a conclusion whether the steriliser passed validation. If any deviations occurred and were resolved, note the corrective actions.
10. Approval: Have the report reviewed and signed by a qualified person e.g. a senior technician or an external validation engineer. File this report in the department records and schedule the next revalidation usually 12 months later.

A similar approach is taken for washer-disinfectors: using test soils and temperature mapping to ensure even cleaning and disinfection. For example, an annual validation protocol for a bedpan washer might involve soiling a bedpan with a standardized soil, processing it, and then swabbing it after to culture for any remaining bacteria, or using protein residue tests to ensure cleanliness. It would also include verifying the machine’s temperature sensor by independent logger to ensure it hit the disinfection temperature for the required time.

By implementing these validation protocols, healthcare facilities uphold the “evidence-based systems” principle of NSQHS Standard 3. They provide concrete evidence that sterilisation and disinfection processes are working as intended. More importantly, thorough validation and monitoring drastically reduce the risk of a critical failure going unnoticed and thus reduce infection risk.

Compliance Best Practices for Risk Mitigation and Continuous Quality Improvement

Achieving and maintaining compliance with NSQHS Standard 3 and related reprocessing standards is an ongoing effort. Health service organisations should foster a culture of continuous improvement in their sterilisation and infection control practices. Below is a summary of best practices that help mitigate risks and drive quality improvement, ensuring sustained compliance:

• Develop Comprehensive Policies and Procedures: Documented policies should cover all aspects of equipment reprocessing, from handling of soiled items, through cleaning, sterilising, storage, to recall procedures for non-conforming loads. Ensure policies explicitly reference compliance requirements (NSQHS actions, AS/NZS 4187 clauses) and are reviewed regularly. Policies should also define responsibilities for who performs daily tests, who can release loads, etc. and include contingency plans e.g. what to do if a steriliser is found to be malfunctioning. As audit tools suggest, there should be policies on loading/unloading, use of indicators, traceability, managing non-conformances, single-use devices, validation processes, etc. all aligned with best practice.
• Staff Training and Competency: The best equipment and protocols mean little if staff are not properly trained. Regularly train and retrain all personnel involved in cleaning, disinfection, and sterilisation, this includes CSSD technicians, theatre nurses who handle sterile packs, and maintenance personnel. Training should cover not just operation of machines, but why each step e.g. using indicators, recording logs is critical, to encourage diligence. Implement a competency assessment program including initial orientation and periodic re-assessment to verify that staff can correctly perform tasks like packaging instruments, running steriliser cycles, interpreting indicator results, and troubleshooting routine problems. Document these competencies (dates and skills verified) as part of the quality system. A well-trained workforce can preempt many issues, for instance, noticing a strange noise in a washer and reporting it before it fails, or catching a chemical indicator slight failure and not ignoring it.
• Internal Auditing and Spot Checks: Conduct periodic internal audits against NSQHS and AS/NZS 4187 criteria. Use tools like the AS/NZS 4187 compliance audit checklist to self-assess. For example, audit whether all maintenance is up to date, logs are complete, and processes are followed. Include tracer activities: pick a random instrument set and trace its path, for example used on patient X, sterilised in load Y on date Z, BI result, etc. to test the traceability system. Audit results should be discussed in infection control or quality meetings, and any gaps addressed. This prepares the facility for external accreditation surveys and, more importantly, catches issues early. NSQHS Standard 3 expects organisations to evaluate and respond to infection control risks, which internal audits facilitate.
• Incident Management and Reporting: Treat every malfunction or processing failure as an opportunity to improve. Establish a clear reporting mechanism for incidents like sterilisation cycle failures, breaches in sterile storage, or suspected post-procedure infections. When such incidents occur, perform a root cause analysis (RCA). For example, if a BI comes up positive, investigate: Was it the steriliser’s fault (mechanical issue, cold spot)? Or a human error (overloading, operator skipped a step)? Implement corrective actions and also a preventive action plan e.g. additional training, adjusting maintenance frequency, modifying load configuration. All this should be recorded in an incident log. Sharing these findings with the team prevents recurrence and shows a commitment to improvement. NSQHS standards encourage learning from incidents as part of the quality improvement system (Std 3 has actions on responding to infection incidents, and Std 1 on risk management).
• Risk Assessment and Contingency Planning: Proactively assess risks related to reprocessing equipment. For instance, consider What is the impact if Steriliser #1 fails mid-day? The risk is surgical instruments shortage or surgery delay. Mitigation might be having a second steriliser (redundancy), or an agreement with a nearby hospital to assist, or maintaining an inventory of pre-sterilised disposable instruments for emergencies. Similarly, if a bedpan washer is down, is there an alternative like disposable bedpans or chemical disinfection temporarily that does not compromise infection control? NSQHS (Action 3.14 and 3.17) implies planning for reprocessing requirements, which includes such contingency plans. Ensure these plans are documented and tested. For example, a drill could be: simulate the main CSSD steriliser breaking down and see how staff manage instrument reprocessing. This can reveal gaps in the plan.
• Monitoring Outcomes and Infection Rates: While compliance focuses on processes, the ultimate goal is reducing infections. Infection Control teams should monitor surgical site infection rates and other infection metrics and see if any trends could relate to reprocessing. If an uptick in infections is noted in a certain department, one of the checks would be to ensure sterilisation practices are being strictly followed there. Conversely, tracking outcomes of sterilisation processes themselves, like frequency of positive spore tests, or how often equipment fails tests can highlight areas for improvement. Ideally, strive for zero incidents of steriliser failure and 100% compliance with routine tests. Any less should trigger a quality improvement initiative.
• Keep Up with Updates: The field of infection control and sterilisation is always advancing. Australia’s standards update with AS 5369 replacing AS 4187 in the pipeline and international guidelines evolve, for example, new types of indicators or monitoring tools become available, or improved washer-disinfector technology. Continuous improvement means periodically reviewing and updating policies to incorporate new evidence or standards. It’s wise to have someone on the team, often the CSSD manager or an infection control practitioner, be responsible for reviewing new literature or guidelines, for instance, new guidance from ACSQHC, or updates to the Australian Guidelines for Infection Prevention and bringing recommendations forward. Regularly liaising with professional bodies like the Sterilizing Research & Advisory Council of Australia (SRACA) or attending relevant workshops can help keep the facility at the forefront of best practice.
• Multidisciplinary Collaboration: Ensure there is collaboration between infection prevention staff, sterile services staff, clinical engineers, and hospital leadership. Each brings a perspective, e.g. engineers ensure technical soundness of equipment, infection control ensures the practices meet clinical requirements, administrators ensure resources and support. Regular meetings or huddles to discuss sterilisation process performance, maybe as part of the Infection Control Committee can be useful. For example, the team can review the quarterly sterilisation audit report together and decide on any improvements or resources needed.
• Documentation and Communication: Finally, maintain open communication with frontline clinical staff e.g. surgeons, nurses about sterilisation and reprocessing. Sometimes end-users may not understand why certain practices are in place, like why an instrument set got pulled because an indicator failed. Educating them on the importance of these measures fosters a safety culture and ensures support for compliance measures. From a documentation standpoint, keeping clear, accessible records and SOPs means anyone can understand the system and step in if needed. Important for cross-coverage or new staff onboarding.

In summary, compliance and quality improvement in steriliser and washer-disinfector management is an active, continuous process. By following the above best practices, healthcare facilities create a robust framework that not only meets the NSQHS Preventing and Controlling Infections Standard, but truly minimises infection risks. This leads to safer patient care and can also improve operational efficiency. Well-maintained equipment and trained staff tend to operate with fewer disruptions).

Conclusion

The management of sterilisation equipment and bedpan washer-disinfectors is a critical component of infection prevention in healthcare facilities. Applying the NSQHS Preventing and Controlling Infections Standard to these practices ensures that organisations not only comply with accreditation requirements but also uphold the highest levels of patient safety. In this whitepaper, we have provided an overview of the relevant NSQHS standards, detailed guidance on record keeping and traceability, templates for maintenance and validation records, and protocols for ongoing performance verification.

For an Australian audience of healthcare administrators, compliance officers, and clinical engineering teams, the message is clear: quality reprocessing of medical devices is a shared responsibility that demands diligent documentation, regular maintenance, rigorous validation, and constant improvement. By aligning steriliser and washer-disinfector management with NSQHS Standards (2021) and Australian guidelines, facilities can significantly mitigate infection risks. Key takeaways include the importance of meeting national standards like AS/NZS 4187/AS 5369 in every reprocessing step, keeping comprehensive records to prove and trace the work done, and maintaining a cycle of review and enhancement in response to data and incidents.

Ultimately, effective implementation of these standards is reflected in everyday practices: a culture where staff automatically run daily tests before using equipment, promptly log every cycle and maintenance action, and feel empowered to speak up and rectify any deviation. This culture, supported by robust systems and oversight, leads to safer outcomes, fewer healthcare-associated infections, confident compliance with regulatory expectations, and assurance to patients and the community that healthcare facilities are indeed safe places for care.

Armed with the information, templates, and best practices outlined in this whitepaper, Australian health service organisations can advance their sterilisation and disinfection processes to the next level of quality and safety. Continuous adherence to these principles will help ensure that the “Preventing and Controlling Infections Standard” is not just a document on the shelf, but a living, breathing part of day-to-day operations that delivers tangible risk reduction and fosters excellence in healthcare delivery.

Sources

1. Australian Commission on Safety and Quality in Health Care - National Safety and Quality Health Service Standards (2nd ed., updated May 2021), Standard 3: Preventing and Controlling Infections.
2. ACSQHC - NSQHS Standard 3, Action 3.17 on reprocessing requirements and traceability.
3. Grampians Health Infection Control - RICPRAC Sterilization Audit Tool (AS/NZS 4187:2014).
4. AS/NZS 4187:2014 - Reprocessing of Reusable Medical Devices in Health Service Organisations (Referenced in NSQHS).