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.

Introduction

This paper sets out the Australian requirements for specifying, testing, maintaining and replacing bedpan washer-disinfectors and steam sterilisers used to reprocess reusable medical devices. AS 5369:2023 is the governing Australian standard. It requires washer-disinfectors to conform to the applicable parts of ISO 15883, large steam sterilisers to EN 285 and ISO/TS 22421, and small steam sterilisers to EN 13060 and ISO/TS 22421. Steam sterilisation processes are validated to ISO 17665.

Regulatory Framework

AS 5369:2023 converts infection prevention requirements into measurable process limits. These include the thermal disinfection dose for washer-disinfectors, the sterilisation temperature, holding time and air removal for sterilisers, water and steam quality, and cycle records. Hospitals and day procedure services are assessed against Action 3.17 of the National Safety and Quality Health Service (NSQHS) Standards. Australian Commission on Safety and Quality in Health Care Advisory AS24/01 requires these services to complete a gap analysis against AS 5369:2023 by 30 June 2025 and to implement a compliance plan with timeframes. AS 5369:2023 does not set a compliance date.

The Therapeutic Goods Administration (TGA) regulates the supply of therapeutic goods in Australia. AS 5369:2023 requires purchasing procedures to address the TGA requirement for reprocessing equipment to be included in the Australian Register of Therapeutic Goods (ARTG). Confirm the ARTG entry for each machine before purchase.

Development of the Standards

• Before 2014: AS/NZS 4187:2003 applied to health care facilities and AS/NZS 4815:2006 applied to office-based health care facilities. Washer-disinfectors were specified to the ISO 15883 series and steam sterilisers to EN 285 or EN 13060.

• 2014 to 2023: AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organisations replaced AS/NZS 4187:2003. It required validation of each washer-disinfector and steriliser by installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), followed by routine monitoring of each process. AS/NZS 4815:2006 continued to apply to office-based practices.

• December 2023: AS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities superseded AS/NZS 4187:2014 and AS/NZS 4815:2006. It applies wherever these devices are reprocessed, including hospitals, medical imaging, medical, dental and podiatry practices, and aesthetics and body modification practices. It classifies devices as critical, semi-critical or non-critical, and requires documented assignment of devices to product families. It requires validation of every process by IQ, OQ and PQ, requalification at least annually, planned preventive maintenance and calibration by a competent person, and a business continuity plan with documented backup procedures. It excludes devices potentially contaminated with transmissible spongiform encephalopathies, e.g. Creutzfeldt-Jakob disease.

Current Requirements

Bedpan Washer-Disinfectors: Specify machines that conform to ISO 15883-1 and ISO 15883-3. AS 5369:2023 lists bedpans, urinals, sponge bowls and commodes as non-critical items that may require thermal disinfection in a washer-disinfector to ISO 15883-3 or ISO 15883-6. The thermal disinfection stage must deliver an A0 value of at least 60, equivalent to 80 deg C [176 deg F] for 1 min. Program a higher A0 value where the infection prevention risk assessment requires it, e.g. A0 600, equivalent to 90 deg C [194 deg F] for 1 min or 80 deg C [176 deg F] for 10 min. Check the process record at the end of every cycle. Confirm water pressure, flow and spray action, detergent dosage, and time at disinfection temperature. Inspect each item for residual soil. Use commercial soil tests for routine monitoring only where they are shown to be equivalent to the test soil used in validation.

Test the supply water before installation. Water for all stages before the final rinse must have a hardness not greater than 150 mg/L and chloride not greater than 120 mg/L. Water of this quality may be used for the final rinse of ISO 15883-3 washer-disinfectors. Treat harder water to prevent scale in the steam generator, pipework and spray nozzles.

Steam Sterilisers: Specify sterilisers that accept at least one sterilisation module of 300 x 300 x 600 mm [12 x 12 x 24 in], or have a chamber volume of at least 60 L [16 US gal], to EN 285. Specify smaller sterilisers to EN 13060, which defines type B, N and S cycles. Use type B cycles for wrapped, porous and hollow loads. Do not sterilise packaged items in a cycle without a drying phase. AS 5369:2023 lists common holding times of 121 deg C [250 deg F] for 15 min, 126 deg C [259 deg F] for 10 min, 132 deg C [270 deg F] for 4 min and 134 deg C [273 deg F] for 3 min.

Throughout the holding time, the temperature measured at the chamber reference point and the saturation temperature calculated from the measured chamber pressure must both be within the sterilisation temperature band. For EN 285 sterilisers the band is 134 to 137 deg C [273 to 279 deg F] for a 134 deg C [273 deg F] cycle and 121 to 124 deg C [250 to 255 deg F] for a 121 deg C [250 deg F] cycle. Saturated steam at 134 deg C [273 deg F] has an absolute pressure of 3.04 bar [44.1 psia], and at 121 deg C [250 deg F] 2.05 bar [29.7 psia]. A measured temperature above the saturation temperature indicates superheated steam. A measured temperature below it indicates air or non-condensable gas in the chamber.

Use an extended cycle, with a longer holding time, higher temperature or longer drying time, only where the device instructions for use (IFU) specify it. Do not apply an extended cycle to a device that does not require it unless the IFU permits it. Monitor extended cycles with biological and chemical indicators validated for that cycle.

Validation: Perform IQ and OQ on each machine and PQ for each process on each machine. Repeat OQ after installation or relocation, a change of service, a modification to deliver a new process, the introduction of new devices or loading configurations, and any repair before return to service. Perform washer-disinfector PQ to the relevant part of ISO 15883. For steam PQ, use the most challenging routine load, measure temperature and expose biological indicators concurrently, add the measured equilibration time to the holding time, and complete at least three consecutive successful cycles. Requalify at least annually.

Routine Tests: Before first use each day, confirm that each steriliser functions as intended. Run a daily air removal and steam penetration test on sterilisers that use vacuum for air removal. Use a Bowie-Dick type test to ISO 11140-3, ISO 11140-4 or ISO 11140-5 on large sterilisers, and a test to ISO 11140-6 on small sterilisers, e.g. a helix hollow load test. Small sterilisers that do not process packaged or hollow devices, e.g. type N cycles, may not require this test. Do not use a Bowie-Dick type test on gravity or positive pressure pulse sterilisers.

On large sterilisers fitted with an air detector, run the leak rate test and the air detector function test weekly. On large sterilisers without an air detector, run the leak rate test daily before the Bowie-Dick type test, and use a suitable process challenge device to confirm air removal from the load. On small sterilisers, run the leak rate test at the frequency in the IFU. Check the process record at the end of every cycle. Apply a chemical indicator to the exterior of every pack, and place one in every load of unwrapped semi-critical items. Set the frequency of biological indicator and internal chemical indicator use in facility policy.

Water and Steam Quality: For sterilisers with a dedicated steam generator, test the feedwater at IQ or OQ and annually. Feedwater limits include conductivity not greater than 5 µS/cm at 20 deg C [68 deg F], evaporative residue not greater than 10 mg/L, chloride not greater than 0.5 mg/L, silicates not greater than 1.0 mg/L, iron not greater than 0.2 mg/L, phosphates not greater than 0.5 mg/L, hardness not greater than 0.02 mmol/L and pH 5 to 7.5. For sterilisers on a non-dedicated steam supply, test the steam condensate against the EN 285 limits at IQ or OQ and annually. Supply small sterilisers with feedwater to EN 13060. Drain and clean small steriliser reservoirs at the interval in the IFU.

Test steam quality on installation or relocation of a large steriliser and after any change to the steam supply. Acceptance criteria are a dryness value not less than 0.95, non-condensable gases not greater than 3.5 % v/v and superheat not greater than 25 deg C [45 deg F]. Take corrective action and retest if any criterion is not met. Repeat the test when wet loads or other faults point to steam quality.

Records: Record for every sterilisation cycle the date, cycle number, steriliser, devices and quantities, the person loading, performance test results, indicator results, the process record and the person releasing the load. Traceability must identify the individual cycle and steriliser for each critical device. Paper or electronic records are acceptable. Retain records for the period set by the relevant regulatory authority, or by facility policy where none is set.

Preventative Maintenance

AS 5369:2023 requires planned preventive maintenance by a competent person to documented procedures, with the frequency of each task specified. Specify the maximum permitted delay for each scheduled task. Do not return equipment to use until scheduled maintenance is complete and documented. Record the reason, date, model and serial number, location, work done, parts replaced, the person or company doing the work, and the person releasing the equipment.

• Daily: Inspect and clean steriliser door seals and seating faces. Replace seals that are cut, cracked or hardened. Check that washer-disinfector spray arms rotate freely and nozzles are clear. Clean chamber strainers. Run the start of day steriliser tests and record the results.

• Weekly: Run the leak rate and air detector function tests on large sterilisers fitted with an air detector. Clean steriliser chamber drain strainers. Inspect air filters and change them as required by the IFU. Drain and clean small steriliser reservoirs where the IFU specifies a weekly interval. Check detergent stock and dosing.

• Quarterly: Run a washer-disinfector cleaning efficacy test with a test soil equivalent to the validation test soil. Investigate any failure for blocked nozzles, low spray pressure, incorrect detergent dosing or overloading. Check temperature and pressure sensors against a calibrated reference instrument and adjust or replace any sensor outside tolerance. Verify detergent dosing volumes. Clean and test solenoid valves. Lubricate and test door hinges and locking mechanisms.

• Six Monthly: Replace wear components at the manufacturer interval, including door seals, filters and dosing pump tubing. Remove and clean spray arms and inspect spray arm bearings.

• Annually: Requalify each machine and process. For washer-disinfectors, include thermometric testing of the load, chamber wall and temperature control, thermal disinfection efficacy, cleaning efficacy, load dryness, and spray system and load carrier alignment. For large sterilisers, include thermal penetration testing, air detector performance testing, drying effectiveness and steam purity testing. For small sterilisers, include thermal penetration testing and drying effectiveness. Recalibrate instrumentation at an interval based on calibration history, not exceeding 12 months, using test instruments traceable to national or international measurement standards. Obtain a calibration report that records the certification number of the reference instrument. Carry out an electrical safety check on all reprocessing equipment. Inspect heating elements, hoses and steam traps, and test safety valves.

• After Change or Repair: Requalify after any change to devices, packaging, process chemicals, processes or IFU, and after any major change or repair that could affect the process. A designated competent person decides the extent of IQ, OQ or PQ required.

Planning for Replacement

AS 5369:2023 requires sufficient reprocessing equipment for the volume and type of devices processed, allowing for planned and unplanned downtime. Record cycle count, unplanned failures, repair cost and downtime for each machine in the asset register. Set a planning life of 10 to 15 years in the capital plan and adjust the replacement date using condition data. Plan replacement when one or more of the following applies.

• Failure Rate: Unplanned failures exceed the threshold set in the asset management plan, e.g. more than three in 12 months, or failures recur in the same subsystem.

• Maintenance Cost: Annual maintenance and repair cost exceeds the proportion of replacement cost set in the asset management plan, e.g. 10 %.

• Support: The manufacturer no longer supplies critical spare parts or service support, e.g. controller boards, pressure transducers or door seals.

• Capability: The machine cannot meet the current specification, e.g. selectable A0 values, electronic cycle data export or conformance to the current editions of ISO 15883 or EN 13060.

Confirm services before purchase, including water, steam, drainage and electrical supply, and test the water before installation. Include IQ, OQ, PQ and operator training in the purchase agreement. Obtain the IFU, maintenance manual, planned maintenance schedule and pressure vessel documentation. Stagger the replacement of multiple machines to maintain capacity. For single-machine sites, activate the backup procedures in the business continuity plan before changeover, e.g. a loan unit, off-site reprocessing or single-use bedpan liners.

Upcoming Changes

• ISO 15883-1:2024 and ISO 15883-3:2024: Second editions were published in October and November 2024. ISO 15883-3:2024 is applied with ISO 15883-1:2024 and ISO 15883-5:2021. Require conformance to these editions when specifying new bedpan washer-disinfectors. Monitor Standards Australia for Australian adoption.

• ISO 17665:2024: Replaces ISO 17665-1:2006, ISO/TS 17665-2:2009 and ISO/TS 17665-3:2013 with one document covering development, validation and routine control of moist heat sterilisation in industrial and health care settings. Where parametric release is adopted, specify independent monitoring of the critical process variables with redundant temperature and pressure sensors.

• EN 13060:2025: Current edition of the European standard for small steam sterilisers. Require conformance to this edition for new small sterilisers.

• Electronic Records: AS 5369:2023 advises that facilities should be working towards electronic tracking and process record systems. Specify electronic export of cycle data to the instrument tracking or records system for new equipment. Specify water and energy consumption per cycle in tenders and compare offers on a per cycle basis.

Glossary

• A0: Measure of thermal disinfection, expressed as the equivalent time in seconds at 80 deg C [176 deg F] with a z value of 10 deg C [18 deg F]. A0 60 equals 80 deg C [176 deg F] for 1 min. A0 600 equals 90 deg C [194 deg F] for 1 min or 80 deg C [176 deg F] for 10 min.

• AS 5369:2023: Australian standard for reprocessing reusable medical devices and other devices in health and non-health related facilities. Published December 2023. Supersedes AS/NZS 4187:2014 and AS/NZS 4815:2006.

• AS/NZS 4187:2014: Superseded standard for reprocessing reusable medical devices in health service organisations.

• AS/NZS 4815:2006: Superseded standard for reprocessing reusable medical and surgical instruments in office-based health care facilities.

• ARTG: Australian Register of Therapeutic Goods. Reprocessing equipment must be included before supply in Australia.

• Bowie-Dick Type Test: Daily air removal and steam penetration test for large sterilisers that use vacuum for air removal, conforming to ISO 11140-3, ISO 11140-4 or ISO 11140-5. A uniform colour change across the indicator confirms air removal and steam penetration.

• Cleaning Indicator: Test piece coated with a standardised test soil and placed in a load to verify washer-disinfector cleaning efficacy. Use only indicators shown to be equivalent to the test soil used in validation.

• CSSD: Central sterile services department. The unit that cleans, disinfects, packs and sterilises reusable medical devices.

• EN 285: European standard for large steam sterilisers that accept at least one sterilisation module or have a chamber volume of at least 60 L [16 US gal].

• EN 13060: European standard for small steam sterilisers that cannot accept a sterilisation module. Defines type B, N and S cycles.

• Extended Sterilisation Cycle: Moist heat cycle specified in a device IFU with a longer holding time, higher temperature or longer drying time than the standard cycles, e.g. 134 deg C [273 deg F] for 10 min.

• Helix Test: Hollow load air removal and steam penetration test for small sterilisers, conforming to ISO 11140-6. A long narrow tube with an indicator at the closed end.

• IFU: Instructions for use supplied by the manufacturer of a device or machine.

• IQ, OQ and PQ: Installation qualification verifies installation and services to specification. Operational qualification verifies that the machine delivers the defined process. Performance qualification verifies that the process consistently produces clean, disinfected or sterile product with defined loads.

• ISO 15883-3: Requirements and tests for washer-disinfectors using thermal disinfection for human waste containers, e.g. bedpans and urine bottles.

• ISO 17665: Requirements for development, validation and routine control of moist heat sterilisation processes for medical devices.

• ISO/TS 22421: Common requirements for sterilisers used for terminal sterilisation of medical devices in health care facilities.

• NATA: National Association of Testing Authorities, Australia. Accredits calibration and testing laboratories to ISO/IEC 17025.

• Parametric Release: Release of a load based on recorded process parameters within validated limits, without waiting for biological indicator results.

• Product Family: Group of devices with similar intended use, materials, design, mass and packaging, assigned the same reprocessing conditions. PQ uses the devices that are most difficult to process.

• Reverse Osmosis (RO) Water: Water treated by a semi-permeable membrane to remove dissolved ions. Used for steam generator feedwater and final rinse water where specified.

• TGA: Therapeutic Goods Administration. Regulates the supply of therapeutic goods in Australia, including medical devices and reprocessing equipment.

Key Takeaway

Specify bedpan washer-disinfectors to ISO 15883-1 and ISO 15883-3, and steam sterilisers to EN 285 or EN 13060 with ISO/TS 22421, and confirm ARTG inclusion. Test water before installation, and test steriliser feedwater or condensate annually. Perform IQ, OQ and PQ, and requalify at least annually and after any change or major repair. Run the daily air removal test and the specified leak rate tests, check every cycle record, and trace each critical device to its cycle. Plan maintenance with defined maximum delays, recalibrate at least annually, and plan replacement from condition data while maintaining reprocessing capacity.