10. Reprocessing of reusable medical devices and other devices in general practice

Components of Steriliser Validation

Infection prevention and control guidelines

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Infection prevention and control guidelines

Last revised: 12 Jun 2026

Components of Steriliser Validation

For each sterilisation cycle used – that is, the specific time, temperature, and pressure parameters – the following needs to be included in the validation:

Heat distribution testing on an empty chamber (may be sourced from manufacturer or prior validation)
Description and diagram of the challenge pack/load and loading configuration
Measurement of penetration time for the challenge pack
Physical qualification, including confirmation of the time at temperature using calibrated instruments
Microbiological qualification, using biological indicators across three identical consecutive cycles.

Table 10.20 Steriliser validation and maintenance summary

Action / Test	Responsibility	Frequency	Purpose / Description	Record required
Full validation (IQ, OQ, PQ)	Qualified technician	On installation/commissioning After relocation, upgrade, or major repair Annually After significant process changes	Confirms consistent steriliser performance with typical loads	Yes – detailed report
Heat distribution test	Manufacturer or qualified technician	At initial validation or as provided	Confirms uniform heat distribution	Yes – validation report
Challenge pack / Load description	Qualified technician	Each annual validation	Document typical load for validation	Yes – included in report
Staff competency check	IPC Coordinator / Practice manager	During validation and annually	Confirm staff understand reprocessing protocols	Yes – training records
Biological indicator testing (PQ phase)	Technician or Reprocessing team	During validation and as needed	Confirms sterility during validation using reference loads	Yes – indicator results
Cycle monitoring – Biological	Reprocessing team	During validation or troubleshooting	Used across 3 cycles to confirm sterility	Yes – keep results
Review of validation report	Reprocessing team	Each time validation is performed	Ensures technician’s results are understood and applied	Yes – review notes
Leak-rate test (vacuum sterilisers) ^a	Reprocessing team	Daily (or weekly if air detector fitted), or according to manufacturer recommendations or frequency of use.	Checks that the chamber is airtight	Yes – log result
Bowie-Dick / Steam penetration test ^b	Reprocessing team	Daily (if required according to the type of steriliser is used and what devices are being sterilised)	Confirms air removal and steam penetration	Yes – record result
Cycle monitoring – Mechanical	Reprocessing team	Every cycle	Review auto printout or data logger	Yes – retain printout
Cycle monitoring – Chemical	Reprocessing team	Every cycle	Indicators in every pack or tray	Yes – note checked and passed
Functional test after offsite servicing	Reprocessing team	On return before reuse	Vacuum, Bowie-Dick, and indicator tests	Yes – test outcomes
Enhanced monitoring if validation delayed	Reprocessing team	Temporary	Use high-level indicators in every load	Yes – all indicators logged
Note: Equipment needs to be requalified at least annually and whenever significant changes occur (eg repairs, new processes, new equipment). Requalification may involve full or partial validation (IQ, OQ, PQ), depending on the risk and nature of the change. A competent person needs to assess and document the need for testing, the rationale, outcomes, and any corrective actions. ^aFor a steriliser that uses a vacuum in any part of its operation, a leak-rate test is required on each day of its use (or weekly, if there is an air detector) to check the leak rate does not exceed the maximum specified in the current relevant standard. Refer to the steriliser operating instructions for information on whether an air detector is fitted and how to perform the leak-rate test. ^b If the practice uses Class B sterilisation cycles and reprocessed narrow-lumen (hollow A) items, a steam penetration/air removal test needs to be performed daily in accordance with steriliser instructions for use and process challenge device instructions for use. Steam penetration tests (eg Bowie-Dick) are a form of process challenge device. These simulate worst-case sterilisation conditions, such as narrow lumens, and confirm air removal and steam penetration during vacuum cycles. The helix device is commonly used for small benchtop sterilisers.

Table 10.21 Washer-disinfector validation and maintenance summary

Action / Test	Responsibility	Frequency	Purpose / Description	Record required
Full validation (IQ, OQ, PQ)	Qualified technician	On installation/commissioning After relocation or repair Annually	Confirms correct function, cleaning efficacy, and temperature control	Yes – validation report
Water quality testing	Reprocessing team or External	Monthly (or more)	Test for hardness, chloride, conductivity	Yes – record results
Review of validation report	Reprocessing team	Each time validation is performed	Ensure technician’s results are applied in practice	Yes – review checklist
Cycle monitoring – mechanical	Reprocessing team	Every cycle	Check temp, time, chemical dose, pressure, flow	Yes – printout or log
Visual inspection of items	Reprocessing team	Every cycle	Inspect cleaned items for visible debris	Optional – note if recleaning needed
Cleaning efficacy testing (optional)	Reprocessing team	As required (eg complex instruments)	Use soil tests or surrogate devices if validated	Yes – if used

Table 10.22 Ultrasonic cleaner validation and maintenance summary ^a

Action / Test	Responsibility	Frequency	Purpose / Description	Record required
Validation (functionality and cleaning efficacy testing) ^b	Qualified technician	On installation/commissioning After relocation or repair Annually	Confirm cleaning efficacy and cavitation performance	Yes – validation report
Water quality monitoring	Reprocessing team	Monthly (or more)	Test rinse water quality if applicable	Yes – water test log
Functionality Test	Reprocessing team	Daily	Confirm cleaner is operating correctly per AS 2773	Yes – daily log
Log solution changes and degassing (if applicable)	Reprocessing team	Every cycle	Confirms safe and effective operation of cleaning cycle	Yes – if used
Visual Inspection of Items	Reprocessing team	Every cycle	Check items after ultrasonic cleaning	Optional – note failures
^a An ultrasonic cleaner is optional for pre-cleaning some reusable medical devices (it is not required in general practice). ^b Ultrasonic cleaners are pre-cleaning devices. They do not disinfect or sterilise, so the validation approach is simpler, but still essential when used in a validated reprocessing pathway.

Table 10.23 Routine cleaning and monitoring summary

Equipment / Process	Responsibility	Frequency	Description	Record required
Manual cleaning	Reprocessing team	Every item, every time	Visual check for cleanliness	Optional – if failed, reprocess
Cleaning efficacy (Was is clean?)	Reprocessing team	Every item	Visually inspect each item after cleaning. Reclean if dirty. Use test devices or soil tests for complex items if available and validated.	Optional – if failed, reprocess
Heat sealer check (if used/applicable)	Reprocessing team	Each session	Check seal function and one test pouch	Yes – note temp & pouch test
Sterilisation containers	Reprocessing team	Before each use	Check for damage, gasket, filters	Optional – in SOP
Packaging checks	Reprocessing team	Every pack	Inspect seal and follow procedure	Optional – redo and document if failed

Note: The above tables summarise typical validation and monitoring requirements for commonly used reprocessing equipment in general practice. If a practice introduces any additional equipment – for example drying cabinets, low temperature sterilisation systems, or other specialised devices – that equipment needs to be:

installed and set up according to the manufacturer’s instructions
serviced and validated by a qualified technician prior to use
included in routine monitoring and recordkeeping schedules.

Validation requirements for such equipment needs to align with relevant standards and manufacturer specifications.

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