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Satellite Reprocessing: Why TOE Probe Reprocessing Requires Performance Qualification

TOE probes are often reprocessed outside CSSD, but the location does not change the need for effective infection prevention controls and process assurance. This article examines the complete TOE probe reprocessing pathway and explains how AS 5369:2023 and the Guidelines for Reprocessing Ultrasound Transducers: 2026 support consistent, effective and appropriately controlled reprocessing practices.

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Performance Qualification

Guidance on validation, testing, Standards and demonstrating reliable process performance.

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Practical insights into reusable medical device reprocessing, cleaning, disinfection and sterilization.

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Design, engineering, commissioning and certification considerations for CSSD, endoscopy and other reprocessing areas.

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Technical guidance on water quality, steam quality, system performance and common causes of reprocessing problems.

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Investigation into unexpected results across microbiology, residual protein, water testing, biofilm and contaminated loads.

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  • A Guide to Performance Qualification under AS/NZS 5369:2023
  • Designing Reprocessing Facilities with Commissioning in Mind
  • Understanding Water Quality in Reusable Medical Device Reprocessing
  • Steam Quality: Why Sterilizer Performance Starts Before the Sterilizer
  • Selecting Data Loggers for Validation Applications
  • Common Reprocessing Issues Identified During Performance Qualification
  • Planning a New CSSD: Key Considerations for Architects and Engineers

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Frequently Asked Questions

Performance Qualification (PQ) is the process of demonstrating that reprocessing equipment and processes deliver effective and consistent results under the conditions in which they are actually used.

It involves testing representative loads, cycles and operating conditions to confirm that the process achieves the required outcome for the reusable medical devices being reprocessed.

Performance Qualification reports should provide documented evidence that the reprocessing process is effective, reproducible and suitable for its intended use.

Performance Qualification (PQ) is required when a reprocessing process is first validated and is then repeated at defined intervals to confirm that the process continues to perform effectively with the equipment, loads and devices used in practice.

For applicable reprocessing equipment and processes, requalification is generally undertaken at least annually.

PQ or other qualification testing may also be required following a change that could affect the validated process. This may include changes or repairs to equipment and/or services, cycle parameters, software, load configuration, packaging, reusable medical devices or other aspects of the process.

Following significant maintenance, repair, modification or relocation of equipment, an assessment of change should be performed to determine whether existing validation remains valid.

The purpose is to confirm that the reprocessing process remains effective, reproducible and appropriate for its intended use.

Performance Qualification (PQ) is applicable to all reprocessing equipment and processes where effective and consistent outcomes are relied upon for safe patient care.

This includes washer-disinfectors, sterilizers, ultrasonic cleaners, heat sealers, controlled storage cabinets and other automated reprocessing equipment.

PQ considers the whole process; assessing the equipment, cycle parameters, load configuration and the reusable medical devices being processed. Testing must reflect the conditions encountered in everyday use, including representative worst-case loads and cycles, to demonstrate that the process consistently achieves its intended outcome.

The specific PQ activities required will depend on the equipment, process and range of devices being reprocessed.

Reusable medical devices can vary significantly in their design, materials and complexity, which means some devices are more challenging to clean, disinfect or sterilize than others.

A master product is selected to represent the most challenging device, or one of the most challenging devices, within a group of similar devices. Testing the master product during Performance Qualification provides evidence that the reprocessing process can achieve its intended outcome under representative worst-case conditions. During PQ, your SVA Validation Specialist can assist in identifying and testing a master product that will represent the greatest challenge within the Product Family using reference data collected outside of your organisation to determine products you may already reprocess.

This provides greater assurance that the validated process is suitable for the range of devices represented by the master product.

A Product Family is a group of reusable medical devices that have similar characteristics and present a similar challenge to the reprocessing process.

Grouping devices into Product Families allows Performance Qualification to focus on the devices that are most challenging to process within each group, rather than requiring every individual device to be tested.

During PQ, a master product that will represent the greatest challenge within the Product Family should be tested. Testing this device under representative worst-case conditions provides evidence that the process is suitable for the other devices represented by that Product Family.

Each Product Family routinely reprocessed should be tested during PQ to ensure that the different challenges presented by the range of reusable medical devices in everyday practice are appropriately tested.

Yes.

Unlike an automated washer-disinfector, manual cleaning relies heavily on the method used and the person performing it. Factors such as cleaning agents, concentration, temperature, contact time, brushing or flushing technique, water quality and the complexity of the device can all influence the cleaning outcome.

Where manual cleaning forms part (or all) of the reprocessing of reusable medical devices, the cleaning process needs to be defined, controlled and shown to be effective.

Performance Qualification provides evidence that the defined manual cleaning process can consistently achieve the required level of cleanliness when applied correctly, including for devices that present the greatest cleaning challenge.

Because manual cleaning is dependent on human technique, validation needs to be supported by clear procedures, appropriate training and competency assessment to help ensure the validated process can be reproduced in everyday practice.

There is no standard timeframe for Performance Qualification. The time required depends on the equipment, processes, cycle lengths, test requirements and the number of representative worst-case loads and Product Families that need to be assessed.

PQ testing can involve running complete reprocessing cycles under defined test conditions. Where a test is required to be performed in triplicate, (steam sterilizers for example), a full cycle must be completed three times, with additional time between cycles to unload, inspect, unwrap, rewrap or reset the test load as required.

For this reason, a thorough PQ can take considerable time, particularly where multiple cycles, loads or Product Families need to be tested. The duration of the testing will reflect the qualification work required, rather than an arbitrary timeframe for completing the PQ.

While efficient testing is important, PQ should allow sufficient time to complete the required cycles and properly assess the process under representative worst-case conditions.

No. Performance Qualification is not limited to hospitals.

The objective of AS/NZS 5369:2023 is to provide uniform minimum requirements for the cleaning, disinfection and sterilization of reusable medical devices (RMDs) and other devices so that they are safe for use and pose no risk of transmission of infectious agents. The prevention of healthcare associated infections applies to hospital, day hospitals, medical practices, dental and specialist clinics, however it also extends to allied health, and non-health related facilities where skin piercing, tattooing and other procedures where the skin is breached, or mucous membranes are contacted [Refer AS/NZS 5369:2023].

The need for PQ is determined by the reprocessing equipment, processes and devices in use, rather than by the size or type of facility.

Where effective and consistent reprocessing outcomes are important to the safe use of reusable medical devices, appropriate validation and Performance Qualification provide assurance that those processes perform as intended in everyday practice.

An independent validation provider brings specialist expertise and an objective assessment of your reprocessing equipment and processes.

Independence means the provider does not have a commercial interest in the outcome of the validation through the sale, servicing or repair of the equipment; supply of chemistries, consumables, or other products and services associated with the process being assessed. The focus will be on determining whether the reprocessing process meets the applicable requirements and defined acceptance criteria under the conditions encountered in everyday use.

An experienced validation provider should help ensure that Performance Qualification (PQ) appropriately considers the equipment, process parameters, reusable medical devices (RMDs), worst-case loads, Product Families and Master Products relevant to the facility, and that testing is performed using appropriate and compliant test methods and test equipment.

Importantly, independence provides confidence that results, including any failures, limitations or opportunities for improvement identified during testing, are assessed objectively and clearly documented.

This provides reliable independent evidence to support the facility’s ongoing management of its reprocessing processes.