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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.

By admin 4 November 2026 1 min read

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The location may change. The principles of reprocessing do not.

Reusable transoesophageal echocardiography (TOE) probes present a particular challenge for healthcare organisations because their reprocessing often occurs outside a traditional Central Sterile Services Department (CSSD).

TOE probes may be used and reprocessed within cardiac catheter laboratories, cardiology departments, operating theatres, intensive care units, echocardiography services and other procedure areas. The equipment, environment and workflows used in these locations can look quite different from those typically associated with a centralised reprocessing department.

However, AS 5369:2023 is concerned with the reprocessing of reusable medical devices, not simply with activities undertaken within CSSD.

The Guidelines for Reprocessing Ultrasound Transducers: 2026, developed collaboratively by the Australasian Society for Ultrasound in Medicine and the Australasian College for Infection Prevention and Control, reinforce this principle. The Guideline applies to staff who use or reprocess ultrasound equipment and to the facilities in which those activities occur.

That distinction is important. Reprocessing requirements follow the device, its intended use and the associated infection risk, regardless of the department responsible for carrying out the process.

An invasive, semi-critical device

A TOE probe is an invasive ultrasound transducer because it is introduced into the body through an orifice. It comes into contact with the mucous membranes of the oesophagus and is therefore classified as a semi-critical reusable medical device under the Spaulding classification.

The 2026 Guideline specifies that semi-critical ultrasound transducers require cleaning followed by, at minimum, high-level disinfection before reuse. This must be undertaken in accordance with the manufacturer’s instructions for use.

The complete reprocessing pathway may include:

point-of-use handling
timely transfer to the reprocessing area
cleaning of the probe, handle and cable as applicable
rinsing and drying
visual inspection for damage or defects
high-level disinfection
post-disinfection rinsing or drying, where required
handling and transfer between stages
protection from environmental contamination
storage
release for clinical use
traceability and record management.

Each stage contributes to the condition of the probe that is ultimately released for use on the next patient.

This is why considering the process only in terms of the high-level disinfection unit provides an incomplete picture of TOE probe reprocessing.

Cleaning is essential to effective disinfection

High-level disinfection cannot compensate for ineffective cleaning.

Cleaning is required to remove visible and non-visible contamination to the extent necessary for subsequent processing. It should occur as soon as practicable after use to reduce the risk of contaminants drying onto the device.

The cleaning agents, wipes and materials used must be compatible with the probe and applied in accordance with the relevant manufacturer instructions. Cleaning materials should be discarded after use and should not subsequently be used for disinfection.

Where cleaning is performed manually, the outcome may be affected by a range of variables, including:

the cleaning method and sequence
detergent or cleaning-product selection
product concentration and contact time, where applicable
water quality and temperature
the parts of the probe, handle and cable included in the process
operator technique
rinsing and drying practices
transfer and handling between cleaning and disinfection.

After cleaning, the probe should be visually inspected for residual contamination, damage or defects. Damage can prevent effective cleaning and disinfection and may create an infection risk. A damaged probe should not be returned to clinical use until it has been appropriately assessed, repaired or replaced.

Probe covers provide an additional barrier, not an alternative to reprocessing

A sterile, purpose-manufactured transducer cover is recommended where a semi-critical ultrasound transducer will contact mucous membranes.

The cover provides an additional protective barrier and may reduce contamination of the probe during use. However, covers can lose integrity and must not be treated as a substitute for cleaning and high-level disinfection.

Only commercially manufactured transducer covers suitable for the intended application should be used. Improvised alternatives, such as gloves, plastic bags or other items not designed for this purpose, should not be relied upon.

Single-use sterile ultrasound gel should also be used when TOE probes are used in semi-critical applications. Gel selection, handling and storage therefore form part of the broader infection-prevention controls surrounding use of the probe.

These precautions support safe clinical use, but they do not alter the required reprocessing classification of the probe.

The reprocessing environment matters

A decentralised reprocessing area can appear relatively simple when compared with CSSD. That does not mean the process, or the environment needed to support it, is simple.

Reprocessing should occur in a dedicated area or facility. Where point-of-use reprocessing is assessed as safe and effective, it should ideally occur in an area or room separate from patient treatment. If physical separation is not possible, patient care and reprocessing should not occur simultaneously, and adequate separation is needed to reduce the risk of contamination.

Environmental considerations include:

separation of clean and contaminated activities
a logical workflow from dirty to clean
appropriate lighting and ventilation
suitable sinks, bench space and workstations
access to hand hygiene facilities
provision and correct use of personal protective equipment
waste disposal arrangements
protection of clean and disinfected probes from recontamination
documentation and record-management systems appropriate to the area.

A process cannot be considered solely through the performance of the equipment if the surrounding workflow allows a cleaned or disinfected probe to be contaminated again.

What Performance Qualification contributes

AS 5369:2023 describes Performance Qualification as the stage of validation in which products are exposed to the relevant cleaning, disinfection, packaging or sterilisation process and the process is demonstrated to operate consistently in accordance with predetermined criteria and produce the required outcome.

Applied to TOE probe reprocessing, Performance Qualification provides objective evidence about whether the processes used by the facility perform effectively and consistently under the conditions in which they are actually used.

This may include consideration of whether:

equipment operates within established acceptance criteria
process parameters are consistent and reproducible
the process is suitable for the TOE probes being reprocessed
site practices align with the manufacturer instructions for the probe, cleaning products, disinfectant and reprocessing equipment
the complete process achieves its defined cleaning and disinfection outcomes
changes to equipment, products, consumables, workflow or the environment have affected performance
handling and transfer practices protect the probe between process stages
storage conditions maintain the probe in a suitable condition until use
traceability records adequately connect the probe, reprocessing cycle and patient-care episode.

The question is not simply:

Did the high-level disinfection unit complete its cycle?

The more meaningful question is:

Can the healthcare organisation demonstrate that its complete, site-specific process consistently produces a probe that has been appropriately reprocessed and is suitable for release for clinical use?

Equipment performance and process performance are not the same

Automated high-level disinfection systems can provide controlled cycles, monitored parameters and process records. These are important controls, but correct operation of the disinfection equipment does not, by itself, demonstrate that the complete reprocessing process is effective.

For example, an automated unit cannot compensate for:

incomplete cleaning
contamination retained around the probe handle or other surfaces
use of incompatible or incorrectly prepared products
inadequate rinsing or drying
damage that prevents effective reprocessing
poor separation between dirty and clean activities
contamination during handling, transfer or storage
incomplete records or loss of traceability.

This is why confirming that a disinfection unit has been serviced, calibrated or is operating correctly should not be treated as evidence that the entire process has been qualified.

Equipment performance and process performance are related, but they are not interchangeable.

Storage and release remain part of the pathway

Following high-level disinfection, TOE probes must be stored in a way that protects them from environmental contamination between uses.

Depending on the validated process and manufacturer instructions, this may involve a dedicated sealed storage cabinet or a suitable single-use storage cover. A cover used to protect a probe during storage is distinct from the sterile transducer cover used during the clinical examination and should not be used on a patient.

Where a healthcare facility relies on a specialised cabinet or other storage technology to maintain the condition of a reprocessed probe, that storage system forms part of the overall process.

Qualification and quality-control considerations may include:

installation and commissioning
compatibility with the probe types being stored
operating parameters
airflow or other environmental controls
alarm functionality
loading and handling practices
cleaning and maintenance requirements
the storage period or other claims relied upon by the facility.

Before clinical use, the user should be satisfied that the probe has been adequately reprocessed for the intended procedure. If this cannot be assured, the probe should not be used until the required reprocessing has been completed and its status can be verified.

Competency and traceability support the validated process

TOE probe reprocessing often involves clinical staff whose primary roles may not be within a reprocessing department. This makes documented training, competency assessment and ongoing oversight particularly important.

Personnel should be trained in all aspects of reprocessing relevant to their responsibilities, including:

infection prevention and control principles
use of personal protective equipment
cleaning of the ultrasound equipment, probe and cable
selection and performance of the required level of disinfection
inspection for contamination, damage and defects
handling and storage
documentation, traceability and record keeping
waste management.

Competency should be objectively assessed and recorded before personnel undertake reprocessing activities independently. Reassessment should occur at intervals established by the facility and when new equipment, products or reprocessing methods are introduced.

For probes undergoing high-level disinfection, traceability should connect an individual patient-care episode with the relevant reprocessing cycle. Records should enable identification of the probe, the person responsible for reprocessing, the process or equipment used, the cycle details and the patient-care episode in accordance with the facility’s requirements.

Traceability does not establish process effectiveness on its own, but it is essential to demonstrating that the defined process was applied and to supporting investigation if a concern is subsequently identified.

Performance Qualification is one part of the quality system

Performance Qualification should not be viewed as an annual test undertaken in isolation.

The 2026 Guideline places ultrasound transducer reprocessing within a broader quality-assurance framework. Healthcare facilities are responsible for developing, implementing and monitoring processes, policies and procedures suited to their work environment.

This framework includes:

documented procedures
staff training and competency
routine monitoring
preventive maintenance
ongoing validation
periodic review of the reprocessing facility
regular audits of reprocessing practices
investigation of failures or uncertainties
corrective action where required.

These controls perform different but complementary functions.

Routine monitoring helps identify changes in day-to-day performance. Preventive maintenance supports equipment condition. Competency assessment provides assurance that tasks are performed correctly. Auditing checks whether established procedures are being followed. Manufacturer instructions define the requirements and limitations applying to the probe, equipment and products.

Performance Qualification contributes documented, objective evidence that the site-specific process continues to achieve its intended outcome under the conditions in which it is actually used.

If a facility cannot be satisfied that a probe has met the required reprocessing standard, the probe should be reprocessed again or quarantined from use until the concern has been investigated and appropriate action taken.

Why the department name should not determine the level of assurance

TOE probe reprocessing highlights a broader issue: the assumption that validation and Performance Qualification primarily belong within sterilising services departments.

AS 5369:2023 has a wider application.

Where reusable medical devices are being reprocessed, healthcare organisations require appropriate environmental controls, documented procedures, trained and competent personnel, monitoring, traceability, validation and quality-assurance activities relevant to those devices and processes.

The 2026 Guideline reinforces that responsibility by applying to the staff who use or reprocess ultrasound equipment and to the facilities within which they work. It also recommends that infection prevention and control practitioners and the clinicians who regularly use and reprocess the equipment be involved in developing local policies and procedures.

For TOE probes, whether reprocessing occurs in CSSD, Cardiology, Theatre, a Cath Lab or another satellite area, the fundamental question remains the same:

Can the healthcare organisation demonstrate that the process is effective, repeatable and appropriately controlled?

The bigger lesson

TOE probe reprocessing provides a useful example of a much broader principle.

Reprocessing requirements follow the reusable medical device, its intended use and the associated risk. They do not depend on the department name on the door.

Moving reprocessing outside CSSD does not remove the need for process assurance. Where healthcare organisations reprocess critical or semi-critical reusable medical devices in decentralised areas, those processes should be incorporated into the organisation’s wider reprocessing and infection-prevention framework.

For TOE probes, this means looking beyond the high-level disinfection unit and considering the complete pathway from point-of-use handling and cleaning through to inspection, high-level disinfection, storage, traceability and release.

Ultimately, the important question is not where reprocessing occurs.

It is whether the healthcare organisation can demonstrate, with documented and objective evidence, that the complete process being relied upon is effective, consistent and capable of providing a probe that is appropriately reprocessed for its next clinical use.

How SVA can help

SVA takes a holistic approach to reprocessing, drawing on the breadth of experience across our multidisciplinary team to assess the complete reprocessing pathway, not simply the performance of individual equipment.

For TOE probe reprocessing, this means considering how cleaning, high-level disinfection, handling, storage, traceability and staff practices work together within the specific clinical environment. By combining specialist knowledge, practical experience and independent testing, SVA can help healthcare facilities identify gaps, challenge assumptions and provide objective evidence that their reprocessing processes are effective, appropriate and well controlled.

This publication contains original content developed by Sterilizer Validation Australia and may reference third-party standards, guidelines and other published works. Copyright in those referenced works remains with the respective copyright owners.

SVA content may be shared in its original, unmodified form with appropriate acknowledgement. Reproduction, modification, adaptation or commercial use of SVA content requires prior written permission from Sterilizer Validation Australia Pty Ltd.