Manual Cleaning Can Be Validated. Here’s What That Means

Cleaning is fundamental to successful reprocessing.

Before a reusable medical device can be effectively disinfected or sterilized, contamination and residual soil need to be adequately removed from the surfaces that require treatment.

Automated cleaning is generally preferred where an appropriate process is available because equipment can provide greater control and repeatability of variables such as temperature, time, water delivery and chemical dosing.

However, automated cleaning does not eliminate the need for manual processes.

Manual cleaning may be required because of the design of a reusable medical device, its manufacturer’s Instructions for Use, or because particular cleaning steps must be completed before the device enters an automated washer-disinfector.

The challenge is therefore not to eliminate manual cleaning simply because it contains human variables. It is to establish enough control over those variables to create a reliable and reproducible process.

The objective is to turn a variable human activity into a defined and repeatable process that can be assessed objectively.

A manual cleaning procedure should not be developed independently of the reusable medical device being processed.

Manufacturer Instructions for Use are an essential starting point because different devices can present very different cleaning challenges.

A straightforward instrument with easily accessible surfaces is fundamentally different from a complex device containing narrow lumens, channels, joints or other difficult-to-clean features.

The cleaning method needs to address the characteristics of the device and ensure that cleaning action reaches all surfaces that require treatment.  This includes internal surfaces and difficult to reach areas.

This is particularly important when selecting devices for Performance Qualification. The process should be challenged using devices that appropriately represent the cleaning challenge presented by the reusable medical devices processed by the facility.

One of the biggest challenges in manual cleaning is controlling the variables that can change between operators or between one cleaning activity and the next.

Consider something as apparently simple as preparing a detergent bath.

If one operator fills a sink to 20 litres and another fills it to 30 litres, and both add the same amount of detergent, the two operators are not using the same chemical concentration.

Similarly, if one operator cleans at the recommended temperature while another uses substantially hotter water, the cleaning process may behave differently.

Useful controls can therefore be very practical.

Cleaning chemistry should be prepared at the required concentration. Where chemical dosing is manual, the method used to measure both water and chemical quantity needs to be reliable and repeatable.

If chemical concentration depends on the volume of water within a sink or cleaning vessel, that volume needs to be reproducible.

A clearly established fill level is considerably more controlled than relying on an operator to estimate the appropriate amount of water.

Temperature can influence both the behaviour of contamination and the performance of cleaning chemistry.

Where the cleaning process specifies a temperature range, that range needs to be measurable and consistently maintained.

If a cleaning agent requires a defined exposure or contact time, operators need a reliable method of achieving and monitoring that time.

For devices incorporating channels, lumens or other difficult-to-access areas, the procedure may need to define the equipment and technique used to deliver cleaning action internally.

Simply immersing a complex device in cleaning solution does not demonstrate that the internal surfaces have been effectively cleaned.

These controls may appear simple, but together they convert the cleaning method into a process that can be described, repeated and tested.

Documenting a detailed work instruction does not, by itself, validate the cleaning process.

The process needs to be challenged, and the resulting cleaning outcome assessed against predetermined acceptance criteria.

Performance Qualification provides an opportunity to do this using representative reusable medical devices and the actual cleaning process used by the healthcare organisation.

Following cleaning, efficacy can be assessed using appropriate methods such as visual inspection and quantitative assessment of residual contamination.

If the required result is not achieved, the response should not simply be to repeat the test until a passing result occurs.

The finding should prompt investigation.

Was the chemistry prepared correctly?

Was the required temperature maintained?

Was sufficient cleaning action applied?

Were internal channels appropriately brushed, flushed or irrigated?

Was the device particularly challenging to clean?

Was the work instruction sufficiently detailed?

Did different operators interpret the procedure differently?

These questions help identify where additional process control may be required.

Manual cleaning inevitably involves operator technique.

That is not something validation can simply remove.

Instead, competency, training and adherence to the validated work instruction become important elements in maintaining the process.

A manual cleaning process that performs effectively when undertaken by one experienced operator but cannot be reproduced by other appropriately trained personnel is unlikely to provide sufficient confidence in routine use.

Good validation should therefore help identify where a process is overly dependent on individual technique.

Sometimes the solution is greater procedural detail. In other situations, improved tools, irrigation equipment, dosing systems or other engineering controls may reduce unnecessary variability.

The aim is not to eliminate people from manual cleaning. It is to make the process less dependent on individual interpretation.

Where a change has the potential to affect the validated cleaning process, its significance should be assessed and appropriate requalification considered.

Routine monitoring, auditing and staff competency also help demonstrate that the established process continues to be followed between Performance Qualification activities.

The important distinction is not whether a cleaning process is manual or automated.

It is whether the process is sufficiently defined, controlled, reproducible and measurable to demonstrate that it achieves its intended outcome.

Manual processes naturally present greater opportunities for variation, which makes clear work instructions, control of process variables and operator competency particularly important.

But that variability is also precisely why manual cleaning should not sit outside the validation framework.

Where manual cleaning is relied upon as part of reusable medical device reprocessing, the healthcare organisation should understand the process, identify the variables that influence its performance, establish appropriate controls and gather objective evidence that the required cleaning outcome can be achieved.

Manual cleaning can be validated. The challenge is making a human-dependent process sufficiently controlled that its effectiveness can be demonstrated, reproduced and maintained.