Common Reprocessing Issues Identified During Performance Qualification

Automated cleaning cannot compensate for every weakness in the process that occurs before an instrument enters the washer-disinfector.

Cleaning efficacy testing undertaken during PQ may identify residual contamination on clinically soiled instruments even though the washer itself appears to be operating normally.

The underlying cause may relate to what happened earlier in the process.

Gross contamination may not have been adequately removed. Soiled instruments may have undergone long dwell times with no pre-treatment applied. Brushing or flushing may not have been sufficient. A device may require additional preparation before automated cleaning. In other situations, the way the device has been presented to the washer may limit exposure to the cleaning process.

Complex reusable medical devices can make these issues particularly apparent.

Hinged, serrated, cannulated and laparoscopic instruments contain areas that can be challenging to access. Placing a cannulated device in a washer basket, for example, does not necessarily mean that water and cleaning chemistry will adequately reach its internal surfaces.

Connections, irrigation, positioning and loading configuration can all influence the result.

The lesson is an important one: the performance of the equipment cannot always be separated from the way reusable medical devices are prepared and presented to it.

A reprocessing process may have been successfully validated, but this does not mean it has remained unchanged.

Wash times, temperatures and other programmed parameters can change over time. Changes may occur following servicing, maintenance, software updates or operational adjustments and may not always be obvious to the people using the equipment every day.

Even changes made with good intentions can introduce risk.

For example, altering a wash parameter in response to an unexpected routine monitoring result may create a process that is different from the process originally validated.

Equipment may still complete the cycle successfully. The cycle record may not indicate any changes. Yet the facility may no longer be using the process for which validation evidence was originally established.

This is why retaining records of validated parameters and routinely comparing process records against those parameters is an important part of maintaining a validated process.

PQ provides an opportunity to determine whether the process being used today is still the process the facility believes it is using.

A cycle can operate exactly as programmed and still be inappropriate for the reusable medical device being processed.

Manufacturer Instructions for Use, device construction and the intended method of reprocessing all need to be considered when determining which process should be applied.

PQ may identify incorrect chemistry being dosed for the cycle phase, heat-sensitive devices being exposed to temperatures outside specified limits, devices being subjected to inappropriate sterilization cycles, or complex products requiring different process parameters to less challenging products processed within the same facility.  SVA have identified all these scenarios (and many others!) across 20 years of conducting Performance Qualification nationwide.

The concept of Product Families and selection of appropriate master products becomes particularly relevant here.

PQ should challenge the process using worst-case products and loads. This helps demonstrate not just that the equipment can complete a cycle, but that the process is suitable for the devices the facility actually reprocesses day-to-day.

Not every performance problem involves a major equipment failure.

Routine cleaning and maintenance of reprocessing equipment can directly influence how effectively the process performs.

During PQ activities, issues may be identified such as debris within washer filters, obstructed spray systems, residues within equipment chambers, damaged seals or deterioration of internal components.

Viewed individually, some of these issues can appear relatively minor.

But a partially obstructed spray arm can impede the wash action and reach within the chamber and affect cleaning chemistry disbursement. Debris accumulating within equipment can alter the environment in which reusable medical devices are being processed. A deteriorating component may continue to function while no longer performing consistently.

PQ provides an opportunity to observe the equipment while it is being used as part of the complete process, rather than considering maintenance status or calibration results in isolation.

Drying efficacy provides another useful example.

A device may meet cleaning or disinfection requirements but still retain residual moisture after completion of the cycle.

It would be easy to conclude that the equipment’s drying stage is inadequate. However, drying performance can also be strongly influenced by device design, material and loading configuration.

Silicone and plastic components, tubing, flexible devices and complex assemblies can retain water even where the equipment is operating as programmed.

Loading technique may also make a significant difference. Consistent positioning that allows water to drain freely can contribute to more reliable and repeatable drying outcomes.

PQ can help distinguish between inadequate equipment performance and a challenge associated with the product, configuration or process.

Depending on the finding, the appropriate response may involve reviewing loading practices, cycle parameters or establishing a separately validated supplementary drying process.

Simply modifying process parameters until a routine monitor produces a passing result may create an unintended consequence: the facility may change a previously validated process without evidence that the change is appropriate for the reusable medical devices being processed.

Routine monitoring and PQ therefore need to be understood within the broader quality system. Neither should be viewed simply as a result to be made to pass.

The underlying issue may involve device preparation, loading configuration, equipment condition, cycle parameters, chemistry, services, device compatibility or routine operating practices. In some situations, several factors may be interacting.

Simply repeating the failed test may confirm that a problem exists. It does not necessarily explain why.

A meaningful investigation asks different questions:

What has influenced this result?
Is the equipment, device or process behaving differently from what was expected?
Has something changed since the process was originally validated?
What evidence is needed to demonstrate that corrective action has addressed the underlying issue?

These questions move Performance Qualification beyond a simple exercise in achieving a pass result.

A meaningful Performance Qualification should do more than confirm that equipment completed its programmed cycle or generate a certificate for the compliance file.

It should provide objective evidence about how the reprocessing process performs under the conditions in which it is actually used.

Unexpected findings are therefore not necessarily a failure of PQ. In many cases, identifying them is precisely where PQ delivers its greatest value.

They create an opportunity to investigate the complete process, understand what is influencing the outcome and make corrective decisions based on evidence rather than assumption.