Finding the Causes Behind Cleaning Efficacy Failures

The investigation identified several issues that were affecting cleaning performance.

SVA found lint and debris obstructing washer spray arms, with some spray arms not operating effectively during automated washing. Significant fibre and lint contamination was also found within the washers, associated with the breakdown of chemical indicator materials during the wash process.

However, the investigation also identified an issue occurring before devices reached the washer-disinfectors. Reusable medical devices were being rinsed with hot water prior to automated cleaning, introducing another factor that could affect subsequent soil removal.

Together, the findings demonstrated that the cleaning failures could not be attributed to a single piece of equipment or one isolated fault. Equipment condition, routine maintenance, materials entering the washer and pre-cleaning practices were all impacting the overall cleaning process reliability.

SVA cleaned the affected washer spray arms and provided advice on the pre-rinsing practices identified during the investigation.

This allowed the facility to address both the immediate equipment issues and the practices contributing to the cleaning efficacy failures.

SVA subsequently returned to site and repeated the affected Performance Qualification testing.

The cleaning efficacy tests passed following the corrective actions.

The investigation demonstrated the value of Performance Qualification in assessing more than whether a washer-disinfector completes its programmed cycle.

Effective cleaning relies on the complete process working as intended, including equipment condition, functioning spray systems, appropriate pre-cleaning practices and control of materials introduced into the washer.

Importantly, a failed PQ result provided an opportunity to investigate and identify the factors affecting the process rather than simply repeating the test.