When Device Protection Creates a Cleaning Challenge

The finding demonstrated that effective automated cleaning depends on more than the washer-disinfector completing its programmed cycle.

How a reusable medical device is positioned and restrained can influence whether water and cleaning chemistry can adequately reach the surfaces requiring treatment. In this instance, the contact points created by the silicone restraints were interfering with cleaning efficacy.

The challenge was therefore to protect the vulnerable distal tips during automated washing without creating contact points that impeded the cleaning process.

Further testing was undertaken using silicone matting as an alternative means of protecting the ureteroscope distal tips.

The matting provided protection against excessive movement during the wash process while reducing the restrictive contact points associated with the original restraints.

Following the change, subsequent cleaning efficacy testing was negative for both visual soil and protein residue, with the tests achieving a Pass result.

Based on the successful testing, SVA recommended consideration of replacing the existing metal tray and silicone restraint arrangement with silicone matting to help protect the ureteroscope distal tips while minimising contact points capable of interfering with cleaning.

The case demonstrates an important principle of Performance Qualification: how a reusable medical device is presented to the process can be just as important as the process parameters themselves.

A solution introduced for a legitimate reason, in this case protecting a delicate device from damage, can unintentionally affect another part of the reprocessing process.

Performance Qualification provided the opportunity to identify that interaction, trial an alternative arrangement and demonstrate through cleaning efficacy testing that the revised approach achieved the required cleaning outcome.