Data loggers provide independent evidence of process conditions during Performance Qualification. However, a logger is not suitable simply because it is calibrated and capable of operating within the required temperature range.
Water is a critical input to reusable medical device (RMD) reprocessing. It is used for cleaning, rinsing and thermal disinfection, and as feedwater for the generation of steam used in sterilization.
Performance Qualification (PQ) forms part of the validation of reusable medical device reprocessing processes.
During Performance Qualification of an automated cleaning process for flexible endoscopes, SVA identified cleaning efficacy failures associated with the way the devices were being presented within the washer-disinfector.
During Performance Qualification, SVA observed inconsistent water flow through the internal channels of dental handpieces during automated cleaning.
During Performance Qualification, SVA identified significant cleaning efficacy failures across the washer-disinfector line.
A health service organisation experienced a significant condensation event within its theatre sterile stores, affecting normal operations and resulting in the loss of consumables and sterile reusable medical devices.
A health service organisation was experiencing repeated failures of routine cleaning monitors used to assess the performance of its automated washer-disinfectors.
During Performance Qualification of Endoscope Storage Cabinets located in a Metropolitan hospital, SVA identified significant bacterial and fungal growth, despite the cabinets being compliant with ISO 16442 requirements.
A health service organisation was experiencing excessive wet loads out of a steam sterilizer.
