Installation, Operation and Performance Qualification: This wide range of washer-disinfector validation services can, if required, be provided by the Miele Service Department. Here, recommendations are taken into account provided by a new guideline already along the lines of the future prEN ISO 15883 standard.
Installation Qualification includes, among others, checking that machines have been correctly installed and on-site supplies/utilities to the machine have been properly inspected. With Operation Qualification, extensive functional tests are carried out, for example on heating, cleaning and disinfection systems. During Performance Qualification, cleaning and disinfection programmes are monitored using test loads which are determined in cooperation with the operator: For example MIS instruments, anaesthetic equipment or containers – depending on machine application. Each instrument is thoroughly inspected at the end of the cleaning stages.
In order to check thermal disinfection effectiveness, the guideline stipulates the use of temperature measuring systems which correspond to the requirements of the prEN ISO 15883 standard. That is why Miele washer-disinfectors feature a test port which allows temperature probes to be used to monitor the temperature at various locations within the cabinet and on the load in order to ascertain whether disinfection temperatures have been maintained over the entire holding time. Furthermore, drying results are also inspected as part of the validation process. Fínally, all relevant data is meticulously documented in writing including photos.
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Reinhild Portmann, Anke Schläger
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