Richard Bancroft, B.Sc (Hons), science and technical director at Steris Corporation explores ISO 15883-4 and its implications for endoscope washer-disinfectors.
The ISO 15883 series considers requirements for washer-disinfectors (WDs) used to clean reusable medical devices. Part 1 has general requirements for all types of washer-disinfectors, whereas ISO 158834 (part 4) has specific requirements for endoscope washer-disinfectors.
These endoscope washer-disinfectors (EWDs) differ from surgical instrument WDs (part 2) in that they are required to clean and disinfect flexible thermolabile endoscopes that have unique requirements. Firstly, these flexible endoscopes have complicated internal channels that must be cleaned and disinfected, and secondly, flexible endoscopes cannot be exposed to the high temperatures associated with thermal (moist heat) disinfection.
Therefore, EWDs have connectors that mate with the endoscope to be processed, allowing flow of the process fluids for cleaning and disinfection, and they use chemical, rather than thermal, disinfection. The first edition of ISO 15883-4 was published in 2008; since that time, there has been much work to update the standard, which was finally published in December 2018.
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