EFHSS Questions and Answers - Question Q00375

What does the washer-desinfectors norm prEN 15883 say about documentation wether on a PC or on a printer? What has to be documented exactly: results for one programe or for each instrument?


thank you very much for your help.
Nina May

Nina

The current draft of prEN 15883 is not specific on whether the monitored data is presented on a PC or a printer. It is the performance of the system that is important. With respect to the position of the recording system there are some requirements for legibility etc which can be met if the data is presented by the machine and this is what would be expected for product release decisions.

The section in Part 1 on process verification (5.11) is very strict and the amount of data collected depends upon the use of the load and the risk from a cycle performed poorly. To me this suggests that if we need to clean and disinfect instruments and that poor performance of either is unacceptable then the process verification system must record all the critical process parameters for each load. There may be 7 or 8 critical parameters for cleaning, disinfecting and drying and the system should be capable of recording these data. This will allow a full product release decision to be made.

I hope this answers your questions.

Peter Hooper

EN ISO 15883 requires validated processes for cleaning and disinfecting medical devices in washer disinfectors. Validation means documented procedure of obtaining, recording and interpreting data required to show that a process will comply consistently with the predetermined specifications. Thermal disinfection is controlled by thermometric measurement. Cleaning efficacy must be tested with methods using defined testsoils. Though at the moment different national methods are listed in Annex B which give different results, it must be decided which of the methods shall be taken. Only with standardised test in the first stage a process with optimal cleaning results can be achieved. After this test tests with relevant loads can be processed to show that the medical devices are clean as far as visual control and protein tests (Annex E) can confirm. Dryness if specified for the washer disinfector shall be tested by sampling drops on crepe paper. Residues of chemicals shall be identified by methods given from the manufacturer of the agents. All data must be documented. They are the base for routine tests and requalification.

Sigrid Krüger
Head of Working Group "Quality" at DGSV Germany