This ➜ RECOMMENDATION replaces the two now obsolete Recommendations 54 “Performance Requalification for No Particular Reason” and 55 “Performance Requalification on Changing the Process Chemicals”.
The Quality Task Group has deemed it necessary to revise these recommendations to bring them into line with the amended version of the “Guideline compiled by DGKH, DGSV and AKI for the validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices”, 5th Edition 2017 (termed the Validation Guideline below).
In the introduction to Recommendation 54 it was suggested that the requalification interval should be based on the number of hours a washer-disinfector (WD) was in operation. That viewpoint has not prevailed since, just like any other periodic inspections (e.g. road traffic or passenger elevators), ➜ DIFFERENT INTENSITIES OF USE do not automatically lead to amendment of the test interval.
Section 5.4 “Performance Requalification (Repeat Performance Qualification)” of the Validation Guideline makes reference to the normative requirements. Section 6.1.5 of standard DIN EN ISO 15883 describes “normal practice” as conduct of repeat performance qualification on a yearly basis. If the recommended test interval is not observed, written risk assessment must be carried out following identification and evaluation of the existing risk.
The stipulation in the now obsolete recommendations that maintenance be carried out within 4 to 6 weeks before performance qualification (PQ) has been rescinded. Annex 9 of the Validation Guideline makes clear reference to that in the section on the “Relationship between Maintenance and Repeated PQ”, with the statement “The abovementioned points and references justify the abolition of the 4-week deadline”. That is explained by the advent of modern maintenance concepts that take account of the most diverse aspects of testing and do not necessarily conform to a rigid calendar.
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