The manufacturing of reusable medical device must accompany detailed instructions on how to reprocess the device between patient uses in the hospitals. Cleaning of the device is a critical step in reprocessing of any device after it has been used on a patient. Failure to remove foreign material from the device can interfere with the effectiveness of subsequent disinfection and/or sterilization.
Residues of protein and TOC are being tested as part of Cleaning Validation, after performing a shortened cleaning procedure according to TIR30.
Log reduction of chosen microorganisms is being tested as part of Disinfection Validation, after performing a shortened disinfection procedure according to TIR12.