Patient infections related to endoscopic procedures have been repeatedly reported in recent years. This has led to ongoing debates whether the current practice of cleaning and disinfection of semi-critical thermolabile endoscopes is sufficient for eliminating the high microbial load after use of the devices.
Process challenge devices (PCDs) according to Annex 9 of the Guideline are used for the process control of the overall reprocessing efficacy for thermolabile endoscopes. The analysis of these PCDs is sophisticated and requires a microbiological laboratory. These PCDs are therefore not appropriate for routine controls in central sterile departments.