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Risk assessment and classification of flexible cystoscopes

Flexible cystoscopes are frequently used endoscopes in the field of urology (lower urinary tract) and are used, for example, for viewing and treating the urinary bladder and urethra. Flexible cystoscopes can be used for purely diagnostic purposes as well as for therapeutic or invasive purposes. Depending on the use of the flexible cystoscope, the risk assessment and classification of the instruments with regard to processing according to the recommendations of the German KRINKO also differs.

If a flexible cystoscope is used exclusively for diagnostic purposes, it can be classified as "semi-critical B". However, if the flexible cystoscope is used therapeutically (invasively), it must be assigned to the higher risk level "critical C". In this case, in addition to mechanical cleaning, low-temperature sterilization in accordance with German KRINKO recommendations is mandatory.

The risk assessment and classification of reprocessing is carried out separately for the accessories used. It should be noted that the accessories used, for example foreign body grasping forceps, are always classified as "critical" and must be reprocessed accordingly.

About the authors

Helmi Henn is a long-standing member of the AKI and is represented in the instrument manufacturers' group. At Richard Wolf GmbH she is responsible for processing, biocompatibility, sterile products, material compliance and product management. She is also a member of national and international standard committees. Dr. Magdalena Lenz also works at Richard Wolf GmbH as an expert for processing.

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