Flexible endoscopes and accessoir

Is a validated reprocessing of flexible endoscopes in a private practice mandatory? Can a manual procedure be validated?

According to the MDD and the Operator Ordinance, your question must be answered in the affirmative. However, according to the RKI, manual reprocessing is still possible, depending on the risk classification of the instrument. If you use instruments classified as "semi-critical", the RKI states that machine-based reprocessing is preferable, but this does not exclude manual processing. These are mainly gastroenterological fibrescopes. However, if the fibrescopes are used in urology, they are all deemed "critical" - with the exception of flexible cystoscopes, which is only used for diagnostic purposes - and hence machine-based reprocessing according to RKI is required. Of course, it is debatable whether a machine-based process can be validated at all. However, it is possible to standardise manual reprocessing if steps are described and documented in detail. Currently, a working group consisting of members of the DGSV (German Society for Sterile Services), DGKH (German Society for Hospital Hygiene) and AKI is working on guidelines for manual reprocessing.

Where can I find the text published in the German Federal Health Bulletin?

Hygiene requirements for the reprocessing of flexible endoscopes and additional endoscopic instruments. After publication in the German Federal Health Bulletin, this text replaces the corresponding appendix to Section 5.1. of the guidelines for hospital hygiene and infection prevention published in the German Federal Health Bulletin 31/1988, No. 11. file download at RKI.

Are there guidelines that state that a flexible cystoscope in a urological outpatient clinic must be sterile?

Strictly speaking, the answer to this question must be "yes". However, there is an exception issued by BfArM and the RKI (as of 28.01.2005), which states that flexible cystoscopes may still be used in a disinfected state if they are only used for diagnostic purposes. However, the conditions described in the publication must be considered.

What is the maximum length of narrow-lumened instruments which can be sterilised in FO and steam?

Until some time ago, sterilisation processes were tested in accordance with DIN 58948 T 13/14 using a 1.5 m long (PTFE tube) test challenge device with an inner diameter of 2 mm and sealed at one end. This can currently be regarded as the limit for FO sterilisation, unless alternative proof is provided by "direct inoculation of the sterilised material". In the case of steam sterilisation (as will soon be the case with FO sterilisation), proof of validation of sterilisation processes must be provided. If the items concerned cannot be tested using thermocouples, a "direct inoculation of the sterilised goods" must also be carried out (for more information, see DIN 58946 T6 or the appendix).