Reprocessing and disinfecting
Here you will find answers to frequently asked questions about reprocessing and disinfecting medical devices.
Where can I order the RKI-BfArM recommendation for the reprocessing of medical devices?
The joint recommendation of the Robert Koch Institute and the BfArM on hygiene requirements for the reprocessing of medical devices (so-called RKI-BfArM recommendation) is available free of charge.
You can find it under the following link:
What legal basis do I have to consider for the reprocessing of medical devices in practice?
Basically, according to § 8 of the Medical Device Operator Ordinance (MPBetreibV), proper reprocessing is presumed if the recommendation of the Robert Koch Institute and the BfArM on hygiene requirements for the reprocessing of medical devices (RKI-BfArM recommendation, 2012) is observed.
Who is responsible for ensuring that the processing is carried out properly?
The user/operator is responsible for a proper execution of the entire reprocessing procedure, taking into account the manufacturer's specifications.
Where can I find information on endoscope reprocessing?
In Annex 8 of the joint recommendation of the Robert Koch Institute and the BfArM on hygiene requirements for the reprocessing of medical devices (so-called RKI-BfArM recommendation) under the following link: