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:
http://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Aufb_MedProd/Aufb_MedProd_node.html (in German)
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.
Is it true that the RKI-BfArM recommendation was revised in 2012?
Yes, a current version is available under the following link:
http://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Aufb_MedProd/Aufb_MedProd_node.html (in German)
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:
http://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Aufb_MedProd/Aufb_MedProd_node.html (in German)
Which disinfectants may I use for ultrasound probes in gynaecology?
The problem of the necessary (fully) virucidal disinfection of ultrasound probes in gynaecology has been discussed for many years. This can be seen in the joint statement of the Federal Institute for Drugs and Medical Devices and the Robert Koch Institute of 2005.02.17 (see page 1309 "Anhang 7: Aufbereitung von Ultraschallsonden zur Anwendung in der Gynäkologie") at http://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/Medprod_Rili_2012.pdf (in German)
Unfortunately, we as the higher federal authority are not allowed to comment on individual products for reasons of neutrality. It is therefore the responsibility of the medical device operator to find suitable disinfectants or procedures in accordance with the manufacturer's instructions. The following information is provided on the test methods and application of virucidal disinfectants in the VAH list: https://vah-online.de/.
How often must disinfectant solutions used to disinfect medical devices be replaced?
Basically, according to § 8 of the Medical Devices 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 is applied.
Accordingly, the cleaning solution must be changed every working day in accordance with point 2.2.2. of the recommendation to avoid cross-contamination. In this context, it must be emphasised that organic material (e. g. protein residues) in particular can negatively influence the effectiveness of a chemical disinfectant. In this respect, if a solution used is visibly contaminated, it is even recommended to change it immediately. We refer here to § 8 of the MPBetreibV, according to which the operator of a medical device is responsible for the proper execution of the entire reprocessing procedure. Effective cleaning and disinfection always requires that the manufacturer's instructions for use are followed, but the user should nevertheless weigh up the risks on site when determining the individual steps in order not to endanger the health of patients, users and third parties. The following information is provided on the test methods and application of virucidal disinfectants in the VAH list (in German): Viruzidie - Zur Prüfmethodik und Anwendung viruzider Desinfektionsmittel.