© DGKH e.V.
About 1000 participants met on site in Berlin at the beginning of May to discuss the latest developments in hospital hygiene. Two sessions also dealt with sterile supply: "Reprocessing of medical devices" and "Cleaning, disinfection and sterilisation".To kick off the symposium Dr. Christian Jäkel reported about "New legal regulations for the reprocessing of single-use medical devices in Germany and Europe".
In Germany, there are two options for reprocessing single-use devices:
- The so-called CE reprocessing according to Art. 17 para. 2 of the MDR, whereby the reprocessor is responsible for all the manufacturer's obligations and, among other things, a new CE mark is applied to the product.
- Reprocessing according to Art. 17 (3) and (4) of the MDR in or (by external reprocessors) for health care facilities in compliance with the Implementing Regulation (EU) 2020/1207 (GS) and the KRINKO/BfArM recommendation. The details result from § 8 para. 4 to 6 of the German Medical Device Operator Ordinance (MPBetreibV).
The EU considers CE marking to be the "gold standard".
A plea for the appreciation of employees was made by Anja Demnick from Berlin. She sees qualification as the key to greater safety for patients, users, employees as well as the operators of the AEMP. A lack of knowledge means a lot of risks with regard to the proper reprocessing of medical devices. In practice, however, up-todate knowledge is not available if qualification measures are not repeated regularly. The reasons for this situation include cost pressure, a lack of supply or ignorance on the part of those responsible.There is also a lack of appreciation. The title of the lecture "Skilled worker or basement child" refers to this. Anja Demnick pointed out that usually all departments of a hospital are listed on the website, but mayn times the CSSD is not. Often the way to the CSSD is not even signposted.
What is needed, therefore, is a culture of recognition as well as access to knowledge.
Endoscope reprocessing again one of the main topics
Endoscopes reprocessing is complex. Nils Andersen, endoscopy assistant, discussed in his lecture "Reprocessing of reusable valves vs. use of single-use valves in endoscopy“. While the use of single-use valves is common, Andersen presented a procedure for reuse.
The Endo team designed a test method to assess the reprocessing from a microbiological and economic point of view. A total of 160 suction and 160 air/water valves were sampled and 20 valves were included as a control group. The results showed that valves can be safely reprocessed in compliance with the manufacturer's instructions, so that from a hygienic point of view, disposable valves are not mandatory.
The sudden increase in detections of gram-negative rods in reprocessed endoscopes at St. Irmgardis Hospital in Meerbusch led to a search for clues, reported hygiene specialist Marc Fiedler. In his presentation he described the "Influence of drying on the microbiological quality of endoscopes“. The endoscopes had to be dried with compressed air. Nevertheless a residual wetness remained. In 2019, Fiedler's team found nonfermenters in four of five colonoscopes, such as Stenothrophomonas matophillia. Intestinal germs and pseudomonads were found in two gastroscopes. In addition, there was a detection of biofilms.
Finally the drying process was identified as the reason for the contamination. By purchasing a drying cabinet germ-free status was achieved after only three hours of drying.
Dr. Markus Wehrl from the wfk – Cleaning Technology Institute presented a new flush – brush – flush (FBF) elution method for the optimised recovery of of microorganisms from channel geometries. The investigations revealed that the recovery rate (RR) for microorganisms could be increased by a factor of 25 to 700 compared to simple flushing.
With the topic "Rapid detection of hygiene-relevant microorganisms on the inner surfaces of of thermolabile endoscopes", Wehrl explored the question of whether there is not another method of determining microorganisms such as recovery after elution. The method group 2.0 is currently developing a rapid test for the in-situ detection of hygiene-relevant microorganisms. The method is based on short-chain nucleic acid molecules (aptamers) that have a specific binding affinity for the the hygiene-relevant microorganisms to be detected. The microorganisms become recognisable after specific fluorescence labelling of the respective detection field.
A full report will be published in issue no. 3 of Zentralsterilization, which will be published on June 21.
