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Current Directions in Biomedical Engineering

Joint Journal of the German Society for Biomedical Engineering in VDE and the Austrian and Swiss Societies for Biomedical Engineering

Editor-in-Chief: Dössel, Olaf

Editorial Board: Augat, Peter / Buzug, Thorsten M. / Haueisen, Jens / Jockenhoevel, Stefan / Knaup-Gregori, Petra / Kraft, Marc / Lenarz, Thomas / Leonhardt, Steffen / Malberg, Hagen / Penzel, Thomas / Plank, Gernot / Radermacher, Klaus M. / Schkommodau, Erik / Stieglitz, Thomas / Urban, Gerald A.

CiteScore 2018: 0.47

Source Normalized Impact per Paper (SNIP) 2018: 0.377

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Standard manual reprocessing of angiographic systems in the hybrid OR

Sebastian Buhl / Carina Werner / Clemens Bulitta
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  • Technical University of Applied Science Amberg-Weiden, Hetzenrichter Weg 15 , Germany, +49 (961) 382-1620, +49 (961) 382-2620
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Published Online: 2017-09-07 | DOI: https://doi.org/10.1515/cdbme-2017-0085


A current FDA guidance demands the validation of cleaning and disinfecting protocols even for non-sterile medical devices. The aim of this work is to clarify whether this is already possible using the guidance itself as well as the German DIN EN ISO 17664. An angiography system (Artis Zeego / Pheno - Siemens) was selected as a test object for the validation of a cleaning and disinfection protocol for medical devices in a hybrid operating room. In pilot study prior to the trial, critical points of the system were evaluated by means of questionnaires to clinical users (OTA, surgical technicians). An initial assessment of the in-house cleaning protocols used in the hospitals was done by using a fluorescence assay. The microbiological examination took place subsequently by contact plates and swabbing to determine the amount and type of germs on the surfaces of the system. These experiments were done at three different clinical sites. It was found that there was a significant germ count on several surfaces of the product even after in-house cleaning and disinfection (C&D). After application of an enhanced C&D plan, these germs could be greatly reduced at all verified sites. In addition, it could be shown that DIN EN ISO 17664 can in principle be applied to non-sterile medical products.

Keywords: angiographic system; cleaning and disinfection protocol; validation

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Published Online: 2017-09-07

Citation Information: Current Directions in Biomedical Engineering, Volume 3, Issue 2, Pages 405–407, ISSN (Online) 2364-5504, DOI: https://doi.org/10.1515/cdbme-2017-0085.

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©2017 Sebastian Buhl et al., published by De Gruyter. This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License. BY-NC-ND 4.0

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