Content Issue 06/2018 Central Service


News Update

  • 22nd DGSV Congress. 30 September – 1 October 2018 in Fulda

Main Articles

  • M. Wehrl*, U. Rosenberg, F.H.H. Brill, H. Gabriel, A. Kampe, W. Michels, K. Roth, L. Schnieder, P. Frey, J. Köhnlein, O. Riebe, A. Hartung, R. Bloß, G. Kirmse, M.-T. Linner, D. Martini, M. Tschoerner, U. Weber, S. Krüger, H. Martiny, J. Gebel: Test method for comparative evaluation of instrument detergents for manual reprocessing of surgical instruments on the basis of fibrin


  • The new French Prion Standard Protocol


  • DGSV Quality Task Group: Information to be provided by the medical device manufacturer for the processing of medical devices – Checklist updated


MAIN ARTICLE - From the field
M. Wehrl1, U. Rosenberg2, F.H.H. Brill3, H. Gabriel3, A. Kampe3, W. Michels4, K. Roth5, L. Schnieder5, P. Frey5, J. Köhnlein6, O. Riebe6, A. Hartung7, R. Bloß8, G. Kirmse9, M.-T. Linner10, D. Martini11, M. Tschoerner12, U. Weber13, S. Krüger14, H. Martiny15, J. Gebel16,17
1 wfk – Cleaning Technology Institute e.V., Krefeld;
2 Borer Chemistry AG, Zuchwil;
3 Dr. Brill + Partner GmbH Institut für Hygiene und Mikrobiologie, Hamburg;
4 Prüflabor DWM, Warburg;
5 SMP GmbH, Tübingen;
6 HygCen Germany GmbH, Schwerin;
7 Schülke & Mayr GmbH, Frankfurt a. M.;
8 Bode Chemistry GmbH, Hamburg;
9 Aesculap AG, Tuttlingen;
10 Hygiene Linner, Munich;
11 Borer Chemistry Deutschland GmbH, Lörrach;
12 Chemische Fabrik Dr. Weigert GmbH & Co. KG, Hamburg;
13 Miele & Cie. KG, Gütersloh;
14 Hygiene Consulting Grünendeich, Grünendeich;
15 TechnischeHygiene, Berlin;
16 Institut für Hygiene und Öffentliche Gesundheit, Universitätsklinikum Bonn AöR, Bonn;
17 Verbund für Angewandte Hygiene (VAH)
Test method for comparative evaluation of instrument detergents for manual reprocessing of  surgical instruments on the basis of fibrin
Currently, there are neither in Germany nor at international level any generally accepted methods for verification of the efficacy of the detergents used for reprocessing of instruments. The requirements addressed to an appropriate test method are as follows:
i) Selection of a test soil that is difficult to remove and of practical relevance,
ii) Defined application of the test soil to a relevant surface,
iii) Quantitative elution of residual soils as well as
iv) Definition of a representative analyte (lead substance) and appropriate methods for quantification of the analyte.
The Working Group for Testing Detergents (AG RMT) of the German Society for Hospital Hygiene (DGKH) e.V.), which was set up in 2011, devised and developed a new test method for comparative evaluation of detergents for instrument reprocessing.
Using the high molecular weight and water-insoluble test soil fibrin, this paper now reports on a method based on a fibrin process challenge device (F-PCD) that for the first time permits comparative testing of the efficacy of different detergents in an immersion model (no mechanical action) and is able to differentiate various instrument detergents in terms of their efficacy. The special feature of this method is the use of water-insoluble fibrin as test soil of practical practical relevance. Fibrin is rated as a critical protein soil component, the most difficult to remove from surgical instruments, and to date it has not been possible to measure and evaluate fibrin by means of conventional elution and protein quantification methods. Based on the development of an innovative elution method, the water-insoluble fibrin soil on the PCDs can be converted into a solubilized form and measured using traditional protein quantification methods (OPA, BCA method). The reproducibility and comparability of the results of the newly devised method were verified and confirmed in several multi-centre trials with up to six participating laboratories. The investigations by the AG RMT have led to the development of a new test method and to an advanced understanding of comprehensive assessment of the residual protein content on reprocessed medical devices.