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Central Service - Issue 5/2011

Central Service - Issue 5/2011

Central Service - Issue 5/2011


  • What's New in Standardisation: Guidance not fit for purpose
  • DGSV 15 years on: DGSV Congress in Fulda
  • Guideline for validation of automated cleaning and disinfection processes for reprocessing flexible endoscopes: Report by the Guideline Group


H. Biering, R. Glasmacher, M. Hermann, E. Schrader:
Biocompatibility of medical devices after automated reprocessing in washer-disinfectors

The cytotoxicity and haemolysis potential (indicators of biocompatibility) of five typical process chemicals used for automated reprocessing of medical devices were experimentally investigated in a graduated test program. The tests revealed that certain constituents of the process chemicals, such as microbicidal substances or non-ionic surfactants, had an important effect on the cytotoxic and haemolytic properties of the products. When validating process chemicals containing such substances it is recommended that the final rinse water be tested for entrainment of such products and that the rinse water test intervals be based on the results obtained.

S. Ries:
Process innovation for surgical loaned instruments - a benchmarking-based concept for a university hospital1 (Part 2)

In view of the increasingly greater challenges posed by the use of loaned instruments in the hospital studied (designated below as the «study hospital»), a decision was taken to optimise the loaned instruments' process. To elucidate the current state, an in-depth analysis of the prevailing situation was carried out and the processes, including the problems encountered in the various areas, were described. The main problem areas were as follows: poor communication, no clear definition of persons, places or duties as well as an inadequately designed form for recording the loaned instruments. There were also problems as regards compliance with the different legal acts and standards.
For the purpose of comparison, three benchmarking partners were recruited. Discussions permitted a number of interesting insights and ideas that, in addition to internal improvement proposals, were incorporated into the concept for optimisation of the loaned instruments' process.
By consulting the description of the new process and the compiled flow charts, each surgeon/physician, operating room (OR) staff member, purchasing officer and CSSD staff member responsible in each case can now get a transparent and well-structured overview of the entire process.


M. Wehrl, U. Kircheis:
Method for Testing the Cleaning Efficacy of Washer-Disinfectors for Flexible Endoscopes


S. Esen, A. Willner, J.P.C.M. van Doornmalen:
One set of requirements for steam penetration tests is enough


Recommendations by the «Quality Task Group»: Reprocessing ophthalmologic medical devices (Part 3)

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