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Central Service - Issue 6/1999

Central Service - Issue 6/1999


  • What's New in Standardisation: prEN ISO 15883 - Washer-Disinfectors
  • New NHS Documents
  • New Societies for New Challenges
  • FDA and IAHCSMM on Reprocessing of Single-Use Devices
  • The CSC - 30 Years on the Move
  • ISSM Conference 1999 in Blackpool, England
  • Sterile Supply: Challenges in the New Millenium (in German only)
  • Perspectives (in German only)


M.J. Alfa:
Process Validation for Reprocessing of Patient-Used Cannulatomesn
(Zentr Steril 1999; 7 (6): 368-382)

Fiscal pressures have stimulated many centres in North America to reprocess complex, difficult to clean medical devices such as papillotomy knives (cannulatomes), despite the fact that these are sold as single-use. The objectives of this study were to assess the current reprocessing methods to determine if they were effective, and to assess alternative approaches to determine if they could be validated as reliable for reprocessing patient-used cannulatomes.
The current in-house cleaning/ethylene oxide sterilisation methods were inadequate, as none of the nine routinely processed cannulatomes tested from two different centres were sterile. Three new reprocessing methods were evaluated, which all incorporated a pump to facilitate fluid flow through the narrow lumen of the cannulatomes. The most stringent method incorporated a pre-rinse of the cannulatome with 10 ml distilled water, exposure to detergent for 15 minutes at room temperature using a pump to circulate the detergent, followed by pump circulated rinsing with distilled water at room temperature for 10 minutes, followed by an alcohol rinse, forced air drying and two hours exposure to ethylene oxide.
Simulated-use testing was performed utilising an artificial test soil containing Enterococcus faecalis and Bacillus subtilis spores to provide an organic/inorganic challenge that was similar to what would be expected from patient-use. It demonstrated that the most stringent reprocessing method could eradicate 106 cfu/device of B. subtilis, however, 3/5 of the devices were not sterile as < 10 cfu/device of other organisms were detected. The same issue of low level residual organisms was found for patient-used cannulatomes that were reprocessed by the most stringent method.
In conclusion the study indicates that even with the most stringent method tested there was difficulty assuring sterility 100% of the time. Centres reprocessing single-use cannulatomes should evaluate whether their reprocessing methods are adequate.
Key Words
cannulatome, sterilisation, reprocessing, single-use, process validation, test soil


S. M. Kovach:
Parametric Release from a Hospital Perspective
(Zentr Steril 1999; 7 (6): 383-392)

Parametric release of steam sterilised items provides hospitals with certain advantages when compared to sterility release procedures currently used in the United States. However, the requirements to implement a quality system leading to parametric release will not be easily met by most hospitals today without major changes taking place. To implement an enhanced quality system leading to parametric release, hospitals in the United States are going to have to take the time and make the effort to understand the principles of parametric release, see its advantages and commit themselves to the changes it will require. The paper deals with the authors view on what are some of the obstacles that a healthcare facility in the United States could face in trying to get to a parametric release type system in their institution.
Key Words
Sterilisation, parametric release, validation, commissioning, performance qualification


U. Kaiser:
Simple Method to Assess Efficacy of Sterilisation Processes for Hollow Instruments
(Zentr Steril 1999; 7 (6): 393-395)

The penetration of the sterilant into hollow devices may be insufficient and can compromise the success of sterilisation depending on the process selected. The use of various process challenge devices (PCD) with different penetration characteristics offers the opportunity to evaluate the possibilities and limitations of steam-, ETO- H2O-, Formaldehyde- H2O- and H2O2-H2O sterilisation processes. The tests may be carried out with suitable biological and/or chemical indicators. Hints are given at how to compare PCD with real surgical instruments.
Key Words
Steam sterilisation, hollow device, process challenge device, PCD, air removal, non-condensable gases


P. Heeg:
Series on Infectiology - Infections by Facultatively Pathogenic Enterobacteria


  • Uncomplicated Humanitarian Aid
  • Instrument Information System
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  • Exact Pollutant Suctioning with the WIBOject System
  • ILS20 ISO-Compliant Test and Validation Steriliser Systems

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