Central Service - Issue 6/2008
- What’s New in Standardisation: Measurement Uncertainty
- 9th CSSD Hygiene Forum at the Damp Congress Centre
- Reprocessing and Reuse of SUDs in Terms of Sustainability
- Trends in Austria
- Uniform Standards for Manufacturers and Reprocessors. MedInform Conference on reuse of medical devices on 8 October 2008 in Bonn
- Computer Chip RFID Boosts Safety and Efficiency of Routine Hospital Tasks
J. Köhnlein, R. Glasmacher, V. Heide, D. Kunde, M. Mohr, D. Otto, K. Roth, J. Staffeldt, P. Tiarks, S. Wagenknecht, H.-P. Werner, W. Michels*:
Multicentre Trial on Standardisation of a Test Soil of Practical Relevance for Comparative and Quantitative Evaluation of Cleaning Pursuant to EN ISO 15883
The cleaning performance of washer-disinfectors can be verified pursuant to ISO 15883-1and ISO/TS 15883-5 using various country-specific test soils. Hence comparability of the results achieved is questionable. The Ad Hoc Group "Test Soil and Methods" was founded by the DIN standardisation committee NA Med 063-04-09 in order to standardise the test soils. To that effect, the Ad Hoc Group aimed to develop an in vitro reference system with a test soil suited to everyday practice, which could then be used to study different variables, such as detergents or the behaviour exhibited by other test soils compared to the reference soil.
Comparative testing was conducted by six experienced laboratories. In several experimental series it was possible to gradually optimise, first, standardisation of soiling the test objects for process challenge devices, second, the test procedure and, third, analysis of residual soils.
On the basis of the series of tests carried out, a system was devised and defined for characterisation of the detachment kinetics, providing for quantification of the cleaning performance relevant to the practical situation.
This meant that there was now a reference standard that also permitted quantifiable comparison of the various test systems available, including those cleaning indicators already commercially available.
F. Netzer, D. Combeau, C. Gouot, C. Doit, E. Bingen, F. Brion:
Must the Reverse Osmosis Purified Water Used for Sterilisation Necessarily Meet Potability Criteria?
Air and water play an important role in the quality of medical device sterilisation processes. Control and verification of the environmental conditions to which this process is subjected are stipulated in legal regulations. Several microbiological tests carried out on the reverse osmosis purified water used for sterilisation at the Robert Debré Hospital showed a bacteriological contamination level exceeding the accepted potability limits. This contamination persisted despite repeated disinfection of the network with peracetic acid.
The aim of the present study was to evaluate the impact of using contaminated water in the washer-disinfectors to reprocess medical devices in the Central Sterile Supply Department (CSSD). Analysis of water samples taken from the network showed microbiological contamination with more than 20,000 CFU/10 ml. The viable bacterial count after culture at 37 °C was more than 100 times higher than the acceptable maximum level, and more than 10 times higher than the acceptable maximum level after culture at 22 °C. Bacteriological analysis of reverse osmosis purified water samples taken during a cleaning/disinfection cycle did not show any microbial contamination. The study results are satisfactory since they show that, although the reverse osmosis purified water circulating in the network and supplying the CSSD did not meet bacteriological potability criteria, the water samples taken at the end of a cleaning cycle was of good microbiological quality. The corrective process carried out to improve the microbiological quality of the water was the installation of a plate heat exchanger, making it possible to cool reverse osmosis purified water by a frozen water circuit. The microbiological analyses carried out for more than two years now have shown that the results have stabilised, with a contamination level lower than the authorised maximum limits.
A. Carter, A. Jones, K. Wiese, A. Johmann, H.Ch. Lüdtke-Handjery, T. Kießling, Dr. G. Oberländer, J. Breder:
Guideline for the Validation of the Sealing Process According to EN ISO 11607-2
The highest goal of every packaging system for medical devices which are terminally sterilized, is the assurance of sterility until the products are used on the patient. The validation of packaging processes is crucial to ensure that sterile barrier system integrity is attained and will remain so until opened by the users of sterile medical devices.
The seam sealing process in the context of the preparation of medical products should be seen as a part of a chain of procedures. The international standard EN ISO 11607, part 2, describes the validation of the packaging process. It serves as the basis for the drafting of this guideline which should be understood as an orientation aid for the successful implementation of validation in reprocessing practice.
Through experience with the implementation of validation guidelines for the sterilization process and cleaning/disinfection processes, it has become clear that a reliable manual with a practical orientation for the implementation of the standardizing requirements is necessary in order to achieve as uniform as possible understanding by operators and validators. The focus on the uniform and correct implementation of the validation of the sealing process is of great importance for all involved in the process as well as for the monitoring and certifying authorities, and finally to minimize confusion.
The authors would like to point out that this guideline is intended as a practical aid and should serve merely as a guide. There is no guarantee of completeness.
RECOMMENDATIONS BY THE QUALITY TASK GROUP (AK »QUALITÄT«)
Requirements for Construction or Conversion of a Hospital Central Sterile Supply Department. Part 3 - Technical and Functional Fittings and their Installation