Central Service - Issue 3/1999
U. Junghannß*, S. Winterfeld, L. Gabele, U. Kulow:
Hygienic-Microbiological and Technical Testing of Steriliser Container Systems
(Zentr Steril 1999; 7 (3): 154-162)
Sterilisation containers used in the everyday hospital setting can compromise sterility as a result of damage and improper maintenance. To elucidate the microbial retention capacity of sterilisation containers and to gauge their operational suitability, hygienic-microbiological and technical testing of container systems, which had been in operation for many years, was conducted in four hospitals. The aim of the investigation was to demonstrate on the basis of microbiological and physical tests that containers comply with the required hygienic safety in the everyday hospital setting.
sterilisation, sterile containers, microbial retention capacity
Ordinance on the Installation, Operation and Use of Medical Devices (Medical Devices Operator Ordinance - MPBetreibV)
FROM THE FIELD
Testing the Cleaning Efficacy in Decontamination Equipment (Part 2)
(Zentr Steril 1999; 7 (3): 180-188)
In the European standards regulating the validation of washer-disinfectors, evaluation of the cleaning performance plays a major role in addition to physical measurements. Already in the first paper N 151, the horizontal draft for the requirements and test methods, methods for evaluation of the cleaning efficacy have been described. In the run-up to the multi-centre trials, several tests were conducted in order to gauge the suitability of the OPA method in two respects: to gauge its suitability for testing for blood residues during a final-product examination and for the quantitative determination of a protein residue soil on test carriers after the cleaning step. As demonstrated by the results of the tests, while an end-product examination cannot be performed with this test, in programmes with a separate cleaning step prior to the process quantitative determination of the cleaning efficacy is possible with reproducible values on withdrawing the test carrier after the cleaning step or before the disinfection step.
Test method, cleaning efficacy, cleaning indicators, OPA protein analysis, end-product examination
M. Christensen*, G. Haustveit, J. Hoborn, O.B. Jepsen, J. Ojajärvi:
Reuse of Sterile Single Use Medical Devices: A Survey of 100 Hospitals in Denmark, Finland, Norway and Sweden (January 1998)
(Zentr Steril 1999; 7 (3): 189-194)
The practise of reusing medical devices labelled "Single Use" was studied in 100 hospitals in four Nordic countries. A questionnaire addressing the extent of reuse, the type of equipment involved and the methods for reprocessing was used to collect relevant information from the wards and from the central sterile supply units. Data were analysed at the National Centre for Hospital Hygiene at Statens Serum Institut in Copenhagen. A total of 542 cases of resterilisation of a wide range of medical devices, including implants, were identified and reported from 53 hospitals while 47 hospitals reported no reuse. The predominating reprocessing methods varied in the four countries but in general these were not validated for this specific application. In one country a similar survey carried out in 1996 had influenced the reuse of certain devices: in 1996 50% of these hospitals had no policy while in 1998 a total of 80% had adopted a restrictive policy against reuse of single use medical devices.
Reuse, medical devices, single use, resterilisation
Series on Infectiology - Infection by Campylobacter Species
INDUSTRY IN FOCUS