Central Service - Issue 2/2011
- What's New in Standardisation: A Single Fault
- 9th Sterilisation Forum at Munich University Hospital
- 3rd Heidelberg Sterilisation Symposium at Heidelberg
- Healthcare Day 2011: Modern E-Health Solutions
- News from the Editorial Board
M. Kremmel, W. Laudner et al.:
Testing the performance of process challenge devices (PCDs) used to check air removal from hollow instruments and effectiveness of sterilisation in steam sterilisation processes
For many years now batch control in validated steam sterilisation processes has been a controversial issue. The investment needed to reliably sterilise modern, often highly complex, instruments is easily underestimated. Besides, sterilisers that are not able to assure adequate sterilisation of hollow instruments continue to be used, especially in medical and dental practices.
Unfortunately, just by inspecting sterile supplies there is no way of knowing whether they are really sterile, hence instruments are released for use even if the indicator has not undergone a change in colour as required. But another question raised is whether successful sterilisation has always been achieved even if the indicator inside the process challenge device (PCD) has changed colour as prescribed.
In Germany several different systems are used in the most diverse forms and designs to verify the results of the sterilisation process; they are based on EN 867-5 (1) or EN ISO 11140-1 (2) or -6 (3), E-DIN 58921 (4), ISO/TS 17665-2 (5) or even on DIN EN ISO 15882 (6).
The situation is further compounded by the various, in some cases contradictory, statements made by the steriliser manufacturers, distributors, manufacturers of indicators or test systems and by validation engineers. Apart from the lack of information given by standards on batch control for steam sterilisation, there is also a tendency to use increasingly cheaper test systems. This therefore raised the issue of whether the performance of the various test systems is comparable in terms of their suitability for the intended purpose. The performance test described in this paper has not, unfortunately, been able to confirm this.
FROM THE FIELD
Y. Uetera, H. Yasuhara, N. Kumada, K. Moriya, R. Saito, M. Okazaki:
Performance of a new type of containers equipped with reusable filters investigated using wireless loggers and microbiological methods
Recently, a new type of containers equipped with reusable filters were developed, which tolerate 5000 autoclaving cycles. New packaging material should be validated before use. Therefore, steam penetration and microbial barrier effectiveness were evaluated for this new type of containers. Wireless loggers and biological indicator tests confirmed sufficient penetration of steam into the new type of containers. It was also revealed microbiologically that sterility in them was maintained for six months.
Incidentally, using the same microbiological methods, it had been revealed in our surgical center that sterility was maintained six months in conventional containers with single-use filters. Therefore, it was suggested that the new type of containers with reusable filters have a similar microbial barrier effectiveness as the containers with single-use filters.
T.W. Fengler, A. Hartwig:
Attention operators: can we delegate responsibilities?
Recommendations by the «Quality Task Group»: Commentary by the Quality Task Group of the DGSV on the topic of the «Hygiene Scandal»