I would like to know what are the european different legislative points of view on the low temperature gaz plasma sterilization?

Olivier Schmitt

There is no specific Dutch legislation on low temperature gas plasma sterilization. However, in the Dutch decree on "sterilized medical devices in hospitals" requirements are given for the sterilization equipment, sterilization process, personnel, packaging, and procedures. For the process, all relevant parameters and the physical behaviour of the medical devices and the packaging shall be identified. One of the requirements for the equipment is that the apparatus is suitable for the sterilization method and properly functioning. For steam sterilization this means validation according to the appropriate European standards or Dutch guidelines.

When standards and guidelines are missing and a sterilization method is new, fulfilling the above mentioned requirements is not an easy task!!

Arjan W. van Drongelen

Concerning low-temperature plasma sterilization there is a rather strict point of view in Austria: The Sterrad 100 S system is not released by the department of health in accordance with the majority of austrian hygienists for routine sterilization. Up to now there is one single Sterrad in use for a restricted range of items and under control of the department for hospital hygiene. The reason for this way of acting is, that the process is hardly reproducable and therefor validation is not possible. Also there is no possibility of a parametric release of the sterilized items as a result of lacking surveillance devices. During the test phase it occured several times, that the bioindicators turned out positive. In my opinion, the Sterrad 100 S should not be recommended for routine sterilization in hospitals. Maybe the next generation of plasma sterilizers (Sterrad 200) is able to fulfil the requirements mentioned above.

T. Miorini, Austria