EFHSS Questions and Answers - Answer to Question Q00628

the hospital i work for is currently looking into the purchase of low temperture steam formaldehyde sterilisers for its medical devices. They are changing from EtO sterilizers! i would like information on the validation and commissioning of LTSF sterilizers and any comments regarding this change

thankyou

Dear Jennifer,

in this forum you find many questions and answers related to EO- and LTSF-sterilisation. Many hospitals in Europe and elsewhere switched from EO-sterilisation to LTSF-sterilisation (LTSF = Low Temperature Steam and Formaldehyde) because of lower toxicity and shorter turnaround times of the latter. Regarding validation let me comment this way: the ISO 14937 is an international standard which prescribes the necessary steps of a validation regardless of the sterilisation process. In order to practically validate you need either a process specific standard or specific recommendations from some acknowledged authority (or both). In Europe we work with the EN 14180 which contains precise descriptions of procedures for the installation (commissioning) and the operational (functional) qualification. The most important aspect namely the performance qualification is often regulated nationally. In Germany we work with very detailed recommendations from the German Association for Hospital Hygiene. In Trinidad you may want to contact your authorities to find out which company is accredited to carry out LTSF-sterilizer validations. In case you encounter difficulties please contact me at any time under . Sincerely, Stephan Trispel (WEBECO GmbH & Co. KG).