EFHSS Questions and Answers - Question Q00394

can u advice

our ETO machine was installed inside the cssd stor and we are loading the items inside the store is it correct place? or we must relocate the machine to the packing area

Dear Ahmed,

The location of the sterilizer should follow the manufactures recommendations. Rooms for ETO sterilizers are often inadequate, unless they have been purpose built. As you know ETO gas is odourless, toxic, flammable and explosive and it can be a potential hazard for both health personnel and patients. There are two main considerations:

1. Worker safety: The ideal location is a seperate, large, well ventilated room (according to size of sterilizer) not centrally located in main packing area. In order to minimise the numbers of people exposed. Enviornmental gas monitoring is recommended as are health check-ups for workers.
2. Safety of medical products: This sterilization method is very sensitive to any organic material and numbers of microorganisms present on materials and therefore requires a very clean preparation and sterilizing area. Preconditioning of products and packaging materials is critical, this will also affect your choice. Recommended humidity not less than 30% RH, however on the other hand no water or condensate is to be present on products or in the sterilizer chamber. After sterilization further aeration is needed to remove remaining ETO residuals from materials, for worker and pasient safety. A seperate, well ventilated room for storage or the use of an aeration chamber is recommended.

More information can be found on the subject in the following European standards: EN 1422 1998 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods. EN 550 Sterilization of Medical devices -Validation and routine control of ethylene oxide sterilization. 3M company provide a lot of excellent information on ETO sterilizing. Contact them at: www.mmm.com (world wide offices)

Good luck!
Linda Ashurst, Rikshospitalet, Norway