Dear Sir,

Our Hospital is going for a E.O gas Steriliser. We have been using steam and formaldehyde sterilisers. I would like to know if it is necessary for us to observe any particular caution in the room we want to install the EO gas steriliser.

Should we keep it in a seperate room; should it have a seperate exhaust hood; does FDA have any regulatory stipulation regarding where and how it has to be kept?

Please let me know regarding this, I am particularly interested to know if there is any guideline or stipulation that the EO gas steriliser has to be kept in a seperate room.

Thanks,
Victor McNamara

In the US, The FDA regulates the medical device Mfg and clears the device for commercial distribution (EO Sterilizers are Class II medical devices), not the hospital. OSHA is the Federal agency that regulates employers to insure a safe working environment for the employee. The OSHA regulation requires work area have 1 PPM or less for a time weight average (TWA) of 8 hours when measured at breathing zones. For the short term exposure limit (STEL) it's 5 PPM measured over 15 minutes (TWA). Ventilation is the key and having the EO sterilizers recessed into a wall and a separate room for loading and unloading is also recommended (not regulated). Normal room air exchanges should be at least 10, with the sterilizer recessed room under negative pressures to "pull" into the recessed area. Sterilizers should have in-chamber aeration and method to capture and exhaust air from the sterilizer door and drain via dedicated/nonrecirculating exhaust. When using nonflammable mixture, exhaust ventilation at the tank area is recommended.

Chip Moore
Senior Market Manager
Sterilization Products
Getinge/Castle
Rochester, NY
800 475 9040 x5123
mail to: [email protected]
Visit our Website: www.getingecastle.com

Good day Victor,

The website listed below will take you to the Occupational Safety and Health Administration document 29CFR 1910.1047. About half way into this document, you will find the Section:
VII. STERILANT USE OF ETO IN HOSPITALS AND HEALTH CARE FACILITIES
1. Workplace Design

This should give you specific answers to your questions about EtO venting, placement, etc. relating to hospital settings.
http://www.osha-slc.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10071

Yes, FDA has regulatory oversight of EtO, but I believe this document is the document that can answer your questions.

Regards, Pete Bobb

Dear Victor,

In Belgium it is a legal obligation - in the EEC it is at least "State of the Art" - to place ethylene oxide sterilizers in a separate room. This local has to meet different requirements on the field of ventilation, electrical equipment, detection of gas, etc., to protect employee and environment against the hazards of EtO.

Kind regards,
Wim Renders

p.s.
I just want to add a personal remark. In Belgium all hospitals that renovate their low temperature sterilization equipment are moving towards gasplasma or towards outsourcing EtO sterilization. I join on complete to the answer of Pete Bobb on question Q00111. See also questions Q00139, Q00136, Q00112, Q00089 and Q00079.