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What's the requirements for using gas sterilization procedures in a veterinary practice?

Ethylene Oxide (EtO) is not only used to sterilize medical supplies; it is used in other industries like the manufacturing of spices for cooking, so some of these regulations may seem a little odd at first.

Hospitals use gas sterilization methods for items that would be damaged by other procedures. Electrical drills, rubber products, and sharps are commonly exposed to EtO as a sterilization agent in human and veterinary medicine. This method has distinct advantages, but since EtO is a suspected carcinogen, precautions must be maintained.

We have all heard of huge fines levied by OSHA against employers who violate the ethylene oxide standard, but what we don't hear is that most of those fines are a result of the employer trying to circumvent the safety rules for the employees. Although fear of OSHA fines has pre vented many veterinary practices from taking advantage of the unique benefits of gas sterilization, any hospital can meet the safety and regulatory requirements with just a little bit of knowledge, money and time.

H.W. Andersen Products is the profession's leading manufacturer and supplier of gas sterilizing equipment. They manufacture and distribute pre-measured, easily used ampules of EtO that are perfect for the average veterinary hospital. Andersen also gives practical advice on installation and operation of their sterilizers designed to meet OSHA's standards.

In the past some hospitals have obtained EtO in large compressed gas containers (similar to the ones used for oxygen) instead of the single-use ampules. These containers have a concentration of only 12% EtO and 88% Fluorocarbons. Because of environmental concerns with using fluorocarbons, this mixture is no longer readily available to the veterinary profession. Use of existing supplies of the 88/12 mixture may be a violation of federal and state laws and is not recommended. Any hospital with a supply of the 88/12 mixture should contact the state Environmental Protection Agency for disposal instructions.

Perhaps the most direct advice that can be given is, "If you're going to gas sterilize materials, invest in the proper equipment and training so that you can do it right."

It must be in writing!

Current OSHA standards require hospitals who use EtO to develop a comprehensive written plan for the safe handling, storage and use of the agent if there is a chance that workers may be exposed to concentrations at or above the Permissible Exposure Level (PEL). At a minimum, the hospital's plan must include the following elements:

• Designation of an appropriate location for storage and use of the agent.
• An acceptable sterilizer for performing the procedure.
• Initial monitoring of exposure levels and periodic monitoring if the levels are above the allow able limits.
• Appropriate employee training, including written hospital-specific instructions for performing the procedure.
• Detailed emergency procedures for accidents involving release of EtO gas into the workplace (e.g., accidental breakage of ampules, etc.)

Click here to see a sample Ethylene Oxide Plan

 More on Ethylene Oxide

The information on these pages is excerpted from
The Complete Veterinary Practice Regulatory Compliance Manual (5th Edition)  by Philip J. Seibert, Jr., CVT,
Copyright 2003 Philip J. Seibert, Jr., CVT  All Rights Reserved
No part of this publication may be reproduced for distribution without prior permission from the publisher