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P2 for Hospital Sterilizers: Reasons for Change
Table of Contents
Background and Overview
Reasons for Change
P2 Opportunities
Glossary of Terms
Where to Go for P2 Help
Complete List of Links

Essential Links:

Detox Sterilization and Disinfection
PowerPoint about balance between sporicidal, viricidal, and bactericidal effectiveness, human and en...

Fact sheet and information papers about Ethylene Oxide (EtO) Sterilizers
Fact Sheet: Background of regulations concerning EtO. Presents alternatives that can be used. *Note ...

Final Regulation Order: Ethylene Oxide Airborne Toxic Control Measure (ATCM)
Final rule promulgated in 1999 by CARB shows an example of a state law regulating EtO sources over 2...

Infection Control Guidelines
This collection of guidelines pertains to keeping patients and healthcare workers in healthcare sett...

Infectious Diseases in Healthcare Settings
Lists infectious diseases that may be transmitted and/or acquired in healthcare settings and links w...

NIOSH Alert: Preventing Worker Injuries and Deaths from Explosions in Industrial Ethylene Oxide Ster...
Website about Ethylene Oxide including; background, industrial sterilization process, safety, curren...

There is a burgeoning interest in sustainability in the health care community. This movement includes incorporating safer building products, clean air, energy and water efficiency, safe working practices, organic food, and a commitment to public health demonstrated through waste volume and toxicity reduction. Cutting back on the use of hazardous air pollutants, like EtO is one of the ways that hospitals are progressing towards sustainability.

New Area Source Rule for Hospitals Using Ethylene Oxide (EtO)
EPA is currently in the process of generating new clean air regulations for the "area sources." Area sources are those that emit less than 10 tons annually of a single hazardous air pollutant or less than 25 tons or more annually of a combination of hazardous air pollutants. Previously they were not regulated since individually they are small emitters, however together these area sources represent a significant contribution to the emission of many hazardous air pollutants. These sectors will soon be subject to emissions standards as defined under the Clean Air Act.

Hospital sterilizers, (specifically ethylene oxide) is one of the area sources that will be probably be regulated by December 2007. It is estimated that approximately half of all hospitals are still using EtO and so will be subject to the new area source rule. Since many states have already regulated EtO hospital emissions, many hospitals have already faced regulations, however with this rule, others will be regulated for the first time. This proposal requires all hospitals which do not control their emissions of ethylene oxide to reduce emissions by sterilizing full loads to the extent practical. Hospitals which route ethylene oxide to a control device are exempt from the management practice. EPA estimates that the proposed rule would prevent 5 tons per year of ethylene oxide emissions at a cost of less than $2 million per year. For the most current information on the Sterilizer Area Source Rule go to

EtO Health and Safety Effects

Proper sterilization represents a critical interest for all hospitals. An estimated 40,000 to 100,000 deaths occur each year because of nosocomial infections (infections contracted by patients while at the health care facility). The need to control and decrease the number of infections contracted within the health care facility is a primary goal for a hospital. On the other hand, EtO use has its own impact on health and safety, so finding suitable alternatives to control infections while reducing EtO use with less hazardous substances is a worthy goal.

EtO irritates the eyes and skin; it may also irritate mucous membranes and cause a strange taste in the mouth. EtO may cause allergies, adverse reproductive effects, and possibly asthma. At high concentrations, it can cause nausea and vomiting. EtO can be detected by odor only when it has already reached the dangerous concentration of 260 ppm. Olfactory fatigue may limit a person's ability to smell EtO, but perception at concentrations below the odor threshold may occur because of mucous membrane irritation and a peculiar taste in the mouth. In 1984, the Occupational Safety and Health Administration (OSHA) classified EtO as a carcinogen and regulated it as such [29 CFR* 1910.1047]. In 1994, the International Agency for Research on Cancer (IARC) classified EtO as a Group 1 human carcinogen. EtO is also ignitable and there is the potential for explosion even by contact with static electricity, so staff that will be in contact with EtO need to be well trained.

Special Handling Requirements

Because EtO is a hazardous substance, it requires extra monitoring and special handling procedures. Hospitals that have moved away from EtO have found it particularly attractive to not only eliminate the costs of the gas and the ethylene oxide sterilizer but also the requirement to do regular testing for occupational exposure to the EtO gas and capture pollutants. This results in reduced effort per sterilization transaction.

To control the risks of using EtO, hospitals use a combination of scrubbers, combustion units, or gas collection. EtO can only be used in well-ventilated areas and filters need to be monitored and disposed of as dangerous waste. EtO cannot be disposed of down the drain or emitted freely into the air. In many states, hospitals must apply for permits to release limited quantities of EtO, so there may be increased regulatory due diligence required. It is also necessary to do routine checks on EtO cylinders and equipment for leaks, ensure venting to the outside and to return cartridges/cylinders to the supplier. If appropriate alternatives to EtO are selected, many of these handling considerations disappear.

Technical Advantages of Other Sterilization Methods
In addition, other sterilization methods have the following advantages over EtO:

  • Quicker average sterilization time
  • Increased availability of instruments and sterilization process control, which ultimately translates into better infection control
  • Instrument upgrade/replacement costs; some of which would have been necessary regardless of the EtO elimination effort
  • Avoided EtO exposure incidents


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Hub Last Updated: 6/4/2013