Ethylene Oxide Sterilization: Safety and Effectiveness

Abstract

Primarily used with heatand moisture-sensitive medical devices that can not be steam sterilized, ethylene oxide (EO) sterilization can be an effective sterilization process. However, given the toxicity and explosiveness (in the pure form) of ethylene oxide gas, the process must be done with care. To aid in the safe and effective use of ethylene oxide as a sterilant, AAMI will release ANSI/AAMI ST41:2008, Ethylene oxide sterilization in health care facilities: Safety and effectiveness in the coming weeks. This standard is intended to promote sterility assurance, help minimize occupational exposure to EO, and guide healthcare personnel in the proper use of processing equipment. An update of the 1999 document, this revision of ST41 reflects new regulatory and technological developments, especially in regard to new diluents and EO monitoring and emission control. It revises recommendations for qualification testing of EO sterilizers and incorporates relevant information from ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities. To help ensure the safe use of EO, this recommended practice addresses design considerations for EO sterilization processing facilities, such as: • Work area location. It provides rationale for the centralization of EO processing and addresses the importance of containment areas and alarms to protect healthcare workers and patients. • Traffic control. It strongly recommends that personnel not directly involved in the sterilization process be routed away so that items are handled only by trained personnel. • Ventilation systems. It addresses the need to ensure a well-ventilated EO sterilization area, the location of exhaust hoods, environmental discharge controls, and the importance of regularly monitoring the ventilation system. • Storage of equipment and supplies. It recommends that hospital supplies be stored in a manner to reduce the possibility that they absorb residual EO from sterilizer exhaust. • Temperature and humidity. It identifies recommended temperature and humidity ranges to reduce microbial growth. ST41 also provides guidance regarding the care and handling of contaminated reusable items; cleaning and other decontamination processes; packaging and handling of sterilized items; installation, operation, care, and maintenance of EO equipment; and quality control. Since an effective EO sterilization process is contingent on the people involved, ST41 provides guidance on staff qualifications and personnel considerations. It identifies specific skills and experiences that Ethylene Oxide Sterilization: Safety and Effectiveness