AAMI - ST41
Ethylene oxide sterilization in health care facilities: Safety and effectiveness
|Publication Date:||1 January 2008|
This recommended practice provides guidelines for EO sterilization processing in hospitals and other health care facilities. These guidelines are intended to promote sterility assurance and to assist health care personnel in the proper use of processing equipment. These guidelines also are intended to help ensure the safe use of EO by defining equipment and procedures, including ventilation recommendations and (if applicable) emission controls, to minimize personnel exposure to EO or its residuals.
NOTE-For purposes of this recommended practice, "health care facilities" means hospitals, nursing homes, extended care facilities, freestanding surgical centers, clinics, and medical and dental offices. For convenience, the term "hospital" is sometimes used in this recommended practice; in all instances, this term should be taken to encompass all other health care facilities.
This recommended practice specifically addresses
a) design considerations for EO sterilization processing facilities, including traffic control; location of work areas; general and local exhaust ventilation systems; and storage of equipment, supplies, and EO gas sources;
b) staff qualifications, supervision, training, health, and other personnel considerations;
c) processing recommendations;
d) installation, operation, care, and maintenance of EO
sterilizers, EO sterilizer-aerators,
e) quality control; and
f) environmental and employee health monitoring.
Definitions of terms, a bibliography, and informative annexes also are provided in this recommended practice.
This recommended practice does not cover
a) specific construction and performance criteria for EO sterilizers (see ANSI/AAMI ST24),
b) detailed design criteria for central service departments (see ANSI/AAMI ST79),
c) guidelines for the use of EO sterilizers that release EO or an EO blend inside the package containing the wrapped items to be sterilized, or
d) the reprocessing of devices labeled for single use only.
NOTE-For more information on the subjects excluded from the scope of this recommended practice and for additional background information on the inclusions, refer to the references listed in Annex K.