scope:

This standard provides guidelines for precleaning, leak-testing, cleaning, packaging (where indicated), storage, highlevel disinfecting, and/or sterilizing of flexible gastrointestinal (GI) endoscopes; flexible bronchoscopes; flexible ear, nose, and throat endoscopes; surgical flexible endoscopes (e.g., flexible ureteroscopes); and semi-rigid operative endoscopes (e.g., choledochoscopes) in health care facilities. These guidelines are intended to provide comprehensive information and direction for health care personnel in the processing of these devices and accessories.

NOTE-For purposes of this standard, "health care facilities" means endoscopy centers, hospitals, nursing homes, extended-care facilities, free-standing surgical centers, ambulatory health centers (clinics), medical offices, and all other areas where flexible and semi-rigid endoscopes are processed.

Inclusions

This document specifically addresses

a) functional and physical design criteria for endoscope processing areas;

b) education, training, competency verification, and other personnel considerations;

c) processing recommendations;

d) installation, care, and maintenance of automated processing equipment;

e) quality control; and

f) quality process improvement.

Definitions of terms and a bibliography are also provided in this standard.

Exclusions

This standard does not cover

a) The processing of rigid endoscopes (e.g., arthroscopes, laparoscopes), transesophageal echocardiogram probes (TEE), or vaginal probes (See ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities; ANSI/AAMI ST58, Chemical sterilization and high-level disinfection in health care facilities; and ANSI/AAMI ST41, Ethylene oxide sterilization in health care facilities: Safety and effectiveness).

b) Specific construction and performance criteria for steam sterilizers (see ANSI/AAMI ST8, Hospital steam sterilizers and ANSI/AAMI ST55, Table-top steam sterilizers), ethylene oxide gas sterilizers (see ANSI/AAMI ST24, Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities), rigid sterilization container systems (see ANSI/AAMI ST77, Containment devices for reusable medical device sterilization), or rigid, protective organizing cases that require wrapping before sterilization (see ANSI/AAMI ST77).

c) The use of containment devices for packaging items other than instrument sets or procedural trays.

d) The processing of devices labeled for single use only (see Food and Drug Administration [FDA], 2000c).

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 the bibliography.