scope:

This standard provides guidelines for point of use treatment, transporting, leak testing (where indicated), cleaning, packaging (where indicated), high-level disinfecting and/or sterilizing, storage, and quality control procedures of flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, flexible ear, nose, and throat endoscopes, flexible urology endoscopes, and other types of reusable flexible endoscopes used in procedural and surgical settings, and semi-rigid operative endoscopes (e.g., choledochoscopes) used in health care facilities. These guidelines are intended to provide comprehensive information and direction for health care personnel in the processing of these reusable devices and accessories to render them safe for patient use.

NOTE For purposes of this standard, "health care facilities" include, but are not limited to, hospitals, ambulatory surgery facilities, physicians' offices, cardiac catheterization laboratories, endoscopy suites and centers, respiratory therapy clinics, urology clinics, and other areas where reusable medical devices are processed, stored, and used.

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) care and inspection of endoscopes;

e) maintenance of processing equipment;

f) facility risk management considerations;

g) quality control;

h) quality process improvement.

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

Exclusions

This standard does not cover:

a) the processing of rigid endoscopes (see ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities [17]; ANSI/AAMI ST58, Chemical sterilization and high-level disinfection in health care facilities [14]; and ANSI/AAMI ST41, Ethylene oxide sterilization in health care facilities: Safety and effectiveness) [12];

b) the processing of transesophageal echocardiogram (TEE) probes, or endocavity ultrasound probes;

c) specific construction and performance criteria for steam sterilizers (see ANSI/AAMI ST8, Hospital steam sterilizers [10], and ANSI/AAMI ST55, Table-top steam sterilizers) [13], 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) [11], rigid sterilization container systems (see ANSI/AAMI ST77, Containment devices for reusable medical device sterilization) [16], or rigid, protective organizing cases that require wrapping before sterilization (see ANSI/AAMI ST77); or

d) the processing of devices labeled for single use only and not intended to be processed by the healthcare facility prior to use.

NOTE For more information on the subjects excluded from the scope of this standard, and for additional background information on the inclusions, refer to the references listed in the Bibliography.