Part I: Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy – Purpose

PART I. Purpose

Decades ago, the advent of flexible endoscopy heralded a new era in diagnostic and therapeutic medicine; not only was invasive surgery potentially avoidable, but it surpassed the spectrum of diagnostic and therapeutic options available at the time with rigid bronchoscopes and esophagoscopes. With improvements in technology, the sophistication and capabilities of these electro-mechanical devices have further increased, in turn leading to better tolerated and quicker procedures with less accompanying morbidity and mortality, and more efficient use of resources. At the same time, however, the complexity of the instruments has presented new challenges in reprocessing.

Flexible endoscopes are complex instruments with not only an external surface, but also internal channels (e.g., suction/biopsy, air/water and elevator channels) and accessories that are exposed to body fluids and other contaminants. These expensive instruments must be designed for reuse.  They are difficult to disinfect and easy to damage because of their intricate design, including narrow long lumens, and delicate materials. For this reason, policies and procedures must be in place to ensure appropriate reprocessing of flexible endoscopes before the endoscope is used on subsequent patients. Research on disposable endoscopes is ongoing. There are some bronchoscopes that can be steam sterilized but most flexible endoscopes require low temperatures for disinfection/sterilization.

This document provides guidance for the development of policies and procedures that will eliminate preventable errors in the reprocessing of flexible endoscopes in all healthcare settings where endoscopy is performed. The document emphasizes the essential elements required and methods to be used for the safe handling, transportation and biological decontamination of endoscopes and their reusable accessories. Definitions used are in accordance with the Canadian Standards Association^{Footnote 11} and the Public Health Agency of Canada Infection Prevention and Control Guidelines^{Footnote 12 Footnote 13}.

Robust evidence upon which to formulate these guidelines is scarce as data from randomized trials are lacking or only preliminary results from clinical trials are available. Thus, these guidelines largely reflect the efforts of organizations and societies within Canada, Britain and the USA that have previously published guidelines on reprocessing flexible endoscopes^{Footnote 1 Footnote 3 Footnote 4 Footnote 5 Footnote 6 Footnote 7 Footnote 8 Footnote 9} , new literature, and current published opinions from experts in the field. The appendices of this document provide examples of audit tools for verification of staff training and competency, cleaning, disinfection, and safe storage of the equipment, and can be adapted for use as required.

Most reported cases of cross-transmission of infection related to endoscopy have identified breaches in proper instrument processing or use of defective equipment. It is therefore essential that all healthcare settings where endoscopy is performed have appropriate guidelines in place for endoscope reprocessing and handling. Adherence to these guidelines should minimize the potential for transmission of infection associated with use of the instrument.