Other considerations: Perspective and obligations of our societies and governmental organizations

Abstract

Recurrent episodes of transmitted infection during gastrointestinal endoscopy have resulted in heightened visibility of the various organizations providing education, guidance, and regulatory oversight for endoscopes and the practice of endoscopy. They include the Food and Drug Administration, the Centers for Disease Control and Prevention, state health departments, accrediting organizations, and national medical societies representing practitioners and nurses. The Food and Drug Administration is responsible for ensuring the safety of manufacturer's products, without constraining the availability of critical medical services, such as gastrointestinal endoscopy. Their ongoing oversight of postmarket surveillance studies, and the results of such studies, will significantly influence the expectations for reprocessing in years to come. As a nonregulatory body, the Centers for Disease Control and Prevention primarily provides investigational expertise pertaining to infectious outbreaks and guidance to the medical industry regarding best practices, with input from the medical experts in their Hospital Infection Control and Professional Advisory Committee. National societies of nurses, reprocessing professionals, and physicians all provide education and guidance to the field, each with viewpoints ostensibly protective of patients and their membership. The Association for the Advancement of Medical Instrumentation, which publishes standards detailing the proper production quality for medical instruments and the procedures in which they are used, is in the midst of rewriting their guidance for reprocessing of gastrointestinal endoscopes. Despite reservations about process, Advancement of Medical Instrumentation deliberations emphasize the original guidance of the Spaulding Criteria for sterilization of semicritical devices, including endoscopes, when feasible and practicable. This is likely the future state for reprocessing in gastrointestinal endoscopy.