Strategies for Disinfection and Sterilization of Endoscopes: The Gap between Basic Principles and Actual Practice

Abstract

In this issue of Infection Control and Hospital Epidemiology, Drs. William Rutala and Geoffrey Gorse and their co-workers report results of their surveys in North Carolina and the United States, respectively, on methods used to clean and disinfect or sterilize flexible fiberoptic endoscopes and other medical devices.1,2 Both surveys showed a wide variety of practices and procedures for reprocessing medical instruments that require, at the very least, high-level disinfection. Under ideal circumstances, some of the medical devices discussed (e.g., "critical" instruments such as laparoscopes, arthroscopes, and biopsy forceps) should be sterilized between uses. A substantial proportion of these practices, however, even when high-level disinfection is the chosen method of reprocessing, is not consistent with current recommendations of the infection control community. This editorial comments on some of the implications of these two surveys regarding the potential for infection transmission in hospital settings. In the United States, disinfection and sterilization procedures for medical devices are influenced by a number of organizations. The Environmental Protection Agency (EPA) regulates chemical germicides formulated as disinfectants or sterilants and approves claims made on the labels of these products. The Food and Drug Administration (FDA) regulates medical devices and approves the label claims regarding the use, safety, and efficacy of the devices; the FDA also approves sterilants or disinfectants recommended by the manufacturer for use in the operation or reprocessing of the devices. The Centers for Disease Control (CDC) publishes guidelines on strategies for disinfection and sterilization of medical devices, and professional organizations, such as the Association for Practitioners in Infection Control, recommend similar strategies and procedures. Almost 30 years ago, Dr. Earl Spaulding proposed that medical devices could be grouped according to risk of infection during their use. He also recommended generic categories of chemical germicides based on germicidal potency that should be used on the different categories of medical devices. Briefly, devices that penetrate skin during use (e.g., surgical instruments) should be sterilized between uses; devices that touch mucous membranes during use (e.g., flexible endoscopes and anesthesia breathing circuits) should either be sterilized or, at a minimum, receive high-level disinfection; and devices that only touch intact skin (e.g., blood pressure cuffs and stethoscopes) should be disinfected with intermediate or low-level germicides or simply cleaned with soap and water, depending on the device and the degree of contamination. In the context of these categorizations, Spaulding not only defined the terms "sterilization" and "highlevel disinfection," but also characterized attributes of the "sterilants" and "high-level disinfectants." These concepts have been accepted widely by the infection control community and have been incorporated into the guidelines of CDC as well as many medical specialty organizations. Sterilization is defined as a