Managing and Preventing Exposure Events from Inappropriately Reprocessed Endoscopes

Abstract

Affiliation: 1. Department of Medicine, University of North Carolina at Chapel Hill, North Carolina; and Department of Hospital Epidemiology, UNC Health Care, Chapel Hill, North Carolina. Received March 21, 2012; accepted March 22, 2012; electronically published May 7, 2012. 2012 by The Society for Healthcare Epidemiology of America. All rights reserved. 0899-823X/2012/3307-0002$15.00. DOI: 10.1086/666339 Each year in the United States millions of invasive procedures are performed, including greater than 10,000,000 gastrointestinal endoscopic procedures (Table 1). All invasive procedures involve contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes. A major risk of all such procedures is the introduction of pathogens that can lead to infection. Failure to properly disinfect or sterilize equipment carries not only the risk associated with breach of host barriers but also the risk of personto-person transmission (eg, hepatitis B virus [HBV]) and transmission of environmental pathogens (eg, Pseudomonas aeruginosa). Proper disinfection and sterilization are essential for ensuring that medical and surgical instruments do not transmit pathogens to patients. More than 55 years ago, Spaulding devised a rational approach to disinfection and sterilization of patient care items or equipment. This classification scheme is so clear and logical it has been retained and refined and continues to be used when planning methods for disinfection and sterilization. Spaulding divided medical devices into 3 categories (ie, critical, semicritical, and noncritical) on the basis of the risk of infection involved in the use of the items. Critical devices are items that enter sterile tissue or the vascular system and include surgical instruments, implants, and intravenous or intra-arterial catheters. Items in this category should be purchased as sterile or should be sterilized by steam sterilization (preferred). Semicritical items are those that come into contact with mucous membranes or nonintact skin and include gastrointestinal endoscopes, bronchoscopes, laryngoscope blades and handles, and diaphragm-fitting rings. These medical devices should be free of all microorganisms (ie, mycobacteria, fungi, viruses, and bacteria), although small numbers of bacterial spores may be present. The minimal requirement for semicritical items is high-level disinfection using Food and Drug Administration (FDA)–cleared highlevel chemical disinfectants. Noncritical items are those that come into contact with intact skin but not mucous membranes (eg, bedpans, blood-pressure cuffs, and bed rails). Such items should undergo low-level disinfection after use when shared by different patients. The Spaulding classification provides an excellent guide for disinfection and sterilization of medical devices, but it should be noted that the scheme is an oversimplification, and preventing transmission of infection by medical devices may require additional modifications. Multiple studies in many countries have documented a lack of compliance with established guidelines for disinfection and sterilization. Failure to comply with scientifically based guidelines has led to numerous outbreaks. Preventing and managing potential outbreaks when there is a breach in established methods of disinfection and sterilization is complex, may consume substantial amounts of personnel time and expense, and may lead to legal problems. In this issue of Infection Control and Hospital Epidemiology, Holodniy et al describe the management of 4 potential outbreaks in Veterans Affairs medical centers (VAMCs), all resulting from failure to follow established guidelines for cleaning and disinfecting endoscopes. The breaches in disinfection led to 9,879 patients being tested in look-back programs for possible acquisition of human immunodeficiency virus (HIV), HBV, and hepatitis C virus (HCV). This excellent article raises a number of important issues. First, what is the frequency of outbreaks and pseudo-outbreaks related to endoscopy? The incidence of infection associated with endoscopy has been reported to be very low (about 1 case per 1.8 million procedures). However, as noted by Holodniy and colleagues, this number may be an underestimate because outbreaks may be unrecognized or never reported. The prolonged incubation period of the key bloodborne viruses (ie, HIV, HBV, and HCV) and the fact that initial infection may be asymptomatic would make detection of an infection from an endoscopic procedure difficult. Fur-