Re-evaluating endoscopy-associated infection risk estimates and their implications.

According to the Centers for Disease Control and Prevention (CDC), approximately 11 million gastrointestinal endoscopies are performed annually in the United States.1,2 The 2008 CDC/Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities states that contaminated endoscopes have been linked to more health care-associated infections than any other medical device.3 Paradoxically, several guideline-issuing organizations assert that the risk of endoscopy-associated infection (EAI) is only 1 in 1.8 million procedures.3-6 Recent audits have documented widespread lapses in infection control involving medical equipment.7-11 Inspections of multiple facilities determined that certain endoscopy equipment was not properly reprocessed for up to several years.8,11-15 Direct observation in a multisite study revealed that endoscopes were virtually never reprocessed in accordance with guidelines.7 The implications of these lapses are unknown because no epidemiologic studies have determined the risk of EAI associated with reprocessing quality. Research was conducted to evaluate the origins and accuracy of the risk estimates after a single outbreak involvedmore cases of EAI than would be expected in 1 year nationwide.15,16 This article describes the methodology used to estimate risk and discusses the patient safety implications of relying on the statistics appearing in guidelines.