Estimating the Rate of Infections Requiring Hospitalization after Endoscopy

Johns Hopkins University, Baltimore MD

Investigators

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Abstract

Project Summary (Abstract): On February 19th, 2015, the Food & Drug Administration (FDA) published a Safety Communication warning that from January 2013 to December 2014 the FDA received 75 Medical Device Reports for health-risk issues encompassing approximately 135 patients in the United States relating to possible transmission of multi-drug resistant organisms (MDR) from duodenoscopes used during endoscopic retrograde cholangiopancreatography (ERCP). This warning prompted concern throughout the endoscopy community to assess if their endoscopes were cleaned in compliance with the manufacturer guidelines to prevent transmission of infections. This also prompted patients to question if it was safe for them to undergo endoscopy and desire to know their risk of developing an infection. This proposal aims to examine the rate of infection requiring hospitalization after the most commonly performed endoscopic procedures: ERCP, endoscopic ultrasound, upper endoscopy (also known as EGD) and colonoscopy. Rates of infection will be assessed in states with linkable ambulatory surgery and inpatient data as obtained from the State Ambulatory Surgery and Services Databases and State Inpatient Databases. The three most and least populous states with a revisit indicator allowing linkage of ambulatory surgery with inpatient encounters will be assessed (California, Florida, New York; Vermont, Nebraska, Nevada). Rates of hospital admission for any reason and infectious reasons will be examined according to the origin of the initial endoscopic procedure (inpatient versus outpatient) and indication for procedure (i.e., screening, surveillance or diagnostic procedure, palliative treatment, other). Rates will be examined overall and by the hospital or ambulatory surgical center where the index endoscopy was performed. Assessing variation by endoscopy unit will allow 1) the assessment in the quality and safety of endoscopic procedures, 2) identify endoscopy unit features that are associated with post-procedural infections and 3) will allow us to conduct outbreak analyses to examine if infections requiring hospitalization cluster in time according to the endoscopy unit. The rates of infections after endoscopic procedures can serve as baseline estimates subsequent to the changes in endoscope reprocessing practices that are expected within the coming year in response to the FDA's safety communication in 2015. This information can also serve as the foundation to identify if targeted interventions are needed in the endoscopy unit to prevent the spread of infection, similar to the interventions targeted to surgical and intensive care units to prevent the spread of infectious disease in those settings.