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Introductions Dr. Atul Mehta, Professor of Medicine at Lerner College of Medicine is a staff physician at the Cleveland Clinic’s Department of Pulmonary Medicine of Respiratory Institute. He also holds the first Buoncore Family Endowed Chair in Lung Transplantation. Dr. Mehta is founder and president Atul Mehta, M.D. of the American Association for Bronchology, and is Senior Editor of The Journal of Bronchology and Interventional Pulmonology
Introductions Founder of LFM Healthcare Solutions LLC, Lawrence F. Muscarella, PhD , has authored more than 200 articles on the topics of disinfection, sterilization, instrument reprocessing, risk management, and both the causes and prevention of healthcare-associated infections (HAIs). His current research focuses on infection transmission during bronchoscopy, gastrointestinal endoscopy, and open-heart-surgery. Lawrence F Dr. Muscarella’s articles have been published in: The Muscarella, PhD American Journal of Infection Control, Gastrointestinal Endoscopy, Chest, Endoscopy, Infection Control and Hospital Epidemiology, The Journal of Hospital Infection, and the World Journal of Clinical Infectious Diseases, among others. In 2013, he founded the blog, “Discussions in Infection Control.”
Bronchoscope Cross-Contamination Is it a real issue? • True entity yet, under recognized. • Physicians play an important role in prevention
Agenda In this hour we will cover: • Recent published outbreaks involving bronchoscopes • Trends involving contaminated bronchoscopes • Risk factors for disease transmission • Recommendations to prevent bronchoscope infections • The most relevant guidelines • Which prevention measures are most important for M.D.s • Why bronchoscope related infection is under recognized • How to identify / evaluate Epidemics & Pseudo-epidemics • Q&A
Recent Published Outbreaks • Contaminated flexible endoscopes are associated with more healthcare – associated infections than any other medical device. • Bronchoscopes and gastrointestinal (GI) endoscopes are examples. • For example, we learned last year that several U.S. hospitals since 2012 had linked deadly “superbug” outbreaks to contaminated duodenoscopes. • Duodenoscopes feature a complex forceps elevator mechanism and recessed areas that are difficult to clean, according to the FDA.
Recent Published Outbreaks • These U.S. hospitals include: • Pasadena’s Huntington Memorial Hospital, which in 2015 linked a deadly outbreak of antibiotic-resistant Pseudomonas aeruginosa – a type of “superbug” -- to contaminated Olympus duodenoscopes • Philadelphia's Fox Chase Cancer Center, which in 2015 linked 3 patients infected with carbapenem-resistant Klebsiella pneumoniae – also “CRE” -- to a contaminated FujiFilm duodenoscope • Illinois’s Advocate Lutheran General Hospital, which in 2013 linked a deadly outbreak of carbapenem-resistant E. coli – or, “CRE” -- to contaminated Pentax duodenoscopes Image credit: CDC/ Melissa Dankel Plates have antibiotic disks (small white circles). Plate on the left contains bacteria that is susceptible to antibiotics and can not grow near discs. Plate on right contains CRE.
Recent Published Outbreaks • But these types of outbreaks are not limited to duodenoscopes. • Contaminated bronchoscopes have also been linked to “superbug” outbreaks. • To identify some recent outbreaks, I reviewed: • the peer-reviewed medical literature; • news reports; and • the FDA’s medical device (“MAUDE”) database . • While peer- reviewed studies are more scientific, the FDA’s MAUDE database provides more timely data.
Recent Published Outbreaks • My review identified a number of peer-reviewed reports linking contaminated bronchoscopes to superbug outbreaks. • Zweiger et al. (2014)* reported that 8 patients were infected with CRE following bronchoscopy (in Germany). • Two bronchoscopes tested “ + ” for the superbug. • Defects in the internal surfaces of the two bronchoscopes’ working channels were found. • These bronchoscopes reportedly transmitted the CRE despite their being reprocessing as recommended by their manufacturer. Scanning electron micrographs of a suction channel showing surface defects such as cracks, grooves and pits. 1 * Zweiger J, et al. Am J Infect Control 2014;42:935-40. [Letter] Pajkos, et al. Journal of Hospital Infection
Recent Published Outbreaks • Almost 15 years earlier, Sorin et al. (2001)* reported that 18 patients tested “+” for imipenem -resistant P . aeruginosa. • While not CRE, these bacteria are a related superbug because they’re also resistant to carbapenems - the “last resort” antibiotic. This may be the 1 st reported case in the U.S. of a bronchoscope • infecting patients with carbapenem-resistant Pseudomonas . • The CDC published a report about this outbreak in MMWR .** • This outbreak was caused by the improper connection of the bronchoscope to the automated endoscope reprocessor , or “AER”. * Sorin M, et al. Infect Control Hosp Epidemiol 2001; 22: 409-413. ** Centers for Disease Control and Prevention (CDC). MMWR July 09, 1999;48(26);557-560.
Recent Published Outbreaks • Other peer-reviewed reports describe bronchoscopes infecting patients with: • Stenotrophomonas maltophilia: The cause? → a bronchoscope’s contaminated suction valves* • Serratia marcescens: The cause? → A loose, contaminated biopsy port caused by a manufacturing defect** (the bronchoscope was recalled) • Atypical mycobacteria: The cause? → Contaminated rinse water • Mycobacterium tuberculosis: The causes? → (A) Use of an AER not designed for the hospital’s bronchoscope; *** (B) A defective bronchoscope (that was recalled); and (C) an undetected leak, due to not performing a leak test.**** * Guy M, et al. Euro Surveill 2016 Jul 14;21(28). ** Kirschke DL, et al. N Engl J Med 2003 Jan 16; 348(3):214-20. *** Larson JL, et al. Infect Control Hosp Epidemiol 2003 Nov;24(11):825-30. **** Ramsey AH, et al. Chest 2002 Mar;121(3):976-81.
News Reports of Outbreaks • Last June, a news source reported that a nurse had filed a lawsuit alleging that an Ohio hospital had linked bronchoscopes to an outbreak of multidrug-resistant bacteria. • More than 24 patients were infected in 2015, the suit alleges. • The bronchoscopes remained contaminated despite being cleaned and disinfected a ccording to the device’s labeling, the suite also claims. • I identified the specific medical device report (MDR) that the bronchoscope manufacturer filed with the FDA recording this outbreak. • The MDR states the hospital began using ethylene oxide (EtO) gas to sterilize potentially contaminated bronchoscopes. • The cause of this outbreak is unclear at this time. Image : Stenotrophomonas maltophilia . CDC/ Dr. William A. Clark
FDA MAUDE database • I also reviewed the FDA’s MAUDE database to identify recent outbreaks linked to contaminated bronchoscopes. • On June 24 2016, a hospital informed the FDA that an “ EBUS ”* bronchoscope may have infected patients with Enterobacter bacteria. • The bronchoscope tested “ + ” for this bacteria despite being cleaned and disinfected according to the device’s labeling. • If resistant to carbapenems, these bacteria are CRE. • At least two patients were infected, one died. • The hospital reported that the complex design of EBUS bronchoscopes is a risk factor for infection, just like duodenoscopes. * “EBUS” refers to endobronchial ultrasound.
FDA MAUDE database • Four months earlier, in February 2016, a manufacturer filed a report notifying the FDA that 13 patients may have been infected (in 2008) with multidrug- resistant Pseudomonas and Stenotrophomonas during bronchoscopy. • The hospital reported that the bronchoscope’s biopsy port was loose and could be twisted off and removed. • A third party repair company had replaced the bronchoscope’s biopsy channel a year earlier. • The repair company used “ non-OEM ”* parts to repair the bronchoscope. (Continued) * “OEM” refers to the original equipment manufacturer (e.g., Olympus).
FDA MAUDE database • Further, the manufacturer reported that the hospital: didn’t pre -clean the bronchoscope at bedside x didn’t immediately clean and disinfect the bronchoscope after use x didn’t properly leak test the bronchoscope x didn’t suction detergent through the bronchoscope’s suction channel x during manual cleaning (performed in the reprocessing room), and didn’t rinse the bronchoscope with clean water to remove detergent after x washing it.
FDA MAUDE database • A year earlier, in December 2014, a manufacturer notified the FDA that 14 patients had tested “ + ” for CRE following bronchoscopy. • The bronchoscopes tested “ + ” for this superbug despite being reprocessed per the manufacturer’s instructions (as others have similarly reported). • The bronchoscopes had been repaired by a third party company. • The cause of these possible infections is unclear. • This report appears to be the first MAUDE report linking a contaminated bronchoscope to a CRE outbreak.
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