A double-reprocessing high-level disinfection protocol does not eliminate positive cultures from the elevators of duodenoscopes

Abstract

Background and study aim Duodenoscopes have been the source of serious infection, despite correct performance of high-level disinfection (HLD). This study aimed to observe the impact of performing HLD twice on the rate of positive cultures from duodenoscope elevators.

Methods We performed double HLD (DHLD; i. e. complete manual cleaning followed by automated reprocessing, with the entire process repeated) and then randomly cultured the elevators of our duodenoscopes on about 30 % of occasions.

Results DHLD was associated with positive elevator cultures for any microorganism in 9.4 % of cases, with a 0.8 % rate of known pathogens (627 cultures) between May 2015 and February 2016. After February 2016, and in association with changing the precleaning fluid, as well as use of a new FDA-recommended cleaning brush, the rate of positive cultures for any microorganism after DHLD was 4.8 % and 0.2 % for known pathogens (420 cultures). In a third phase, characterized by a change in personnel performing DHLD and retirement of a duodenoscope with a high rate of positive cultures, the rate of positive cultures for any microorganism was 4.9 % (783 cultures) and the rate of positive culture for known pathogens was 0.3 %. To our knowledge, no duodenoscope transmission of infection occurred during the study interval.

Conclusions DHLD resulted in a low rate of positive cultures for known pathogens and for organisms of low pathogenic potential, but did not eliminate these, from duodenoscope elevators. Additional improvements in HLD protocols and/or duodenoscope design are needed.

• References

• 1 Classen DC, Jacobson JA, Burke JP. et al. Serious Pseudomonas infections associated with endoscopic retrograde cholangiopancreatography. Am J Med 1988; 84: 590-596
• 2 Earnshaw JJ, Clark AW, Thom BT. Outbreak of Pseudomonas aeruginosa following endoscopic retrograde cholangiopancreatography. J Hosp Infect 1985; 6: 95-97
• 3 Kovaleva J, Peters FT, van der Mei HC. et al. Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol Rev 2013; 26: 231-254
• 4 Low DE, Micflikier AB, Kennedy JK. et al. Infectious complications of endoscopic retrograde cholangiopancreatography. A prospective assessment. Arch Intern Med 1980; 140: 1076-1077
• 5 Seoane-Vazquez E, Rodriguez-Monguio R, Visaria J. et al. Exogenous endoscopy-related infections, pseudo-infections, and toxic reactions: clinical and economic burden. Curr Med Res Opin 2006; 22: 2007-2021
• 6 Struelens MJ, Rost F, Deplano A. et al. Pseudomonas aeruginosa and Enterobacteriaceae bacteremia after biliary endoscopy: an outbreak investigation using DNA macrorestriction analysis. Am J Gastroenterol 1993; 95: 489-498
• 7 Allen JI, Allen MO, Olson MM. et al. Pseudomonas infection of the biliary system resulting from use of a contaminated endoscope. Gastroenterology 1987; 92: 759-763
• 8 Schousboe M, Carter A, Sheppard PS. Endoscopic retrograde cholangio-pancreatography: related nosocomial infections. N Z Med J 1980; 92: 275-277
• 9 Alrabaa SF, Nguyen P, Sanderson R. et al. Early identification and control of carbapenemase-producing Klebsiella pneumoniae, originating from contaminated endoscopic equipment. Am J Infect Control 2013; 41: 562-564
• 10 Aumeran C, Poincloux L, Souweine B. et al. Multidrug-resistant Klebsiella pneumoniae outbreak after endoscopic retrograde cholangiopancreatography. Endoscopy 2010; 42: 895-899
• 11 Carbonne A, Thiolet JM, Fournier S. et al. Control of a multi-hospital outbreak of KPC-producing Klebsiella pneumoniae type 2 in France, September to October 2009. Euro Surveill 2010; 15
• 12 Gastmeier P, Vonberg RP. Klebsiella spp. in endoscopy-associated infections: we may only be seeing the tip of the iceberg. Infection 2014; 42: 15-21
• 13 Epstein L, Hunter JC, Arwady MA. et al. New Delhi metallo-beta-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes. JAMA 2014; 312: 1447-1455
• 14 US FDA. Infections associated with reprocessed duodenoscopes. 2015 Available from: https://wayback.archive-it.org/7993/20161022055601/http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/ucm454630.htm [Accessed: 19 October 2017]
• 15 US FDA. Endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes: FDA Safety Communication – Design may impede effective cleaning. 2015 Available from: https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm434922.htm [Accessed: 19 October 2017]
• 16 US FDA. Olympus validates new reprocessing instructions for model TJF-Q180V duodenoscopes: FDA Safety Communication. 2015 Available from: https://wayback.archive-it.org/7993/20161022044047/http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm439999.htm [Accessed: 19 October 2017]
• 17 CDC. Interim Duodenoscope Surveillance Protocol. 2015 Available from: https://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html [Accessed: 19 October 2017]
• 18 Guh AY, Bulens SN, Mu Y. et al. Epidemiology of carbapenem-resistant Enterobacteriaceae in 7 US Communities, 2012–2013. JAMA 2015; 314: 1479-1487
• 19 Patel G, Huprikar S, Factor SH. et al. Outcomes of carbapenem-resistant Klebsiella pneumoniae infection and the impact of antimicrobial and adjunctive therapies. Infect Control Hosp Epidemiol 2008; 29: 1099-1106
• 20 US FDA. Duodenoscope reprocessing: FDA Safety Communication - Supplemental measures to enhance reprocessing. 2015 Available from: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm457132.htm [Accessed: 19 October 2017]
• 21 Petersen BT, Cohen J, Hambrick 3rd RD. et al. Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update. Gastrointest Endosc DOI: 10.1016/j.gie.2016.10.002.
• 22 Smith ZL, Oh YS, Saeian K. et al. Transmission of carbapenem-resistant Enterobacteriaceae during ERCP: time to revisit the current reprocessing guidelines. Gastrointest Endosc 2015; 81: 1041-1045
• 23 Ross AS, Baliga C, Verma P. et al. A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli . Gastrointest Endosc 2015; 82: 477-483
• 24 Humphries RM, McDonnell G. Superbugs on duodenoscopes: the challenge of cleaning and disinfection of reusable devices. J Clin Microbiol 2015; 53: 3118-3125
• 25 Haney PE, Raymond BA, Lewis LC. Ethylene oxide. An occupational health hazard for hospital workers. AORN J 2015; 51: 480-481 , 483, 485–486
• 26 ASGE Quality Assurance in Endoscopy Committee, Petersen BT, Chennat J et al. Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011. Gastrointest Endosc 2011; 73: 1075-1084
• 27 ASGE Technology Committee, Varadarajulu S, Banerjee S et al. GI endoscopes. Gastrointest Endosc 2011; 74: 1-6 e6
• 28 Brandabur JJ, Leggett JE, Wang L. et al. Surveillance of guideline practices for duodenoscope and linear echoendoscope reprocessing in a large healthcare system. Gastrointest Endosc 2016; 84: 392-399
• 29 Almario CV, May FP, Shaheen NJ. et al. Cost utility of competing strategies to prevent endoscopic transmission of carbapenem-resistant Enterobacteriaceae . American J Gastroenterol 2015; 110: 1666-1674