Safely reprocessing duodenoscopes: current evidence and future directions

Rubin, Zachary; Kim, Stephen; Thaker, Adarsh M.; Muthusamy, V. Raman

doi:10.1016/s2468-1253(18)30122-5

Cited by 43 publications

(73 citation statements)

References 57 publications

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“…Seventeen cases in the USA and six in other countries (primarily Europe) associating infections (and colonizations) of CRE or a related MDRO with exposure to a duodenoscope were reviewed, and are listed in tables 1 and 2, respectively. (These tables use a format similar to that provided in other reports 8 21 22…”

Section: Resultsmentioning

confidence: 99%

Use of ethylene-oxide gas sterilisation to terminate multidrug-resistant bacterial outbreaks linked to duodenoscopes

Muscarella¹

2019

BMJ Open Gastroenterol

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BackgroundCleaning and high-level disinfection have been the standard in the USA and other countries for reprocessing flexible endoscopes, including duodenoscopes and other types of gastrointestinal endoscopes. For decades, this practice has been a cornerstone for infection prevention in the endoscopic setting. However, amid recent reports associating the use of duodenoscopes with infections and outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) and related multidrug-resistant organisms (MDROs), reasonable questions about the adequacy of current practices for reprocessing duodenoscopes have emerged.ObjectivesTo review and evaluate the adequacy of current reprocessing practices for preventing duodenoscopes from transmitting CRE and related MDROs.MethodsThe MEDLINE/PubMed database was searched to identify published cases associating confirmed (or suspected) infections of CRE or a related MDRO with exposure to a duodenoscope since 2012, when duodenoscopes became a recognised risk factor for the transmission of CRE. The Internet was also searched to identify news articles and other reports documenting eligible cases occurring during this same timeframe but not identified during the MEDLINE database’s search. The Food and Drug Administration’s (FDA) medical device database was queried to identify regulatory reports describing these same types of cases, also recorded since 2012. The clinical and reprocessing details of each eligible case were reviewed to identify (when possible): (a) the reprocessing method (e.g., high-level disinfection) performed at the time of the infections, (b) whether the facility’s compliance with the manufacturer’s reprocessing instructions was confirmed, and (c) the measure(s) or corrective action(s) the facility implemented to prevent additional multidrug-resistant infections.ResultsSeventeen cases in the USA and six in other countries (primarily Europe) associating infections (and colonizations) of CRE or a related MDRO with exposure to a duodenoscope were reviewed. Fourteen of these 23 outbreaks were caused by CRE, and six by a related MDRO. Two of these six latter cases identified Klebsiella pneumoniae carrying the mcr-1 gene as the pathogen. For 12 of these 23 cases, it was reported or implied that the duodenoscope was being high-level disinfected at the time of the infections, consistent with published guidelines. For the remaining 11 cases, the associated report(s) did not clearly identify how the duodenoscope was being reprocessed at the time of the infections (although it may be reasonably concluded that at least some, if not all, of these 11 cases involved high-level disinfection).Further, eight of the 23 cases reported the duodenoscope was being reprocessed in accordance with the manufacturer’s instructions for use (and professional guidelines) at the time of the infections. Seven of the cases discussed the design of the duodenoscope (eg, the forceps elevator mechanism) in the context of reprocessing and the infections. Three of the cases identified one or more reprocessing lapses, including inadequate cleaning, delayed reprocessing and improper drying and/or storage of the duodenoscope. Most of these 23 cases were associated with exposure to a duodenoscope model featuring a sealed elevator-wire channel. Six of the cases reported adopting (or in one case supplementing high-level disinfection with) ethylene oxide (EO) gas sterilisation of the duodenoscope, with at least three reporting this measure terminated the outbreak. Other measures adopted to prevent additional infections included removing the implicated duodenoscope from use, re-training staff about proper cleaning, microbiological culturing of the duodenoscope and returning the duodenoscope to the manufacturer for evaluation, maintenance and/or repair.ConclusionsThis study's findings suggest current reprocessing practices may not always be sufficiently effective to prevent a duodenoscope from transmitting CRE and related MDROs, at least in some circumstances including an outbreak setting. Factors this review identifed that may contribute to the device remaining contaminated after reprocessing include the device’s design; breaches of recommended reprocessing guidelines (eg, inadequate manual cleaning, delayed reprocessing or improper device storage); damage to the device; lacking servicing, maintenance or repair; and/or the presence of biofilms. Measures that can mitigate the impact of these and other reprocessing challenges and reduce, if not eliminate, the risk of transmission of CRE or a related MDRO by a duodenoscope include the use of EO gas sterilization (or another comparably effective process or method). In 2015, the FDA suggested healthcare facilities consider performing at least one of four supplemental measures, which include EO gas sterilisation, to improve the effectiveness of duodenoscope reprocessing. Whether the FDA and Centers for Disease Control and Prevention might reclassify duodenoscopes as critical devices requiring sterilisation is currently unresolved.

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Section: Resultsmentioning

confidence: 99%

Use of ethylene-oxide gas sterilisation to terminate multidrug-resistant bacterial outbreaks linked to duodenoscopes

Muscarella¹

2019

BMJ Open Gastroenterol

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“…The former includes the use of ATP and bioburden testing for point-of-care testing for contamination to measure the performance of manual cleaning [4,19,20]. However, this method shows a poor correlation with cultures of fully reprocessed devices [4] and requires extra work, particularly in a high-volume unit. The microbiological culture of endoscopes is critical to understanding the e cacy of reprocessing and transmission of microorganisms during outbreak investigations [8,17,18,[21][22][23].…”

Section: Discussionmentioning

confidence: 99%

“…Failure of reprocessing can result in the transmission of pathogens. Endoscopy-associated infection has become an important issue since the outbreak of carbapenem-resistant Enterobacteriaceae (CRE) infection after endoscopic retrograde cholangiopancreatography in the USA between 2012 and 2015 [4]. These outbreaks resulted in efforts to investigate the quality and e cacy of endoscope reprocessing, as well as factors that in uence transmission between endoscopes and patients [2,5,6].…”

Section: Introductionmentioning

confidence: 99%

Monthly endoscopy surveillance culture facilitates detection of breaches in the scope reprocessing procedure: 5 year-experience in an endoscopy center

Yen

Chen

Lai

et al. 2019

Preprint

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AIM To review the clinical impact of monthly microbiology surveillance culture for monitoring endoscope contamination after high-level disinfection.METHODS Monthly surveillance culture of the endoscopes was conducted from January 2014 to December 2018 at our endoscopy center. A total of 1931 cultures were collected, including 765 cultures from 16 gastroscopes, 730 cultures from 18 colonoscopes, 379 cultures from 8 duodenalscopes, 46 cultures from 1 echoscopes, and 11 cultures from 1 enterscope. Cultures were obtained from ready-to-use endoscopes after a full reprocessing cycle and storage. Samples were cultured to test for aerobic and anaerobic bacteria.RESULTS The positive culture rates for the endoscope were 2% (15/765) for gastroscopes, 1.9% (14/730) for colonoscopes, 0.8% (3/379) for duodenscopes, 4.3% (2/46) for echoscopes, and 9.1% (1/11) for enterscopes. These findings were predominantly attributed to human factors (71.4%, 25/35) followed by storage cabinet failure (14.3%, 5/35), automatic endoscope reprocessing failure (11.4%, 4/35), and endoscope channel damage (2.8%, 1/35). Multivariate analysis showed that the years 2015 [odds ratio (OR) 0.19, 0.04 to 0.91], 2016 (OR 0.21, 0.05 to 0.80), and 2017 (OR 0.22, 0.06 to 0.83) were associated with decreased risk of endoscope contamination. The age, type, and number of times the scope was used were not related to contamination.CONCLUSIONS A low risk of endoscope contamination was found over a 5-year period in our endoscopy center. The most common cause of contamination was human factor. Duodenalscopes showed the lowest scope contamination rate. We suggested the implantation of a systematic endoscope culture regardless of the type of scope to facilitate early detection of breaches in the scope reprocessing procedure in clinical practice.

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“…Over the past decade, numerous outbreaks of carbapenemresistant enterobacteriaceae infections transmitted via duodenoscopes have been reported worldwide [1]. These outbreaks have identified a variety of potential etiologies for infection transmission, but a primary culprit has been the complexity of the elevator mechanism of duodenoscopes and the challenges of cleaning this element of the scope [2].…”

mentioning

confidence: 99%

Detachable distal cap duodenoscopes: a step in the right direction?

Muthusamy

2020

Endoscopy

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Safely reprocessing duodenoscopes: current evidence and future directions

Cited by 43 publications

References 57 publications

Use of ethylene-oxide gas sterilisation to terminate multidrug-resistant bacterial outbreaks linked to duodenoscopes

Use of ethylene-oxide gas sterilisation to terminate multidrug-resistant bacterial outbreaks linked to duodenoscopes

Monthly endoscopy surveillance culture facilitates detection of breaches in the scope reprocessing procedure: 5 year-experience in an endoscopy center

Detachable distal cap duodenoscopes: a step in the right direction?

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