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Original article Clinical endoscopy: Editorial| Volume 88, ISSUE 2, P314-315, August 2018

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Duodenoscope-related and echoendoscope-related infections: Is “never” possible?

      Abbreviations:

      HLD (high-level disinfection), NQF (National Quality Forum)
      In 1999, the term “never event” was introduced by the National Quality Forum (NQF) to refer to particularly egregious and entirely preventable errors such as wrong-site surgery.

      Serious reportable events. Available at: http://www.qualityforum.org/topics/sres/serious_reportable_events.aspx. Accessed March 2, 2018.

      The NQF more recently transitioned toward using the slightly more flexible term “serious reportable events” to describe events that are “unambiguous, usually preventable, serious,” “indicative of a problem in a health care facility's safety systems,” and/or “important for public credibility or…accountability.”
      • Kizer K.W.
      • Stegun M.B.
      Serious reportable adverse events in health care.
      The widely reported duodenoscope-related outbreaks in the past several years, which have been associated with equipment from all 3 major endoscope manufacturers, meet the NQF criteria for “serious reportable events.”
      Unlike typical narratives of medical device–associated infectious outbreaks, which have been attributed to identifiable breaches in infection control practices such as reuse of needles and syringes, or improper endoscope cleaning, the reports of duodenoscope-related outbreaks occurred in settings where industry-standard high-level disinfection (HLD) practices were followed appropriately for the affected duodenoscopes.
      • Nelson D.B.
      Infectious disease complications of GI endoscopy: part II, exogenous infections.
      • Wendorf K.A.
      • Kay M.
      • Baliga C.
      • et al.
      Endoscopic retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak.
      In our own practice, it has been an unfortunate reality that more patients are now familiar with the term ERCP because of the negative media attention that occurred during the series of reported outbreaks. Improving our approaches to endoscope disinfection will be critical both for patient safety and to maintain public credibility and accountability in GI endoscopy.
      In this issue of Gastrointestinal Endoscopy, 2 different approaches are evaluated to determine whether endoscope culture positivity can be reduced. Higa et al
      • Higa J.T.
      • Choe J.
      • Tombs D.
      • et al.
      Optimizing duodenoscope reprocessing: rigorous assessment of a culture and quarantine protocol.
      instituted a rigorous “culture and quarantine” approach for duodenoscope reprocessing starting in 2014, in direct response to an outbreak experienced at their institution. During the study period, all scopes first underwent manual cleaning and 1 cycle of HLD. Culture samples were then taken from port openings, working channels, and the elevator mechanism. After this culturing, the scope underwent a second round of automated reprocessing before being stored. The duodenoscopes could not be used clinically until culture negativity had been confirmed at 48 hours. Two “high-frequency culture-positive” duodenoscopes were withdrawn from use. The authors note that during the study the Olympus scopes were all retrofitted with a new elevator channel (in 2016) and new channel/elevator brushes were also introduced. Before this protocol, endoscope culture positivity with high-concern pathogens was 1.9%, and during the study the rate gradually dropped, first to 0.697% and then to 0.277%.
      • Higa J.T.
      • Choe J.
      • Tombs D.
      • et al.
      Optimizing duodenoscope reprocessing: rigorous assessment of a culture and quarantine protocol.
      A second study in this issue, by Bartles et al,
      • Bartles R.L.
      • Leggett J.E.
      • Hove S.
      • et al.
      A randomized trial of single versus double high-level disinfection of duodenoscopes and linear echoendoscopes using standard automated reprocessing.
      took a different approach to reducing endoscopic culture positivity, in a nonoutbreak setting. In this well-designed, optimally powered randomized control trial, Bartles et al studied whether a repeated a cycle of HLD (leaving the scope in the automated endoscope reprocessor for a second round of cleaning) would lead to lower culture positivity, compared with a single round of HLD. In both groups, manual cleaning occurred only once, before the first cycle of HLD. No difference was identified in culture positivity after single HLD versus double HLD (3.9% vs 4.2% for growth of any organism, and 0.2% vs 0.1% for growth of high-concern pathogens, P = not significant). There was a trend toward lower culture positivity for all pathogens and high-concern pathogens in the double-HLD group, which raises the question whether the study was not powered to detect a very small benefit of double HLD.
      • Bartles R.L.
      • Leggett J.E.
      • Hove S.
      • et al.
      A randomized trial of single versus double high-level disinfection of duodenoscopes and linear echoendoscopes using standard automated reprocessing.
      It is worth emphasizing that the study by Higa et al
      • Higa J.T.
      • Choe J.
      • Tombs D.
      • et al.
      Optimizing duodenoscope reprocessing: rigorous assessment of a culture and quarantine protocol.
      represented 1 institution’s response to an outbreak and an initially high rate of duodenoscopes culturing positive for high-risk organisms (1.9%), whereas the study by Bartles et al
      • Bartles R.L.
      • Leggett J.E.
      • Hove S.
      • et al.
      A randomized trial of single versus double high-level disinfection of duodenoscopes and linear echoendoscopes using standard automated reprocessing.
      occurred in an environment with a lower rate of culture positivity for high-risk organisms (0.6%). These studies both demonstrate that a culture positive rate of near 0.2% should be an achievable target for all practices. This target rate of ≤0.2% high-risk organism culture positivity for duodenoscopes should be debated as a quality metric that all institutions should attain, with higher rates triggering more rigorous disinfection, culture, and surveillance pathways. Importantly, Higa et al
      • Higa J.T.
      • Choe J.
      • Tombs D.
      • et al.
      Optimizing duodenoscope reprocessing: rigorous assessment of a culture and quarantine protocol.
      have identified an effective approach to managing aggressive culture and quarantine approaches, withdrawing problem endoscopes from the rotation, which can help reduce the contamination rate toward 0.2% from a much higher prior rate of culture positivity. The study by Bartles et al
      • Bartles R.L.
      • Leggett J.E.
      • Hove S.
      • et al.
      A randomized trial of single versus double high-level disinfection of duodenoscopes and linear echoendoscopes using standard automated reprocessing.
      asks whether we can push these numbers down further (to zero?) by double HLD; however, the answer so far seems to be “no.”
      Both Higa et al
      • Higa J.T.
      • Choe J.
      • Tombs D.
      • et al.
      Optimizing duodenoscope reprocessing: rigorous assessment of a culture and quarantine protocol.
      and Bartles et al
      • Bartles R.L.
      • Leggett J.E.
      • Hove S.
      • et al.
      A randomized trial of single versus double high-level disinfection of duodenoscopes and linear echoendoscopes using standard automated reprocessing.
      provide the evidence to support a benchmark quality metric of 0.2% or less culture positivity in duodenoscopes. However, there are several challenges we must face. First, the simple question of how best to culture a duodenoscope is fraught. The U.S. Food and Drug Administration recently released a 58-page document detailing optimal approaches for culturing and surveillance.

      Duodenoscope surveillance sampling & culturing reducing the risks of infection. Available at: https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/UCM597949.pdf. Accessed March 1, 2018.

      Variability in culturing approaches will influence expected rates of culture positivity. The second challenge is that the optimal approaches for duodenoscope disinfection are still uncertain. It is clear from the prior root cause analyses of duodenoscope-related infectious outbreaks that contamination of the scope can occur during the multiple phases of cleaning and hanging the instruments. Contamination of the scope can result from the manufacturers’ scope design; use by physicians, nurses, and technicians; and handling of the scope, cleaning, and reprocessing machines; solutions and techniques; hanging of the scopes; and more. The potential points of contamination are multiple, and the weak link in the process for any institution may be different. At our own institution, for instance, with an already low rate of scope culture positivity, it was not possible even to demonstrate a measurable benefit for ethylene oxide gas sterilization over standard HLD.
      • Snyder G.M.
      • Wright S.B.
      • Smithey A.
      • et al.
      Randomized comparison of 3 high-level disinfection and sterilization procedures for duodenoscopes.
      In the end, we are left with 2 possible conclusions: (1) a near-zero scope culture positivity rate will be sufficient to mitigate patient risk, and we can “get there” with further validation and broader adoption of rigorous disinfection and endoscope surveillance protocols; quality reporting; a team-based approach between physicians, nurses, and technicians; and regulatory and industry collaboration; or (2) near zero is not good enough, and we must advocate for redesign of the elevator mechanisms and recesses in modern duodenoscopes and echoendoscopes to allow for more reliable disinfection, and perhaps even move toward the use of scopes with single-use or disposable tips, or a removable portion of the scope tip assembly for easier cleaning, the latter design being already in wide use in Japan. We believe that the 2 articles in this issue demonstrate the first conclusion should be feasible. Process improvements and quality reporting for duodenoscope disinfection are certainly likely to be a more economic approach (compared with disposable scopes or sterilization, for instance), in a healthcare system already overburdened by tremendous costs.

      Disclosure

      Dr Berzin is a consultant for Boston Scientific and Fujifilm. The other author disclosed no financial relationships relevant to this publication.

      References

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        • Kizer K.W.
        • Stegun M.B.
        Serious reportable adverse events in health care.
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        Optimizing duodenoscope reprocessing: rigorous assessment of a culture and quarantine protocol.
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