A randomized trial of single versus double high-level disinfection of duodenoscopes and linear echoendoscopes using standard automated reprocessing

Published:February 21, 2018DOI:https://doi.org/10.1016/j.gie.2018.02.016

      Background and Aims

      In a pilot study, we demonstrated that current guidelines for duodenoscope and linear echoendoscope (DLE) reprocessing using a single cycle of high-level disinfection (HLD) in an automated reprocessor may be inadequate. In August 2015, the U.S. Food and Drug Administration offered double HLD as a possible response to address this concern. As a result, Providence Health and Services adopted double HLD as standard procedure for DLEs, but no rigorous clinical studies supported this practice. We undertook a quality improvement study to compare single HLD versus double HLD at 4 of our 34 hospitals.

      Methods

      HLD of DLE was randomized, separately in each facility, to either single HLD or double HLD on weekdays, with standard double HLD on weekends or holidays. There was 99.7% compliance with the randomization scheme. Daily qualitative surveillance cultures of dried, post-HLD DLEs were collected for 6 months (1 swab sample from the elevator mechanism and 1 combined brush sample from the suction and working channels for each encounter), and each sample was incubated for 48 hours. Positivity rates of any microbial growth and growth of high-concern pathogens (potentially pathogenic enteric flora) were compared between the 2 study arms.

      Results

      Altogether, 5850 surveillance culture specimens were obtained during 2925 encounters from the 45 DLEs in clinical use in the participating hospitals. Of these, 3052 (52.2%) were from endoscopes cleaned by double HLD. Double HLD demonstrated no benefit over single HLD because similar positivity rates were observed (all P > .05). The elevator mechanism was more frequently colonized than the biopsy channel (5.2% vs 2.9%, P < .001). Among the 224 encounters with positive growth, 140 (62.5%) recovered microbes from only the elevator mechanism specimens, 73 (32.6%) recovered microbes from only the channel specimens, and 11 (4.9%) recovered microbes from both types of specimens. Double HLD failed to improve contamination rates for either sample site at any of the 4 endoscopy facilities, although there were significant overall differences in contamination rates among the facilities (P < .001), as observed in our previous study. Only 8 high-concern pathogens were recovered from 5 DLEs, all from the elevator mechanism. Persistent growth was observed on 2 duodenoscopes. One grew Enterococcus spp (not vancomycin-resistant enterococci) on 3 occasions, and Escherichia coli was present on 2 of these occasions, 1 of which was a multidrug-resistant organism. The other grew different enteric flora on 2 specimens.

      Conclusions

      Our prospectively randomized study, involving 4 separate endoscopy facilities and standard automated endoscope reprocessing, showed that double HLD did not reduce culture positivity rates compared with single HLD in facilities with an already low positive culture rate. Alternative risk mitigation strategies will be assessed in an ongoing effort to reduce endoscope contamination.

      Abbreviations:

      AER (automated endoscope reprocessor), DLE (duodenoscope and linear echoendoscope), FDA (U.S. Food and Drug Administration), HLD (high-level disinfection)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Gastrointestinal Endoscopy
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Peterson B.T.
        • Koch J.
        • Ginsberg G.G.
        Infection using ERCP endoscopes.
        Gastroenterology. 2016; 151: 46-50
        • Epstein L.
        • Hunter J.C.
        • Arwady M.A.
        • et al.
        New Delhi metallo-betalactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes.
        JAMA. 2014; 312: 1447-1455
        • Kovaleva J.
        • Peters F.T.
        • van der Mei H.C.
        • et al.
        Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy.
        Clin Microbiol Rev. 2013; 26: 231-254
        • Wendorf K.A.
        • Kay M.
        • Baliga C.
        • et al.
        Endoscopic retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak.
        Infect Control Hosp Epidemiol. 2015; 36: 634-642
      1. Division of Industry and Consumer Education, U.S. FDA. Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning: FDA safety communication. Available at: https://wayback.archive-it.org/7993/20170723124406/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM445596.pdf. Accessed September 13, 2017.

      2. Center for Devices and Radiological Health, U.S. FDA. Meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee: effective reprocessing of endoscopes used in endoscopic retrograde cholangiopancratography (ERCP) procedures, May 14-15, 2015. Available at: https://wayback.archive-it.org/7993/20170113091323/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM445592.pdf. Accessed September 13, 2017.

        • Rutala W.A.
        • Weber D.J.
        ERCP scopes: What can we do to prevent infections?.
        Infect Control Hosp Epidemiol. 2015; 36: 643-648
        • Brandabur J.J.
        • Leggett J.E.
        • 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
        • Ross A.S.
        • 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
        • Rutala W.A.
        • Weber D.J.
        Outbreaks of carbapenem-resistant enterobacteriaceae infections associated with duodenoscopes: What can we do to prevent infections?.
        Am J Infect Control. 2016; 44: e47-e51
      3. U.S. FDA. Supplemental measures to enhance duodenoscope reprocessing: FDA Safety Communication 2015. Available at: https://wayback.archive-it.org/7993/20170111065959/http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454766.htm. Accessed September 13, 2017.

        • Petersen B.T.
        Duodenoscope reprocessing: risk and options coming into view.
        Gastrointest Endosc. 2015; 82: 484-487
        • Visrodia K.
        • Petersen B.T.
        Echoing concerns related to endoscope reprocessing.
        Gastrointest Endosc. 2017; 85: 398-400
        • Petersen B.T.
        • Cohen J.
        • Hambrick R.D.
        • et al.
        Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update.
        Gastrointest Endosc. 2017; 85: 282-294
      4. Centers for Disease Control and Prevention. Interim protocol for healthcare facilities regarding surveillance for bacterial contamination of duodenoscopes after reprocessing. Available at: https://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html. Accessed September 13, 2017.

        • Chapman C.G.
        • Siddiqui U.D.
        • Manzano M.
        • et al.
        Risk of infection transmission in curvilinear array echoendoscopes: results of a prospective reprocessing and culture registry.
        Gastrointest Endosc. 2017; 85: 390-397
        • Alfa M.J.
        • Ribeiro M.M.
        • da Costa Luciano C.
        • et al.
        A novel polytetrafluoroethylene-channel model, which simulates low levels of culturable bacteria in buildup biofilm after repeated endoscope reprocessing.
        Gastrointest Endosc. 2017; 86: 442-451
        • Almario C.V.
        • May F.P.
        • Shaheen N.J.
        • et al.
        Cost utility of competing strategies to prevent endoscopic transmission of carbapenem-resistant enterobacteriaceae.
        Am J Gastroenterol. 2015; 110: 1666-1674
        • Gazdik M.A.
        • Coombs J.
        • Burke J.P.
        • et al.
        Comparison of two culture methods for use in assessing microbial contamination of duodenoscopes.
        J Clin Microbiol. 2016; 54: 312-316
      5. Department of Health and Human Services (2018). Duodenoscope surveillance sampling and culturing: reducing the risks of infection. Available at at: https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/UCM597949.pdf. Accessed March 14, 2018.

        • Beekmann S.E.
        • Palmore T.N.
        • Polgreen P.M.
        • et al.
        Adequacy of duodenoscope reprocessing methods as reported by infectious disease physicians.
        Infect Control Hosp Epidemiol. 2016; 37: 226-228
        • Pineau L.
        • De Philippe E.
        Evaluation of endoscope cleanliness after reprocessing: a clinical-use study.
        Central Service. 2013; 1: 22-27
        • Alfa M.J.
        • Fatima I.
        • Olson N.
        The adenosine triphosphate test is a rapid and reliable audit tool to assess manual cleaning adequacy of flexible endoscope channels.
        Am J Infect Control. 2013; 41: 249-253
      6. Association for the Advancement of Medical Instrumentation. Safe handling and biological decontamination of medical devices in health care facilities and in nonclinical settings. AN SI/AA MI ST35: 2003. Available at: http://www.aami.org/. Accessed September 1, 2017.

      7. Association for the Advancement of Medical Instrumentation. A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. AAMI TIR 30: 2003. Available at: http://www.aami.org/. Accessed September 1, 2017.

      Linked Article

      • Duodenoscope-related and echoendoscope-related infections: Is “never” possible?
        Gastrointestinal EndoscopyVol. 88Issue 2
        • Preview
          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.1 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.”2 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.”
        • Full-Text
        • PDF