Advertisement

Challenges in achieving effective high-level disinfection in endoscope reprocessing

Published:October 30, 2019DOI:https://doi.org/10.1016/j.ajic.2019.09.013

      Highlights

      • Fully reprocessed flexible endoscopes frequently harbor viable microbes.
      • High-level disinfectants commonly fail minimum effective concentration tests.
      • Instructions for using and testing high-level disinfectants are complex.
      • Human factors contribute to widespread non-adherence with guidelines.
      • New approaches are needed from manufacturers and infection preventionists.
      Endoscope reprocessing is often ineffective, and microbes frequently remain on endoscopes after the use of high-level disinfectants (HLDs). Several factors impact reprocessing effectiveness, including non-adherence to guidelines, use of damaged endoscopes, use of insoluble products during endoscopy, insufficient cleaning, contaminated rinse water, and inadequate drying before storage. Our team suspected that issues with HLD chemistries and monitoring could also contribute to reprocessing failures. We conducted a mixed-methods analysis of published literature, our interviews with frontline personnel, and evidence from our previous studies. The evidence showed that reusable HLDs commonly failed tests for minimum effective concentration (MEC) before their maximum usage periods. MEC tests also detected failures associated with single-use HLDs that did not fully deploy. These failures were due to product issues, process complexities, and personnel non-adherence with guidelines and manufacturer instructions. HLDs will likely continue to be used for the foreseeable future. More research is needed to assess real-world practice patterns related to the high-level disinfection step and MEC testing and to establish more realistic usage periods for reusable HLD chemistries. Manufacturers and researchers should evaluate the ability of technological solutions and engineered safeguards to overcome human error. Recognition of the need for quality improvement is growing, and infection preventionists should take action to build on this momentum and collaborate with manufacturers, endoscopists, and reprocessing personnel to improve the effectiveness of high-level disinfection.

      Key Words

      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 American Journal of Infection Control
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Snyder GM
        • Wright SB
        • Smithey A
        • Mizrahi M
        • Sheppard M
        • Hirsch EB
        • et al.
        Randomized comparison of 3 high-level disinfection and sterilization procedures for duodenoscopes.
        Gastroenterology. 2017; 153: 1018-1025
        • Saliou P
        • Le Bars H
        • Payan C
        • Narbonne V
        • Cholet F
        • Jezequel J
        • et al.
        Measures to improve microbial quality surveillance of gastrointestinal endoscopes.
        Endoscopy. 2016; 48: 704-710
        • Legemate JD
        • Kamphuis GM
        • Freund JE
        • Baard J
        • Oussoren HW
        • Spijkerman IJ
        • et al.
        Pre-use ureteroscope contamination after high-level disinfection: reprocessing effectiveness and the relation with cumulative ureteroscope use.
        J Urol. 2019; 201: 1144-1151
        • Ofstead CL
        • Wetzler HP
        • Eiland JE
        • Heymann OL
        • Held SB
        • Shaw MJ
        Assessing residual contamination and damage inside flexible endoscopes over time.
        Am J Infect Control. 2016; 44: 1675-1677
        • Ofstead CL
        • Quick MR
        • Wetzler HP
        • Eiland JE
        • Heymann OL
        • Sonetti DA
        • et al.
        Effectiveness of reprocessing for flexible bronchoscopes and endobronchial ultrasound bronchoscopes.
        Chest. 2018; 154: 1024-1034
        • Ofstead CL
        • Doyle EM
        • Eiland JE
        • Amelang MR
        • Wetzler HP
        • England DM
        • et al.
        Practical toolkit for monitoring endoscope reprocessing effectiveness: identification of viable bacteria on gastroscopes, colonoscopes, and bronchoscopes.
        Am J Infect Control. 2016; 44: 815-819
        • Ofstead CL
        • Wetzler HP
        • Heymann OL
        • Johnson EA
        • Eiland JE
        • Shaw MJ
        Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: results of visual inspections, biochemical markers, and microbial cultures.
        Am J Infect Control. 2017; 45: e26-e33
        • Visrodia K
        • Hanada Y
        • Pennington KM
        • Tosh PK
        • Topazian MD
        • Petersen BT
        Duodenoscope reprocessing surveillance with adenosine triphosphate testing and terminal cultures: a clinical pilot study.
        Gastrointest Endosc. 2017; 86: 180-186
        • Ofstead CL
        • Wetzler HP
        • Doyle EM
        • Rocco CK
        • Visrodia KH
        • Baron TH
        • et al.
        Persistent contamination on colonoscopes and gastroscopes detected by biologic cultures and rapid indicators despite reprocessing performed in accordance with guidelines.
        Am J Infect Control. 2015; 43: 794-801
        • Ofstead CL
        • Heymann OL
        • Quick MR
        • Eiland JE
        • Wetzler HP
        Residual moisture and waterborne pathogens inside flexible endoscopes: evidence from a multisite study of endoscope drying effectiveness.
        Am J Infect Control. 2018; 46: 689-696
      1. Food and Drug Administration. Supplemental measures to enhance duodenoscope reprocessing: FDA safety communication. Available from:https://www.fdanews.com/ext/resources/files/08-15/081015-duodenoscopes-fda.pdf?1520541508. Accessed September 18, 2019.

        • Rutala WA
        • Weber D
        ERCP scopes: what can we do to prevent infections?.
        Infect Control Hosp Epidemiol. 2015; 36: 643-648
        • Rutala WA
        • Weber DJ
        Reprocessing semicritical items: current issues and new technologies.
        Am J Infect Control. 2016; 44: e53-e62
        • Rex DK
        • Sieber M
        • Lehman GA
        • Webb D
        • Schmitt B
        • Kressel AB
        • et al.
        A double-reprocessing high-level disinfection protocol does not eliminate positive cultures from the elevators of duodenoscopes.
        Endoscopy. 2017; 50: 588-596
        • Bartles RL
        • Leggett JE
        • Hove S
        • Kashork CD
        • Wang L
        • Oethinger M
        • et al.
        A randomized trial of single versus double high-level disinfection of duodenoscopes and linear echoendoscopes using standard automated reprocessing.
        Gastrointest Endosc. 2018; 88: 306-313
        • Kumarage J
        • Khonyongwa K
        • Khan A
        • Desai N
        • Hoffman P
        • Taori SK
        Transmission of multi-drug resistant Pseudomonas aeruginosa between two flexible ureteroscopes and an outbreak of urinary tract infection: The fragility of endoscope decontamination.
        J Hosp Infect. 2019; 102: 89-94
        • Greene DJ
        • Gill BC
        • Hinck B
        • Nyame YA
        • Almassi N
        • Krishnamurthi V
        • et al.
        American Urological Association antibiotic best practice statement and ureteroscopy: does antibiotic stewardship help?.
        J Endourol. 2018; 32: 283-288
        • Wendelboe AM
        • Baumbach J
        • Blossom DB
        • Frank P
        • Srinivasan A
        • Sewell CM
        Outbreak of cystoscopy related infections with Pseudomonas aeruginosa: New Mexico, 2007.
        J Urol. 2008; 180: 588-592
        • Jimeno A
        • Alcalde MM
        • Ortiz M
        • Rodriguez A
        • Alcaraz B
        • Vera F
        Outbreak of urinary tract infections by Salmonella spp. after cystoscopic manipulation.
        Actas Urol Esp. 2016; 40: 646-649
        • Galdys AL
        • Marsh JW
        • Delgado E
        • Pasculle AW
        • Pacey M
        • Ayres AM
        • et al.
        Bronchoscope-associated clusters of multidrug-resistant Pseudomonas aeruginosa and carbapenem-resistant Klebsiella pneumoniae.
        Infect Control Hosp Epidemiol. 2019; 40: 40-46
        • Guy M
        • Vanhems P
        • Dananche C
        • Perraud M
        • Regard A
        • Hulin M
        • et al.
        Outbreak of pulmonary Pseudomonas aeruginosa and Stenotrophomonas maltophilia infections related to contaminated bronchoscope suction valves, Lyon, France, 2014.
        Euro Surveill. 2016; 21
        • Jorgensen SB
        • Bojer MS
        • Boll EJ
        • Martin Y
        • Helmersen K
        • Skogstad M
        • et al.
        Heat-resistant, extended-spectrum beta-lactamase-producing Klebsiella pneumoniae in endoscope-mediated outbreak.
        J Hosp Infect. 2016; 93: 57-62
        • Reddick E
        Investigation of salmonellosis outbreak following a hospital endoscopy: a public health case study.
        Can J Infect Control. 2017; 32: 156-159
        • Bajolet O
        • Ciocan D
        • Vallet C
        • de Champs C
        • Vernet-Garnier V
        • Guillard T
        • et al.
        Gastroscopy-associated transmission of extended-spectrum beta-lactamase-producing Pseudomonas aeruginosa.
        J Hosp Infect. 2013; 83: 341-343
        • Rauwers AW
        • Troelstra A
        • Fluit AC
        • Wissink C
        • Loeve AJ
        • Vleggaar FP
        • et al.
        Independent root cause analysis of contributing factors, including dismantling of 2 duodenoscopes, to an outbreak of multidrug-resistant Klebsiella pneumoniae.
        Gastrointest Endosc. 2019; 90: 793-804
        • Ross AS
        • Baliga C
        • Verma P
        • Duchin J
        • Gluck M
        A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli.
        Gastrointest Endosc. 2015; 82: 477-483
        • Robertson P
        • Smith A
        • Anderson M
        • Stewart J
        • Hamilton K
        • McNamee S
        • et al.
        Transmission of Salmonella enteritidis after endoscopic retrograde cholangiopancreatography because of inadequate endoscope decontamination.
        Am J Infect Control. 2017; 45: 440-442
        • Humphries RM
        • Yang S
        • Kim S
        • Muthusamy VR
        • Russell D
        • Trout AM
        • et al.
        Duodenoscope-related outbreak of a carbapenem-resistant Klebsiella pneumoniae identified using advanced molecular diagnostics.
        Clin Infect Dis. 2017; 65: 1159-1166
        • Shenoy ES
        • Pierce VM
        • Walters MS
        • Moulton-Meissner H
        • Lawsin A
        • Lonsway D
        • et al.
        Transmission of mobile colistin resistance (mcr-1) by duodenoscope.
        Clin Infect Dis. 2018; 68: 1327-1334
        • Kim S
        • Russell D
        • Mohamadnejad M
        • Makker J
        • Sedarat A
        • Watson RR
        • et al.
        Risk factors associated with the transmission of carbapenem-resistant Enterobacteriaceae via contaminated duodenoscopes.
        Gastrointest Endosc. 2016; 83: 1121-1129
        • Ofstead CL
        • Wetzler HP
        • Snyder AK
        • Horton RA
        Endoscope reprocessing methods: a prospective study on the impact of human factors and automation.
        Gastroenterol Nurs. 2010; 33: 304-311
        • Ofstead CL
        • Hopkins KM
        • Eiland JE
        • Wetzler HP
        Managing bronchoscope quality and cost: results of a real-world study.
        PROCESS. 2019; March/April: 63-71
        • Ofstead CL
        • Hopkins KM
        • Eiland JE
        • Wetzler HP
        Endoscope reprocessing: current practices and challenges in the field.
        PROCESS. 2019; July/August: 60-71
        • Ofstead CL
        • Heymann OL
        • Quick MR
        • Johnson EA
        • Eiland JE
        • Wetzler HP
        The effectiveness of sterilization for flexible ureteroscopes: a real-world study.
        Am J Infect Control. 2017; 45: 888-895
        • Barakat MT
        • Girotra M
        • Huang RJ
        • Banerjee S
        Scoping the scope: endoscopic evaluation of endoscope working channels with a new high-resolution inspection endoscope (with video).
        Gastrointest Endosc. 2018; 88: 601-611
        • Thaker AM
        • Kim S
        • Sedarat A
        • Watson RR
        • Muthusamy VR
        Inspection of endoscope instrument channels after reprocessing using a prototype borescope.
        Gastrointest Endosc. 2018; 88: 612-619
        • Ofstead CL
        • Wetzler HP
        • Johnson EA
        • Heymann OL
        • Maust TJ
        • Shaw MJ
        Simethicone residue remains inside gastrointestinal endoscopes despite reprocessing.
        Am J Infect Control. 2016; 44: 1237-1240
        • Ofstead CL
        • Hopkins KM
        • Eiland JE
        • Wetzler HP
        Widespread clinical use of simethicone, insoluble lubricants, and tissue glue during endoscopy: a call to action for infection preventionists.
        Am J Infect Control. 2019; 47: 666-670
        • van Stiphout SH
        • Laros IF
        • van Wezel RA
        • Gilissen LP
        Crystallization in the waterjet channel in colonoscopes due to simethicone.
        Endoscopy. 2016; 48: E394-E395
        • Barakat MT
        • Huang RJ
        • Banerjee S
        Simethicone is retained in endoscopes despite reprocessing: Impact of its use on working channel fluid retention and adenosine triphosphate bioluminescence values (with video).
        Gastrointest Endosc. 2010; 89: 115-123
        • Visrodia KH
        • Ofstead CL
        • Yellin HL
        • Wetzler HP
        • Tosh PK
        • Baron TH
        The use of rapid indicators for the detection of organic residues on clinically used gastrointestinal endoscopes with and without visually apparent debris.
        Infect Control Hosp Epidemiol. 2014; 35: 987-994
        • Seidelman JL
        • Wallace RJ
        • Iakhiaeva E
        • Vasireddy R
        • Brown-Elliott BA
        • McKnight C
        • et al.
        Mycobacterium avium pseudo-outbreak associated with an outpatient bronchoscopy clinic: lessons for reprocessing.
        Infect Control Hosp Epidemiol. 2019; 40: 106-108
        • Epstein L
        • Hunter JC
        • Arwady MA
        • Tsai V
        • Stein L
        • Gribogiannis M
        • et al.
        New Delhi metallo-beta-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes.
        JAMA. 2014; 312: 1447-1455
        • Rieger KL
        Discriminating among grounded theory approaches.
        Nurs Inq. 2019; 26: e12261
        • Singh S
        • Estefan A
        Selecting a grounded theory approach for nursing research.
        Glob Qual Nurs Res. 2018; 5 (2333393618799571)
        • Advanced Sterilization Products
        Cidex OPA instructions for use.
        Advanced Sterilization Products, Irvine (CA)2016
        • Advanced Sterilization Products
        Cidex OPA concentrate instructions for Use.
        Advanced Sterilization Products, Irvine (CA)2017
      2. Metrex Research Corp. Metricide OPA Plus Solution. Available from:https://www.metrex.com/sites/default/files/content/education-file/education-file-upload/metricide-opa-plus-wall-chart-77-1191.pdf. Accessed September 16, 2019.

        • Medivators
        Medivators Rapicide OPA/28 high-level disinfectant instructions for use.
        Medivators, Minneapolis (MN)2016
        • Medivators
        Medivators Rapicide PA high-level disinfectant directions for use.
        Medivators, Minneapolis (MN)2015
      3. STERIS. S40 Sterilant concentrate package insert. Mentor (OH): STERIS Corporation; 2018.

      4. Olympus. Acecide-C high-level disinfectant and sterilant instruction manual. Center Valley (PA): Olympus Corporation of the Americas; 2011.

      5. Olympus. Acecide®-C high-level disinfectant. Available from:https://medical.olympusamerica.com/sites/default/files/pdf/Acecide-C_Product_Brochure.pdf. Accessed September 17, 2019.

        • Advanced Sterilization Products
        Cidex activated dialdehyde solution (glutaraldehyde 2.4%) instructions for use.
        Advanced Sterilization Products, Irvine (CA)2018
        • Medivators
        Medivators Rapicide [glutaraldehyde]: high-level disinfectant and sterilant.
        Medivators, Minneapolis (MN)2013
      6. Metrex Research Corp. MetriCide technical bulletin. Available from: https://www.metrex.com/sites/default/files/content/education-file/education-file-upload/metricide-technical-bulletin-us-en.pdf. Accessed September 16, 2019.

      7. Metrex Research Corp. MetriCide. Available from: www.metrex.com/en-us/products/high-level-disinfectants/metricide. Accessed September 18, 2019.

        • Metrex Research Corp
        MetriCide™ 28 [glutaraldehyde].
        Metrex Research Corp, Romulus (MI)2010
      8. Metrex Research Corp. MetriCide 28. Available from: www.metrex.com/en-us/products/high-level-disinfectants/metricide-28. Accessed September 18, 2019.

        • Olympus
        Aldahol 1.8: high-level disinfectant instruction manual.
        Olympus Corporation of the Americas, Center Valley (PA)2013
      9. STERIS. Revital-Ox RESERT high-level disinfectant instructions for use. Mentor (OH): STERIS Corporation; 2011.

        • AAMI, ANSI
        ANSI/AAMI ST91: 2015 flexible and semi-rigid endoscope processing in health care facilities.
        Association for the Advancement of Medical Instrumentation, Arlington (VA)2015: 1-70
        • Van Wicklin SA
        • Conner R
        • Spry C
        Guideline for processing flexible endoscopes.
        Guidelines for perioperative practice. Association of periOperative Registered Nurses, Denver (CO)2017: 1-84
        • Medivators
        Rapicide OPA/28 Test Strips instructions for use.
        Medivators, Minneapolis (MN)2016
      10. STERIS. Revital-Ox RESERT R60 Solution Test Strip instructions for use. Mentor (OH): STERIS Corporation; 2015.

      11. STERIS. Verify chemical indicator for S40 sterilant instructions for use. Mentor (OH): STERIS Corporation; 2012.

        • Advanced Sterilization Products
        Cidex OPA solution test strips instructions for use.
        Advanced Sterilization Products, Irvine (CA)2015
        • Advanced Sterilization Products
        Cidex [glutaraldehyde] solution test strips instructions for use.
        Advanced Sterilization Products, Irvine (CA)2015
        • Olympus
        Aldechek ALDAHOL 1.8 glutaraldehyde indicator instructions for use.
        Olympus Corporation of the Americas, Center Valley (PA)2013
      12. Olympus. Acecide peracetic acid test strips–quick reference. Center Valley (PA): Olympus Corporation of the Americas; 2011.

        • Medivators
        Rapicide PA high-level disinfection test strip directions for use.
        Medivators, Minneapolis (MN)2016
      13. Metrex Research Corp. Quick reference for using MetriCide® OPA Plus Solution Test Strips. Available from:https://www.metrex.com/sites/default/files/content/education-file/education-file-upload/guide-to-using-metricide-opa-plus-solution-test-strips-77-1401.pdf. Accessed July 15, 2019.

      14. Metrex Research Corp. Quick reference for using MetriTest Test Strips. Available from:https://www.metrex.com/sites/default/files/content/education-file/education-file-upload/guide-to-using-metritest-test-strips-77-1400.pdf. Accessed September 18, 2019.

        • Cooke RP
        • Goddard SV
        • Whymant-Morris A
        • Sherwood J
        • Chatterly R
        An evaluation of Cidex OPA (0.55% ortho-phthalaldehyde) as an alternative to 2% glutaraldehyde for high-level disinfection of endoscopes.
        J Hosp Infect. 2003; 54: 226-231
        • Vesley D
        • Melson J
        • Stanley P
        Microbial bioburden in endoscope reprocessing and an in-use evaluation of the high-level disinfection capabilities of Cidex PA.
        Gastroenterol Nurs. 1999; 22: 63-68
        • Foliente RL
        • Kovacs BJ
        • Aprecio RM
        • Bains HJ
        • Kettering JD
        • Chen YK
        Efficacy of high-level disinfectants for reprocessing GI endoscopes in simulated-use testing.
        Gastrointest Endosc. 2001; 53: 456-462
        • Hession SM
        Endoscope disinfection by ortho-phthalaldehyde in a clinical setting: an evaluation of reprocessing time and costs compared with glutaraldehyde.
        Gastroenterol Nurs. 2003; 26: 110-114
        • Leong D
        • Dorsey C
        • Klapp M
        Dilution of glutaraldehyde by automatic endoscope machine washers: the need for a quality control program.
        Am J Infect Control. 1987; 15: 86
        • Cooke RP
        • Goddard SV
        • Chatterley R
        • Whymant-Morris A
        • Cheale J
        Monitoring glutaraldehyde dilution in automated washer/disinfectors.
        J Hosp Infect. 2001; 48: 243-244
        • Cox HM
        • Cheung K
        • Fletcher AJ
        • Whitby RM
        • Hickman PE
        Glutaraldehyde concentration in the sterilization of endoscopes.
        Pathology. 1995; 27: 362-364
        • Kaczmarek RG
        • Moore Jr., RM
        • McCrohan J
        • Goldmann DA
        • Reynolds C
        • Caquelin C
        • et al.
        Multi-state investigation of the actual disinfection/sterilization of endoscopes in health care facilities.
        Am J Med. 1992; 92: 257-261
        • Reynolds CD
        • Rhinehart E
        • Dreyer P
        • Goldmann DA
        Variability in reprocessing policies and procedures for flexible fiberoptic endoscopes in Massachusetts hospitals.
        Am J Infect Control. 1992; 20: 283-290
        • Barbosa JM
        • Souza AC
        • Tipple AF
        • Pimenta FC
        • Leao LS
        • Silva SR
        Endoscope reprocessing using glutaraldehyde in endoscopy services of Goiania, Brazil: a realidade em servicos de endoscopia de Goiania, GO.
        Arq Gastroenterol. 2010; 47: 219-224
        • Centers for Medicare and Medicaid Services
        Yakima Valley Memorial Hospital, Yakima, WA: statement of deficiencies.
        Centers for Medicare and Medicaid Services, Baltimore (MD)2018
        • Centers for Medicare and Medicaid Services
        Mary Greeley Medical Center, Ames, IA: statement of deficiencies.
        Centers for Medicare and Medicaid Services, Baltimore (MD)2017
        • Centers for Medicare and Medicaid Services
        The Physicians’ Hospital, Anadarko OK: statement of deficiencies.
        Centers for Medicare and Medicaid Services, Baltimore (MD)2018
        • Centers for Medicare and Medicaid Services
        Wagoner Community Hospital, Wagoner OK: statement of deficiencies.
        Centers for Medicare and Medicaid Services, Baltimore (MD)2018
        • FDA
        MAUDE adverse event report: Medivators Inc. DSD-201 Automated Endoscope Reprocessor 7182901.
        Food and Drug Administration, Silver Spring (MD)2018
        • FDA
        MAUDE adverse event report: Advanced Sterilization Products Cidex OPA Solution Biocides Solutions 8072138.
        Food and Drug Administration, Silver Spring (MD)2018
        • FDA
        MAUDE adverse event report: Advanced Sterilization Products US Cidex OPA Solution Biocides Solution 7558700.
        Food and Drug Administration, Silver Spring (MD)2018
        • FDA
        MAUDE adverse event report: Advanced Sterilization Products Cidex OPA Solution Biocides Solutions 7833925.
        Food and Drug Administration, Silver Spring (MD)2018
        • FDA
        MAUDE adverse event report: Medivators Rapicide PA High-Level Disinfectant Test Strips Chemical Indicator 7639885.
        Food and Drug Administration, Silver Spring (MD)2018
      15. FDA, MAUDE adverse event report: Olympus Medical Systems Corporation Olympus OES Cystonephrofiberscope 8364744, 2019, Food and Drug Administration; Silver Spring (MD).

        • Centers for Medicare and Medicaid Services
        Palomar Health: statement of deficiencies and plan of correction.
        Centers for Medicare and Medicaid Services, Baltimore (MD)2010
        • Garrick D
        Escondido: PPH testing 3,400 patients when only 45 at risk of exposure; officials blame use of expired disinfectant.
        The San Diego Union-Tribune, June 15, 2010
      16. Food and Drug Administration. The FDA provides interim results of duodenoscope reprocessing studies conducted in real-world settings: FDA safety communication. Available from:https://www.fda.gov/medical-devices/safety-communications/fda-provides-interim-results-duodenoscope-reprocessing-studies-conducted-real-world-settings-fda. Accessed September 16, 2019.

        • Ofstead CL
        • Quick MR
        • Eiland JE
        • Adams SJ
        A glimpse at the true cost of reprocessing endoscopes: results of a pilot project.
        Communiqué. 2017; Jan/Feb: 63-78
        • FDA
        MAUDE adverse event report: Medivators Inc. DSD-201 Automated Endoscope Reprocessor 8332264.
        Food and Drug Administration, Silver Spring (MD)2019
        • FDA
        MAUDE adverse event report: Medivators Inc. DSD-201 Automated Endoscope Reprocessor 8368486.
        Food and Drug Administration, Silver Spring (MD)2019
        • FDA
        MAUDE adverse event report: Medivators DSD-201 Automated Endoscope Reprocessor 8466920.
        Food and Drug Administration, Silver Spring (MD)2019
        • Centers for Medicare and Medicaid Services
        UCSF Medical Center, San Francisco CA: statement of deficiencies.
        Centers for Medicare and Medicaid Services, Baltimore (MD)2015
      17. Metrex Research Corp. Metrex MetriCide™ 28 material safety data sheet. Available from:https://www.metrex.com/sites/default/files/content/education-file/education-file-upload/MetriCide%2028%20Canada%20MSDS%20(7-14-2015).pdf. Accessed September 16, 2019.

      18. Olympus Corporation of the Americas. Acecide®-C use-solution material safety data sheet. 2014. Available from:https://medical.olympusamerica.com/sites/default/files/pdf/Acecide-C_MSDS_Use_Solution.pdf. Accessed September 18, 2019.

        • FDA
        MAUDE adverse event report: Medivators Advantage Plus Automated Endoscope Reprocessor 7293237.
        Food and Drug Administration, Silver Spring (MD)2018
        • FDA
        MAUDE adverse event report: Medivators Advantage Plus Automated Endoscope Reprocessor 8214665.
        Food and Drug Administration, Silver Spring (MD)2018
        • FDA
        MAUDE adverse event report: Medivators Advantage Plus Automated Endoscope Reprocessor 8180192.
        Food and Drug Administration, Silver Spring (MD)2018
        • Mehta AC
        • Gildea T
        Response to Shulimzon and Chatterji.
        Chest. 2019; 155: 1301
        • Pynnonen MA
        • Whelan J
        Reprocessing flexible endoscopes in the otolaryngology clinic.
        Otolaryngol Clin North Am. 2019; 52: 391-402
        • Mehta AC
        • Gildea T
        Burying our heads in the sand: cross-contamination during bronchoscopy.
        Chest. 2018; 154: 1001-1003
        • Gawande A
        The checklist manifesto.
        Picador, New York (NY)2010