Endoscopy 2008; 40(11): 939-957
DOI: 10.1055/s-2008-1077722
Guidelines

© Georg Thieme Verlag KG Stuttgart · New York

ESGE–ESGENA guideline: Cleaning and disinfection in gastrointestinal endoscopy

Update 2008U.  Beilenhoff1 , C.  S.  Neumann2 , J.  F.  Rey3 , H.  Biering4 , R.  Blum5 , M.  Cimbro6 , B.  Kampf7 , M.  Rogers8 , V.  Schmidt9 ,   and the ESGE Guidelines Committee
  • 1ESGENA President, Ulm, Germany
  • 2ESGENA Past President, Birmingham, UK
  • 3ESGE Guidelines Commitee Chairman, Institute A. Tzanck, Saint Laurent du Var, France
  • 4R,D&E Health Care EMEA, Ecolab GmbH & Co OHG, Düsseldorf, Germany
  • 5BU Endoscopy Reprocessing Systems, Olympus Medical Systems Europa GmbH, Hamburg, Germany
  • 6CBC (Europe) Ltd., MILAN Branch, Nova Milanese (MI), Italy
  • 7PENTAX Europe GmbH, Service Division, Hamburg, Germany
  • 8Sterilox Endoscopy, PuriCore International Limited, Stafford, UK
  • 9Microbiology and Hygiene Department, Chemische Fabrik Dr. Weigert GmbH & Co. KG, Hamburg, Germany
Further Information

Publication History

submitted 9 September 2008

accepted after revision 23 September 2008

Publication Date:
13 November 2008 (online)

Contents

1. Introduction
2. Definition of terms
3. Endoscopy-related infections
4. Principles of infection control
5. Chain of infection
6. Health and safety of endoscopy personnel
7. General requirements
7.1. Classification of endoscopic equipment
7.2. Aims of the reprocessing procedure
7.3. Staff requirements
7.4. Reprocessing room
7.5. The reprocessing procedure
7.6. Manual versus automated reprocessing
8. Process chemicals
8.1. Detergents
8.1.1. Detergents with enzymatic boosters
8.1.2. Detergents with alkaline boosters
8.1.3. Detergents with enzymatic and alkaline boosters
8.1.4. Detergents containing antimicrobial active substances
8.2. Disinfectants
8.2.1. Glutaraldehyde
8.2.2. Orthophthalaldehyde (OPA)
8.2.3. Peracetic acid (PAA)
8.2.4. Chlorine dioxide
8.2.5. Electrolytically generated disinfectants
8.3. Rinse aid
8.4. Combination of products from different manufacturers
8.5. Change of products
9. Reprocessing of endoscopes
9.1. Manual cleaning
9.1.1. Pre-cleaning in the endoscopy room
9.1.2. Manual cleaning in the reprocessing room
9.2. Reprocessing in washer-disinfectors
9.2.1. Definition and process basics for washer-disinfectors
9.2.2. Process specifications for washer-disinfectors
9.2.3. Specific recommendations for washer-disinfectors
9.2.4. Advantages and disadvantages of washer-disinfectors
9.3. Reprocessing in automated disinfection devices
9.3.1. Definition and process basics for automated disinfection devices
9.3.2. Process specifications for automated disinfection devices
9.3.3. Specific recommendations for automated disinfection devices
9.3.4. Advantages and disadvantages of automated disinfection devices
9.4. Manual reprocessing of endoscopes
9.4.1. Definition and process basics for manual reprocessing
9.4.2. Process specifications for manual reprocessing
9.4.3. Advantages and disadvantages of manual reprocessing
9.5. Drying, storage and reuse of endoscope
10. Quality assurance
10.1. Documentation
10.2. Maintenance of washer-disinfectors and automated disinfection devices
10.3. Process validation and microbiological surveillance
10.4. Outbreak management
11. Reprocessing of endoscopic accessories
11.1. General recommendations
11.2. Process specifications
11.2.1. Manual cleaning
11.2.2. Reprocessing in washer-disinfectors
11.2.3. Manual reprocessing
11.2.4. Sterilization
11.2.5. Storage
11.3. Specific recommendations
11.3.1. Biliary and pancreatic procedures
11.3.2. Injection needles
11.3.3. Biopsy forceps
11.3.4. Water bottle and its connectors
12. Appendices
Appendix 1: Manual cleaning of flexible endoscopes
Appendix 2: Reprocessing of flexible endoscopes in washer-disinfectors and automated disinfection devices
Appendix 3: Manual reprocessing of flexible endoscopes
Appendix 4: Manual reprocessing of reusable endoscopy accessories
Appendix 5: Reprocessing of endoscopic accessories in washer-disinfectors and automated disinfection devices
13. References

13. References and guidelines

  • 1 Guidelines on cleaning and disinfection in GI endoscopy.  Endoscopy. 2000;  32 76-83
  • 2 ESGE/ESGENA Technical note on cleaning and disinfection (2003).  Endoscopy. 2003;  35 869-877
  • 3 ESGE/ESGENA Guideline for process validation and routine testing for reprocessing endoscopes in washer-disinfectors, according to the European Standard prEN 15 883 parts 1, 4 and 5.  Endoscopy. 2007;  39 85-94
  • 4 ESGE–ESGENA guideline for quality assurance in reprocessing: Microbiological surveillance testing in endoscopy.  Endoscopy. 2007;  39 175-181
  • 5 International Organization for Standardization .EN 14885: Chemical disinfectants and antiseptics – Application of European Standards for chemical disinfectants and antiseptics. (2006) Section 3.3.1 http://www.iso.org
  • 6 Rutala W. APIC Guidelines for selection and use of disinfectants. APIC 1990.  Am J Infect Control. 1990;  58 99-117
  • 7 Food and Drug Administration .Guidance for industry and FDA reviewers: Content and format of premarket notification [510(k)] (2000). Submissions for liquid chemical sterilants/high level disinfectants. Center for Devices and Radiological Health; Food and Drug Administration. http://www.fda.gov/cdrh/ode/397.pdf
  • 8 International Organization for Standardization . ISO 11137: Sterilization of health care products (2006).  http://www.iso.org
  • 9 International Organization for Standardization .DIN EN ISO 15883 Washer-disinfectors – Part 1: General requirements, terms and definitions and tests. 2006;. http://www.iso.org
  • 10 Empfehlungen der Kommission für Krankenhaushygiene und Infektionsprävention beim Robert-Koch-Insitut zu den Anforderungen an die Hygiene bei der Aufbereitung flexibler Endoskope und endoskopischen Zusatzinstrumentariums.  Bundesgesundheitsblatt. 2002;  45 395-411
  • 11 ASGE Guideline: Reprocessing failure.  Gastrointest Endosc. 2007;  66 869-871
  • 12 Spach D H, Silverstein F E, Stamm W E. Transmission of infection by gastrointestinal endoscopy.  Ann Intern Med. 1993;  118 117-128
  • 13 Ayliffe G A. Nosocomial infections associated with endoscopy. In: Mayhall CG, ed Hospital epidemiology and infection control. Baltimore; Williams & Wilkins 1995: 680-693
  • 14 Cowen A E. The clinical risks of infections associated with endoscopy.  Can J Gastroenterol. 2001;  15 321-331
  • 15 Langenberg W, Rauws E A, Oudbier J H, Tytgat G N. Patient to patient transmission of Campylobacter pylori by fiberoptic gastroduodenoscopy and biopsy.  J Infect Dis. 1990;  161 507-511
  • 16 Moayyedi P, Lynch D, Axon A. Pseudomonas and endoscopy.  Endoscopy. 1994;  26 554-558
  • 17 Bronowicki J P, Vernard V, Botte C. et al . Patient-to-patient transmission of hepatitis C virus during colonoscopy.  N Engl J Med. 1997;  337 237-240
  • 18 Birnie G G, Quigley E M, Clements G B. et al . Endoscopic transmission of hepatitis B virus.  Gut. 1983;  24 71-174
  • 19 Ciancio A. Digestive endoscopy is not a major risk factor for transmitting hepatitis C virus.  Ann Intern Med. 2005;  142 903-909
  • 20 Singh S, Singh R, Kochhar R. et al . Contamination of an endoscope due to Trichosporon beigelii.  J Hosp Infect. 1989;  14 49-53
  • 21 Fronmeyer L, Bihl P, Schmidt-Wilcke H A. [Iatrogene Candidainfektion von Pankreaspseudozsten].  Z Gastroenterol. 1991;  29 392-394
  • 22 LoPasso C, Pernice I, Celeste A, Perdichizzi G, Todaro-Luck F. Transmission of Trichosporon asahii oesophagitis by a contaminated endoscope.  Mycoses. 2001;  44 13-21
  • 23 BSG guidelines for decontamination of equipment for gastrointestinal endoscopy. Report of a Working Party of the British Society of Gastroenterology Endoscopy Committee. February 2008. http://www.bsg.org.uk/pdf_word_docs/decontamination_2008.pdf
  • 24 Axon A TR. et al . ESGE–ESGENA Guideline on variant Creutzfeld–Jacob diseases (vCJD) and gastrointestinal endoscopy.  Endoscopy. 2001;  33 1070-1080
  • 25 Rutala WA, ed Disinfection, sterilization and antisepsis in health care. Association for Professionals in Infection Control and Epidemiology, Inc. Washington DC, and Polyscience Publications, Inc. Champlain, New York, USA. 1998
  • 26 Empfehlungen der Kommission für Krankenhaushygiene und Infektionsprävention beim Robert-Koch-Insitut (RKI) und des Bundesinstitutes für Arzneimittel und Medizinprodukte (BfArM) zu den ”Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten“.  Bundesgesundheitsblatt. 2001;  44 1115-1126
  • 27 International Organization for Standardization .EN ISO 15883-4: 2008. Washer-disinfectors – Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes. http://www.iso.org
  • 28 International Organization for Standardization .ISO/TS 15883-5; (2005) Washer-disinfectors – Part 5: Test soils and methods for demonstrating cleaning efficacy. http://www.iso.org
  • 29 European Medical Device Directory .Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ No L 169/1 of 1993 – 07 – 12). 
  • 30 Rideout K, Teschke K, Dimich-Ward H, Kennedy S M. Considering risks to healthcare workers from glutaraldehyde alternatives in high-level disinfection.  J Hospital Infect. 2005;  59 4-11
  • 31 Wen Sun H, Feigal R J, Meser H H. Cytoxicity of glutaraldehyde and formaldehyde in relation to time of exposure and concentration.  Pediatr Dent. 1990;  12 303-307
  • 32 Axon A TR, Banks J, Cockel R. et al . Disinfection in upper digestive tract endoscopy in Britain.  Lancet. 1981;  I 1093-1094
  • 33 Cowan R E, Manning A P, Ayliffe G AJ. et al . Aldehyde disinfectants and health in endoscopy units. Report of a British Society of Gastroenterology Working Party.  Gut. 1993;  34 1641-1645
  • 34 Grenet M, Tsouria D, Desseaux G. et al . [Colite hémorragique avec choc après une coloscopie Hemorrhagic colitis after colonoscopy].  Annales Francaise d’Anesthésie et de Réanimation. 2004;  23 499-500
  • 35 Hanson J M, Plusa S M, Bennett M K. Glutaraldehyde as a possible cause of diarrhoea after sigmoidoscopy.  Br J Surg. 1998;  85 1385-1387
  • 36 Janos G, Mahoney A, Murray J, Gertler S. Chemical Colitis due to endoscope cleaning solutions: a minic of pseudomembranous colitis.  Gastroenterology. 1995;  (1988) 1403-1408
  • 37 West A B, Kuan S F, Bennick M, Lagarde S. Glutaraldehyde colitis following endoscopy: clinical and pathological features and investigation of an outbreak.  Gastroenterology. 1995;  108 1250-1254
  • 38 Durante L, Zulty J, Israel E. et al . Investigation of an outbreak of bloody diarrhea: association with endoscopic cleaning solution and demonstration of lesions in an animal model.  Am J Med. 1992;  92 476-480
  • 39 Griffiths P A, Babb J R, Bradley C R. Glutaraldehyde resistant Mycobacterium chelonae from endoscope washer disinfectors.  J Appl Microbiol. 1997;  82 519-526
  • 40 Medical Devices Agency -MDA/2004/022. http://www.mhra.gov.uk
  • 41 OMGE/OMED Practice Guideline Endoscope Disinfection, December 2005. http://www.worldgastroenterology.org/endoscope-disinfection.html
  • 42 Nelson D B, Jarvis W R, Rutula W A. et al . Society for Healthcare Epidemiology of America. Multi-society guideline for reprocessing flexible gastrointestinal endoscopes.  Infect Control Hosp Epidemiol. 2003;  24 523-527
  • 43 Alvarado C J, Reichelderfer M. APIC guideline for infection prevention and control in flexible endoscopy.  Am J Infect Control. 2000;  28 138-155
  • 44 International Organization for Standardization .EN 868 (2007): Packaging materials for terminally sterilized medical devices –Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 – Requirements and test methods. http://www.named.din.de
  • 45 International Organization for Standardization .EN 285 (2006): Sterilization – Steam sterilizers – Large sterilizers. http://www.named.din.de
  • 46 Jung M, Beilenhoff U, Pietsch M. et al . Standardized reprocessing of reusable colonoscopy biopsy forceps is effective: results of a German multicenter study.  Endoscopy. 2003;  35 197-202
  • 47 Bader L, Blumenstock G, Birkner B. HYGEA (Hygiene in der Gastroenterologie-Endoskop-Aufbereitung): Studie zur Qualität der Aufbereitung von flexiblen Endoskopen in Klinik und Praxis [HYGEA (Hygiene in gastroenterology – endoscope reprocessing): Study on quality of reprocessing flexible endoscopes in hospitals and in the practice setting].  Z Gastroenterol. 2002;  40 157-170

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