by Mr. Rosauro P. Benito

1. Gastrointestinal Endoscope
ROCHI P. BENITO, RN, MSN
Junior Assistant Manager
Manila Doctors Hospital
Reprocessing and Disinfection

2. • Flexible endoscopes are high output, extremely useful,
enormously versatile, minimally-invasive diagnostic
and therapeutic instruments
• They are sturdy, reusable yet expensive and complex systems
• These channel-containing scopes carry a much higher bioload
due to the unique environment associated with GI endoscopy
• Special design properties of endoscopes render the
entire instrument more difficult to disinfect
• Proper reprocessing of endoscopes, and endoscopic gadgets,
is safe, cost-effective and an accepted norm in many centres
Flexible Endoscopy: the Beauty and the Beast!

4. • Inadequate reprocessing of endoscopes may result in patient to
patient transmission of bacterial/viral diseases or infection of
endemic hospital pathogens1,2
• Prevention of serious endoscopy-associated clinical infections
requires strict compliance with detailed reprocessing protocols
by specially trained (nursing) staff 4
Current Issues with Endoscope
Reprocessing
1. Bronowicki JP et al. N Engl J Med 1997;337:237-240 2. Crenn P et al. Gastroenterology 1988;114LA1229
3.Surgeon transmits HIV to 4 patients. Austrl Health Med law Rep 1995;22-520,25,504
4. Cowen AE. Can J Gastroenterol 2001;15(5);321-331

5. Transmission of Infectious Agents
via Flexible Endoscopy
• Salmonella species
• Escherichia coli
• Serratia marcesens
• Pseudomonas aeroginosa
• Mycobacterium tuberculosis
• Atypical mycobacterium
• Proteus species
• Helicobacter pylori*
• Hepatitis B virus (HBV)
• Hepatitis C virus (HCV)
• Human immunodeficiency
virus (HIV)
• Creutzfeldt-Jakob disease
(CJD)
• Microsporidia species
• Cryptosporidia species
*known to have been transmitted by contaminated endoscopy biopsy forceps
Pathogens of Concern

6. Many reports of M tuberculosis transmission with
bronchoscopy, but none with gastrointestinal endoscopy1-7
1. Wheeler PW et al. J Infect Dis 1989;159:954-958. 2. Leers WD et al. Can Med Assoc J
1980;123:275-583. 3. Bryce EA et al. Can J Infect Control 1993;8:35. 4. Reeves DS et al. J Hosp
Infect 1995;30:531-536. 5. Agerton T et al. JAMA 1997;278:1073-1077. 6. Michele TM et al. JAMA
1997;278:1093-1095. 7. Winsor RP et al. JAMA 1997;278:111
Transmission of hepatitis C virus (HCV) reported with
gastrointestinal endoscopy8-10
8. Bronowicki JP et al. N EnglJ Med 1997;337:237-240. 9. Crenn P et al.
Gastroenterology 1988;114:A1229 10. Goudin JL et al. Gastroenterology 1995;114:A15
Transmission of Infectious Agents
via Flexible Endoscopy

7. Only 1 reported case of hepatitis B virus transmission with
gastrointestinal endoscopy1
1. Ayoola EA. Gastrointest Endosc 1981;2:6-2
To date, there are no reported human immunodeficiency
virus (HIV) transmission with gastrointestinal endoscopy 2-5
Transmission of Infectious Agents
via Flexible Endoscopy
• HIV is relatively sensitive to many chemical disinfectants
2. Hanson PJV et al, BMJ 1989 3. Resnick L et al. JAMA 1986
• Recommended reprocessing protocols have been shown to eliminate
the virus from contaminated endoscopes
4. Hanson PJV et al. Lancet 1989 5. Hanson PJV et al. Gut 1990

8. AIHW Bulletin, Issue 8, Sept 2003
Potential Weaknesses and Deficiencies
of Endoscope Reprocessing

9. AIHW Bulletin, Issue 8, Sept 2003
Potential Weaknesses and Deficiencies
of Endoscope Reprocessing

10. AIHW Bulletin, Issue 8, Sept 2003
Potential Weaknesses and Deficiencies
of Endoscope Reprocessing

11.  Endogenous transmission from patient’s
microbial flora
 Patient to patient transmission from contaminated
endoscopes and accessories
 Transmission from patient to endoscopy staff
Routes of Endoscopy-related Infections
Pathogen Transmission via Flexible
Endoscopy is Preventable!

12. Non-Critical
items come in contact with intact skin but not with mucous
membranes, rarely transmit disease; can be cleansed with
detergent and low level disinfectant solution
Level of Disinfection
and Risk Category of Instruments
Semi-Critical
items come in contact with mucous membranes and requires
decontamination and either intermediate or high level of
disinfection or/but not sterilization, e.g., GI endoscopes
Critical
items enter directly into bloodstream or into other normally
sterile of the body thus, needs sterilizatioin, e.g., endoscopic gadgets

13. : a multi-stepped process that renders a contaminated
endoscope safe for reuse
The Rigors of Endoscope Reprocessing
• Cleaning
- manual, mechanical, ultrasonic, etc
• High-level disinfection
- complete immersion in liquid chemical disinfectant
• Water rinsing
• Drying and proper handling
• Storage
Steps in Endoscope Reprocessing

14. Objective of the Reprocessing Procedures

15. Different Methods for Reprocessing Endoscopes

16. Disinfectants: Antimicrobial agents that are applied to non-living objects to destroy
microorganisms. They should generally be distinguished from antibiotics (these destroy
microorganisms within the body), and from antiseptics (on living tissue).
Disinfection: Reduction of the number of viable microorganisms on a device by
irreversible destruction, to a level appropriate for safe use on a patient, where sterilization
of the device is not necessary. Disinfection is a prerequisite to sterilization. Disinfection
should be carried out immediately after cleaning.
High level disinfectant: A germicide that inactivates all microbial pathogens,
except large numbers of bacterial endospores, when used according to labelling.
The USFDA further defines it as a sterilant used under the same contact conditions
except for a shorter contact time
Beilenhoff U et al. ESGE±ESGENA guideline: Cleaning and disinfection in gastrointestinal endoscopy¼ Endoscopy 2008; 40: 939±957 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
Definition of Terms

17. • Adequate sterilization achieved with shortest contact time
(immersion) to increase the efficiency of the endoscopy centre
• Disinfectant solutions should be safe to the medical,
nursing and technical personnel
• Highly potent with long, stable storage life to optimize utilization
Preferred Qualities of a Disinfectant
for Endoscope Reprocessing
• They should not cause damage to the physical and functional
attributes of the endoscope, as well as, the endoscopy unit
• Versatile and environmentally friendly

18. AIHW Bulletin, Issue 8, Sept 2003
Issues on Gluteraldehyde

19. Issues on Gluteraldehyde

20. AIHW Bulletin, Issue 8, Sept 2003
Issues with Ophthalaldehyde (OPA) Use

21. Sokol WN. J Allergy Clin Immunol 2004;114:392-7

22. Issues with PerAcetic Acid Use

23. AIHW Bulletin, Issue 8, Sept 2003
Issues with
Electrolytically Generated Disinfectant Use

24. Issues with Chlorine Dioxide Use

25. 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)
Requirements for
Chemicals for Endoscope Reprocessing

26. AIHW Bulletin, Issue 8, Sept 2003
Issues with Washer-Disinfectors Use

27. AIHW Bulletin, Issue 8, Sept 2003
Issues with Automated Disinfection Device Use

28. AIHW Bulletin, Issue 8, Sept 2003
Issues with Manual Reprocessing

29. • Rigorous adherence to best practices in endoscopic procedures,
disinfection and reprocessing is essential to the assurance
of quality and safety of gastrointestinal endoscopy

30. SUMMARY
• Reprocessing of GI endoscopes, and endoscopic gadgets,
is safe, cost-effective and an accepted practice
• Endoscope reprocessing is a multi-step process which
entails standardization, accountability and rigorous adherence
to recommended protocols
• In resource-scarce settings, shortcuts due to insufficient
number of endoscopes and/or reprocessing materials should
be avoided, monitored, and addressed appropriately
• High level disinfection with current disinfectants are
satisfactory but novel alternatives have offered better safety
and acceptability