endoscopy unit

Gastrointestinal Endoscope

ROCHI P. BENITO, RN, MSN

Junior Assistant Manager

Manila Doctors Hospital

Reprocessing and Disinfection

• 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!

• 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

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

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

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 disinfectants2. 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 endoscopes4. Hanson PJV et al. Lancet 1989 5. Hanson PJV et al. Gut 1990

AIHW Bulletin, Issue 8, Sept 2003

Potential Weaknesses and Deficiencies of Endoscope Reprocessing

AIHW Bulletin, Issue 8, Sept 2003

Potential Weaknesses and Deficiencies of Endoscope Reprocessing

AIHW Bulletin, Issue 8, Sept 2003

Potential Weaknesses and Deficiencies of Endoscope Reprocessing

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!

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

: 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

Objective of the Reprocessing Procedures

Different Methods for Reprocessing Endoscopes

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

• 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

AIHW Bulletin, Issue 8, Sept 2003

Issues on Gluteraldehyde

Issues on Gluteraldehyde

AIHW Bulletin, Issue 8, Sept 2003

Issues with Ophthalaldehyde (OPA) Use

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

Issues with PerAcetic Acid Use

AIHW Bulletin, Issue 8, Sept 2003

Issues with

Electrolytically Generated Disinfectant Use

Issues with Chlorine Dioxide Use

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

AIHW Bulletin, Issue 8, Sept 2003

Issues with Washer-Disinfectors Use

AIHW Bulletin, Issue 8, Sept 2003

Issues with Automated Disinfection Device Use

AIHW Bulletin, Issue 8, Sept 2003

Issues with Manual Reprocessing

• Rigorous adherence to best practices in endoscopic procedures,

disinfection and reprocessing is essential to the assurance

of quality and safety of gastrointestinal endoscopy

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