1. Keeping Our Patients Safe in Endoscopy
Pathogens of concern
Keeping Our Patients Safe
in Endoscopy
Holly Knauf RN, MSN, AGTS
Clinical Education Specialist
MEDIVATORS

2. Disclosures
Successful completion: Participants must complete the entire program and submit required documentation.
Conflict of interest: Planners disclose no conflict; the speaker discloses employment with Medivators, thereby declaring a conflict of interest
Commercial company support: Fees are underwritten by education funding provided by Medivators.
Non-commercial company support: None.
Non-endorsement of products: Accredited status does not imply endorsement by the provider, Educational Dimensions, or ANCC of any commercial products or services from the commercial entity.
Alternative/Complementary therapy: None

3. Learner Objectives
Upon completion of this presentation, participants will be able to:
Discuss potential complications resulting from the presence of various pathogens in endoscopy equipment
Discuss the role biofilm plays in contamination of endoscopes
Recognize the impact of infections related to endoscopy
State the steps required to correctly reprocess an endoscope in the clinical area

4. Microbiology Microorganisms in our environment Evolution & Purpose
Requirements for growth
Transmission
Types & Location
Bacteria
Viruses
Fungi
Worms & Insects
Pathogens
Everything we do in relation to infection prevention in endoscopy leads us one way or another back to microbiology.
Pathogen is a term used to describe a microbe that produces a disease. It is estimated that 90% of the cells on or in the human body are viruses, bacteria, fungi, worms and insects which make up our normal flora.
Bacteria make up the largest part of our normal flora. One half the weight of feces is made up of bacteria (there are approximately 1 million (106) bacteria per gram of feces.
Viruses can be found in the absence of infection.
The gastrointestinal tract is the major site for colonization and there are an estimated 2-4 pounds of bacteria in this part of the adult body. There is also great diversity, particularly in the colon. This normal bacterial flora is important in the proper development of the gut and also in synthesizing some vitamins (K and B complex). It is estimated that different species live in the gut. The metabolic activity of the bacteria in our intestines greatly exceeds our own metabolism. The genetic diversity of these bacteria is immense.
**Normal skin flora serve useful roles in killing exogenous bacteria picked up by touching. However the hands are relatively deficient in normal flora and are an important means of transfer of bacteria. That is why hand washing is so important to prevent infection.

5. Staphylococcus aureus (“Staph”) Streptococcus pyogenes
Pathogenic Bacteria
Staphylococcus aureus (“Staph”)
Streptococcus pyogenes
Pseudomonas aeruginosa
Escherichia coli (“E coli”)
Helicobacter pylori (“H. pylori”)
Mycobacterium tuberculosis (TB)
Most are free living and can grow in humans, other animals and in the environment. Smallest living cell with an average size of one micron (1/1000 of a millimeter). Make up the major component of our normal body flora. Found all over the earth and are thought to be one of the first life forms. Survival lies in their ability to go dormant for extended periods.
Under ideal conditions, bacteria divide every 20 minutes and it is estimated that the mutation rate is, at the lowest, one in every 100 million cells. The colon, at normal growth, will produce one million mutant bacteria every 20 minutes.
Pseudomonas is the fourth most commonly isolated hospital acquired pathogen. found in any moist environment, can rapidly contaminate a moist endoscope with biofilm. Has been found in endoscope irrigation systems, automated reprocessors and even in the hospital water supply. Bronchoscopies and ERCP are especially at risk for this pathogen.
E coli although part of the normal intestinal flora, some strains are more pathogenic and can cause meningitis and septicemia.
H pylori is another solely human pathogen that has adapted to living in the harsh acidic environment of the stomach. It is estimated that half of the world’s population is colonized or infected with H. pylori.
tuberculosis fThis cell wall makes it resistant to destruction by drying and many chemical agents. TB remain alive and viable for weeks or months, much longer than other bacteria. Although it does not form spores, the resting form of these bacteria can survive many years without food or water

6. Endospores Resistant, dormant, survival form of bacteria
Spore producing organisms
Bacillus anthractis
Anthrax
Clostridium tetani
Tetanus
Clostridium botulinum
Food poisoning
Clostridium difficile
C diff
Endospores are a resistant, dormant, survival form of bacteria. They are resistant to high temperatures, most disinfectants, low level radiation and drying. Endospores can survive thousands of years until environmental stimuli trigger germination. Most high level liquid disinfectants require a longer time and specific instructions to kill spores. However, many of the spores that are found in the body are in the vegetative state and are susceptible to high level disinfection. Examples of spore-producing organisms include those that cause anthrax, tetanus, botulism and gangrene.

7. Four Major C. difficile-Associated Disease (CDAD) Clinical Problems
Inability to prevent CDAD in high-risk settings such as the hospital
Lack of a sensitive and rapid diagnostic test for CDAD
Absence of a treatment that will prevent recurrence of CDAD
Inability to effectively treat fulminant CDAD

8. Viruses Characteristics Species specific Cell specific
Hepatitis B – Liver
HIV – Certain White Blood Cells (WBCs)
Hepatitis C
Cytomegalovirus – AIDS
Cryptosporidium – Diarrhea
Human Papillomavirus (HPV) – Condyloma
All living things are cellular except viruses. A virus is a tiny, lifeless, totally inert particle which is incapable of existing without a host. Virus size varies from 20 to 250 nanometers (one nanometer is one billionth of a meter). Once inside a cell however, thousands of virus particles spread to other cells, killing the host cell in the process.
Viruses, though fragile and easily destroyed, can still be vectors of infection, as demonstrated by recent headlines warning patients of potential risks after endoscope reprocessing breaches. Fifty to ninety percent of HIV infected patients are also infected with Hepatitis C. Cytomegalovirus is the most frequent opportunistic infection seen with AIDS.. Human Papillomavirus (HPV) has been suspected of being transmitted during colonoscopy, causing condyloma infection (venereal warts). Can you imagine the horror of becoming infected with a sexually transmitted disease during a colonoscopy?

9. Unicellular Organisms
Protozoa
Complex organism
Complex life cycles
Mode of
transmission
Cause of diarrheal
illnesses
Protozoa have very complex life cycles, dividing by binary fission or budding. They may require a host for part of the cycle. Protozoa are quite fragile and those that are shed into the environment or host usually produce thick walled cysts that are similar to spores. These cysts are excreted in feces and may be ingested in contaminated water, causing diarrheal illnesses.

10. Unicellular Organisms
Fungi
Exist in yeast or mold
Tinea pedis
Candida albicans

11. Biofilm Micro-organisms surrounded by the slime they produce
Exists wherever surfaces contact water
Bacteria live in biofilm communities
Interferes with disinfection
All surfaces easily colonized
Difficult to remove
Physical properties
Simply put, biofilm is a collection of microorganisms surrounded by the slime they secrete, attached to either an inert or living surface. You are already familiar with some biofilm: the plaque on your teeth, the slippery slime on river stones and the gel-like film on the inside of a vase which held flowers for a week.
Biofilm is composed of millions of micro organisms that accumulate on surfaces in aqueous environments. They adhere to surfaces by producing extra cellular polysaccharide. As nutrients accumulate, the pioneer cells proceed to reproduce.. Pretty soon a thriving colony of bacteria is established. Pseudomonas aeruginosa is a common ‘pioneer’ bacteria and is used in a lot of biofilm research. In one experiment, researchers found that Pseudomonas cells adhere to stainless steel, even to electro polished surfaces, within 30 seconds of exposure. The adherent bacteria produce micro colonies which initially are composed of only one bacterial type but frequently develop to contain several different species of micro organism living in a complex community.
In a 2003 Australian study, samples of scope channels were removed from scopes sent for repair. Biofilm was present in five out of thirteen biopsy channels and twelve out of thirteen air water channels. However, any scope channel is at risk if it is not promptly reprocessed and thoroughly dried before storage. This same caveat applies to water bottles and accessory tubing used during endoscopy for irrigation and cleaning.

12. In an experiment to determine the effectiveness of scope cleaning procedures, Dr. David Lewis, Visiting Scientist, Department of Marine Sciences, University of Georgia, conducted an experiment in which he replicated the high pressure environment of a colon during a colonoscopy by placing the tip of an endoscope contaminated with a florescent biofilm into a balloon and inflating the balloon. He grew the biofilm from water in a brook and added florescence so that the biofilm would be more visible in photographs. The scope was then manually cleaned and disinfected with glutaraldehyde and peracetic acid. As a final step, the air water nozzle was removed to check the air water channel for any residual biofilm.
This series of photos clearly illustrate the challenge presented by biofilm.
This photo shows the distal tip of the colonoscope contaminated with the biofilm mixture. The fluorescence permits better visualization of the biofil

15. You can see biofilm still on tip of scope

16. This photo is the distal tip of the colonoscope after 10 minutes in peracetic acid. Most biofilm has been eliminated from the tip.

17. Brushing of the colonoscope air/water channel after removal of air water nozzle reveals biofilm debris remaining in the channel. The increased pressure of the balloon shows how bioburden from the patient can backfill the channels. In the case of the air/water and auxiliary water channel, the inability to access the channel with a brush make mechanical cleaning impossible and removal of bioburden and biofilm more difficult.

18. Endoscopy Related Infection in the News
2000 – New Jersey: Reprocessing Machine Malfunction
2001 – Tennessee: Outbreak!
2002 – Maryland: Pseudomonas aeruginosa Outbreak at Major Medical Center
2002 – USA Today: Medical Community Debates Scope Cleaning Procedures
2002 – Good Morning America: Contamination Controversy: Are endoscopes being disinfected properly?
More than 10 million gastrointestinal endoscopies are performed annually in the United States
Documented rates of post-endoscopy infection are low, but experts agree they underestimate the problem
Lack of thorough cleaning has been implicated in post-endoscopy infections
Reprocessing failures resulted in 7,034 patient notifications
Recent examples:
Feb. 2008: hepatitis C outbreak caused 50,000 patients to be tested
Dec 2008: incorrect connector usage caused widespread notifications
April 2009: HIV and hepatitis C passed to 1 and 7 patients respectively
Oct 2011: 6,800 patients notified when improperly reprocessed scopes
Transmission of opportunistic bacteria by a contaminated endoscope is typically due to inadequate drying or improper storage of the endoscope, whereas transmission of a patient-borne pathogen, such as the hepatitis C virus or TB, is typically due to inadequate cleaning or ineffective high level disinfection of the endoscope.

19. Gastrointestinal (GI) Endoscopy
Benefits
Useful for many GI procedures
Safer than surgery
Patient Safety Considerations
Potential for patient harm
Potential for infection transmission
Identification of Risk
Gastrointestinal endoscopy is an important tool for the identification and treatment of disorders of the gastrointestinal tract. In the past, many patients had to undergo extensive surgical procedures which are now accomplished using an endoscope.
While the endoscopy procedures are safer than surgery, there is still the inherent risk of infection. A thorough understanding of infection prevention and its application to GI endoscopy are crucial to preventing lapses in the reprocessing procedures that could lead to cross contamination and infection spread.
The potential to transmit an infection via an endoscope has been well documented. These incidents have been a result of defective design, reprocessing errors, improper use of accessories and improper storage. Also, improper use of accessories or failure to promptly notify health care facilities of recalled instruments have resulted in unnecessary illness, death and public concern.

20. Spaulding Classification System
Classification system for device disinfection and sterilization processes
Critical – Sterilization, i.e., reusable biopsy forceps
Semi-critical – Sterilization or high-level disinfection, i.e., endoscopes
Non-critical – Germicide or soap & water, i.e., BP cuffs, stethoscopes
In 1968, Dr. Earl Spaulding developed a classification system to determine what type of disinfection or sterilization process is appropriate for medical devices. These three classes: critical, semi- critical and non-critical, stratify the risk of infection associated with each device. Critical devices break the mucosal barrier and should be sterilized (e.g. reusable biopsy forceps). Semi-critical devices (e.g. endoscopes) come in contact with mucous membranes or non-intact skin and should be sterilized or receive high level disinfection. Blood pressure cuffs and stethoscopes come into contact with intact skin and fall into the non-critical category. These items can be cleaned with soap and water or disinfected with a germicide.

21. Factors Affecting High Level Disinfection and Sterilization Efficacy
Complex endoscope design
Biofilm formation
Cleaning impacts efficacy of disinfection / sterilization
Considerations for use of germicides
Resistant microorganisms to destruction methods
Endoscopes are considered semi-critical and should receive at a minimum, high level disinfection with a liquid sterilant/disinfectant approved by the FDA. Complex endoscope design features may allow organic debris and microorganisms to accumulate, making manual cleaning essential. Biofilm formation may harbor microorganisms, making strict and meticulous adherence to reprocessing guidelines imperative in order to prevent cross- contamination and hospital acquired infections. B

22. Training and Safety
Training & policy development major influencers of infection prevention & safe practice
Reprocessing has narrow margin of safety
Ongoing education
Annual competency requirement
New equipment & instrument training
Strict adherence to policies
Accuracy of documentation
Staff safety considerations
Training is an important factor in infection prevention and safety. All staff in any setting where gastrointestinal endoscopy is performed must adhere to infection control principles that will maintain a safe environment, free from the possibility of spreading disease to patients and co-workers.. Any slight deviation from recommended reprocessing protocol can lead to the survival of microorganisms and an increased risk of infection. I
Personnel responsible for scope reprocessing must have the time and resources to perform their duties without interruption. Endoscopy nurses should have a thorough understanding of the steps in reprocessing to be able to precept and monitor the process. There must be a policy of invariable adherence to the reprocessing protocol.

23. Quality Assurance Standards
Highest priority
Documentation requirements
Procedure date and time
Patient’s name & medical record number
Person performing the procedure
Endoscope model & serial number or other identifier
Automated endoscope reprocessor (AER) model & serial number or other identifier
Staff member(s) reprocessing the endoscope
Quality assurance standards should receive the highest priority and include training, supervision, annual competency and procedures to report any adverse event. In 2003, a multi-society guideline was published which suggested that, as part of a quality control program, documentation of endoscope reprocessing should include but is not limited to the following:
the procedure date and time
the patient’s name and medical record number
the endoscopist
the endoscope's model and serial number or other identifier
the automatedendoscope reprocessor (AER) model and serial number or other identifier (if used)
the staff member(s) reprocessing the endoscope

24. Reprocessing Overview
Designated area
Adequate space
Proper airflow
Adequate ventilation
User-friendly work area design
Delineation of clean and dirty areas
Identification mechanism for clean vs dirty scopes
Availability of recommended chemicals
Availability of reprocessing equipment
Considerations include adequate space for reprocessing activities, proper airflow and ventilation requirements, work flow patterns, work surfaces, lighting, adequate utilities such as electrical support and water, hand washing and eye washing facilities, air drying capability and storage.
There should be a clear delineation of clean and dirty space within the reprocessing area(s) and a failsafe mechanism to determine if a scope is clean or contaminated.

25. Reprocessing Policy Development
Manufacturer instruction manual
Organizational policy & procedure
Adherence to federal (CDC) and professional standards (AORN & SGNA)
Timing
Use of PPE
Procedural steps
Environmental cleaning
The steps for properly cleaning and disinfecting an endoscope can be found in the original equipment manufacturer’s manual and these steps should be incorporated into each unit’s policy and procedure manual. The general requirements discussed here include recommendations from the guidelines and resources previously discussed.

26. Reprocessing Equipment
Personal protective equipment (gloves, eye protection, impervious gown, face shield or simple surgical mask that will not trap vapors)
Leak-testing equipment
Channel cleaning adapters (per OEM)
Large basin or sink
Detergent solution prepared according to manufacturer's instructions
Channel cleaning brushes
Sponge and/or lint-free cloth
You may already know what reprocessing equipment is required, so this is a basic list will be a review for you.
Reprocessing equipment should include:
personal protective equipment (gloves, eye protection, impervious gown, face shield or simple surgical mask that will not trap vapors). Let’s not overlook the importance of personal protective equipment, affectionately known as PPE. PPE should always be worn for reprocessing, all the time. It protects the health care worker from unexpected contamination from the patient and chemicals. Because these incidents are "unexpected" it is important to always protect ourselves.

27. Precleaning
Wipe down the insertion tube with a detergent-soaked lint free cloth
Immerse distal tip in detergent; depress suction valve to aspirate detergent for 30 seconds
Remove distal tip from detergent solution and depress suction valve to aspirate air for 10 seconds; repeat till clear
Alternating air and suction will assist in removal of debris from channel; flush with clean water
Attach air/water channel cleaning adapter and set the light source airflow to HIGH
The first step of the reprocessing steps take place in the procedure room immediately after the removal of the scope from the patient. Appropriate personal protective equipment should be worn.

28. Precleaning
Immerse the distal tip in clean water; depress air/water channel cleaning adapter and feed water for 30 seconds, release the air/water channel cleaning adapter for 10 seconds or more to let air through the channels
Use a syringe to flush the auxiliary water channel or ERCP elevator channel till clear
Turn OFF light source; attach protective video cap and transport endoscope to the reprocessing area in a covered container
Immerse the distal tip in clean water; depress air/water channel cleaning adapter and feed water for 30 seconds, release the air/water channel cleaning adapter for 10 seconds or more to let air through the channels
Use a syringe to flush the auxiliary water channel or ERCP elevator channel till clear
Turn OFF light source; attach protective video cap and transport endoscope to the reprocessing area in a covered container

29. Environment
Between patients, the procedure room, equipment (monitors, video processors, light sources) and all surfaces should be wiped clean and disinfected with a surface disinfectant designed for this purpose.
Follow disinfectant contact time recommendations
Between patients, the procedure room, equipment (monitors, video processors, light sources) and all surfaces should be wiped clean and disinfected with a surface disinfectant designed for this purpose.

30. Reprocessing Procedure
Precleaning
Leak Testing
Manual Cleaning
Manual High-Level Disinfection
Automated Endoscope Reprocessors
Drying
Accessories

31. Leak Testing Remove all valves
Pressurize the instrument using a manual or automated leak tester
Identify that the distal tip is inflated
Submerge the scope in water to observe for leaks
Some automated leak testers may not require submersion
If bubbles are seen, keep scope pressurized
If bubbles are not seen, deflate and disconnect the leak tester from the device
timing is everything when conducting a leak test. I can tell you the proper steps of conducting a leak test, however I found the pressures of turn overs, physicians demands, the reprocessing of scopes is the area where people take short cuts, I find staff cleaning the scope while doing the leak test, not manipulating the knobs or pushing buttons to check for leaks.

32. Manual Cleaning (1)
Fill a sink or basin with cleaning solution following manufacturer’s recommendations
Immerse the endoscope; wash all debris from the exterior of the endoscope by brushing and wiping the instrument while submerged
Use a small, soft brush to clean all removable parts
Brush all accessible endoscope channels including the body, insertion tube and the umbilicus of the endoscope
Its important to remember to rinse the brush between passes, removing any visible debris before the next pass of the brush, this is to be continued until no debris is seen.
Buttons should be depressed to get all surfaces
Elevator water channels as well as auxillary water channels are often missed, and require the use of 2 to 5 milliliter syring
Its important to know the detergent being used and the recommended soak time

33. Flush all channels with the detergent solution to remove debris.
Manual Cleaning (2)
After each passage, rinse the brush in detergent solution; continue brushing until there is no debris visible on the brush
Attach the endoscope manufacturer’s cleaning adapters for suction, biopsy, air and water channels
Attach the manufacturer’s cleaning adapters for special endoscope channels
Flush all channels with the detergent solution to remove debris
After each passage, rinse the brush in the detergent solution, removing any visible debris before retracting and reinsertin g it. Continue brushing until there is no debris visible on the brush.
Attach the endoscop e manufact urer’s cleaning adapters for suction, biopsy, air and water channels. You will want to refer to manufact urer’s guideline s for the use of automate d pumps available for this step.
Attach the manufact urer’s cleaning adapters for special endoscop e channels (e.g., elevator channel, auxiliary channel, and double- channel scopes). It should be noted that the elevator channel of a duodeno scope has a very small lumen, so this channel requires manual reprocess ing (all steps) using a 2 to 5 milliliter syringe.
Flush all channels with the detergent solution to remove debris.

34. Manual Cleaning (3)
Soak the endoscope and its internal channels for the period of time specified by the label, if using an enzymatic detergent or biofilm detaching agent
Thoroughly rinse the endoscope and all removable parts with clean water to remove residual debris and detergent
Purge water from all channels using forced air
Dry the exterior of the endoscope with a soft, lint- free cloth before immersing
The scope is clean but not patient ready label, if using an enzymatic detergent.
Thoroughly rinse the endoscope and all removable parts with clean water to remove residual debris and detergent.
Purge water from all channels using forced air.
Dry the exterior of the endoscope with a soft, lint-free cloth to prevent dilution of the liquid chemical germicide used in subsequent steps if manually reprocessing.

35. Manual Reprocessing Follow manufacturer’s recommendations for use
Make sure the scope is completely submerged in the disinfectant
Using a syringe draw fluid into all channels so that all internal and external surfaces have disinfectant contact
After the recommended contact time remove the scope and rinse with clean water with the number of recommended separate rinses
Use a syringe and flush alcohol through all the channels
Use forced air to dry internal channels after alcohol flush
Dry the external surface with a lint free cloth
Knowing your product, contact time, volume of disinfectant, number of rinses, how much alcohol and use the forced air.

36. High Level Disinfection using an Automated Endoscope Reprocessor
Place the endoscope into the AER basin
Connect all appropriate channels to the AER hookups
Test the disinfectant for minimal effective concentration level according to the manufacturer’s recommendations
Determine correct cycle for the endoscope processing and start the cycle
Complete all documentation required for high level disinfection
AER provided standardization of the high level disinfection process and decreases personnel exposure to HLD and sterilants. It helps to reduce the human error factor of reprocessing.
Not to be used for the reprocessing of single use items, water bottle, or any tubing with a lumen with a hook up.

37. Automated Endoscope Reprocessing
Make sure an alcohol purge and air purge were completed during the AER reprocessing
When removing the endoscope from the AER use a dry lint free cloth to dry any damp areas on the scope surface
The air purge at the end of a cycle does not negate the need to follow manufacture guideline of using air to purge the scope once our of the AER

38. Time Out: Test Your Knowledge
Why does the ERCP elevator wire channel have to be processed separately?
Most reprocessors do not have adequate pressure to flow this very narrow lumen. Pseudomonas colonized in this channel has been responsible for many infections.
Why is drying such an important part of reprocessing?
If a scope is not completely dry, waterborne bacteria will grow as biofilm in the scope channels.
Time out:
Why does the ERCP elevator wire channel have to be processed separately?
Why is drying such an important part of reprocessing?
(Advance slide to reveal the first response)
Most reprocessors do not have adequate pressure to flow this very narrow lumen. Pseudomonas colonized in this channel has been responsible for many infections.
(Advance slide to reveal the second response)
If a scope is not completely dry, waterborne bacteria will grow as biofilm in the scope channels.

39. Storage
Scopes should be hung vertically to promote any drainage of residual fluids
Storage area should be well ventilated
All accessories should stay removed from the scope during storage
There should be limited access to the storage area

40. Breaking the Chain of Infection
Following Guidelines and Recommended Practices from professional organizations
Yearly competency testing for staff
Quality Improvement Programs
SGNA has two very important document that provide guidance for cleaning, decontamination, and high level disinfection
Guideline for Performance of Flexible Sigmoidoscopy by Registered Nurses for the Purpose of Colorectal Cancer Screening (2009)
Guideline for the Use of High Level Disinfectants and Sterilants for Reprocessing of Flexible Gastrointestinal Endoscopes (2011)

41. Conclusion Our patients are at risk
We have a responsibility for consistent adherence to guidelines and practices
Rigid adherence will ensure safety and quality for both patients and staff
In conclusion, our patients are at risk for infection because of the nature and variety of autologous and environmental pathogens.
We healthcare providers have an obligation to protect our patients by consistently adhering to guidelines and procedures related to scope reprocessing and environmental cleaning.
In order to protect ourselves, our families and our patients, wearing proper personal protective equipment and frequent hand washing are essential.

42. Resources:
CDC
Guideline for Disinfection & Sterilization in Healthcare Facilities (
SGNA
Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (
AORN
Recommended Practices for Cleaning & Processing Flexible Endoscopes and Accessories (
Here are some resources you may wish to consult…