Infection Control Guidelines for Endoscopy Unit [compatibility mode]

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KING KHALID HOSPITAL
INFECTION PREVENTION
AND
CONTROL MANUAL

ENDOSCOPY
Dr. Nahla Abdel Kader, MD, PhD.
Infection Control Consultant, MOH
Infection Control CBAHI Surveyor
Infection Prevention Control Director
KKH.

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DEFINITION
To provide recommendations for cleaning, disinfecting and
sterilizing endoscopes/accessories in order to minimize the risk
of infection transmission from one patient to another.

COMMENTS
▪▪ Flexible endoscopy has become an invaluable diagnostic and therapeutic tool. As
with all diagnostic and therapeutic procedures, there are always intrinsic and
extrinsic risks of complications. To minimize the risk of infection, healthcare
providers must ensure that equipment is designed and maintained properly and that
guidelines for reprocessing are strictly followed.
▪▪ Reprocessing requires meticulous cleaning and high-level disinfection or
sterilization of internal channels, external surfaces, openings, valves and caps.
Accessory equipment used to biopsy, brush, or cut tissue must be cleaned and
sterilized, or if disposable, discarded.
▪▪ Some disinfectants are inactivated by organic material. Organic soil including
blood, excretions, and embedded microbes may contribute to disinfectant failures and
prevent the penetration of germicides

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DEFINITIONS
Chemical sterilants refer to liquid chemical agents cleared by
the Food and Drug Administration (FDA) for reprocessing
reusable medical devices. These products are considered
high-level disinfectants or sterilants depending upon time,
temperature, concentration, and sporicidal activity.
Manufacturer’s instructions must be followed.
Cleaning refers to the physical removal of organic and
inorganic material from objects and surfaces.
Endogenous Infection occurs when the microflora colonizing
the mucosal surfaces of GI or respiratory tract gain access
to the blood stream or other normally sterile body sites as a
consequence of the endoscopic procedure. (e.g., cholangitis,
pneumonia)
Endoscope refers to a flexible device use to visualize the
interior of a hollow organ.

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Next…DEFINITIONS
Endoscopic accessory refers to biopsy forceps, brushes, snares, or other
devices introduced through the internal channel of the endoscope during
procedures.
Exogenous Infection occurs when microorganisms are transferred from
previous patients or the inanimate environment via contaminated
endoscopes or accessories. Most common factors associated with
transmission include inadequate manual cleaning, inadequate exposure of
all endoscopy surfaces to the sterilant, inadequate rinsing and drying, and
use of automated endoscope reprocessors.
High-level disinfection is the elimination of all forms of microbial life
with the exception of large numbers of bacterial spores.
Reprocessing refers to the cleaning and high-level disinfection or
sterilization of reusable endoscopic devices by either manual or
automated methods.
Sterilization is the complete elimination or destruction of all forms of
microbial life

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RECOMMENDATIONS
A. Processing endoscopes and accessories:
1. If an Automated Endoscope Washer Disinfector (AEWD) is
used, ensure that the endoscopes and its components can be
effectively reprocessed in the AEWD. Obtain and review
model-specific reprocessing protocols from the endoscope
and AEWD manufacturers and check for compatibility.
2. Reusable endoscopic accessories (e.g., biopsy forceps or
other cutting instruments) that break the mucosal barrier
should be mechanically cleaned as described earlier and
then sterilized between each patient use (high-level
disinfection is not appropriate).
3. Endoscopes (and accessories) that come in contact with
mucous membranes are classified as Semicritical items and
should receive at least high-level disinfection after each
patient use.

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Next…..RECOMMENDATIONS

4. All endoscopes received for reprocessing must have the following
information on the Endoscope Nursing Record Sheet:
a. patient name
b. medical record number
c. procedure, endoscopist
d. identifier number of endoscope used (serial number)
5. Perform pressure/leak testing after each use according to
manufacturer guidelines.
a. Observe the instrument carefully for continuous bubbling. If
continuous bubbling is observed from a given area, this indicates a
leak. Remove instrument from water immediately after leak test
cycle. Do not use the instrument.
b. Dry and clean instrument and place in plastic bag and pack into
transport case. Contact appropriate department for repairs.
6. Disconnect and disassemble endoscope components (e.g., air/water
and suction valves) as far as possible and completely immerse the
endoscope and components in the enzymatic detergent.

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7. Cleaning is essential before manual or automated disinfection.
a. Meticulously clean the entire endoscope immediately after use,
including valves, channels, connectors, and all detachable parts,
according to the manufacturer’s instructions, using an enzymatic
detergent compatible with the endoscope.
b. Flush and brush all accessible channels to remove all organic
(e.g., blood, tissue) and other residues. Repeatedly actuate the
valves during cleaning to facilitate access to all surfaces.
c. Clean the external surfaces and components of the endoscope
using a soft cloth, sponge, or brushes.
8. Use brushes appropriate for the size of the endoscope’s channel,
parts, connectors, and orifices (e.g., bristles should contact all
surfaces) for cleaning. Cleaning items should be disposable or
thoroughly cleaned and disinfected/ sterilized between uses.

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9. Ultrasonic cleaning of reusable endoscopic accessories and endoscope
components may be used to remove soil and organic material from hard
to clean areas.
10. Select a disinfectant/sterilant that is compatible with the endoscope.
Exposure time, concentration, and temperature for disinfection the
scope must be followed as per manufacturer’s recommendations.
11. After high-level disinfection, rinse the endoscope and flush the channels
with sterile, filtered, or tap water to remove the disinfectant/sterilant.
Discard the rinse water after each use/cycle.
a. Flush the channels with 70–90% ethyl or isopropyl alcohol and dry
using forced-air. The final drying steps greatly reduce the possibility of
recontamination of the endoscope by waterborne microorganisms. For
storage refer to section: G. Storage of Clean/Sterile Endoscopes
12. High-level disinfect or sterilize the water bottle (used for cleaning the
lens and irrigation during the procedure), and its connecting tube at
least daily. Sterile water should be used to fill the water bottle.

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13. Perform routine testing of the liquid sterilant/high-level disinfectant
to ensure minimal effective concentration (MEC) of the active
ingredient.
a. Check the solution at the beginning of each day of use (or more
frequently) and document the results. If the chemical indicator shows
that the concentration is less than the MEC, the solution should be
discarded.
14. Discard the liquid sterilant/high-level disinfectant at the end of its
reuse life (which may be single use) regardless of the MEC. If
additional liquid sterilant/ high-level disinfectant is added to an
AEWD (or basin, if manually disinfected), the reuse life should be
determined by the first use/activation of the original solution (i.e., the
practice of “topping off” of a liquid sterilant/high-level disinfectant
pool does not extend the reuse life of the liquid sterilant/high-level
disinfectant).
15. Discard enzymatic detergents after each use, as these products are
not microcidal and will not retard microbial growth.

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B. Safety and Quality Control:
1. Policy and procedure on device-specific reprocessing
instructions must be written and followed by all CSSD
personnel.
2. Operate AEWD or Automated Endoscope Reprocessor systems
as per manufacturer’s recommendations.
3. A regular schedule basis, the CSSD technician must carry out
a biological test.
4. Diagnostic test must be carried out and passed prior to
instruments being loaded.

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5. Material and Safety Data Sheets must be obtained for
each chemical used and stored in the department.
6. Use to correct amount or dilution of chemicals
required for each load.
7. A Chemical indicator must be used on each
instrument.
8. Filters must be changed as per the manufacturer
instructions.
9. Healthcare facilities should develop protocols to
ensure that users can readily identify whether an
endoscope is contaminated or is ready for patient use.

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C. Quality Control Sampling:
1. Quantitative microbiologic cultures may be taken randomly
from the endoscopes and washing machines for quality
assurance. The criterion of acceptability is absence of
growth of vegetative bacteria. Depending on the results of
monitoring, the need for ongoing routine microbiologic
culturing should be discussed with the Infection Control
Staff.
2. Cultures of endoscopes are indicated only where clinical or
epidemiological findings suggest endoscopy-related
transmission of infection.
3. Brushings should be obtained from the suction and biopsy
channels with a sterile brush, and sent for culture and
sensitivity. The criterion of acceptability is the absence of
growth of vegetative bacteria

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D. Design of the endoscopy suite:
There are a number of factors to be considered in the design and use
of space for endoscopic procedures and the cleaning, disinfection,
sterilization and storage of endoscopes and endoscopic equipment.
1. Separate space used for the performance of procedures from the
space used for cleaning, and sterilization equipment.
2. Provide separate designated sinks for hand hygiene and utility.
3. Air exchanges in the suite should meet the latest CDC guidelines to
prevent the transmission of Tuberculosis, 12 air changes per hour.
4. The area should be planned to allow for sound infection control
practices e.g., avoidance of proximity of clean and contaminated
equipment.
5. Do not allow eating or drinking in procedure and utility rooms

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E. Reprocessing Technicians:
1. Personal protective equipment (gloves, gowns, eyewear, respiratory protection
devices, etc.) should be readily available and should be used, as appropriate, to
protect workers from exposure to chemicals, blood, or other potentially infectious
material.
2. Strict use of hand hygiene by all healthcare workers.
3. All healthcare personnel assigned to reprocess endoscopes should be trained in,
and adhere to, standard infection control recommendations, including those to
protect both patients and healthcare workers.
a. Personnel should receive device-specific reprocessing instructions to ensure proper
cleaning and high-level disinfection or sterilization.
b. Competency testing of personnel should be done regularly (e.g. annually)
c. Temporary personnel should not be allowed to reprocess endoscopes until
competency has been established.
4. All personnel using chemicals should be educated about the biological and
chemical hazards present while performing procedures that use disinfectants

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F. Cleaning and disinfection area:
1. Space used for the cleaning, disinfecting, and sterilizing should have
adequate ventilation to exhaust toxic vapors.
2. Air-exchange equipment (ventilation system, exhaust hoods, etc)
should be used to minimize the exposure of all persons to potentially
toxic vapors released from chemical sterilants.
3. The air system should provide at least 12 air change per hour for
negative room pressure.
4. The utility sink used to clean instruments should be functionally
separate from the hand hygiene sink, and be large enough to
accommodate the endoscope and accessories.
5. Adequate space should be designated for the storage of chemical
sterilant, with consideration given to their special handling
requirements as hazardous materials.
6. Cleaning/disinfection and sterilization will be carried out by trained
personnel only.

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G. Storage of Clean/Sterile Endoscopes:
1. Examine and test endoscope for proper angulation before storing. Hold
fiberscope with both hands when storing to prevent banging against
cupboard and therefore damaging fiberoptic bundles.
a. When storing the endoscope, hang it in a vertical position to facilitate
drying (with caps, valves and other detachable components removed
as per manufacturer instructions).
2. Endoscopes should be stored in a vertical manner that will protect the
endoscope and minimize the potential for residual moisture
accumulation; and allow for proper airing to ensure endoscopes are
kept dry.
3. Cabinets used for drying and storage of endoscopes should be
constructed of material that can be cleaned easily.
4. Endoscopes should not be stored in foam-lined cases, as foam lining is
impossible to clean and harbors contamination.
5. Endoscopes should be stored in a manner that will protect the
endoscope from contamination

Infection Control Guidelines for Endoscopy Unit [compatibility mode]

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