Author:Sivakumar Murugesan.
Consultant Hospitals Project and Patient Safety & Quality Improvement
a. To detect damaged
endoscopes, test each flexible endoscope for leaks as part of each reprocessing
cycle. Remove from clinical use any instrument that fails the leak test, and
repair this instrument.
b. Immediately after use, meticulously
clean the endoscope with an enzymatic cleaner that is compatible with the
endoscope. Cleaning is necessary before both automated and manual disinfection.
c. Disconnect and
disassemble endoscopic components (e.g., suction valves) as completely as
possible and completely immerse all components in the enzymatic cleaner. Steam
sterilize these components if they are heat stable.
d. Flush and brush all
accessible channels to remove all organic (e.g., blood, tissue) and other
residue. Clean the external surfaces and accessories of the devices by using a
soft cloth or sponge or brushes. Continue brushing until no debris appears on
the brush.
e. Use cleaning brushes
appropriate for the size of the endoscope channel or port (e.g., bristles
should contact surfaces). Cleaning items (e.g., brushes, cloth) should be
disposable or, if they are not disposable, they should be thoroughly cleaned
and either high-level disinfected or sterilized after each use.
f. Discard enzymatic
cleaners (or detergents) after each use because they are not microbicidal and,
therefore, will not retard microbial growth.
g. Process endoscopes
(e.g., arthroscopes, cystoscope, laparoscopes) that pass through normally
sterile tissues using a sterilization procedure before each use; if this is not
feasible, provide at least high-level disinfection. High-level disinfection of
arthroscopes, laparoscopes, and cystoscopes should be followed by a sterile
water rinse.
h. Phase out endoscopes
that are critical items (e.g., arthroscopes, laparoscopes) but cannot be steam
sterilized. Replace these endoscopes with steam sterilizable instruments when
feasible.
i. Mechanically clean
reusable accessories inserted into endoscopes (e.g., biopsy forceps or other
cutting instruments) that break the mucosal barrier (e.g., ultrasonically clean
biopsy forceps) and then sterilize these items between each patient.
j. Use ultrasonic cleaning
of reusable endoscopic accessories to remove soil and organic material from
hard-to-clean areas.
k. Process endoscopes and
accessories that contact mucous membranes as semicritical items, and use at
least high-level disinfection after use on each patient.
l. Use an FDA-cleared
sterilant or high-level disinfectant for sterilization or high-level
disinfection
m. After cleaning, use
formulations containing glutaraldehyde, glutaraldehyde with phenol/phenate,
ortho-phthalaldehyde, hydrogen peroxide, and both hydrogen peroxide and
peracetic acid to achieve high-level disinfection followed by rinsing and
drying (see Table 1 for recommended concentrations).
n. Extend exposure times
beyond the minimum effective time for disinfecting semicritical patient-care
equipment cautiously and conservatively because extended exposure to a
high-level disinfectant is more likely to damage delicate and intricate
instruments such as flexible endoscopes. The exposure times vary among the Food
and Drug Administration (FDA)-cleared high-level disinfectants
o. Federal regulations are
to follow the FDA-cleared label claim for high-level disinfectants. The FDA-
cleared labels for high-level disinfection with >2% glutaraldehyde at 25°C
range from 20-90 minutes, depending upon the product based on three tier
testing which includes AOAC sporicidal tests, simulated use testing with
mycobacterial and in-use testing.
p. Several scientific
studies and professional organizations support the efficacy of >2% glutaraldehyde
for 20 minutes at 20ºC; that efficacy assumes adequate cleaning prior to
disinfection, whereas the FDA-cleared label claim incorporates an added margin
of safety to accommodate possible lapses in cleaning practices. Facilities that
have chosen to apply the 20 minute duration at 20ºC have done so based on the
IA recommendation in the July 2003 SHEA position paper, “Multi-society
Guideline for Reprocessing Flexible Gastrointestinal Endoscopes.”
q. When using FDA-cleared
high-level disinfectants, use manufacturers’ recommended exposure conditions.
Certain products may require a shorter exposure time (e.g., 0.55%
ortho-phthalaldehyde for 12 minutes at 20°C, 7.35% hydrogen peroxide plus 0.23%
peracetic acid for 15 minutes at 20°C) than glutaraldehyde at room temperature
because of their rapid inactivation of mycobacteria or reduced exposure time
because of increased mycobactericidal activity at elevated temperature (e.g.,
2.5% glutaraldehyde at 5 minutes at 35°C).
r. Select a disinfectant
or chemical sterilant that is compatible with the device that is being
reprocessed. Avoid using reprocessing chemicals on an endoscope if the
endoscope manufacturer warns against using these chemicals because of
functional damage (with or without cosmetic damage).
s. Completely immerse the
endoscope in the high-level disinfectant, and ensure all channels are perfused.
As soon as is feasible, phase out nonimmersible endoscopes.
t. After high-level
disinfection, rinse endoscopes and flush channels with sterile water, filtered
water, or tapwater to prevent adverse effects on patients associated with
disinfectant retained in the endoscope (e.g., disinfectant induced colitis).
Follow this water rinse with a rinse with 70% - 90% ethyl or isopropyl alcohol.
u. After flushing all
channels with alcohol, purge the channels using forced air to reduce the
likelihood of contamination of the endoscope by waterborne pathogens and to
facilitate drying.
v. Hang endoscopes in a
vertical position to facilitate drying.
w. Store endoscopes in a
manner that will protect them from damage or contamination.
x. Sterilize or high-level
disinfect both the water bottle used to provide intraprocedural flush solution
and its connecting tube at least once daily. After sterilizing or high-level
disinfecting the water bottle, fill it with sterile water.
y. Maintain a log for each
procedure and record the following: patient’s name and medical record number
(if available), procedure, date, endoscopist, system used to reprocess the
endoscope (if more than one system could be used in the reprocessing area), and
serial number or other identifier of the endoscope used.
z. Design facilities where
endoscopes are used and disinfected to provide a safe environment for
healthcare workers and patients. Use air-exchange equipment (e.g., the
ventilation system, out- exhaust ducts) to minimize exposure of all persons to
potentially toxic vapors (e.g., glutaraldehyde vapor). Do not exceed the
allowable limits of the vapor concentration of the chemical sterilant or high-level
disinfectant (e.g., those of ACGIH and OSHA).