Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)
Last update: June 2024 89 of 163
k. Process endoscopes and accessories that contact mucous membranes as semicritical items, and
use at least high-level disinfection after use on each patient. Category IA.
1, 6, 8, 17, 108, 113, 115, 116, 129,
138, 145-148, 152-154, 278
l. Us
e an FDA-cleared sterilant or high-level disinfectant for sterilization or high-level disinfection
(Table 1). Category IA.
1, 6-8, 17, 85, 108, 113, 115, 116, 147
m. Af
ter 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). Category IB.
1, 6-8, 17, 38, 85, 108, 113, 145-148
n. Ex
tend 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 (Table 2). Category IB.
17, 69, 73, 76, 78, 83
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. Category IC.
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.”
12,
17, 19, 26, 27, 49, 55, 57, 58, 60, 73, 76, 79-81, 83-85, 93, 94, 104-106, 110, 111, 115-121, 124, 125, 233, 235, 236, 243, 265, 266, 609
Up
date [June 2011]:
Multisociety guideline on reprocessing flexible gastrointestinal
endoscopes: 2011 [PDF - 547KB]
(http://www.asge.org/uploadedFiles/Publications_and_Products/Practice_Guidelines/Multisociety%
20guideline%20on%20reprocessing%20flexible%20gastrointestinal.pdf).
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). Category IB.
83, 100, 689, 693, 694, 700
r. Sel
ect 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). Category IB.
69, 113, 116
s. Com
pletely immerse the endoscope in the high-level disinfectant, and ensure all channels are
perfused. As soon as is feasible, phase out nonimmersible endoscopes. Category IB.
108, 113-116, 137,
725, 856, 882
t. Af
ter 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. Category IB.
17, 31-35, 38, 39, 108, 113, 115, 116, 134, 145-148, 620-622, 624-630, 1017
u. Af
ter 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. Category IB.
39, 113, 115, 116, 145, 147
v. Hang
endoscopes in a vertical position to facilitate drying. Category II.
17, 108, 113, 115, 116, 145, 815
w. St
ore endoscopes in a manner that will protect them from damage or contamination. Category II.