STERILIZATION of

ENDOSCOPES
Dr.T.V.Rao MD
 Endoscopes and Infection

 Physicians use endoscopes to diagnose and treat

numerous medical disorders. Even though endoscopes
represent a valuable diagnostic and therapeutic tool in
modern medicine and the incidence of infection
associated with their use reportedly is very low (about 1
in 1.8 million procedures) 97, more healthcare–
associated outbreaks have been linked to contaminated
endoscopes than to any other medical device.
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 Dealing with heat senstive Endoscopes
 To prevent the spread of health-care–associated
infections, all heat-sensitive endoscopes (e.g.,
gastrointestinal endoscopes, bronchoscopes,
nasopharygoscopes) must be properly cleaned and, at a
minimum, subjected to high-level disinfection after
each use. High-level disinfection can be expected to
destroy all microorganisms, although when high
numbers of bacterial spores are present, a few spores
might survive.
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 Uses of Flexible Endoscopes
Flexible fiber optic or
video endoscope used in
the examination of the
hollow viscera (i.e.
colonoscope,
gastroscope,
duodenoscope,
sigmoidoscope,
bronchoscope).
 Why sterilizing Endoscopes
 Endoscopes are routinely
exposed to mucus and
other gastrointestinal
secretions, blood, saliva,
faeces, bile, and
sometimes pus. The
process of
decontamination
comprises two basic
components:
 Endoscopes are used in Invasive
procedures
 Endoscopes are classified as semi critical
instruments; if they enter sterile body cavities,
they are critical equipment. Certainly some
endoscopic accessories are considered critical --
sclerotherapy needles and cutting forceps are
two named in the AJIC article.
 Basic cleaning of Endoscopes
 Manual cleaning, which includes brushing with
single-use wire brushes, and exposure of all
external and accessible internal components to a
low-foaming enzymatic detergent known to be
compatible with the endoscope;
 Automatic disinfection, rinsing and drying of all
exposed surfaces of the endoscope
 Dealing with Endoscopes
 Semi critical items contact mucous membranes or no
intact skin. This category includes respiratory therapy
and anaesthesia equipment, some endoscopes,
laryngoscope blades , oesophageal manometer probes,
cyst scopes, anorectic manometer catheters, and
diaphragm fitting rings. These medical devices should
be free from all microorganisms; however, small
numbers of bacterial spores are permissible.

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 Dealing with Endoscopes
 Intact mucous membranes,
such as those of the lungs
and the gastrointestinal tract,
generally are resistant to
infection by common
bacterial spores but
susceptible to other
organisms, such as bacteria,
mycobacteria, and viruses
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Chemical Methods of
sterilization
 FDA cleared agents
 Glutaraldehyde, hydrogen peroxide, ortho-
phthalaldehyde, and per acetic acid with
hydrogen peroxide are cleared by the Food and
Drug Administration (FDA) and are dependable
high-level disinfectants provided the factors
influencing germicidal procedures are met.

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 Decontamination of Endoscopes
 Decontamination of endoscopes should be
undertaken at the beginning and the end of each
list, and between patients, by trained staff in
dedicated rooms. Thorough manual cleaning
with an enzymatic detergent, including the
brushing of all accessible endoscope channels,
must be undertaken before automatic endoscope
disinfection.
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 Minimal requirements
All disinfectants should be used at the
correct temperature in accordance with the
manufacturers’ instructions. Some
manufacturers provide test strips and/or
kits, the use of which they recommend in
ensuring optimal activity of their product.

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 The Ideal disinfectant ?
 Effective against a wide range of organisms including
blood-borne viruses and Prions proteins.
 Compatible with endoscopes, accessories and
endoscope reprocesses.
 Non-irritant and safe for users.
 Environmentally friendly
 However yet no totally safe chemical available.

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 Ethylene Oxide
 Ethylene oxide gas has been the standard for sterilizing
heat-sensitive items, including endoscopes. Sterilization
cycles are typically one and one-half to two hours at
55°C. Items must then be aerated mechanically for
eight to 12 hours. Ethylene oxide (EO) is being
gradually replaced in some hospitals with other
sterilization methods, such as steam, vapor-phase
methods and par acetic acid because of cost and safety
concerns. However, caution should exercised before
eliminating EO,
 Ethylene Oxide
A safety concern
 Ethylene oxide (EtO) gas sterilizers have been used by
hospitals for over 40 years to sterilize surgical
equipment and supplies that are heat sensitive or that
cannot tolerate excessive moisture. However, in recent
decades, EtO has been recognized as a potential
mutagenic, reproductive, neurological, and fire and
explosion hazard to workers, and one agency has
reportedly voted to classify EtO as carcinogenic to
humans.
 OSHA regulates Use of Ethylene Oxide

 Strict regulations
concerning EtO
exposure have been
imposed by the
Occupational Safety
and Health
Administration
(OSHA),
 Use of Aldehydes
 It should be emphasised that aldehydes, such as ortho-
phthalaldehyde and glutaraldehyde, fix protein, a
property which may not only stabilise prion infectivity,
but also render it more difficult to remove by other
means. Aldehydes should never be used for
disinfection until the equipment has been
thoroughly cleaned, with all accessory channels
manually brushed, washed with enzymatic
detergent and rinsed with water.
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 Glutaraldehyde
 Glutaraldehyde should be in contact with all internal
and external surfaces and channels of the device for at
least 20 minutes. Since it is an irritant, the following
measures should be considered to ensure safer working
conditions (superior ventilation) for reprocessing staff:
"ducted exhaust hoods, air systems that provide seven
to 15 air exchanges per hour, ductless fume hoods with
absorbents for the vapour, tight fitting lids on
immersion baths, and automated endoscope
processors."
 Effectiveness of Glutarladehyde
 The FDA label claim for high-level disinfection
with greater than 2% glutaraldehyde at 25°C
ranges from 20 to 90 minutes depending on the
product. However, multiple scientific studies
and professional organizations support the
efficacy of greater than 2% glutaraldehyde at 20
minutes at 20°C
 Hydrogen Peroxide
 Although hydrogen peroxide can damage rubber and
plastics and corrode copper, zinc and brass, it is suitable
for endoscope reprocessing as long as it is not
contraindicated in the endoscope reprocessing
instructions. The solution to be used should be 7.5
percent hydrogen peroxide and 0.85 percent
phosphoric acid.

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 Peracetic acid
 Peracetic acid is connected to several health
hazards, including severe burns (from direct skin
contact), irreversible damage or blindness (from
direct contact with the eyes), and irritation of the
nose, throat and lungs (from inhalation of the
per acetic acid vapor).
 However the compound found to be useful in
decontamination of endoscopes.
 Peracetic acid with hydrogen peroxide
 The combination
of these agents has
been approved by
the FDA for
sterilizing semi
critical medical
devices
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 Orthophalaldehyde
 Orthophalaldehyde apparently has several
advantages over glutaraldehyde; it has "excellent
stability over a wide pH range of 3-9" and does
not irritate the eyes or nasal passages, and it does
not require activation before use.
 Emerging chemical agents
 Super oxidized water is the aqueous solution which is
produced in the anode side by electrolysis of sodium
chloride or potassium chloride added to the water and
shows strong sterilization action. The super oxidized
water is a powerful disinfectant which follows
glutaraldehyde, and it is effective for nutrition bacteria,
MRSA, general viruses and other microbes. There is no
resistant microbe against the super oxidized water. The
super oxidized water is safe to the human body.
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 Super Oxidized water in sterilization
 Super-oxidized water” – also
known as anolyte – is water
that has had an electric
current passed through it,
thereby generating a number
of oxidized species. This is an
electrochemical (or
oxidation-reduction) process.
Specifically, it is an
electrolysis process.
 Super-oxidized water
 In recent years, neutral
electrolyzed water ('NEW')
has been developed as a high-
level non-corrosive
disinfectant, able to penetrate
cell membranes more
effectively in comparison
with acidic electrolyzed water
('AEW') or Sodium
Hypochlorite or other
traditional chemical
disinfectants.
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 High level disinfection
 The FDA definition of high-level disinfection is
a sterilant used for a shorter contact time to
achieve a 6-log10 kill of an appropriate
Mycobacterium species. Cleaning followed by high-
level disinfection should eliminate enough
pathogens to prevent transmission of infection.
 Physical exposure too is important
 Completely immerse the
endoscope and its
components in the high-level
disinfectant/sterilant and
ensure that all channels are
perfused. Nonimmersible
gastrointestinal endoscopes
should be phased out
immediately.
Final removal of disinfectant after
disinfection.
 After high-level disinfection,
rinse the endoscope and
flush the channels with
sterile, filtered, or tap water
to remove the disinfectant.
Discard the rinse water after
each use/cycle. Flush the
channels with 70% to 90%
isopropyl alcohol.
 STERIS® from Steris Corporation
 STERIS®  is a "cold" liquid sterilization. Acetic
peroxide is mixed with sterile water; the
instruments to be  sterilized are washed with
solvents. After twelve minutes of dipping the
instrument in the sterilizing solution,     the
solution is pumped out and the instrument is
rinsed with sterile water four times

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 STERIS® from Steris Corporation
 The working channel of rigid / flexible
endoscopes can be attached to a pressurized
fitting for sterilization.  The mixture of water
and acetic peroxide is controlled during the
dipping procedure with recording concentration
and temperature increasing to 50 0C (122 0F)  -
55.5 0C (131.9 0F) . 

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 Ortho-phthalaldehyde: a New Chemical
Sterilant

 Ortho-phthalaldehyde (OPA) received clearance by FDA in

October 1999. OPA solution is a clear, pale-blue liquid (pH, 7.5),
which typically contains 0.55% OPA. OPA has demonstrated
excellent microbiocidal activity in in vitro studies For example, it
has shown superior mycobactericidal activity (5-log10 reduction
in 5 minutes) compared with Glutaraldehyde. The mean time
required to effect a 6-log10 reduction for M. bovis using 0.21%
OPA was 6 minutes, compared with 32 minutes using 1.5%
glutaraldehyde
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 Ortho-phthalaldehyde: a New Chemical
Sterilant
 When tested against a wide range of microorganisms,
including glutaraldehyde-resistant mycobacteria and
Bacillus subtilis spores , OPA showed good activity
against the mycobacteria tested, including the
glutaraldehyde-resistant strains, but 0.5% OPA was not
sporicidal within 270 minutes of exposure. Increasing
the pH from its unadjusted level (about 6.5) to pH 8
improved sporicidal activity.
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 Emerging Methods
 Other agents currently
being investigated for
efficacy in sterilization
and disinfection include
chlorine dioxide, ozone,
vapor-phase hydrogen
peroxide and plasma
technology.

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 Emerging Technology – Gas Plasma
 Low-temperature hydrogen
peroxide gas plasma has also
made its mark on device
manufacturers for sterilizing
temperature-sensitive
polymeric materials. This
method offers rapid
turnaround time, in-house
control of the sterilization
process, and lower inventory
requirements.
 Sterilization of autoclavable
Endoscopes          
 Prepare the Endoscope by washing the outside with
mild soap and warm water. Approved instrument wraps
should  be folded around the Scope and it should be
placed in an approved sterilizer tray on a soft surface.
 The instrument should be autoclaved.
 At present few endoscopes can be sterilized by heat
( Autoclaving )
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 Testing the sterilization activity
 Perform routine testing of the
liquidsterilant/high-level disinfectant to ensure
minimal effective concentration of the active
ingredient. 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
minimal effective concentration, the solution
should be discarded. CategoryIA
 Health care workers should follow
standard guidelines
 All healthcare personnel in the endoscope suite
should be trained in and adhere to standard
infection control recommendations (eg, standard
precautions), including those to protect both
patients and healthcare workers.Category IA9
 Keep a Log for accountability of
Transmission of Infections
 A record should be kept
of the serial number of
each endoscope used in
each patient. This is
important for any future
contact tracing when
possible endoscope
transmission of disease is
being investigated.
 Endoscopy staff – Occupational Safety
 Endoscopy staff should be educated regarding hazards
associated with performing/assisting with endoscopies
and with reprocessing. They should be trained
regarding the Occupational Safety and Health
Administration (OSHA)s hazardous communications
standard, and should have access to a spill containment
plan pertinent to the sterilant or disinfectant being used
when reprocessing occurs.

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 Protection against the Chemical
disinfectants.
 All personnel using
chemicals should be
educated about the
biological and chemical
hazards present while
performing procedures
that use disinfectants.

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 Decontaminating vCJD
 At present conventional
sterilisation methods cannot
reliably destroy PrPsc, the
infecting agent in vCJD, but
the likelihood of equipment
becoming contaminated with
infective tissue is small.
Rigorous cleaning techniques
will reduce the risk even
further.

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 Routine Methods not effective in
decontamination of vCJD
 Putative infecting agent
in vCJD cannot be
removed or destroyed by
conventional sterilisation
or decontamination
methods.
 Emerging methods to sterilize CJD
 ERI's new process, or MIDAS, will effectively reduce
the incidence of CJD infection and number of
operations cancelled due to contaminated instruments,
according to ERI researchers. The team at ERI also
reports that their studies demonstrate that the MIDAS
process is at least 1,000 times more effective than
traditional cleaning methods and does not damage
surgical instruments.

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 Compliance reduces transmission of
Infections
 Compliance with accepted
guidelines for the
reprocessing of
gastrointestinal endoscopes
between patients is critical to
the safety and success of
their use. When these
guidelines are followed,
pathogen transmission can be
effectively prevented.

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Dr.T.V.Rao MD
Email
doctortvrao@gmail.com