Chapter 6:

Decontamination and Reprocessing of

Medical Devices

1
 Learning Objective
• Understand General overview of sterile services
• Describe the steps of instruments and other items
processing
• List commonly used disinfectants
• Elucidate the steps of cleaning process, sterilization and
HLD
• Explain how to store safely sterilized and high level
disinfected instrument and other items
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 Overview
• Instruments which are reused without being properly processed and made
safe are one of the causes of infections in developing countries.
• Healthcare workers are increasingly at risk of becoming infected with serious
blood borne viruses such as HBV, HCV and HIV.
• The basic infection prevention processes recommended to reduce disease
transmission from soiled instruments; surgical gloves and other reusable
items are by way of cleaning and either sterilization or high-level disinfection
(HLD).
• In all steps, special attention should be given to proper handling of the
instruments and other items to
– Minimize the risk of accidental injury or exposure to blood and other
body fluids of the sterile processing staff and
– To attain high quality end result.
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 Level of Disinfection or Sterilization Required
• A rational approach for processing medical devices and
surgical instruments for patient care was first described by
Earle H. Spaulding in 1968.
• It is still relevant in making decisions about the final
approach to instrument processing.

4
 Spaulding’s category of potential infection risk
• Spaulding classified instruments and patient care devices into
three categories, based upon how the device is used. Items are
classified as:
– Non-critical—come in contact with intact skin but not
mucous membranes
– Semi-critical—come in contact with mucous membranes or
non-intact skin
– Critical—come in contact with sterile areas of the body
including the vascular system

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 Spaulding’s Risk Classification and Level of Processin

Risk category Level of Examples

disinfection/sterili
zation
Critical Sterilization Reusable surgical instruments
Semi-critical High-level Respiratory instruments, speculum
disinfection used for vaginal examination
,endoscopes
Non-critical Low/Intermediate Blood pressure cuffs, stethoscopes
disinfection/
Cleaning 6
Work flow for instrument processing

7
 Overview cont’d…
• Do not soak instruments in disinfectant prior to cleaning
• According to the WHO, soaking of instruments in 0.5% chlorine
solution or any other disinfectant prior to cleaning
– May damage/corrode the instruments
– The disinfectant may be inactivated by blood and body fluids,
which could become a source of microbial contamination and
formation of biofilm
– May contribute to the development of antimicrobial resistance to
disinfectants.
– May pose a risk to health care workers and result in inappropriate
handling and accidental damage (while transportation of
contaminated items soaked in chemical disinfectant to the
decontamination area)
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 What are Disinfectants?
• Disinfectants are chemicals that destroy or inactivate
microorganisms in inanimate objects.
– Alcohols
– Chlorine and chlorine releasing compounds
• Sodium hypochlorite (Chlorine bleach), Calcium
hypochlorite or chlorinated lime, Sodium
dichloroisocyanurate
– Glutaraldehyde
– Formaldehyde
– Iodine and Iodophor solutions
– Hydrogen Peroxide
– Orthophthalaldehyde (OPA)
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 Properties of an Ideal Disinfectant
• Wide antimicrobial spectrum • Easy to use with clear label
• Rapidly kills microorganisms instructions
• Non-toxic • Pleasant odor or no odor to
• Active in the presence of organic facilitate its routine use
matter and compatible with • Not prohibitively high in cost
soaps, detergents, and other • Soluble in water
chemicals encountered in use • Stable in concentrate and at use-
• Does not cause the deterioration dilution
of cloth, rubber, plastics, and • Good cleaning properties
other materials. • Environmentally friendly on
disposal
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 Cleaning
• Cleaning is a process of physically removing infectious agents
and other organic matters on which they live and thrive but does
not necessarily destroy infectious agents.
• It is an essential pre-requisite to ensure effective disinfection or
sterilization by reducing the number of microorganisms,
especially endospores causing tetanus.
• Cleaning is the first and a critical step in reprocessing a device
after use..
• It reduces damage to instruments.
• It makes instruments easier to process.
• One can clean without sterilizing, but one cannot sterilize without
cleaning!
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 If instruments are not properly cleaned:
• Bioburden and residual cleaning agents remaining on an item can
inactivate chemical disinfectants or sterilants and protect
microorganisms from destruction, which can result in disinfection and
sterilization failures.
• And also instruments and materials used during an operation that are
covered with blood and tissue remains may also have been in touch also
with chemicals and fluids, dirt and dust.
• Hinged instruments may have remnants of blood and tissue from the
operation. The tubing of hollow instruments may be also full of these
soiled materials.
• Therefore, it is important to follow all the necessary steps to properly
clean instruments prior to high-level disinfection or sterilization.

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 Effectiveness of Methods of Processing Instruments
EFFECTIVENESS (kill
METHOD END POINT
or remove
microorganisms)
Cleaning (soap and Up to 80% Until visibly clean
rinsing with water)

High-Level Disinfection 95% (does not inactivate Boiling or chemical for 20

endospores) minutes

High-pressure steam,
Sterilization 100%
dry heat or chemical for
the recommended time
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 Steps of manual cleaning:
• Put on Personal Protective Equipment (PPE) including a water resistant gown,
gloves, face mask and head cover.
– If gloves are torn or damaged, they should be discarded; otherwise, they
should be cleaned and left to dry for re-use in the following day.
– Even when wearing heavy-duty utility gloves, care should be taken to
prevent needle sticks or cuts when washing sharps.
• Fill sink or appropriate basin with sufficient warm water for complete
immersion of the devices being cleaned.
• Add the appropriate quantity of detergent following the manufacturer’s
instructions for dosage.
• Clean the device under the surface of the water so that aerosols are not
produced.
• All devices be disassembled so that all surfaces may be cleaned and disinfected,
irrespective of the cleaning method chose.
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 Steps of manual cleaning cont’d…
• Use appropriate brushes to properly clean box locks, lumens and other hard-to-clean
areas
– Use soft (nylon) bristle brushes so that the surface of the instrument is not
damaged.
– Brushes used to clean lumens must be the same diameter as the instrument to
ensure that all internal surfaces can be reached.
– Brushes must also be long enough to exit the distal end of the instrument
– Brushes should be thermally or chemically disinfected at the end of the day, if this
is not possible, they should be cleaned and left to dry.
– Brushes should be replaced when damaged.
• In another sink or basin, completely immerse the device in clean purified water and
rinse the device thoroughly.
• Air-dry or hand-dry using a disposable clean, non-linting cloth.
• Items that cannot be cleaned thoroughly should not be reused, but be discarded after
use.
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 Cleaning Products and their properties
• There is no single cleaning agent that removes all types of
bioburden.
• Bioburden is made up of a variety of matter, which may be
soluble or insoluble in water and can be organic or inorganic.
• Properties associated with ideal cleaning agents:
– Emulsification and Surfactation
– Dispersion and suspension
– Water softening
– Free rinsing
– Non-toxic
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 Packing and Wrapping
• The inspection, assembly and packaging is a crucial part of the
instruments reprocessing cycle.
• Thoroughly clean and dry before being disinfected or prepared
for sterilization.
• In some cases, it is not necessary to completely dry the items (the
small amount of water left inside needles openings help in the
steam sterilization process.
• For such items, flushing them with distilled or boiled water just
prior to packaging for steam sterilization should be done after
cleaning.
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 Packing and Wrapping cont’d…
• Finally, all jointed instruments should be open (or be
unlocked) and disassembled.
• Reusable cloth items should be laundered and dried after use
or prior to sterilization in order to:
– Remove organic matter, and
– Prolong the life of the cloth by restoring the fabric’s
normal moisture (water) content.

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 Inspection and function testing (post-cleaning)
• Each set should be inspected separately
• Box joints, serrations and crevices should be critically inspected
for cleanliness
• Hinges on devices, such as artery forceps and clamps, should be
checked for ease of movement
• Jaws and teeth should be checked for alignment
• Ratchets should be checked for security
• Multi-part instruments should be assembled to ensure that all
parts are complete and working

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 Inspection and function testing (post-cleaning)
cont’d…
• Multi-part instruments should be assembled or disassembled for
sterilization per manufacturers’ instructions.
• Any damaged, incomplete or malfunctioning devices should be
reported immediately to the supervisor.
• Cutting edges on devices, such as scissors, rongeurs, chisels and
curettes, should be checked for sharpness.
• Hinges on devices, such as artery forceps and clamps, should be
checked for ease of movement.
• Each device should be checked after each cleaning cycle to ensure that
all screws on jointed devices are tight and have not become loose
during the cleaning process.

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 Packing and wrapping for steam sterilization
• Wrapping items to be sterilized permit sterile items to be
handled and stored without being contaminated
• Materials used for wrappers should:
– Allow air removal and steam penetration
– Act as a barrier to microorganisms and fluids
– Capable of withstanding high temperatures
– Resist tears and punctures and be free of holes
– Be nontoxic and low-lint
– Not be costly
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Typical Wrapping Techniques

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 Tips for wrapping cont’d…
• The outer wrapper of the pack can be loosely secured
using linen ties.
• Packs can be secured with linen ties made from the same
cloth.
• Do not wrap items in any waterproof material such
as plastic or canvas for steam sterilization as the steam
cannot penetrate the material and leave the item
unsterilized.
• Wrappers should not be reused if they are torn, stained
with oils or have hard or gummy deposits.

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 Tips for wrapping
• At least two layers of wrapping should always be used to reduce the
possibility of contaminating the contents during unwrapping.
• Do not wrap packages too tightly.
– If they are wrapped too tightly, air can become trapped at the center of the
packages preventing the temperature from getting high enough to kill all the
microorganisms.
– Also, wrapping with strings or rubber bands or tying linen too tightly can
prevent steam from reaching all surfaces.
• Hemmed strips of about ½ inch wide and of varied lengths., one or
two of such strips can be used for each package.
• Because they can fit to almost any size of package, they eliminate the
need for an expensive and hard-to-remove indicator tape.

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 Packing and wrapping for dry heat sterilization
• Packaging materials for dry-heat sterilization should
– Allow easy heat penetration,
– Provide an adequate barrier to microorganisms after
sterilization,
– Resist tearing or puncturing before and after sterilization,
– Have proven seal integrity,
– Allow for ease of aseptic presentation,
– Be free of toxic ingredients,
– Be low-linting or lint-free, and
– Be cost-effective and readily available.
– The material should have been approved for use with dry-heat
sterilization.
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 High level disinfection
• Sterilization is the safest and most effective method for the
reprocessing of surgical instruments because it kills all vegetative
microorganisms and microbial spores.
• However, sterilization is not always suitable because some
materials cannot with-stand the high temperatures used during
the sterilization process and sterilization may not be consistently
available in some low-resource settings.
• Semi-critical devices) must, at a minimum, be high level
disinfected.
• Non-critical devices that come in contact with intact skin should
be processed by intermediate- or low-level disinfection.
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 High level disinfection cont’d…
• Destroys all microorganisms including HBV, HCV, and HIV;
but does not reliably kill all bacterial endospores.
• High-level disinfection can be achieved by:
– Pasteurization/ Boiling in water,
– Steaming
– Soaking instruments in chemical disinfectants (chemical
disinfection).

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 High-level disinfection by boiling

• Pasteurization by boiling; is carried out by

– heating at 770C (170.60F) for 30 minutes or boiling at
1000C (2120F) for 20 minutes.
• Boiling in water is an effective and practical way to HLD
instruments and other items.
• Boiling can be sometimes used for critical procedures in some
low-income countries if it is the only available option.

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 Instructions for HLD by boiling
• STEP 1 Clean all instruments along with other items to be
high level disinfected.
• STEP 2 If possible, completely immerse items in the water.
• Adjust the water level so that there is at least 2.5cm (1 inch)
of water above the instruments.
• Metal instruments should be completely covered with water
during boiling.

29
 Instructions for HLD by boiling cont’d…
• STEP 3 Close-lid over pan and bring water to a gentle rolling
boil.
• Boiling too vigorously wastes fuel, rapidly evaporates the
water and may damage delicate [or sharp] instruments or
other items.
• STEP 4 Start timer.
– In the HLD log, note time on the clock and record the
time when rolling boil begins.
– Do not add anything to the pot after timing begins.
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 Instructions for HLD by boiling cont’d…
• STEP 5 Boil all items for the required time: 30 minute at 770C
(170.60F) or 20 minutes at 1000C (2120F).
• STEP 6 Remove all items after the recommended time with a
high-level disinfected forceps.
• STEP 7 Use instruments and other items immediately or
else, pick them up with high-level disinfected forceps or
gloves and place objects in a high-level disinfected container
with a tight-fitting cover.

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 High-level disinfection by steaming
• High-level disinfection by steaming is an option for plastic items used for
patient care.
• Materials needed for high-level disinfection by steaming include:
– Steamer pan without holes to hold water (such as momo steamer)
– Two to three additional pans with holes to allow steam to move to
upper pan
– The pans should be deep enough to fit the largest item being steamed
– A tight-fitting lid to cover the upper pan
– An additional bottom pan for drying the processed items

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Steamer Used for HLD

33
Steamer Used for HLD

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 Instructions for HLD by steaming

• STEP 1 Perform hand hygiene and

• STEP 2 Fill the bottom pan of the steamer with
approximately 1 liter of clean water – about half the volume
of the pan
• STEP 3 Place instruments, plastic MVA cannula and other
items in one of the steamer pans with holes in its bottom.

35
 Instructions for HLD by steaming
• To make removal from the pan easier, do not overfill the pan.
• Repeat this process up until three steamer pans have been
filled. Stack the filled steamer pans on top of a bottom pan
containing water for boiling. A second empty pan without
holes should be placed on the counter next to the heat source
(see Step 7)
• STEP 4 Place a lid on the top pan and bring the water to a full
rolling boil.
• It should be noted that when water only simmers, very little
steam is formed and the temperature may not get high enough
to kill microorganisms.
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 Instructions for HLD by steaming
• STEP 5 When steam begins to come out between the pans and
the lid, start the timer or note the time on a clock and record the
time in the HLD log.
• STEP 6 Steam items for 20 minutes.
• STEP 7 Remove the top steamer pan and put the lid on the pan
that was below it (the pan now on top). Gently shake excess
water from the pan just removed.
• STEP 8 Put the pan just removed onto the empty pan (see Step 3).
Repeat until all pans are restacked on this empty pan and cover
the top pan with the lid. This step allows the items to cool and
dry without becoming contaminated.
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 Instructions for HLD by steaming
• STEP 9 Allow items to dry in the air while in the steamer
pans (1 to 2 hours) before using.
• STEP 10 Using a high-level disinfected forceps; transfer the
dry items to a dry, high-level disinfected container3 with a
tight-fitting cover.
Instruments and other items can also be stored in the
stacked and covered steamer pans as long as a bottom pan
(with no holes) is used.

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 Boiling Versus Steaming
• In both boiling and steaming, moist heat is used to kill
microorganisms.
• Steaming has several distinct advantages over boiling for the final
processing of surgical gloves and other items such as plastic
cannula and syringes.
• It is less destructive and more cost-effective for it uses much less
fuel than boiling
• It is free from discoloration of instruments resulting from calcium
or other heavy metals contained in some tap water for the steam
contains only pure water molecules.
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 Boiling Versus Steaming
• The major limitation of steaming is that if the steamers
available locally are small, they can practically be used only
for a small number of items.
• For steaming to be effective, the bottom pan must contain
enough water to continue boiling throughout the steaming
process
• By contrast, large boiling pots are easier to use for metal
instruments and do not need to be monitored the entire time
to be sure that the process is being done correctly.

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 High-level disinfection using chemicals
• Commercially available in most countries, four disinfectants-
– Formaldehyde,
– Glutaraldehydes,
– Ortho-phthalaldehyde (OPA) and
– Peroxide-are routinely used as high- level disinfectants.
• Selection is based on the characteristics of the items to be
disinfected, the physical area and the skills of personnel available
to do the procedure.
• Items must be thoroughly cleaned before immersion disinfected
to effective high-level disinfection.
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 Key steps in chemical high-level disinfection
• STEP 1 Thoroughly Clean instruments and other items
• STEP 2 Completely immerse all items in the high-level
disinfectant chemicals.
• STEP 3 Soak them for 20 minutes.
• STEP 4 Remove items using high-level disinfected or sterile
forceps or gloves.
• STEP 5 Rinse well with boiled and filtered (if necessary) water
three times and air dry.
• STEP 6 Use promptly or store in a dry, high-level disinfected
and covered container

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 Factors That Affect Disinfection Process
• Quantity and location of the microorganisms
• Quantity and location of organic matter
• Concentration of the disinfectant
• Physical and chemical factors
• Duration of exposure
• Resistance of microorganism to the chemical agent

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 Sterilization
• Sterilization is a process in which the destruction of all micro-
organisms including bacterial endospores takes place.
– Necessary for medical devices penetrating sterile body sites
• Sterilization in health facilities can be achieved by either
physical or chemical methods
– High pressure steam (autoclaves),
– Dry heat (oven),
– Chemical sterilants (Glutaraldehyde or formaldehyde
solutions)

44
 Essentials of Sterilization Process:
1. The sterilants and sterilizing equipment must be validated and
appropriate in design and operation to correctly integrate key
yardsticks like: time, temperature, contact, pressure (for steam
sterilization) and right sterilants (for chemical sterilization) to be as
effective as they should be.
2. Instruments must be thoroughly cleaned to reduce dirt in order to
guarantee effectiveness of the sterilization process.
The higher the dirt the greater the challenge to the sterilization
process. Therefore, it could be said that the effective sterilization is
entwined with an effective removal of the dirt before making it ready
for sterilization.
3. There must be close and adequate contact between the chemical
sterilant and all surfaces and crevices of the device to be sterilized.

45
The effectiveness of any sterilization method is dependent upon
four other factors

1. The type of micro-organism present.

2. The number of micro-organisms present.
3. The amount and type of organic material that protects the
micro-organisms.
4. The number of cracks and scratches on an instrument
that might harbor micro-organisms.
• Sterilization is a process, not a single event; therefore, all
phases and steps in the process must be carried out correctly.
46
 High pressure steam sterilization method
• Saturated steam is an extremely effective carrier of thermal
energy that makes it many times more effective in conveying the
necessary energy to the items to be sterilized than dry air.
• Steam is an effective sterilant in that it can soften any resistant
and protective outer layer of the micro-organisms allowing
coagulation of the inner sensitive portion of the micro-
organisms.
• Advantages
– Most commonly used effective method of sterilization.
– Sterilization cycle time is shorter in steam sterilization
than in any other type of sterilization.
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High pressure steam sterilization method cont’d…
• Limitation
– Requires a continuous source of heat (wood fuel, kerosene or electricity).
– Requires a trained biomedical technician to perform preventative
maintenance.
– Requires strict adherence to time, temperature and pressure settings.
– Difficult to produce dry packs because breaks in procedure are
common (e.g. not allowing items to dry before removing, especially in
hot, humid climates).
– Repeated sterilization cycles can cause pitting and dulling of cutting
edges of instruments i.e. scissors).
– Plastic items cannot withstand high temperatures.

48
 There are three types of high-pressure steam sterilizers:

1. Gravity displacement
2. Prevacuum
3. Flash or Immediate use sterilizers (IUS)

49
 Operation
• A steam sterilizer will reliably sterilize items only when kept in
good working condition and operated correctly.
• Sterilization by steam requires four conditions:
– Adequate contact,
– Sufficient temperature,
– Proper time and
– Sufficient moisture.
• Even if these conditions are all necessary for sterilization to
take place, sterilization failures in clinics and hospitals are
most often caused by lack of steam contact or failure to attain
adequate temperature
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 Effective sterilization depends on correctly
following procedures of the process
• These include:
– Routine maintenance,
– Preparing items to be sterilized,
– Packaging and wrapping,
– Loading,
– Operating, and
– Unloading the sterilizer.

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 Routine Maintenance
• The chamber should be cleaned daily using a soft cloth, or for
large sterilizers, a long- handled mop which is used only for this
purpose. Do not use abrasives or steel wool because they may
scratch the stainless steel surface and increase the occurrence of
corrosion.
• All door gaskets should be cleaned daily with a lint-free cloth
and checked for defects. Defective rubber gaskets should be
replaced.
• The carriage (loading cart used to hold the packs placed in a
sterilizer) should be cleaned daily using a mild soap and lint-
free cloth.
• The exhaust line (or chamber drain) should be flushed weekly.
52
 Loading
• To load items into the autoclave in such a way that it allows
passage of the most steam through the load.
• The total weight of an individual pack should not exceed 11
kg (24 pounds).
• When loading, leave sufficient space for steam to circulate
freely and avoid overloading. Always leave 3 inches between
the top-most pack and the top of the chamber. Items should
not touch the chamber wall. Never overload the sterilization
chamber.
• Do not place packages on the floor of the chamber.
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Loading Steam Sterilizer

54
 Unloading
• To unload the steam autoclave so as to maintain the sterility of the items
processed through a sterilizing cycle.
• Open the sterilizer door slightly 12-14 cm (5-6 inches) at the end of the
cycle (when the chamber gauge reaches “0”) and allow items to remain
inside to reduce the potential for condensation (formation of water
drops on the packages).
• Allow instrument packs to dry completely before removal (usually takes
30 minutes). Cooling time could be as long as 2 hours, based on room
temperature and humidity.
• Wet packs are never acceptable.
• Return any pack that is wet for reprocessing (remove items from the
package and repackage before reprocessing).
• Do not handle the packs during the cooling time
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 Unloading cont’d
• Place sterile trays and packs on surfaces padded with paper or
fabric (avoid placing warm packs on cold metal surfaces so as
to prevent condensation).
• Store when packs reach room temperature (usually takes about
an hour).
• Sterilized packs and articles should be handled gently and used
as reasonably as possible.
• Return any pack that drops on the floor for reprocessing
(remove items from the package and repackage before
reprocessing).
• If a pack is dropped, turns to be moist or comes into contact
with moisture, it must be considered contaminated.
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 Instructions of operating a steam sterilizer
• STEP 1 Thoroughly clean and dry all instruments and other items to be
sterilized.
• STEP 2 All jointed instruments should be in an open or unlock position,
while instruments composed of more than one part or sliding parts should
be disassembled.
• STEP 3 Instruments should not be held tightly together by rubber bands or
any other means that will prevent steam contact with all surfaces.
• STEP 4 Arrange packs in the chamber to allow free circulation and
penetration of steam to all surfaces.
• STEP 5 When using a steam sterilizer, it is best to wrap clean instruments or
other clean items in a double thickness of muslin or newsprint.
(Unwrapped instruments must be used immediately after removal from the
sterilizer, unless they are kept in a covered, sterile container.)

57
 Instructions of operating a steam sterilizer
• STEP 6 Sterilize at 1210C (2500F) for 30 minutes for wrapped items and 20
minutes for unwrapped items; set time of the clock.
• STEP 7 Wait 20 to 30 minutes (or until the pressure gauge reads zero) to permit the
sterilizer to cool sufficiently. Then open the lid or door to allow steam to escape. Allow
instrument packs to dry completely before removal which may take up to 30 minutes
(Wet packs act like a wick drawing in bacteria, viruses and fungi from the
environment). Wrapped instrument packs are considered unacceptable if there are
water droplets or visible moisture on the package exterior when they are removed from
the steam sterilizer chamber. If using rigid containers (e.g. drums), close the gaskets.
• STEP 8 To prevent condensation when removing the packs from the chamber, place
sterile trays and packs on a surface padded with paper or fabric.
• STEP 9 After sterilizing, items wrapped in cloth or papers are considered sterile as long
as the pack remains clean, dry (including no water stains) and intact. Unwrapped items
must be used immediately or stored in covered sterile containers.

58
 Remember
• Maintain a steam sterilizer log including heat begun, correct temperature
and pressure achieved, heat turned down, and heat turned off.
• Each load should be monitored with mechanical (time, temperature
and pressure) and chemical (internal and external chemical test strips)
indicators.
• Autoclave should be tested daily with an air-removal test to ensure proper
removal of air.
• If steam escapes from the safety valve or under the lid, the autoclave is not
working correctly. Rather, it is merely steaming items at low-pressure
(which may be equivalent to HLD, not sterilization). Then, what is to be
done?
– If steam escapes from the safety valve instead of the pressure valve,
the pressure valve must be cleaned and inspected.
– If steam escapes from under the lid, the gasket (rubber ring) must
be cleaned and dried or replaced.
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 Dry heat sterilization method
• Dry heat sterilization is caused by hot air that destroys micro-organisms
through oxidation that causes slow destruction of the micro-organisms
protein.
• It is accomplished by thermal (heat) conduction. Initially, heat is absorbed by
the exterior surface of an item and then passed to the next layer.
• Eventually, the entire object reaches the temperature needed for sterilization.
• Dry heat sterilization methods have limited value because it is difficult to
maintain the same temperature throughout the process.
• Moreover, dry heat sterilization takes longer than steam sterilization, because
the moisture in the steam sterilization process significantly speeds up the
penetration of heat and shortens the time needed to kill microorganism.

60
 Dry heat sterilization method cont’d…
• Just as with steam sterilization, thorough cleaning of the object
prior to dry heat sterilization is critical. If an instrument is not
properly cleaned, effective sterilization cannot be ensured regardless of
how long the instrument is heated.
• Advantages
– An effective method as dry heat reaches all surfaces of instruments
by conduction , even for instruments that cannot be disassembled.
– Protective of sharps or instruments with a cutting edge (fewer
problems with dulling of cutting edges).
– Leaves no chemical residue.
– Eliminates “wet pack” problems in humid climates.
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 Dry heat sterilization method cont’d…
• Limitation
– Plastic and rubber items cannot be dry-heat sterilized
because temperatures used (160 to 1700C) are too high for
these materials.
– Dry heat penetrates materials slowly and unevenly.
– Requires oven and continuous source of electricity.

62
 Conditions for effective use of dry-heat sterilizers
• Adherence to specific instructions
• Airflow rate and distribution
• Load configuration and distribution
• Temperature
• Time

63
 Instructions for operating on dry heat oven
• STEP 1 Decontaminate, clean and dry all instruments and other items to
be sterilized.
• STEP 2 If desired, wrap instruments in aluminum foil or place in a metal
container with a tight- fitting closed lid. Wrapping helps prevent
recontamination prior to use. Hypodermic or suture needles should be
placed in glass tubes with cotton stoppers.
• STEP 3 Place loose (unwrapped) instruments in metal containers or on
trays in the oven and heat them to the desired temperature.
• STEP 4 After the desired temperature is reached, begin timing. The
following temperature/time ratios are recommended
• STEP 5 After cooling, remove packs and/or metal containers and store.
Loose items should be removed with sterile forceps/pickups and used
immediately or placed in a sterile container with a tight-fitting lid until the
time of use.
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Recommended time cycle for dry heat sterilization
– 1700C (3400F) 60 minutes
– 1600C (3200F) 120 minutes
– 1500C (3000F) 150 minutes
– 1400C (2850F) 180 minutes
– 1210C (2500F) overnight
• Depending on the temperature selected, the total cycle time (preheating,
sterilization time and cool down) will range from about 2.5 hours at 1700C
to more than 8 hours at 1210C.
– Heat treatment in 1700C (3400F) for an hour (total cycle time-placing
instruments in the oven for an hour, and then cooling for 2 to 2.5
hours), or
– Heat treatment in 1600C (3200F) for 2 hours (total cycle time is from 3
to 3.5 hours).
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 Chemical sterilization
• Chemical sterilization is an alternative to high-pressure steam or
dry-heat sterilization and often called “cold sterilization”.
• If objects need to be sterilized and when the availing methods like
high-pressure steam or dry-heat sterilization would damage
them or equipment are not available (or operational), they can be
chemically sterilized.
• Many chemicals, both in liquid and gas form, are available for
processing instruments. Chemicals that are approved as
sterilant’s can also be used as high-level disinfectants but those
approved only for HLD cannot be used as sterilants.
• Formaldehyde is no longer included as a sterilant or a high-level
disinfectant due to its toxicity.
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Instructions on the use of chemical sterilization
• STEP 1 Thoroughly clean and dry all instruments and other items to be
sterilized.
• STEP 2 Check the expiry date on the container and prepare the
chemical sterilant solution following manufactures instruction.
• STEP 3 Completely submerge items in a clean container filled with the
chemical solution and place the lid on the container for the
recommended period of time..
• STEP 4 Remove objects from the solution with sterile forceps; rinse all
surfaces three times in sterile water; and airdry them. Ideally, three
separate (sequential) rinse containers should be used.
• STEP 5 Store objects in a sterile container with a tight-fitting lid if they
will not be used immediately.
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 Monitoring Sterilization Procedures
• Sterilization procedures can be monitored routinely using a
combination of
– Biological,
– Chemical and
– Mechanical indicators as parameters.
• Different sterilization processes have different monitoring
requirement.

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 Storage area
• All sterile items should be stored appropriately to protect
them from dust, dirt, moisture, animals and insects.
• The storage area should be located next to the place of
sterilization or connected to it in a separately enclosed area
with limited access that is used just to store sterile and clean
patient care supplies.

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 Instructions for Storing Sterile Items
• Keep the storage area clean, dry, dust-free and lint-free.
• Control temperature and humidity (approximate temperature 240C and relative humidity <70%)
when possible.
• Packs and containers with sterile (or high-level disinfected) items should be stored 20 to 25cm off
the floor, 45 to 50cm from the ceiling and 15 to 20cm from an outside wall.
• Do not use cardboard boxes for storage because cardboard boxes shed dust and debris and may
harbor insects.
• Date and rotate the supplies (first in/first out). This process serves as a reminder, but does not
guarantee sterility of the packs.
• Distribute sterile and high-level disinfected items from this area.

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 Shelf Life
• The shelf life of an item (how long items can be considered
sterile) after sterilization is event-related.
• An item remains sterile until something causes the package or
container to become contaminated as time goes on since
sterilization is not the determining factor.
• An event can be a
– Tear or worn-out area in the wrapping,
– The package becoming wet or
– Anything else that will enable microorganism to enter the
package the package or container.

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 The shelf life of sterilization depends on the following factors

• Quality of the wrapper or container.

• Number of times a package is handled before use.
• Number of people who have handled the package.
• Whether the package is stored on open or closed shelves.
• Condition of storage area (e.g. humidity and cleanliness).
• Frequent or improper handling or storage.
• Use of plastic dust cover and method of sealing

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 Summary
• Applying Spaulding’s classification of non-critical, semi-critical, or critical
items determines the method that should be used to process instruments.
• All instruments must be thoroughly cleaned before further processing.
Cleaning is the most important step in instrument processing.
• All semi-critical instruments and devices that come in contact with
mucous membranes and non-intact skin should be, at a minimum, high-
level disinfected.
• Sterilization of medical devices and surgical instruments plays a vital role
in reducing surgical site infections and infection as a result of other
invasive procedures.
• Monitoring the quality of the sterilization process as well as appropriately
following recommendations will assist health care facilities in optimizing
the safety of sterile medical devices and surgical instruments used for
patient care

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