Basics of Sterilization 2

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Basics of Sterilization

David R. Woodard, MSc, CIC


Dr. Earle Spaulding

“You can clean without


disinfecting, but you cannot
disinfect without cleaning”
Decontamination Area
 The location designated for the collection,
retention, & cleaning of soiled instruments
 Physically separated from all other areas
to decrease risk of cross infection
 Air from decontam area is exhausted to
the outside and not recirculated
Types of Cleaning
 Decontamination
 Process that removes as many
microorganisms as possible by physical,
mechanical or chemical means
 Also known as cleaning
 Utilizes water, detergent and enzyme soln
 Enzyme separates blood, bone and tissue from
instruments
Types of Cleaning
 Disinfection
 Immediate state between physical cleaning &
sterilization
 Uses thermal processes or chemical
germicides
Manual Cleaning of Instruments
 Cleaned under water with nonabrasive
neutral PH detergent
 Low sudsing and & does not leave residue
 Special attention given to hard to clean
areas
 Items with lumens are cleaned with
brushes and flushed with water
Inspection of Instruments
 Cleanliness, & absence of corrosive substances
 Free motion of hinged instruments-absence of
stiffness
 Proper alignment of jaws & teeth
 Proper tension with closed ratchets
 Sharpness of blades, trocars, absence of burrs,
gouges
 Screws and pins are clean
Inspection Con’t
 General integrity-absence of cracks, dents,
chipping, worn areas
 Intact insulation sheathing, absence of tears
 Items composed of more than one part are
complete & parts fit together securely
 Powered surgical instruments appropriately
lubricated & tested for proper functioning
Preparation of Instruments
 Remove gross soil at point of use
 Jaws, blades, serrations, box locks commonly retain
high levels of bioburden
 Remove blood/tissue with water & sponge
 ↓number of organisms
 Reduces nutrient material that promotes bacterial growth
 Minimizes potential for environmental contamination
 Removes substances that damage the instruments
Organization of Instruments
 Maximize surface area of instruments
 Place instruments in a mesh bottom tray to allow
for full exposure of cleaning mechanism
 Open jointed instruments at box locks
 Disassemble instruments composed of more
than one part
 Separate delicate scissors & microsurgical
instruments from heavier instruments to avoid
damage
Assembly of Items for Sterilization

 All hinged instruments must be opened &


secured with stringers in a wire mesh basket
 The weight of an instrument set should be
evenly distributed to avoid collection of moisture
during sterilization
 A towel may be positioned in the tray to
facilitate revaporization of condensate
 Delicate instruments require tip guards/foam
 Count sheet in every tray
Packaging Materials
 Items must be packages in a manner that
maintains their sterility
 Appropriate packaging material
 Allows effective sterilant penetration
 Must contain the sterility of the processed
items
 Must allow aseptic presentation of contents
Paper-Plastic Package System
 Allows for proper sealing to secure contents
 Remove as much air as possible to facilitate
effective sterilization
 Double peel packages should be sequentially
sized & sealed to allow fro proper fit of inner
pouch
 Paper sides of both packages are positioned
together to allow adequate penetration of the
sterilant
Rigid Sterilization Containers
 Reduce cost and management of waste
 Perforations in the lid and bottom are
covered with disposable bacterial filters
 Filters allow sterilant to penetrate
 Tamperproof locks & ID labels
 Need to follow recommended weight,
density, sterilization cycles & times &
loading practices
Storage of Packaging Materials
 Room temperature
 Humidity 35% to 70%
 High humidity
 Packaging may become over hydrated which can
affect integrity of adhesives & seals of peel
packages
 Low humidity
 Dehydration
 Brittle and easily tear
High Level Disinfection
 Uncontrolled process
 Efficacy is directly affected by the
cleanliness of the device, preparation of
the device, the level of the active
ingredient, temperature of solution and
the exposure time
 Testing the solution according to directions
Chemical Disinfection
(Cidex OPA)
High Level Disinfection
 Performed by submersing an item in a
covered basin of germicidal solution for a
designated length of time to achieve the
desired level of microbial kill
 May eliminate many or all pathogenic
microorganisms
 Will not kill spores
Disinfecting Issues
 Product must be:
 Tested once each day of use or each time
used when not used daily.
 Changed as manufacturer requires
 Test strips tested for accuracy (high/low) at
time of introduction to use
 Test strips expire!
 Temperature sensitive
Disinfection
 Improper cleaning and organic debris are
among many factors that have been
known to nullify or limit the efficacy of this
process.
Washer Sterilizers
 Wash, rinse, & use gravity steam sterilization
 High temps & steam leads to total destruction
but they should not be considered ready or safe
for patient use
 Must clean & remove bioburden
 Tissue or debris not removed during wash cycle may
be baked on during sterilization cycle
Advantages of Washer Sterilizer
 ↑ penetration capability
 Exposure of higher temps to all surface areas
 Greatest incidence of microbial lethality
 Automatic time-released lubrication cycle
Sterilization
 The process of killing all forms of microbial
life
Sterilization Indicators
 Class I – External, time, temp, pressure indicator, says
item went through autoclave (tape, peel packs)
 Class II – Bowie Dick, checks for air removal
 Class III – Internal, time & temp, rarely used today
 Class IV – Internal, reacts to two or more parameters,
rarely used today
 Class V – Integrators, melted chemical pellet, reacts to
all parameters, all steam cycles
 Class VI – Emulating indicators, cycle specific
 Biological – gold standard, shows kill of organisms
WELCOME PA
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EQUIP / INST COUNT SHEETS
Steam Sterilization
Moist Heat
 Most economical & efficient
 Rapid processing time allows frequent
availability
 Items must be able to tolerate high temps
& moisture
 Works with time, temperature & moisture
Steam Sterilization
Time, Temperature, Moisture
 Steam circulates within the jacket space surrounding
chamber
 Steam enters the chamber & displaces all the air
 Air and steam do not mix
 As pressure increases, saturated steam contacts all
surfaces , penetrates packages, & forces air out through
a drain at the bottom of sterilizer
 Sterilization is initiated once all air is removed
 High temp of saturated steam causes microbial
destruction
 Proper loading is crucial to allow the steam to freely
circulate
Steam Sterilization Con’t
 Temperature affects the time of exposure
in that the higher the temperature, the
less exposure time is required.
 As pressure ↑ in a closed chamber, so does the
temperature
 If these parameters are not represented in
a cycle, sterilization will not occur
Cycle Phases
 Conditioning
 Air removal
 Exposure
 Load is heated to sterilization temp
 Exhaust
 Bottom drain opens and steam is exhaused
 Drying
 Dry heat revaporizes existing moisture & removes
from the load
Proper Loading & Unloading
 Proper Loading
 Prevents formation of air pockets & obstructions to
the circulation of steam
 Proper Unloading
 Hot packages are allowed to cool before being
handled
 Moisture will form upon contact and cause
contamination
 Called strike through
 Do not place hot items on cool surfaces
Sterilization Process Monitors
Chemical Monitors (Indicators)
 Monitor one or more process parameters of a
sterilization cycle
 Detects failures in packaging, loading or sterilizer
function
 Consist of a sensitive chemical or ink dye that develops a
visual change after the exposure to certain physical
process conditions (temp & humidity)
 Placed on the outside of every package
 Need to be examined after sterilization & before use
Chemical Monitors Con’t
 Internal monitors placed in the area of greatest
challenge within the package
 Visible once package is opened
 Both internal l& external indicators reflect
exposure of an item to one or more sterilization
parameters
 Do not guarantee sterility
 If questionable, item is not considered sterile
Biologic Monitors
 Standardized preparation of known
microorganisms highly resistant to a
specific mode of sterilization.
 Their purpose is to reveal evidence of the
efficacy of a sterilization cycle by utilizing
a high number or resistant spores to
challenge the function of the sterilizer.
 Most reliable monitors
Biologic Monitors Con’t
 After cycle is complete put in incubator to
observe microbial growth
 Negative biologic monitors contain no growth &
indicates that conditions necessary for
sterilization & microbial kill were met
 If growth detected:
 Notify supervisor immediately
 Further test & evaluate to determine viability of
organisms & efficacy of the cycle
Biologic Monitors Con’t
 Bacillus stearothermophilus
 Steam sterilization
 Bacillus subtilis
 Gas sterilization
 Impregnated on paper strips or capsules
and placed within the chamber
 Special test packs or
 Wrapped in items
Biologic Monitors Con’t
 A control biologic monitor, which has the
same lot number, as the test and has not
bee exposed to a cycle is also incubated
and examined for growth
Routine Biologic Monitoring
 Frequency of Use:
 During installation of sterilizer or after major
repairs
 Daily in steam autoclaves
 Gas-with each load
 Any load with implants
Routine Biologic Monitoring
 Placement:
 Steam
 In loaded chamber over drain or coolest part of sterilizer
 Gas
 In the middle of the loaded chamber
 Incubation:
 Usually 48 hours
 1 hr incubation monitors available for gravity displacement
steam sterilizers
Bowie Dick Test
 Daily air removal test
 Insures proper function of the vaccuum
and detects any air leaks
 Monitor is placed on the bottom rack over
the drain before the first load
 Satisfactory test occurs when there is a
uniform color change
Bowie Dick Test
Biological Indicators
 Following the autoclave
cycle, the BI is placed in
an incubator; also a
control
 Length varies with the
product; rapid readout 1-3
hours, or 24 hours
 Positive test = sterilization
process has failed due to
improperly processed load,
failure to meet
temperature or exposure Yellow = pus Purple = bugs
parameters, mechanical FAIL killed, PASS
Ethylene Oxide Sterilization
 Used to sterilize heat-labile and/or
moisture-sensitive items
 Toxic & flammable
 Lengthly processing /aeration time
 High cost
 Environmental concerns
ETO Sterilization
Gas
 Colorless, noncorrosive, highly penetrative
 For items that are sensitive to high
concentrations of moisture and/or heat
 Appropriate conditions of time, (105-300
min) temp, (low) EO concentration,
relative humidity (45%-74%)
 Appropriate aeration is required to remove
residual EO
EO Aeration
 Continuous currents warm filtered air
 12 hrs = 120 degrees
 8 hrs = 140 degrees
Hydrogen Peroxide Gas Plasma
Sterilization
Sterrad
 Rapidly destroys microorganisms utilizing low
temperatures without toxic residue
 Used for heat and moisture sensitive items
 Uses radio frequency energy to vaporize
hydrogen peroxide
 Takes approximately one hour
 For narrow lumens that are longer than 12” or
narrower than ¼ “ , a special adaptor is needed
Chemical Sterilization
The Steris
 Used on items that are heat sensitive
 Delicate instruments, scopes, cameras
 Uses a lower temperature & shorter cycles
 Peracetic Acid
Steris
Peracetic Acid Sterilization
“Just In Time”
 Peracetic Acid
 Acetic acid, hydrogen peroxide, water
 Adversely reacts with protein & enzymes of
microorganisms penetrating cell wall & causing
destruction
 Sterilant mixes with water, which reduces
concentration of the acid
 Takes about 30 minutes
 Works by time, temp and concentration
Immediate Use Sterilization
 Only used in special situations
 Use open , perforated mesh bottom trays
 Trays with lids may impede air removal &
steam penetration
 Gravity displacement method
 Disassemble all instruments
 Flush lumens with distilled water
Flash Sterilization Con’t
 Parameters
 Simple instruments
 Gravity displacement 270 degrees for 3 minutes
 Complex instruments
 Gravity displacement 270 degrees for 10 minutes
Flash Sterilization Con’t
 Several like instruments can be sterilized
together
 More than 1 instrument tray requires 10
min
 Lumens must be flushed with water
 Trays with rubber or cloth run for 10 min
Flash Log
The same tracking process as for items
put up in CS.
Review daily for compliance
Report to ICC and department of surgery
at regular intervals
Use to support additional sets
“We need to flash the hyster tray
because we only have one”
Issues
 Documentation
 Pt name/MR #
 Items in load
 User initials
 Recalls
 Policies and Procedures
Sterility
 The loss of sterility is related to an event,
not to time.
 Germs don’t have a calendar that says – “ok it
28 days, lets contaminate the Kockers”
 Events –
 Dampness
 Loss of package integrity

 Dirt
Why Expiration Dates?
 Why are their expiration dates if we
believe that sterility is event related?
 Commercially prepared products are tested
for sterility at time intervals (the guarantee).
 At some point in time, they stop testing, and
that’s as long as the guarantee can be made.
Scopes the bane of our
existence
 Which scope was used on which patient
 Cross contamination
 Biological
 Tissue
 Disinfection
 Storage
Problems in Ambulatory
Infection Control
 Many well-publicized outbreaks in
ambulatory centers
 Two main causes:
Unsafe injection practices
Improper cleaning, disinfection,
sterilization of instruments, endoscopes
 Nevada & Nebraska outbreaks resulted
in criminal charges and license
revocations
CMS IC Requirements
Must list national guidelines being used
Follow them!
 CDC/HICPAC Guidelines:
 Guideline for Isolation Precautions (CDC/HICPAC)
 Hand hygiene (CDC/HICPAC)
 Disinfection and Sterilization in Healthcare Facilities (CDC/HICPAC)
 Environmental Infection Control in Healthcare Facilities
(CDC/HICPAC)
 Perioperative Standards and Recommended Practices (AORN)
 Guidelines issued by a specialty surgical society / organization (List)
Please specify (please print and limit to the space provided):
CMS IC Requirements
 NOTE! If the ASC cannot document that it has
designated a qualified professional with training
(not necessarily certification) in infection control to
direct its infection control program, a deficiency
related to 42 CFR 416.51(b)(1) must be cited.
 Lack of a designated professional responsible for

infection control should be considered for citation


of a condition-level deficiency related to 42 CFR
416.51.
CMS IC Requirements
 Prefilled syringes- single patient use
 IV bags- single patient use, spike just
prior to use
 IV tubing and connectors- single
patient use
 Sharps safety devices, proper disposal
The Great Clave Experiment…

15 clave ports from 15 different


hospital units were randomly selected
and cultured. 11 of the 15 grew Coag-
Neg Staph or Staph Epidermidis plus
lots of other nasty stuff. Four cultures
grew nothing…
(but 2 of them were from brand new IV sets…)
Scope Processing

 Written policy and procedure for:


 Immediate post-procedure cleaning,
leak testing, what to do if it fails
 Thorough cleaning, brushing channels
 Proper connections for AERs
 High-level disinfection/sterilization
 Manufacturers’ written instructions

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