Cleaning, Packaging &
Sterilization of Instruments
Continuing Education Program
Following established protocols for
instrument processing is an
important aspect of modern health
care as it helps to minimize the
patient’s risk for infection of the
surgical site.
Approved for 1.5 contact hours
This program is intended to provide through IAHCSMM and 1.0 contact
hour through CBSPD
an “overview” of current
recommended practices and is
approved for continuing education
credit.
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6 Steps of Instrument Reprocessing
1. Transport
2. Cleaning & Inspection
3. Packaging
4. Sterilization
5. Storage & Delivery
6. Quality Assurance
3
TRANSPORT
Contaminated instruments should
be handled carefully to prevent
exposure using appropriate PPE
(personal protection equipment).
At point of use, they should be
placed in a sealed, leak proof
container (displaying a biohazard
symbol) to prevent any injuries
or cross contamination during
transport to the processing area.
4
TRANSPORT
from Treatment Area
• Organization
• Efficiency
• Safety
• Puncture resistant, leak-proof
container with lid
5
CLEANING
Manually or mechanically clean
soiled instruments as soon as
possible in a designated area,
wearing appropriate PPE.
Quick cleaning removes blood
much easier, and can minimize
instrument staining, corrosion
and/or pitting.
6
CLEANING
Be sure to use approved cleaning solutions and
cleaning brushes as commercial products not intended
for use with surgical instruments can cause damage
and/or limit cleaning effectiveness.
7
CLEANING
Mechanical cleaning is a safer
practice for staff and a more
effective process over manual
cleaning.
Therefore, whenever possible,
mechanically clean instruments,
using warm water and a neutral
pH detergent.
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Ultrasonic Cleaner
• Remove gross soil before using
• Use an enzymatic cleaning solution
• Use treated water when needed
• Change solution AT LEAST daily
• Must use lid
• Don’t overload
• Periodically perform ‘foil test’
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Instrument Washer
• Increase productivity
• Improve cleaning effectiveness
• Decrease personnel sharps risk
• Accommodate more instruments than ultrasonic units
• Use automated washing cycles
• Eliminate need for manual presoaking, hand
scrubbing rinsing, and drying
• Some have high temp cycle = thermal disinfection
10
RINSING
After cleaning, thoroughly rinse
instruments with tap water and
ensure all debris and detergent
residue is removed.
If the tap water is of poor quality,
consider using treated water as a
final rinse to avoid instrument
staining.
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INSPECTION
Each instrument should be
critically inspected after
each cleaning for residual
debris or damage.
Replace instruments as
needed and never sterilize
a “dirty” instrument.
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INSPECTION
In addition, check each
instrument for proper
function and lubricate as
required by the instrument
manufacturer.
Hinged instruments with
stiff joints may be a sign
of inadequate cleaning..
13
PACKAGING
Instrument packaging should
be done in a clean and low
contamination area, using
FDA approved products:
• Sterilization pouch
• Sterilization wrap
• Sterilization container
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PACKAGING
Sterilization pouches are for
packaging loose instruments
and small, light weight items.
Paper/plastic pouches allow
you to see the contents and
come with a build in adhesive
strip for seal sealing. It is important to remove all
excess air, prior to sealing the sterilization pouch.
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PACKAGING
For quality assurance, be sure
to include a chemical indicator
inside each pouch.
Per CDC guidelines, this will
verify sterilization parameters
were met inside, as well as
outside the pouch (time,
Chemical Indicator
temperature and sterilant
contact). 16
PACKAGING
Special Note:
Some new technology pouches
come printed with an external
and internal chemical indicator.
If the internal indicator is a
multi-parameter chemical
indicator, there is no need
to add a separate indicator
strip inside.
17
PACKAGING
To assist sterilization and
aid drying, place pouches
facing each other and on
edge using a divider.
Note: Pouch dividers are commercially
available to accommodate different
size sterilizers.
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PACKAGING
Sterilization wrap is ideal for packaging surgical kits.
For sterility maintenance, be sure to use two layers of
wrap per industry
standards and the
wrap MFR’s FDA
clearance.
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PACKAGING
For quality assurance, include
a chemical indicator inside to
verify the sterilant reached the
inside of the package.
Wrap in a way that allows
sterile presentation and
aseptic and delivery of the
surgical pack or kit.
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PACKAGING
Sterilization indicator tape
should be used to secure
the wrapper.
Special Note:
Most steam indicator tapes contain
latex in the adhesive and lead in the
color change ink. Latex and lead-
free indicator tape is commercially
available.
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STERILIZATION
Heavier wraps should be
placed on the lower shelf of
the sterilizer and pouches
(being lighter) on the top,
on edge.
This enables moisture to
To maintain sterility, packages should be
drain out without wetting visibly dry before removal from
the sterilizer
other items in the load.
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STERILIZATION
Sterilizers are Class 2 medical
devices requiring FDA clearance.
They are available in a variety of
sizes with the following processes
most common to medical:
• Steam
• Chemical vapor
• Dry heat / Rapid heat transfer
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STERILIZATION
Saturated steam under pressure
is one of the oldest methods
used to sterilize surgical
instruments.
The CDC recommends steam
Chamberland autoclave
sterilization as the process of built in 1880
choice, because it is efficient,
fast, and inexpensive.
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STERILIZATION
By heating distilled water under
pressure, moist heat is created
and rapidly kills microorganisms.
Some common steam sterilizer
cycle parameters are:
Dry times are additional and can
be from 15 to 30 minutes,
• 250°F/121°C for 30 min (Gravity) depending on load
• 270°F/132°C for 10 min (Gravity)
• 270°F/132°C for 4 min (DAR)
Gravity = Gravity Displacement; DAR = Dynamic Air Removal
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STERILIZATION
There are three (3) different types of steam sterilizers:
1. Gravity Displacement
2. Prevacuum
3. Steam Flush Pressure Pulse (SFPP)
Gravity displacement sterilizers heat the water which
converts it to steam and pushes the air out the drain
gradually. This is called “passive air removal”.
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STERILIZATION
Prevacuum (also called Class B) sterilizers heat water
and convert it to steam; however, they use a vacuum
pump to quickly remove the air which allows for faster
cycles. This is called “dynamic air removal”.
Because prevacuum steam sterilizers
rely on a pump to remove air, an air
removal test called Bowie-Dick test
should be performed daily.
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AIR REMOVAL TEST
Test Procedure:
Place a Bowie-Dick test pack on
the lowest shelf, over the drain in
an empty chamber at 273°F for 3.5
or 4 minutes exposure time.
After processing, the color change
indicator inside the test pack should
show a uniform color to pass.
Retain the indicator as part of
your Infection Control records.
PASS FAIL
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STERILIZATION
Steam-flush-pressure-pulse (SFPP) sterilizers are also
considered dynamic air removal, but use steam flushes
and pressure pulses to remove the trapped air from the
chamber and load. As with prevacuum sterilizers, air
removal is more efficient than gravity displacement
sterilizers and permits shorter cycle times.
Because SFPP air removal occurs through atmospheric
pressure pulses rather than the vacuum pulses used in
prevacuum sterilizers, a daily air removal test is not
necessary. 29
Storage & Delivery
Sterile items should be stored
in a manner that reduces the
potential for contamination.
The shelf-life of sterile items
is event related and depends
on the quality of the packaging
material, storage conditions and
amount of handling.
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Storage & Delivery
Sterile packages should always
be handled with care. Avoid
dragging, crushing, bending,
compressing or puncturing, as
this can compromise sterility.
Sterilant Microbes
Be sure to inspect sterile
packages before distributing.
Do not use any package that ____________
is damaged, wet or opened.
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Quality Assurance
Sterility assurance of processed instruments should be
routinely verified using three (3) types of indicators:
1) Physical
2) Chemical
3) Biological
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Quality Assurance
1) Physical indicators are the
time, temperature and pressure
gauges built into sterilizers.
These readings should be
recorded for every cycle and verified prior to unloading
the sterilizer. Hospital sterilizers are required to have a
chart or printout, whereas this is optional for sterilizers
located in private offices or clinics.
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Quality Assurance
2) Chemical indicators should
be on the outside and inside of
all packages to verify they have
been processed.
The outside can be a single
parameter indicator, i.e. change
with heat alone; however, the
internal should be multi-parameter
requiring more than just heat to
make it pass.
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Quality Assurance
We mentioned that some newer
pouches now offer external and
internal indicators printed with
every pouch.
Be sure the supplier has validated
the internal indicator as a multi-
parameter indicator, per CDC
guidelines.
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Quality Assurance
3) Biological indicators provide
users the highest level of sterility
assurance and contain bacterial
spores available in plastic vial or
paper strip format.
The CDC says sterilizers should be
tested at least weekly, and every
load that contains an implant. An
unprocessed Control test, from the
same lot must be included.
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Quality Assurance
In-office biological monitors are
processed along with a normal load.
After processing, the plastic vial is
activated by crushing the side and
then incubated.
Sterilizer failure is noted if the
test vial changes color from purple
to yellow. An unprocessed vial
should be incubated each time to
verify test results.
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Quality Assurance
A BI inside a Test Pack should be
used to monitor large sterilizers when
processing packaged instruments.
Steam - place on the bottom shelf,
directly above the drain with a load.
The SPSmedical Steam BI test pack
includes a BI, along with a Class 5 integrator for immediate
release of load, and is FDA cleared for use with standard or
extended sterilization cycles.
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Quality Assurance
Paper strip biological indicators
can be sent to an outside lab for
3rd party verification.
After processing a spore strip
along with a normal load, the
strip(s) are sent to a lab for If a failure is recorded, the
incubation. Test results are Laboratory calls the user with
recommendations and
returned via mail or fax, with instructions to retest
some services offering internet
record keeping via password.
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Quality Assurance
What’s New?
The FDA has approved the SPS
STEAMPlus integrator as equal
in performance to the spore test.
This does not mean it replaces
the weekly spore test; however,
we do recommend it be used
with each steam cycle to protect
against the release of non-sterile
items.
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Quality Assurance
While sterilizers can and do
mechanically fail, operator
error is the leading cause of
sterilizer failure, e.g.
• Cold start
• Wrong cycle Per CDC guidelines, sterilizers that fail
• Overloading the weekly spore test, should not be
used until a passed test
is recorded
• Improper packaging
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Now, let’s test your knowledge on
Instrument Reprocessing
1. Transport
2. Cleaning & Inspection
3. Packaging
4. Sterilization
5. Storage & Delivery
6. Quality Assurance
Or visit www.henryschein.com/assure
42
Test Questions
1. You should wear PPE when handling soiled instruments. __ True __ False
2. Manual cleaning is preferred over mechanical cleaning. __ True __ False
3. All instruments should be inspected after cleaning. __ True __ False
4. Peel pouches are ideal for packaging loose instruments. __ True __ False
5. The CDC says steam sterilization is the process of choice. __ True __ False
6. All sterilizers have the same setting for time and temperature. __ True __ False
7. Packages should be dry when removing from the sterilizer. __ True __ False
8. The shelf-life of sterilized packages is event-related. __ True __ False
9. Each package should have an external and internal indicator. __ True __ False
10. Steam sterilizers should be spore tested at least weekly. __ True __ False
After successfully answering these test questions, you may print the “Certificate
of Completion” posted on the next slide
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Presented by:
Crosstex/SPSmedical and Henry Schein
EDUCATION DEPARTMENT
Attended the Continuing Education Program:
“Cleaning, Packaging and Sterilization of Instruments”
1.5 Contact Hours / CEU - IAHCSMM (Code 00070511A)
1.5 Contact Hours / CEU - CBSPD (Code: 21741WCOR09)
1 Contact Hour / CEU - DANB (Code: 32336-001-05-05)
Charles Hughes Provider approved by the California Board of Registered
Chuck Hughes, VP Infection
Nursing. Provider # CEP 15711, for 1.0 Contact Hour. This
Prevention Consulting Services Certificate must be retained by the licensee for a period of
www.SPSmedical.com
4 years after the course end.
Your Sterility Assurance Experts
Crosstex/SPSmedical
6789 W. Henrietta Road
Rush, NY 14543 USA
Fax: (585) 359-0167
Ph: (800) 722-1529
website: www.SPSmedical.com
Crosstex Biological Monitoring
109 Inverness
Englewood, CO 80112 USA
Fax: (303) 699-8255
Ph: (800) 819-3356
website: www.CrosstexBMS.com
© 2014,SPSmedical Supply Corp.
Or visit www.henryschein.com/assure 44
References & Resources
Association for the Advancement of Medical Instrumentation
4301 North Fairfax Dr, Suite 301, Arlington, VA 22203-1633
703-525-4890 Fax: 703-276-0793 www.aami.org
Association of periOperative Registered Nurses
2170 South Parker Road, Suite 400 Denver, CO 80231-5711
800-755-2676 www.aorn.org
Centers for Disease Control and Prevention
1600 Clifton Road Atlanta, GA 30333
800-232-4636 www.cdc.gov
Certification Board for Sterile Processing & Distribution (CBSPD)
148 Main St, Suite C-1 Lebanon, NJ 08833
908-236-0530 www.sterileprocessing.org
International Assoc. of Healthcare Central Service Materiel Management
55 West Wacker Dr., Suite 501 Chicago, IL 60601
312-440-0078 Fax: 312-440-9474 www.iahcsmm.org
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Continuing Education
Additional Self-Study CD-ROMS available:
• Hazard Communication
Monthly
• Decontamination, You & Biofilms Audio
Seminars
• Personal Protective Equipment
• Cleaning Surgical Instruments
• Selection & Use of Packaging Systems
• Steam Sterilization: Process of Choice
• Flash Sterilization in the OR
• Safe & Effective Use of ETO
• Sterilization Quality Assurance
• Eliminating Sterile Outdates
www.SPSmedical.com
• CJD: A Sentinel Event
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