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

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 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.
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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.

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 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.

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 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
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 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..
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 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.
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 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

43
 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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