Nursing Lesson Plan 618
by Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT
President/CEO of Seavey Healthcare Consulting
Packaging Systems
for Sterilization
LEARNING OBJECTIVES
1. Explain the purpose of sterilization
packaging materials and systems
2. Outline the selection criteria for
sterilization packaging methods
3. List the three basic types of packaging
systems for sterilization
4. Describe basic processing protocols
for peel pouches, woven or non-woven
material wrappers, and rigid containers
This series of self-study lessons on CS topics was developed by the International Association of Healthcare
Central Service Materiel Management (IAHCSMM),
and can be used toward CRCST re-certification or
toward nursing credits. Pfeidler Enterprises and
IAHCSMM both offer grading opportunities.
Earn Continuing Education Credits Online:
Nursing Credit: Pfiedler Enterprises will award nursing credit for this Self-Study Lesson Plan.
Pfiedler Enterprises is a provider approved by
the California Board of Registered Nursing, Provider
Number CEP 14944, for 1 contact hour.
Obtaining full credit for this offering depends upon
attendance, regardless of circumstances, from beginning to end. Licensees must provide their license
numbers for record keeping purposes.
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O
NE OF THE JOINT COMMISSION’S (TJC’S) NATIONAL PATIENT
Safety Goals is to implement evidence-based practices for preventing
surgical site infections (SSIs). There are many steps involved in preventing
SSIs and some of them begin even before the patient reaches the Operating
Room (OR). Delivery of sterile surgical instruments to the OR is one of many processes
performed by Central Service (CS) professionals each day. After instruments’ delivery
to the OR, the surgical team depends on the consistency of the packaging systems to
facilitate the ease of opening and transfer of the package’s contents to the sterile field.
The sterility and the integrity of the packages should be verified by the end user at the
point of use, before they are placed on the sterile field or used on the patient.
OBJECTIVE 1: EXPLAIN THE
PURPOSE OF STERILIZATION
PACKAGING MATERIALS AND
SYSTEMS
The U.S. Food and Drug Administration
(FDA) classifies sterilization packaging
as a Class II medical device (a device that
presents a potential risk to the patient).
Using items that are not sterile during a
surgical procedure can cause an adverse
and life-threatening event, such as an SSI.
CS technicians must be able to
construct packages that allow the
sterilization process to be successful and
protect the package contents. Packaging
systems that contain a medical item must
allow for the sterilization of the contents.
Packaging systems must also protect the
integrity of the sterilized contents until
the package is opened for use and provide
for the removal of the contents to the
sterile field, without contamination.
The three primary objectives for any
sterilization packaging system are:
• To allow penetration of the chosen
sterilant and be compatible with any
other requirements of the sterilization
process, such as drying.
The certificate of course completion issued at the
conclusion of this course must be retained in the participant’s records for at least four (4) years as proof of
attendance.
In order to receive credit you must go to
www.pfiedlerenterprises.com/IAHCSMM/618 and
complete the test, evaluation and registration forms.
Once completed, you will be directed to print your
certificate of completion.
Each online quiz with a passing score of 70% or
higher is worth two points (2 contact hours) toward
CRCST re-certification of 12 CEs.
Scoring: IAHCSMM will award credit for this SelfStudy Lesson Plan toward the renewal of a CRCST
certification.
To receive IAHCSMM credit, please visit
www.iahcsmm.org for online grading (nominal
fees will apply).
For more information: For questions or problems
about Nursing Credits available for this lesson plan,
please contact [email protected].
For questions about IAHCSMM Credit available
for this lesson plan, please contact us at
312.440.0078 or [email protected].
NOVEMBER / DECEMBER 2016
Communiqué 55
Nursing Lesson Plan 618
•
•
To be able to maintain the sterility of
package contents until opened.
To create a package that can be opened
without contaminating the contents by
the user.
OBJECTIVE 2: OUTLINE THE
SELECTION CRITERIA FOR
STERILIZATION PACKAGING
METHODS
The first step in the packaging process is
to select an appropriate type of packaging
material and method.
An effective packaging material for
steam sterilization processing should:
• Be cleared by the FDA for the intended
use;
• Be suitable for the items being sterilized;
• Include the manufacturer’s Instructions
for Use (IFU);
• Allow adequate air removal from and
sterilant penetration of the package
contents;
• Provide an adequate barrier to
microorganisms or their vehicles;
• Resist tearing or puncture;
• Permit secure and complete closure
of items;
• Permit tamper-evident sealing;
• Protect contents from physical damage;
• Allow for ease of aseptic presentation;
• Be free of toxic ingredients and non fast dyes;
• Be nonlinting;
• Be large enough to permit equal
distribution of the contents; and
• Be shown by value analysis to be cost
effective.
Before selecting packaging systems,
the healthcare facility should evaluate
and verify the performance of the
packaging system and materials in
the environment in which they will be
used. This performance evaluation and
verification will help determine whether
the conditions for sterilization, as well
as shelf life, transportation, storage and
56 Communiqué
NOVEMBER / DECEMBER 2016
Photo 1: Scissors in self-seal pouch with proper tip protection and internal sterilization indicator
handling, can be met in accordance with
the IFU.
Different types of packaging are needed
for alternative sterilization methods, and
styles of packaging may vary according
to package contents. CS technicians
must make good packaging choices by
selecting the material that is best suited
for the item(s) being packaged and the
method of sterilization used.
OBJECTIVE 3: LIST THE THREE
BASIC TYPES OF PACKAGING
SYSTEMS FOR STERILIZATION
There are three basic methods of
packaging systems used to maintain, store
and transport sterile surgical instruments.
Packaging systems can be:
• Peel pouches - Paper-plastic packs,
Tyvek®-plastic pouches, plastic-plastic
pouches;
• Woven fabrics - Textiles
• Non-woven material or containment
devices – Some flat wrappers,
sterilization containers, instrument
cases, cassettes and organizing trays
(composed of a variety of materials)
The selection of the packaging system
primarily depends on the sterilization
method used, size and weight of contents,
and user preference. Ease of storage and
removal at the point of use, as well as
cost effectiveness, should be taken into
consideration.
Regardless of the packaging system
used, proper storage and handling is
necessary to maintain content sterility.
The packaging system should be tamper
evident, so a package opened in error
cannot be resealed without undergoing
complete reprocessing.
OBJECTIVE 4: DESCRIBE BASIC
PROCESSING PROTOCOLS FOR
PEEL POUCHES, WOVEN OR NONWOVEN MATERIAL WRAPPERS, AND
RIGID CONTAINERS.
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NURSING LESSON PLAN
PEEL POUCHES
Paper-plastic and spunbond polyolefinplastic combinations (called peel packs
or peel pouches) are commonly-used
packaging material. The plastic side of the
pouch allows for direct visualization of
the contents and chemical indicator (CI).
The paper side allows for air removal and
for the sterilant to enter the pouch. Figure
1 shows a photo of an instrument in a
self-seal pouch.
Not all pouches can be utilized in
all types of sterilization processes.
Paper-plastic peel pouches are typically
acceptable for use with steam and
ethylene oxide (EtO) sterilization
processes. They are not compatible with
hydrogen peroxide or ozone sterilization.
Tyvek is a brand name for a peel pouch
used with hydrogen peroxide and ozone
sterilization; these pouches will melt
in high-temperature processes, such as
steam sterilization.
Peel pouches may be used for small
instruments and lightweight, low-profile
items (e.g., Scissors, one or two clamps).
Heavy or bulky devices, such as drills
and weighted vaginal speculums, should
not be packaged in peel pouches. Heavy
or bulky items placed in peel pouches
could result in problems with sterility
maintenance, such as inadequate drying
of the package after sterilization, or
rupture of the package seal.
The peel pouch should be large enough
to allow the instrument to move from side
to side and not compromise the seams
by overstretching the material. Note:
The proper size for a single or double peel
package should have ¼-inch clearance
on all sides of the package for package
contraction and proper circulation.
Pouches that are too tight can stress the
edges of the package. Pouches that are too
large are vulnerable to seal breaks because
contents can move excessively.
Curved instruments should be placed
with the curved end toward the plastic
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side of the pouch to avoid punctures
though the paper side. If instruments have
sharp tips, tip protectors should be used
to prevent punctures through the pouch.
A CI should be placed inside the peel
pouch next to the surgical instrument, so
the appropriate endpoint response (e.g.,
Color change) can easily be seen through
the plastic side of the pouch.
Before sealing, excess air should be
removed from the pouch. Peel pouches
can be either self sealed or manually
heat sealed when the items are packaged.
When using self-sealed pouches, the
fold lines provided by the manufacturer
should be strictly followed to prevent
overlapping and small openings between
the package and the sealant. Also, the
seal’s fold should be free of wrinkles or
creases.
If the peel pouch is heat sealed,
the instructions (including proper
temperature ranges provided by the heat
sealer’s manufacturer) should always
be followed. Note: Sealing temperatures
are affected by the type of pouch being
sealed (e.g., Tyvek pouches require a lower
temperature range). When manually
sealing a pouch, it is important to ensure
there is ample space at the end of pouch
for users to use their thumb to open
the package and present its contents
aseptically to the sterile field. Creating
a chevron by clipping off the corners of
the sealed end beyond the seal may help
ensure easier opening by the end user.
This may prevent the pouch from tearing
in a way that contaminates the contents
during delivery. Some peel pouch
manufacturers provide a printed picture
on the pouch to indicate which direction
the pouch should be opened.
Double pouching (e.g., Placing
the item within one pouch and then
placing this pouch inside another) is not
necessary for sterility maintenance. For
aseptic presentation, OR personnel may
request double pouching of multiple
items or instruments having more than
one part; however, double pouching
should not be performed without
written instructions from the pouch
manufacturer. These instructions should
clearly indicate that this practice has been
validated and the pouch in question has
been cleared by the FDA for this purpose.
Sterilization validation studies performed
by the manufacturer present confirmation
that the pouch will perform as intended
when two pouches are used in a single
package.
If double pouching is used, each peel
pack should be sealed separately and the
paper side of the inner pouch should be
placed toward the paper side of the outer
pouch. Care is needed when selecting the
appropriate sequential sizing. The same
rule applies for the inside peel pouch as
for single pouching instruments (leave
about ¼ inch per side of the package).
Folding the inside pouch is not permitted
when its plastic side would fold over
and cover the paper side of the outer
pouch because this could interfere with
sterilization and air removal.
Paper–plastic pouches should not be
used within wrapped sets or containment
devices, unless the practice has been
validated by the packaging manufacturer
and verified by product testing in the
healthcare facility. The pouches cannot
be positioned to ensure adequate air
removal, sterilant contact and drying. The
plastic laminate used in paper–plastic
pouches is impervious to the sterilant
and, therefore, might prevent the sterilant
from reaching the surface of items with
which the plastic side is in physical
contact.
Peel pouches should be labeled with a
permanent marker or another labeling
technique that is approved for the
sterilization process used. Wax markers
or petroleum-based inks used in most
ballpoint pens are not recommended
for labeling packages before or after
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Communiqué 57
Nursing Lesson Plan 618
sterilization. Information about the item,
its storage location, the date it is wrapped,
and the package assembler’s name (or
initials, according to facility’s policy)
should be included on the plastic side of
the pouch package. Note: Writing on the
paper side of the pouch can compromise
package sterility.
WOVEN OR NON-WOVEN
MATERIAL WRAPPERS
Woven wrapping materials (textiles) are
usually 100% cotton, cotton-polyester
or synthetic blends. Woven materials
are reusable and require laundering,
de-linting, and inspection for holes and
fabric degradation (using a light table)
before each use. Inspection and mending
of holes and defects are time-consuming
tasks.
Disposable (non-woven) materials
made of spunbond-meltblown-spunbond
(SMS) is a popular flat wrap. It is made
by a process in which polyolefin layers
(synthetic materials softened by heat and
hardened by cooling) are exposed to high
heat and pressure bonded together to
form sheets. Flat wraps are available in a
wide variety of sizes and weights.
As with peel pouch packaging,
the instruments must be wrapped
in a manner that facilitates aseptic
presentation of the contents. The
instruments should be wrapped with two
layers of wrap. Wrapped packages that
will be sterilized by steam may require a
non-linting, absorbent material be placed
under the item to absorb moisture that
occurs during the steam cycle.
All wrapped items should be handled
with care. Package integrity may be
compromised by rough handling and
contact with sharp surfaces. There are
several devices on the market (e.g.,
Corner protectors or transport trays)
that help protect larger/heavy trays
from damage, such as tears in wraps.
Organizations may choose to use those
58 Communiqué
NOVEMBER / DECEMBER 2016
devices if they are experiencing issues
with wrap integrity.
The ability of sterilization wrappers
to maintain the content’s sterility has
historically been based on two layers of
wrap material. Polypropylene wrappers
that are sealed together on two sides and
allow use of a simultaneous envelope fold
wrapping technique are available options.
If this product is not available, two layers
of wrap should be used with a sequential
wrapping technique. Note: This involves
wrapping the item completely using one
layer of wrap and then wrapping the item
a second time with another single layer of
wrap; however, no tape is placed to secure
the last fold of the inside wrap. It will be
held securely in place with the application
of the second layer of wrap.
It is important that CS professionals
always use wrap materials as directed
by the manufacturer. This is because the
company has performed the required
validation testing to demonstrate correct
application that provides the required
sterility maintenance.
It is important that CS professionals
do not write directly on the wrapping
material because doing so may
compromise sterility. Instead, they should
use an approved printed label or write on
the wrapper’s sterilization tape.
After sterilization, the wrapped package
must cool to room temperature and
dry before it is handled. If the wrapped
package is handled while it is still warm
and moist, it can wick the bacteria from
the hands of the person handling it.
After the package has cooled and dried,
bacteria cannot travel through the
wrapper, unless facilitated by external
moisture and/or a wrapper’s rips and
tears.
RIGID CONTAINERS
Rigid containers systems are box-like
structures consisting of an inner basket,
an outer container and sealable lids. The
locking and filtering mechanisms of
rigid containers vary according to their
manufacturer. Despite these variations,
rigid container systems must allow for
the removal of moisture, proper drying,
and the aseptic presentation of contents
to the sterile field. Selection factors for
rigid containers include the size needed
for the instrument set, ease of assembly
and cleaning, purchase price, and
the materials and supplies needed to
maintain them (including locks, filters,
labels and replacement parts). A concern
is that not all rigid containers can be used
for all sterilization methods. Some rigid
containers require specific placement in
the sterilizer, and some can be stacked for
sterilization, while others cannot.
Not all rigid containers require filters;
however, some require a paper filter on
the bottom and top of the container.
Some containers have a solid bottom
and do not require a bottom filter. Other
rigid containers feature a reusable filter
that, unless damaged, can be used for a
specified number of cycles. Other rigid
containers have a pressure valve system
that allows air removal and entry of the
steam sterilant into the container. The
valve closes at the completion of the cycle,
allowing the contents to remain sterile.
Most rigid containers require an
integrity lock on both sides of the
container to indicate that the container
has not been tampered with; however, one
rigid container system does not require
integrity locks. Instead, locks pop down
on both ends when the contents have
been processed at the proper pressure
and temperature. One potential concern
is that some containment systems have
no CI color change on the outside of the
container. To address this, personnel in
many facilities add a strip of wrapping
tape on the label to show color change.
Rigid sterilization container systems
should be scientifically proven to be
suitable for the specific sterilization
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NURSING LESSON PLAN
After sterilization, the wrapped package must cool to room
temperature and dry before it is handled. If the wrapped
package is handled while it is still warm and moist, it can
wick the bacteria from the hands of the person handling it.
After the package has cooled and dried, bacteria cannot
travel through the wrapper, unless facilitated by external
moisture and/or a wrapper’s rips and tears.
cycle to be used; when items are being
prepared for sterilization, the container
system should be verified as the correct
one for the cycle. Only filter materials
that have been tested and documented
to be efficacious in the specific container
system should be used.
Rigid sterilization container systems
vary in their mechanics, their specific
performance characteristics and their
suitability for particular sterilization
cycles. A change in the filter material (e.g.,
Change in brand) can affect air removal
or sterilant penetration and evacuation in
a container system. Before use, all filters
should be inspected for integrity.
When rigid containers are utilized,
every person involved with their
processing and use must be aware of the
limitations and recommendations to
assure product sterilization. As reusable
devices, rigid containers must be
routinely inspected and maintained. The
latching mechanism or closure should
be checked prior to use to ensure it will
remain secure. The sealing or mating
surfaces or edges of the container system
and lid should be checked to ensure
they are not dented or chipped. Filter
retention mechanisms and fasteners, such
as screws and rivets, should be secure and
not be distorted or burred; the securing
mechanism should function properly and
the filter media should be examined for
integrity. The gaskets should be pliable,
securely fastened, and free of breaks or
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cuts. The valves should work freely and be
without breaks, cuts, chips or dents. Some
rigid container systems have a limitation
on their number of uses.
The weight of instrument trays
or other item should not exceed 25
pounds (this weight includes container
and instruments). Excess weight can
compromise the sterilization and drying
processes, and increase risks of worker
injury due to lifting.
All items removed from the sterilizer
after sterilization, including items
packaged in rigid sterilization container
systems, should remain on the sterilizer
cart until adequately cooled. Packages
should not be touched during the cooling
process. Thermal temperature guns are
commercially available and may be used
to determine the temperature without
touching the packages.
Service Materiel Management. 2016. Central
Service Technical Manual, Eighth Edition.
Association for the Advancement of Medical
Instrumentation. ANSI/AAMI ST79: 2010 &
A1:2010 & A2:2011 & A3:2012 & A4:2013.
Comprehensive guide to steam sterilization and
sterility assurance in health care facilities.
Association for the Advancement of Medical
Instrumentation. ANSI/AAMI ST79: Guidelines
for Selection and Use of Packaging Systems
for Sterilization. In: Guidelines for Perioperative
Practices. 2016.
IN CONCLUSION
Proper selection and use of a packaging
system is critical to patient care. As
outlined in this lesson, there are several
types of packaging systems available
that should be carefully evaluated for
each of the facility’s processing needs.
CS personnel should always ensure that
the manufacturer’s IFU are consistently
and carefully followed for each type of
packaging system used.
RESOURCES
International Association of Healthcare Central
NOVEMBER / DECEMBER 2016
Communiqué 59