Education & Training

Packaging for Sterilization

IT’S NOT JUST A BOX, A BAG OR GIFT WRAPPING!
by Rose Seavey, RN, BS, MBA, CNOR, ACSP

Objectives 4. Rigid sterilization container systems should

After completion of this self-study activity, the learner will be able to: be cleaned after each use following the
1. Describe available options for sterilization packaging and containment manufacturers written recommendations.
devices. True False
2. Discuss appropriate use for each type of sterilization packaging.
3. Develop a Quality Control Program for evaluation, selection and use of 5. Room temperature and relative humidity
packaging systems for items to be sterilized. has no effect on packaging materials and the
4, Order the Association for the Advancement of Medical Instrumentation ability to achieve sterilization.
(AAMI) and Association of periOperative Registered Nurses (AORN) True False
documents for your reference library.
6. Using the proper wrap size and grade is
Test Questions important and wrapping procedures should
True of False. Circle the correct answer. be standardized.
1. If major changes are made to packaging such as switching the type of True False
wrappers, peel pouches or containment devices used, or changing the
package dimensions or weight of the set, facilities should conduct 7. If packages are wrapped too loose, it could
product testing with biological indicators (BIs) and chemical indicators create low spots that can collect condensate.
(CIs) as well as moisture content assessment. True False
True False
8. If items are to be put in a double peel pouch,
2. Both AAMI and AORN recommendations agree on a maximum weight the inner pouch should fit inside the outer
limit of 25 pounds for a containment device, the instruments, and any pouch without folding and the plastic side of
accessories or wrapper due to ergonomic and drying issues. the inner pouch should face the plastic side
True False of the outer pouch.
True False
3. Both solid and perforated bottom rigid containers can be sterilized by
gravity or dynamic-air-removal steam sterilization cycles. 9. Paper-plastic pouches should not be placed
True False inside wrapped sets or containment devices.
True False

Many thanks to the team at 3M Health Care for working with 10. Instrument count sheets should be placed on
Managing Infection Control to provide the following accredited course. the inside of sterile packages.
IAHCSMM has awarded one and one-half (1.5) contact points for True False
completion of this continuing education lesson toward IAHCSMM
recertification. The CBSPD has preapproved this inservice for one and
one-half (1.5) contact hours for a period of five (5) years from the date
of publication, and to be used only once in a recertification period. This Introduction
inservice is 3M Health Care Provider approved by the California Board There are several types of sterilization
of Registered Nurses, CEP 5770 for one (1) contact hour. This form is packaging systems on the market today. These
valid up to five (5) years from the date of publication. Instructions for devices help to maintain sterility, as well as
submitting results are on page 97. protect the contents of the package and support
Managing Infection Control and 3M Health Care will be working aseptic presentation. Most healthcare facilities
collaboratively to provide continuing education courses in monthly use a variety of sterilization packaging systems.
editions of Managing Infection Control. The available systems include woven and
nonwoven wrappers, peel pouches of plastic,

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paper and containment devices such as reusable rigid WHICH PACKING TO USE?
sterilization containers, organizing trays and instrument case/ Deciding on the appropriate packaging system for
cassettes available in both plastic and metal. There are also a sterilizing devices has become a challenging quest. The devel-
wide variety of devices used to protect instruments or opment of high tech, complicated surgical devices—especially
components. These include insert cases or trays, reusable for minimally invasive surgical procedures—and an increasing
accessories, paper-paper bags, foam and towels. variety of sterilization processes require greater diligence
Sterilization packaging is classified by the Food and and critical thinking skills when choosing the type of pack-
Drug Administration (FDA) as a Class II medical device and aging system to use for each device, or instrument set or
is defined as: sterilization process.
“A sterilization wrap (pack, sterilization wrapper, Issues of cost, rapid turnover, ease of use, material
bag or accessories) is a device intended to be used to compatibility and storage space need to be balanced with
enclose another medical device that is to be sterilized patient safety and instrument protection concerns. Healthcare
by a health care provider. It is intended to allow steril- professionals should work closely with the instrument,
ization of the enclosed medical device and also to sterilizer and packaging manufacturers to determine the appro-
maintain sterility of the enclosed device until used.”1 priate devices to wrap, package and contain sterilized items.

Sterilization packaging is more complicated than you EVALUATING PACKAGING SYSTEMS

might think. It is not just a box, bag or wrap! As a Class II Before deciding on which packaging system(s) to purchase
medical device, there are specific validated guidelines that must and use, an evaluation should take place to investigate suitability
be followed with each type of system used. To ensure patient for items being sterilized, types and methods of sterilization
safety, manufacturers’ written instructions must be followed. used. According to the Association of periOperative Registered
Not all packaging systems are compatible with all types of Nurses (AORN), sterilization packaging systems should:
sterilization processes.  have a sufficient barrier to microbes, particulates and liquid;
This article will cover the various types of sterility  maintain sterility of contents until used;
packaging and container systems, their intended use, and limi-  permit sterilant saturation and removal while allowing
tations. This educational offering will also discuss labeling, direct contact with all surfaces of each item;
closures, tamper evidence, product evaluations and testing,  have no toxic ingredients or nonfast dyes;
weights and density of sets, compability issues, instrument  allow aseptic presentation to the sterile field;
inventory list placement, options for internal containment  close completely and securely;
devices, and maintenance of reusable containers.  protect items from physical damage;
 provide a sufficient, reliable tamper-evident seal;
Purpose of packaging  be resistant to tears or punctures;
The intention of any sterilization packaging system is to  have very little lint;
allow sterilization of the package contents, maintain sterility  allow for content identification;
of contents until the package is opened, and permit delivery of  be of sufficient size to uniformly distribute the items;
contents without contamination.  be easy to use when preparing and opening the package
or container;
PACKAGING OPTIONS  be cost effective and;
The choice of packaging systems includes:  have manufacturer’s written instructions for use.2
 woven fabrics, usually 100 percent cotton, cotton-
polyester blends and synthetic blends, either treated or Important items to consider when evaluating a rigid
untreated; container system include:
 nonwoven materials, made of plastic polymers,  Ergonomics of container design for ease of carrying;
cellulose fibers or washed paper pulp bonded under  Empty container weight;
pressure into sheets not woven on a loom. These are  Ease of locking and closing the container;
usually designed for single use;  Ability to stack containers for storage and transportation;
 peel pouches of plastic and/or paper, made of a variety of  Design of filter retention and ease of use;
materials, including paper, cellophane, polyethylene  Types of accessories for organization;
and various paper-plastic combinations; and  Ability to stack baskets internally;
 rigid container systems which are specially designed  Various sizes to accommodate a wide variety of
metal or plastic containers. instrument sets;

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 Ability to clearly label sets; Weight and density of sets

 Ability to put container through an automatic washer; and An ongoing issue is the instrument set weights.
Preventative maintenance and service. Instrument sets sometimes seem to take on a life of their own,
growing at alarming rates. Some of the complete sets from the
original manufactures are almost too heavy to lift. Often
Practical Application additional items get repeatedly added to sets creating a set with
• Work closely with the instrument, sterilizer a metal mass that is not equally distributed. From time to time,
and packaging manufacturer to determine the due to lack of storage space or for staff convenience, we merge
appropriate packaging to use for each device and multiple sets into one. With all of these issues there is a
instrument set. growing concern with the weight of instrument sets.
• Evaluate packaging before purchasing. Due to ergonomic, sterilization and drying issues, both
AAMI and AORN recommendations agree on a maximum
weight limit of 25 pounds. AORN states:
Product testing “The total weight of instrument containment
Whenever there are major changes made to packaging, devices should not exceed 25 pounds, including the
e.g., switching the type of packaging material or containers contents and containment method (eg., wrappers,
used, and/or changes in the package dimensions or weight, rigid container systems, cassettes, organizing trays).
product testing should always be performed. This test should Excessively heavy instrument sets may compromise
include biological indicators (BIs) and chemical indicators sterilization and drying. The focus should be on the set
(CIs) as well as moisture content (wet pack) assessment after configuration (i.e., how the instruments are distributed
the cycle is complete.3 in the set) and the overall weight of the set. Lifting and
The BIs and CIs should be placed in the most challenging moving heavy instrument sets may cause health care
area of the packages being tested and in multiple locations. worker injury.”2
More than likely, that will be the center of a wrapped pack or
the corners of containers, inside containment devices and on The AAMI Containment devices for reusable medical
each level of multilevel packs and next to the largest heat device sterilization, ANSI/AAMI ST77 and ANSI/AAMI
sink. The placement of the indicators should be identified for ST79:2006 section 4 Requirements, 4.3.5 recommends a
record keeping purposes. The packages should be labeled as maximum combined weight limit of 25 pound. This weight
product tests and run in a full load using the medical device limit includes the containment device, the instruments, and
manufacturer’s instructions. The packages are sacrificed and any accessories or wrappers.5
not used so the CIs can be read and the BIs incubated. If you are using a containment device, the manufacturer
Test results should be documented and maintained with the should be consulted on the recommendations for weights
sterilization log and the quality assurance records. The prod- and density of instrument sets. However, it is the facility’s
ucts with the changes should not be placed into routine use responsibility to verify that the instrument set can be effec-
until the CIs reach their endpoint and the BIs are negative.2-4 tively sterilized and dried in their sterilizers by doing product
For specific instructions on facility product testing, testing and following the medical device manufacture’s
healthcare providers should refer to the Association for instructions for use.3
the Advancement of Medical Instrumentation’s (AAMI) Four years ago, The Children’s Hospital of Denver
Comprehensive guide to steam sterilization and sterility (TCH) chose to institute a maximum weight limit of 20
assurance in health care facilities, ANSI/AAMI ST79:2006 pounds for any sterilized package. This was instituted to
section 10 Quality Control, 10.9 Periodic product quality comply with the container manufacturers recommendations
assurance testing of routinely processed items.3 of a 16-20 pound limit as well as ergonomic issues for staff.
The implementation of this weight limit was established
not only for the rigid containers but for any package
Practical Application including wrapped trays and loaner instrumentation trays.
• Perform product testing whenever there are This program has proven very successful in many ways. The
major changes made to packaging, e.g., switching complaints of back, neck, shoulder and wrist pain from
the type of packaging material or containers used, employees have been significantly reduced as well as almost
and/or changes in the package dimensions or virtually eliminating any wet loads while decreasing some of
weight on loaner instruments. the dry times. Here are steps for an instrument set weight
reduction strategy:

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 Establish the maximum acceptable weight limits STEAM

for your healthcare facility instrument sets with Steam sterilization is affected by such things as the amount of
input from surgical services. available humidity, the altitude, the type of packaging material, its
 Add the established weight limit to your policy contents, the size and configuration of the load, the size, weight and
and be sure to get the approval of surgical services, density of the pack or container, and the parameters of the sterilization
infection control and risk management; also cycle. It is important to follow the manufacturers’ written instructions
inform the facility and loaner instrument vendors. for each type of packaging system used in the steam sterilizer.2
 Obtain written reprocessing and sterilization
guidelines from all medical device manufac- ETHYLENE OXIDE (EO)
turers including rigid containers. When using EO sterilization, the packaging systems must be EO,
 Redesign the instrument sets to even out the moisture and air permeable, allow aeration of the gas, be constructed of
metal mass. a material recommended by the sterilizer and sterilant manufacturer,
 Perform product testing using biological and and be compatible with the process of EO sterilization. Peel-packs,
chemical indicators inside representative sets in wrappers, both woven and nonwoven and some rigid container systems
the areas determined to be the most challenging are permeable to EO.2
and following the medical device manufac-
turers’ sterilization parameters. HYDROGEN PEROXIDE GAS PLASMA
 Place the sets into use. Sterilization packaging systems used for packages undergoing
 Routinely monitor sets to ensure the weight is hydrogen peroxide gas plasma sterilization must allow vapor phase
not “inching” up.4 hydrogen peroxide to penetrate packaging materials, be compatible
with the process, and be recommended by the manufacturer. Both
Figure 1. Wrapped pan being weighed the packaging and sterilizer manufacturer’s written instructions should
be followed. Because cellulose products are not compatible with
hydrogen peroxide gas plasma, peel packs used in these sterilizers must
be made of plastic. Only compatible container systems which have been
validated for this application should be used.2

OZONE
Packages used for sterilization with Ozone must allow Ozone to
penetrate the package material, be compatible with the process, and be
recommended by the manufacturer. Both the packaging and sterilizer
manufacturer’s written instructions for use should be followed. Ozone
compatible packaging includes uncoated nonwoven materials, plastic
pouches and commercially available anodized aluminum containers
using noncellulose disposable filters.2

Practical Application
Practical Application
 Choose a packaging system that is cleared by the FDA for
• Establish a maximum weight limit of 25
the purpose and sterilization method you are using.
pounds for a containment device, the
instruments, and any accessories or
wrapper to protect your employees’
health and to decrease drying times. Types of packaging systems available
RIGID STERILIZATION CONTAINER SYSTEMS
Reusable rigid container systems are used for the packaging,
transportation and storage of surgical instruments prior to, during and
Packaging systems compatibility after sterilization. These self-contained closed sterilization containers
Not all packaging systems are compatible with use filters or valves as a barrier system to permit air removal and the
all types of sterilization processes. As a Class II sterilant to enter and exit the container. The reusable box-like structures
medical device, packaging systems must be cleared act as a microbial barrier and must have a tamper proof seal.
by the FDA for their intended purposes as well as the Rigid container systems have internal baskets, come in many sizes,
method of sterilization used. and may have solid or perforated bottoms. The container manufacturer’s

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written recommendations for sterilization cycle container should be large enough to allow the metal mass of instruments
parameters should be followed. In general, the to be distributed evenly.
solid bottom containers are to be used in steam Only filter materials that have been tested and documented to
sterilizers using dynamic-air-removal cycles only. be efficacious in the specific container system should be used. If
Perforated bottoms can be sterilized by gravity or disposable filters are used, a new filter should be used each time the
dynamic-air-removal steam sterilization. Some container is sterilized. If mechanical filters are used, their functionality
containers have been validated for use in Ethylene may need to be checked daily or before each use. Follow the manufac-
Oxide, Hydrogen Peroxide Gas Plasma, Ozone turers’ instructions.
and flash sterilization. Solid bottoms can also be
used to transport contaminated moist instruments. Internal stacking
Some container manufacturers have validated internal stacking of two
Figure 2. Solid bottom rigid container or more layers within a containment device. According to ANSI/AAMI
ST77:2006 4.3.4.1, Internal stacking:
“If organizing trays are to be stacked within a containment
device, the following factors shall be addressed for each
sterilization method for which stacking is recommended:
a) ease of removal of stacked items within a containment device;
b) the maximum density of contents within the containment
device to allow for proper sterilization and drying;
c) adequate perforations to allow for sterilant penetration,
sterilant evacuating, drying, and, if applicable, aeration;
d) the stability of the stacked items during transport and handling;
e) a dry outcome (see 4.4.2.1);
f) achievement of sterilization throughout the layers of stacked
organizing trays and the recommended accessories (e.g.,
Pre-assembly mats, holders) within the containment device. If any of the
Before placing items in the tray, both the box accessories are incompatible with a specific sterilization
and the lid of the container system should be method, the incompatibility should be indicated in the
inspected to ensure the entire container, top and instructions for use.”5
bottom is free from dents or cracks. The gaskets
should be pliable and securely fastened without If trays are stacked internally, a chemical indicator/integrator (CI)
breaks or cuts. The locking mechanism should should be placed in each layer in the area of the tray or container system
function properly. considered to be the least accessible to sterilant penetration.3 AORN
All of the container’s components (top, Recommended Practices for Selection and Use of Packaging Systems
bottom, valve or filter mechanisms, securing or recommends placing two chemical indicators/integrators in opposite
latching mechanisms) must function effectively as corners of each level of trays.2
a unit. It is vital to the maintenance of sterility, that
these components work together to allow air Tamper-evident closure Figure 3.
removal, to facilitate sterilant penetration and Self-contained steril- Tamper-evidence closure or lock
removal, and to inhibit contamination. ization containers require
Filter retention mechanisms, valves and a tamper-evident closure
fasteners such as screws and rivets should be secure (usually a plastic lock) to
and not loose. If the filter or valve is found loose, provide the user with
the sterility of the contents should be questioned. If visual confirmation that
any part of the container is not satisfactory or free of the container has not
functional defects, the container should be repaired been opened after sterili-
or replaced. zation until the time of
use. The tamper-evident
Assembly closure system shall be
To assure all instruments are exposed to the effortlessly and safely
sterilization agents, the basket(s) placed in the removed.5

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Immediately before use

Before it is opened, the container should be
inspected for the appropriate appearance of the
filters or valves and external chemical indicators
and the physical integrity of the outer containers
and tamper-evident devices.
The 2007 AORN Recommended Practices
for Maintaining a Sterile Field states:
“Rigid container systems should be
opened on a separate surface. The
external indicator should be verified
for appropriate color change. Locks
should be inspected for security to
verify there has not been a breach of the
container seal prior to use. The lid
should be lifted toward the person
opening the container and away form
the container. The filter should be
checked and changed according to the
manufacturer’s written instructions.”6

Care should be taken to ensure that there is

no contact between the lid and the inner rim of
the sterile contents, or any part of the inside of
the container.
Before removing the instrument basket, the
surgically attired scrub person should check the
internal chemical indicator(s) for the appropriate
change. The scrub person should avoid all
contact with the table, external surfaces of the
container and the upper rim of the container.
Before the instrument basket is placed on
the sterile field, the container bottom should be
inspected visually for the proper appearance of
the filter or valve assembly; and the instruments,
basket and container bottom should be inspected
for moisture.

Cleaning
Reduction of bioburden is essential for steril-
ization. Rigid container systems should be cleaned
after each use following the manufacturers’
written recommendations. The cleaning and
decontamination of rigid sterilization containers
systems is as important as the cleaning and decon-
tamination of the soiled/contaminated contents.
During routine cleaning, the container should be
inspected for mechanical wear and stress.
If the container system has removable filters,
the filter holders (retention plates) should be
removed to disengage the filter. If disposable, the

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Figure 4. Sequential double-wrapping: entire filter should be disposed of. Reusable filters should be disassembled,
envelope fold cleaned and replaced according to the manufacturer’s instructions.
Most container systems can be cleaned and decontaminated in
mechanical equipment. The cleaning method selected depends on the
container manufacturer’s instructions. If the container has valve-type
closures, the manufacturer’s instructions for frequency and method of
removal, disassembly and cleaning should be followed.

Practical Application
• Follow the rigid container manufacturer’s instructions for
pre-assembly, assembly, internal stacking, tamper-evident
closures, how to open and cleaning.

PACKAGING MATERIALS (WRAPPERS)

Sterilization wrappers used today for sterilization packaging are
either disposable nonwoven fabrics made of natural or manmade fibers
which are pressure-bonded together to form sheets of fabric; or reusable
woven textiles made of natural and/or synthetic materials. Some are
treated for water repellence.1
Reusable materials must be free of detergents, bleaches or other
chemicals that could react with the sterilant and cause discoloration
and/or adversely affect the contents of the pack.1 Wrappers made of
“Reprinted from ANSI/AAMI ST79:2006 with permission of the
Association for the Advancement of Medical Instrumentation,
reusable woven textile need to be rehydrated by laundering between
Inc. © 2006 AAMI www.aami.org. All rights reserved.” every use. Superheating, which could limit the ability to achieve
sterilization, may result if textiles are not re-laundered.3
All reusable textiles need to be de-linted before using. Textile
Figure 6. Simultaneous double-wrapping: fabrics need to be inspected over a light table for defects before each
envelope fold use. Rips should not be sewn, which would increase the number of
holes in the material. Defects should be repaired on both sides with
a vulcanized patch applied using heat.2
All packaging materials should be at room temperature (68°-
73°F/20°-23°C) and at a relative humidity of 30 percent to 60 percent
for at least two hours before use. Sustaining room temperature and
moisture content of woven material allows sterilant penetration and
prevents superheating during the sterilization process.2
“Single-use packaging material should be used for one sterilization
cycle. Disposable packaging material should be discarded after opening.”2

Pre-assembly
Packaging materials should be routinely examined for any holes,
defects and inappropriate extraneous material. Wrap comes in various
sizes and grade (sturdiness). Using the proper wrap size is important.
The wrap must be of sufficient size and grade to adequately cover and
support the weight and configuration of the medical device being
wrapped. If the wrap is too large it will be hard to wrap and open
aseptically. If the wrap is not sturdy enough for the weight or design of
the items, it may have a tendency to tear during handling.
Using manufacturers’ written recommendations, facilities should
“Reprinted from ANSI/AAMI ST79:2006 with permission of the develop policies and procedures for all packaging techniques.3 Wrapping
Association for the Advancement of Medical Instrumentation, procedures should be standardized. To decrease confusion for the end user,
Inc. © 2006 AAMI www.aami.org. All rights reserved.” like packages should be wrapped in the same size wrapper every time.

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Assembly simultaneous the package is wrapped once but is done with a

When using wrappers, reusable or disposable, the package special double layered synthetic nonwoven material welded on
should be wrapped snug, but not too tightly. If loose it could the sides with a special double layered synthetic nonwoven
cause low spots which could collect condensate and if wrapped material welded on the sides.
too tightly it could result in strike-through.3
Packages can be wrapped by the envelope fold method or Decreasing the chance for tears
the square fold method that is either sequential (see Figure 4 on Some larger devices or items with sharp corners may
page 90) or simultaneous (Figure 6 on page 90). benefit by placing a towel or foam under the device being
When sequential wrapping is done the items are wrapped wrapped (Figure 5 on page 92). This provides a type of
twice, creating a pack within a pack. When a pack is wrapped “cushion” to help prevent rips or tears in the wrap. The user

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must make sure the “cushion” is compatible with designed specifically for sterile packaging are acceptable as
the type of sterilization being used. outside closures only if the wrapper manufacturer explicitly
recommends their use and only if care is taken to choose the
Figure 5. Towel as cushion to decrease proper size (relative to the length and width of the package) so
chance for tears that the elastomer band fits snugly yet does not constrict the
package (e.g., create an “hour-glass” effect) or cause excessive
wrinkles or folds in the package.”3

Practical Application
• Follow recommended practices and manufacturer’s
instructions on pre-assembly, assembly, decreasing the
chance for tears, and closures for wrapped packages.

PEEL PACKS
Paper-plastic or plastic pouches are frequently used to package small
lightweight, low-profile items (e.g., one or two needle holders or small
retractors). One side of the peel pack is clear plastic which is important
when it is necessary to view the items before they are opened. Pouches are
Transfer trays are another device to help not recommended for heavy or bulky items, because the seals may break
protect the integrity of the wrap. These are specifi- open.3
cally designed plastic trays that can help alleviate There are various size peel pouches and peel pack rolls (which can be
the possibility of tears due to manipulation onto and cut to size) on the market today. Choosing the correct size and application
off of carts. The packages can be placed on the of the pouch is important. If the pouch is too tight, the seal may not hold
trays before or after sterilization. and if it is too loose, the item will move which could stress the seals to the
point of rupturing. Proper sizing also allows for adequate air removal,
Figure 7. Transfer trays steam penetration and drying.3
Some peel pouches are self sealing, meaning they come with a sticky
strip that will fold over to form a seal after the item(s) is placed inside.
Some need to be heat sealed with a special machine that applies pressure
and heat, bonding the two together to form a seal. The user needs to make
sure there are no creases or gaps in the seal which could allow microor-
ganisms to enter the package and contaminate it.
A single peel pouch is adequate unless the package contains more
than one item or would be complicated to open aseptically with only one
peel package (e.g., very small items).
“If the item is to be double-packaged, two sequentially sized pouches
should be used (i.e., the sealed inner pouch should fit inside the other pouch
without folding).” When assembled, the pouches should be positioned so that
plastic of the inner one faces the plastic of the out one.3 See Figure 8.

Closures for wrapped packages Figure 8. Example of single- and double-packaging with
Once assembled, the sterilization package paper-plastic pouches
needs to be secured. The most common closure for NOTE: Instruments should be oriented
packages is indicator tape. The devices must ensure within paper-plastic pouches according
the package remains together, allow for sterilization to the healthcare facility’s policies
penetration, avoid constriction of the pack, and and procedures.
“Reprinted from ANSI/
maintain integrity of the package.
AAMI ST79:2006 with
“Tape (other than sterilization indicator permission of the Association
tape) should not be used to secure packages, for the Advancement of Medical
nor should safety pins, paper clips, staples, Instrumentation, Inc. © 2006 AAMI
or other sharp objects. Elastomer bands www.aami.org. All rights reserved.”

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Practical Application
• Follow recommended practices and manufacturer’s instructions on
how to use peel pouches.
• When using double peel pouches, the inside peel pouch should fit
without folding and be placed so the plastic of the inner pouch
faces the plastic of the outer pouch.

ORGANIZING DEVICES Figure 9. Containment devices

Organizing devices are some-
times used inside of containers or
trays to help keep items contained
together (Figure 9). The devices are
also used as protection for sharp
and/or small items.
Small basket-type accessory,
containers with covers or lids
should only be used if they have
been designed and tested for this
purpose. The user has responsibility to test and evaluate the effectiveness
of sterilization and drying of protective organizing devices. Specific recom-
mendations of the device manufacturer should be consulted. See “Product
testing” above for more information.
According to both AORN and AAMI:
“Paper-plastic pouches should not be used within wrapped sets or
containment devices because the pouches cannot be positioned
to ensure adequate air removal, sterilant contact, and drying.
The practice of confining instruments in paper-plastic pouches
and then including them in wrapped or containerized sets has not
been validated as appropriate and efficacious by packing and
container manufacturers.”2

Other options for containing

devices include all paper bags
(Figure 10), foam or woven material
that are designed and tested for
this purpose.

Figure 10.
Paper sterilization pouches

In order to verify adequate sterilant contact, upon assembly, a CI should be

placed inside each organizing device within the instrument set.

Practical Application
• Follow recommended practices and manufacturer’s instructions on
how to use peel pouches.
• Never place paper-plastic peel pouches inside a containment
device because you can not ensure adequate air removal, sterilant
contact, and drying. This would also be true of plastic peel
pouches.

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CHEMICAL INDICATOR/INTEGRATOR Count sheets

Chemical indicators/integrators, both internal and external, Instrument count sheets should not go inside wrapped or
should be specific to the sterilization process being used. containerized instruments sets. Various types of copy paper
The end user should be knowledgeable and demonstrate (not medical grade paper) and toners are usually used to print
competency regarding the performance characteristics of the count sheets. Currently, there is no available research regarding
monitoring products.3 the effects of the copy paper or toners to the sterilization
process. Paper and toner ink may pose a risk of reaction to
Internal CIs some sensitized patients due to the chemicals used in the manu-
At least one chemical indicator/integrator should be facturing of these products.2
used within each wrapped package. The CI may be a Class 3 One option is to attach the instrument inventory count
(single parameter indicator), a Class 4 (multi-variable sheets to the outside of the container or wrapped package.
indicator), or Class 5 (integrating indicator).2 AAMI ST79 Folding and then attaching the count sheet to the container
states the Class 4 and Class 5 CIs provide more information handle or taping it to the wrap is one acceptable method to
than the Class 3 CIs that only measure temperature. ensure the count sheet stays with the package (Figure 11 below).
The CI should be placed in the area of the package
considered to be the least accessible to sterilant penetration Figure 11. Count sheet placement on outside of package
and air removal. This may or may not be the geometric
center of the package. For rigid containers, the corners and
the area away from the filters are the likeliest location of air
pockets, therefore, resulting in the biggest challenge for the
CI. So place two CIs, one in each of two opposite corners of
the inside basket. For multi-levels, either in rigid containers
or wrapped sets, a CI should be placed on each level of the
set in opposite corners.3 End users should know how to
interpret the CI and not use the package if the endpoint is not
achieved. Other packages in the load should be quarantined
until the BI results are available or other indicators are
checked if the BI was not run.3
Practical Application
External CIs • Do not place count sheets inside of wrapped or
An external chemical indicator, classified as Class 1, containerized instruments sets to avoid the patient
should be affixed to each package unless the internal CI is contacting paper or toner ink which may cause a
visible. The purpose of the external CI is to distinguish reaction in sensitized patients.
between processed and unprocessed devices. The external
chemical indicator maybe located on the package, an identi-
fication card, tamper-proof locks, the filter, or elsewhere Labeling the packages
according to the policy of each healthcare facility. The Packaging systems should be labeled with the description
indicator should be examined after sterilization and before of the package contents, identification of the person assembling
use to make sure that the package and its contents were the package and a lot control number. To decrease confusion,
exposed to a sterilization process.3 packages should be labeled before being put into the sterilizer.2
Package labels (i.e., process indicators, product identification,
expiration statement labels) should be fixed firmly to the package
Practical Application all the way through processing, storage, and distribution to the
• Place internal CIs inside each package in the point of use. If a marking pen is used to mark surgical packages,
areas that create the greatest challenge to air the information should be written on the indicator tape or
removal and sterilant penetration. attached label. Marking pens should only be used on the plastic
• Place an external CI on the outside of each side of peel-pouches.2
package unless the internal CI is visible. “Writing on the paper side of the pouch or on
• If the external or internal CI have not reached a wrapper (woven or nonwoven) could cause damage
their acceptable endpoint, do not use the package. to the package (which might not be noticeable) and
thereby compromise the barrier protection.”3

94 MANAGING INFECTION CONTROL January 2008

 Education & Training

To avoid toxins being deposited on packs or instruments, Competency

the ink in marking pens should be nontoxic. Employees responsible for selecting and using pack-
When asking sterile processing professionals what they aging systems should be knowledgeable about sterilization
use for package labeling, they tell me they use a black felt principles and each manufacturer’s written directions
tip marker. To my knowledge, the only felt tip marker tested and sterilization compatibility issues of each type of pack-
to withstand extreme heat and steam as well as processing aging. The competency of each staff member responsible
chemicals and cleaners is the “Industrial Sharpie.” It comes in for packaging systems should periodically be evaluated
fine point (item no. 13601) or extra fine point (item no. 13801). and documented.2
The Industrial Sharpie package states one of the specific uses is
for sterilization such as autoclaving.
Practical Application
• All the information in this inservice should be
Practical Application part of the competency testing of all employees
• Only write on the indicator tape, attached label or that select and use packaging systems.
plastic side of a peel pouch so that toxins do not
contact the medical devices.
Summary
Sterilization packaging is not a simple topic. It must
Extended cycles adequately allow sterilization of the enclosed medical
Today’s sterile processing professionals are faced with device and also maintain sterility of the contents until
the issue of extended steam sterilization cycles for surgical used. Classified by the FDA as a Class II medical device,
instruments (a cycle time longer than four minutes at 270°- it is much more than a box, bag or gift wrap! To ensure
275°F/132°-135°C in a dynamic-air-removal sterilizer). AORN’s patient safety, specific manufacturers written validated
Sterile Processing/Materials Management Specialty Assembly guidelines for each type of system must be followed and
(SP/MM SA) Coordinating Council released a general statement staff must demonstrate competency in each packaging
on extended cycles: system used. Meanwhile, save the gift wrapping skills for
“Each medical facility needs to make sure that the holidays!
all their products used for sterilization (peel
pouches, wrap, etc.) can withstand these longer steam Glossary of Terms
sterilization cycles. Each medical facility needs to  Aseptic presentation: Maintaining the sterility of the
make sure that the products used in extended cycles are contents as a sterilized package is opened and the
validated for these types of cycles. Many manufactures contents are removed.5
have tested their products for these longer cycle  Containment device: Reusable rigid sterilization
times. The manufacture of the products should supply container, instrument case, cassette or organizing tray
information to the user for their records.”7 intended for use in healthcare facilities for the purpose
of containing reusable medical devices for sterilization.5
At the time of writing this article there are two manufacturers  Reusable rigid sterilization container: Sterilization
of sterilization packaging products that have documentation containment device designed to hold medical devices
posted on AORN’s SP/MM SA Web portal at http:// for sterilization, storage, transportation, and aseptic
communities.aorn.org/COP/SPMatMngmt/FileSharing/index. presentation of contents.5
fusion that state their products can withstand sterilization  Organizing tray: Reusable metal or plastic contain-
cycles with extended exposure times up to 30 minutes.7 ment device that organizes and protects instruments
and components in specified locations within the
device, and that is usually wrapped with an approved
Practical Application wrapping material.5
• Check with the manufacturer of the packaging  Insert case or tray: Reusable case or tray that is placed
material to make sure it can be used in extended inside a reusable rigid sterilization container, that is
cycles or cycles longer than four minutes at fixed or not fixed in place, and that serves to group or
270°-275°F/132°-135°C in a dynamic-air-removal protect instruments and components.5
sterilizer.  Reusable accessory: Optional component not essential
in itself but that aids in the organization and protection

January 2008 MANAGING INFECTION CONTROL 95

 Education & Training

of instruments within a sterilization container system. Available in an attractive binder featuring sturdy metal
Such items include, but are not limited to, insert cases, rings, ledger-weight pages, and a laminated tab for each section
organizing trays, cassettes, brackets, posts, partitions, for easy navigation. AAMI will issue revised pages that can be
instrument mats, racks and stringers.5 substituted into the binder when changes are made.
 Instrument case/cassette: Sterilization containment device Also available in PDF format and as part of AAMI’s
that consists of a lid and a base with means to allow electronic CD and subscription products.
sterilant penetration and removal, and that is enclosed in a Price/Member discount price: $200/$100.
sterile barrier system if sterility is to be maintained.5
 Product testing: Routinely testing processed items with AAMI documents can be purchased through AAMI by
biological and chemical indicators whenever “major credit card using the following four options:
changes are made in packaging, wraps, or load configu- 1. Internet: http://www.aami.org
ration, such as dimensional changes, weight changes, or 2. Call: 1-877-249-8226 or 240-646-7013
changes in the type or material of packaging or wrapper.3 3 Fax: 301-206-9789
 Biological indicator(BI): “Test system containing viable 4. Mail: AAMI, Customer Service Center, 1100 N. Glebe
microorganisms providing a defined resistance to a Road, Suite 220, Arlington, VA 22201-5762
specified sterilization process.”3
 Chemical indicator(CI): “Device used to monitor the AORN
presence or attainment of one or more of the parameters AORN Standards can be purchased through AORN using
required for a satisfactory sterilization process, or used the following options:
in specific tests of sterilization equipment.”3 1. Internet: www.aorn.org/bookstore/ordering.htm
 Drying time: Time required to dry steam sterilized items 2. Call: 1-800-755-2676 ext. 1 or 303-755-6304 ext. 1 (Monday-
inside the sterilizer.5 Friday, 8AM to 4:30PM mountain standard time)
 Dynamic-air-removal sterilizers: Type of sterilization 3. Fax: 303-750-3212
cycle in which “air is removed from the chamber and 4. By mail: AORN, Inc., Customer Service/Book Orders, 2170
the load by means of a series of pressure and vacuum South Parker Road, Suite 300, Denver, CO 80231-5711, USA
excursions (prevacuum cycle) or by means of a series of 5. Payment can be made by:
steam flushes and pressure pulses above atmospheric VISA, MasterCard, American Express, or Discover, either
pressure (steam-flush pressure-pulse [SFPP] cycle).”1 online or by mail/fax/phone.
 Gravity-displacement steam sterilizers: Type of steriliza- By authorized PO, and AORN will bill you ($100 minimum
tion cycle in which incoming steam displaces residual air purchase). Sorry, we cannot accept POs for education
through a port or drain in or near the bottom (usually) of conferences or services. (Not available for online orders).
the sterilizer chamber.3 6. A CDRom of the standards is available for the first time
 Ethylene oxide: Type of gaseous chemical sterilization this year.
cycle in which the four process variables are ethylene
oxide (EO) gas concentration, exposure time, temperature References
and relative humidity.5 1. Central Service Technical Manual. 6th ed. Chicago, International
 Hydrogen peroxide gas plasma: Type of gaseous chem- Association of Healthcare Central Service materiel Management, 2003,
p 200.
ical sterilization cycle in which the four process 2. Recommended Practices for Selection and Use of Packaging Systems.
variables are hydrogen peroxide concentration, time, Association of periOperative Registered Nurses. AORN Standards,
temperature and gas plasma power level.5 Recommended Practices, and Guidelines. 2007.
3. The Association for the Advancement of Medical Instrumentation.
 Ozone sterilization: Type of gaseous chemical sterilization Comprehensive guide to steam sterilization and sterility assurance in
cycle in which the four process variables are ozone dose health care facilities. ANSI/AAMI ST79:2006.
injected, humidity, exposure time and temperature.5 4. Seavey R. Just Say No! Don’t Get Weighed Down by Instrument Sets
That Are Too Heavy. Managing Infection Control. 2006, April volume
 Flash sterilization: Process designed for the steam Six Issue 4, p 86-97.
sterilization of patient care items for immediate use.5 5. The Association for the Advancement of Medical Instrumentation.
Containment devices for reusable medical device sterilization.
ANSI/AAMI ST77:2006.
Ordering Information 6. Recommended Practices for Maintaining a Sterile Field. Association of
AAMI periOperative Registered Nurses. AORN Standards, Recommended
ANSI/AAMI ST79:2006, Comprehensive guide to steam Practices, and Guidelines. 2007.
7. AORN. Sterile Processing/Materials Management Specialty Assembly
sterilization and sterility assurance in health care facilities Portal. Available at: http://communities.aorn.org/COP/SPMatMngmt/
Order code: ST79 or ST79-PDF FileSharing/index.fusion.

96 MANAGING INFECTION CONTROL January 2008

 Education & Training

Sterile Process and Distribution CEU Information

CEU Applicant Name _________________________________________________

Address___________________________________________________________

City____________________________ State________ Zip Code ______________

The CBSPD (Certification Board for Sterile Processing and Distribution) has
pre-approved this inservice for one and one-half (1.5) contact hours for a period of
five (5) years from the date of publication. Successful completion of the lesson and
post test must be documented by facility management and those records maintained
by the individuals until recertification is required. DO NOT SEND LESSON OR TEST
TO CBSPD.
For additional information regarding Certification contact: CBSPD, 121 State
Hwy 31N, Suite 500, Flemington, NJ 08822 or call 908-788-3847 or visit the Web site
Rose Seavey, RN, BS, MBA, at www.sterileprocessing.org.
CNOR, ACSP, is the director of the IAHCSMM has awarded one and one-half (1.5) Contact Points for completion of
sterile processing department at this continuing education lesson toward IAHCSMM recertification.
The Children’s Hospital of Denver. Ms
Seavey is an active member of the Nursing CE Application Form
Association of periOperative Registered This inservice is approved by the California Board of Registered Nurses, CEP
5770 for one (1) contact hour. This form is valid up to one (1) year from the date
Nurses (AORN) and was elected of publication.
to the National AORN Nominating 1. Make a photocopy of this form.
Committee for 2005-2007. She was 2. Print your name, address and daytime phone number and position/title.
3. Add the last 4 digits of your social security number or your nursing license number.
honored with AORN’s award for
4. Date the application and sign.
Outstanding Achievement in Clinical 5. Answer the true/false CE questions.
Nurse Education in 2001. She served 6. Submit this form and the answer sheet to:
as the President of the American Workhorse Publishing
Managing Infection Control
Society of Healthcare Central Service
PO Box 25310, Scottsdale, AZ 85255-9998
Professionals (ASHCSP) in 2003 and 7. For questions or follow-up, contact craig@manageinfection.com.
is the 2002 recipient of the ASHCSP 8. Participants who score at least 70% will receive a certificate of completion
National Educator of the Year award. within 30 days of Managing Infection Control’s receipt of the application.
She is currently the chair for the
AORN speciality assembly for Sterile Application
Please print or type.
Processing Materials Management.
Ms. Seavey is a member of several Name______________________________________________________________
AAMI working group committees
that are developing recommended Mailing Address______________________________________________________
practices and is currently a co-chair City, State, Country, Zip _______________________________________________
for the AAMI ST8, Hospital steam
sterilizers. In addition she has lectured Daytime phone ( )__________________________________________
and authored many articles on various
Position/Title_______________________________________________________
topics relating to perioperative
services and sterile processing, Social Security or Nursing License Number ________________________________
locally, nationally and internationally.
Date application submitted _____________________________________________

Signature __________________________________________________________
ANSWERS Offer expires January 2013
1. T 6. T On a scale of 1-5, 5 being Excellent and 1 being Poor, please rate this program
for the following:
2. T 7. T
3. F 8. T 1) Overall content ___________________
4. T 9. T 2) Met written objectives ______________
5. F 10. F 3) Usability of content ________________

<01/08>
Reprint with permission from Workhorse Publishing L.L.C.
Copyright©2008/Workhorse Publishing L.L.C./All Rights Reseved. 70-2009-9611-7

January 2008 MANAGING INFECTION CONTROL 97