Healthcare Hygiene magazine November 2019 | Page 12

IAHCSMM Insider for CS/SPD
By Susan Klacik, BS, CRCST, CHL, CIS, ACE, FCS
Newly Revised AORN Guideline on
Sterilization Packaging
R
esearch has led to many improvements in patient care,
including those involving sterilization packaging. Use
of the correct sterilization packaging permits the sterilant
from entering and exiting the package, maintains the sterility,
and allows for aseptic presentation.
The Association of periOperative Registered Nurses
(AORN)’s Guideline for Sterilization Packaging Systems has
been relied upon as a best practice since it addresses all
activities related to sterilization packaging and has recently
undergone key revisions. This article will highlight some of
the key changes to this guideline.
The sterilization packaging system begins with the
pre-purchase evaluation of a packaging system. The guideline
provides a listing of considerations such as:
• Product quality assurance testing results
• Compatibility with the intended sterilization method(s)
and cycles used within the facility
• Requirements for cleaning according to the instructions
for use (IFU) (e.g., laundry for textiles, equipment for cleaning
rigid containers)
• Requirements for tracking use
• Method for tracking use
Compatibility with a sterilization process is a primary
consideration. This updated guideline includes packaging
for sterilization using hydrogen-peroxide combined with
ozone, which was recently introduced in the U.S.
Guidance for the preparation for packaging was revised
to recommend that packaging for sterilization be performed
in an area intended, designed and equipped for sterilization
packaging activities, such as the packaging area of the sterile
processing department (SPD). Prior to packaging, users are
advised to verify that instruments and other medical devices
have been cleaned, inspected and assembled according to
the manufacturer’s IFU.
This updated guideline recommends use of colored or
tinted tip protectors for sharp items to protect instrumen-
tation from damage and to protect personnel from injury.
The main concern is that colored or tinted tip protectors
make it easier for personnel to see, which is important on
a sterile field. Clear tip protectors are difficult to see and
can pose a risk for a retained surgical item.
The importance of hand hygiene during instrument
preparation is also addressed in the guideline. As instru-
mentation is handled during preparation, there is concern
of transferring what is on the hands of the assembler to the
instrumentation. Research has shown that contaminants,
oils and soils transferred to instruments from the hands of
personnel can compromise sterilization. Due to this research,
AORN’s updated guideline recommends that personnel who
inspect, assemble and package reusable surgical instruments
perform hand hygiene within the hour or wear clean gloves
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to perform these tasks. AORN also recommends performing
hand hygiene before handling instruments and medical
devices for sterilization.
The updated AORN packaging guideline includes
guidance on the packaging of loaned instrumentation,
including the recommendation to obtain (from the vendor
that provides the instrumentation) sterilization packaging
information for loaned instrument sets.
The practice of placing count sheets inside instrument
sets has sparked some controversy and there is insufficient
evidence for making a recommendation on this practice;
therefore, each healthcare organization will need to deter-
mine if count sheets may be placed in trays. The decision
should consider the limited research available regarding the
safety of subjecting toners, inks and various papers to any
sterilization method. Chemicals used in the manufacturing
of paper, toners and inks pose a theoretical risk of reaction
in some sensitized individuals. One research study concluded
that the label and toner ink transferred during sterilization
was not cytotoxic; however, further study is needed to
incorporate a larger sample, various sterilization methods,
and instruments of a variety of compositions.
Checking IFU for products used for sterilization is a key
principal of sterilization and packaging. AORN’s updated
guideline now includes what to look for in the IFU when
selecting a single-use, nonwoven sterilization wrapper. In
addition, the IFU can provide information for the correct
use and maintenance. It is important to note that not all
single-use, nonwoven packaging systems are validated for
all sterilization methods and cycles.
The guideline also includes recommendations regarding
use of corner protectors for wrapped trays. To prevent tears
when using flat wrappers for instrument trays, especially those
with sharp edges, many facilities use corner guards. The use
of corner guards prevents the tears that occur on corners,
especially if they are sharp. A tear or hole in a wrapper destroys
the integrity of the packaging system since it creates a pathway
for microbes to enter a sterilized package and contaminate
it. As with all sterilization packaging, it is important to check
the IFU of the corner protector manufacturer for information
regarding the type of validated sterilization method.
The updated guideline also recommends that users estab-
lish and implement a schedule for routine rigid sterilization
container inspection, maintenance and repair. Also, new
factors have been added regarding what to look for in the
container’s IFU that provides information on their correct use.
The complete guideline is available for purchase at
www.aorn.org.
Susan Klacik, BS, CRCST, CHL, CIS, ACE, FCS, is clinical
director at IAHCSMM.
november 2019 • www.healthcarehygienemagazine.com