Studies in the early 1970s suggested that wrapped surgical trays
remained sterile for varying periods depending on the type of
material used to wrap the trays. Safe storage times for sterile
packs vary with the porosity of the wrapper and storage conditions
(e.g., open versus closed cabinets). Heat-sealed, plastic peel-down
pouches and wrapped packs
sealed in 3-mil (3/1000 inch) polyethylene overwrap have been
reported to be sterile for as long as 9 months after
sterilization. The 3-mil
polyethylene is applied after sterilization to extend the shelf life
for infrequently used items. Supplies wrapped in double-thickness
muslin comprising four layers, or equivalent, remain sterile for at
least 30 days. Any item that has been sterilized should not be used
after the expiration date has been exceeded or if the sterilized
package is wet, torn, or punctured.
Event-Related
Storage:
Although some hospitals continue to date every sterilized product
and use the time-related shelf-life practice, many hospitals have
switched to an event-related shelf-life practice. This latter
practice recognizes that the product should remain sterile until
some event causes the item to become contaminated (e.g., tear in
packaging, packaging becomes wet, seal is broken).
Event-related factors that
contribute to the contamination of a product include
bioburden (i.e., the amount of
contamination in the environment), air movement, traffic, location,
humidity, insects, vermin, flooding, storage area space, open/closed
shelving, temperature, and the properties of the wrap material.
There are data that support the event-related shelf-life practice.
One study examined the effect of time on the sterile integrity of
paper envelopes, peel pouches, and nylon sleeves. The most
important finding was the absence of a trend toward an increased
rate of contamination over time for any pack when placed in covered
storage. Another evaluated the effectiveness of event-related
outdating by microbiologically
testing sterilized items. During the 2-year study period, all of
the items tested were sterile. Thus, contamination of a sterile
item is event-related and the probability of contamination increases
with increased handling.
Dos and Don’ts:
Following the sterilization process, medical and surgical devices
must be handled using aseptic technique in order to prevent
contamination. Sterile
supplies should be stored far enough from the floor (8 to 10
inches), the ceiling (5 inches unless near a sprinkler head [18
inches from sprinkler head]), and the outside walls (2 inches) to
allow for adequate air circulation, ease of cleaning, and compliance
with local fire codes (e.g., supplies must be at least 18 inches
from sprinkler heads). Medical and surgical supplies should not be
stored under sinks or in other locations where they can become wet.
Sterile items that become wet are considered
contaminated because moisture
brings with it microorganisms from the air and surfaces. Closed or
covered cabinets are ideal but open shelving may be used for
storage. Any package that has fallen or been dropped on the floor
must be inspected for damage to the packaging and
contents (if the items are
breakable). If the package is heat-sealed in impervious plastic and
the seal is still intact, the package should be considered not
contaminated. If undamaged, items packaged in plastic need not be
reprocessed.See the complete
recommendations on sterilizer and disinfection at
www.cdc.gov
“Guideline for Disinfection and Sterilization in Healthcare
Facilities, 2008”.
ATS, Inc. stocks
sterile-processing packaging supplies such as sterilization pouches
or bags – see Supplies.
DID YOU KNOW?
§
Autoclave Testing Service, Inc. is one of the first companies
nationwide to offer a
Mail-In sterilizer
monitoring service using biological indicators. Serving the
healthcare industry throughout the United States and Canada since
1986, we have thousands of satisfied customers.
§
We have on-line test results
allowing you to access your results at your convenience! Your
Sterilizer Test Report (STR) is posted
on-line upon completion of
culturing, offering minimum turn-around time.
§
We have 24-hour test results for Steam sterilizers!
§
We have a comprehensive Glossary of Terms related to the sterile
processing area (scroll below to view the Glossary). This is
invaluable information, assisting you with this important area of
your facility.
ATS, Inc. now
stocks sterilization pouches, sterilizer cleaners, chemical
indicator products, sterilizers (new and used), ultrasonic cleaners,
water distillers, and more! (see
Supplies).
In-Office and Mail-To-Lab Testing!
Verify the sterilization process of all steam
sterilizers which include Statim, Midmark,
Tuttnauer, Lisa, Mocom and Pelton & Crane
sterilizers.
Bowie-Dick Test
Packs should be used daily to evaluate the
performance of air-removal (vacuum) system of
dynamic pre-vacuum type sterilizers. Available
as test cards or preassembled test packs.
Internal CI’s should be used within
each pouch or package, tray, or container. Class 5
Integrators should be used in conjunction with
physical monitoring and biological indicator
testing for verifying the efficacy of a
sterilization system. (See AAMI ST79:2006)
Recordkeeping is a must for all
sterile processing departments. This ensures
accountability and allows operators to trace
errors to their source. Tips on sterilizer
maintenance and technical advice are included with
each book.
