|
Since sterilization failure can occur
(about 1% for steam sterilizers), a procedure to follow in the event
of positive spore tests with steam sterilization has been provided
by CDC and the Association of periOperative Registered Nurses (AORN).
The 1981 CDC recommendation is that "objects, other than implantable
objects, do not need to be recalled because of a single positive
spore test unless the steam sterilizer or the sterilization
procedure is defective." The rationale for this recommendation is
that single positive spore tests in sterilizers occur sporadically.
Most “Positive Test Results” occur within
24 hours, with the sterilizer user notified immediately of the test
failure. Most failed tests are caused by operator error –
overloading being a common reason for failed tests. Chemical vapor
and Dry Heat sterilizers are especially sensitive to overloading.
Running or testing a sterilizer from a COLD start can also cause
sterilizer failure. Sterilizer manufacturers recommend initially
running the sterilizer EMPTY to preheat the chamber before using it
and some manufacturers suggest running longer cycles if the
sterilizer is used from a COLD start.
If the
mechanical (e.g., time, temperature, pressure in the steam
sterilizer) and
chemical
(internal and/or external) indicators suggest that the sterilizer
was functioning properly, a single positive spore test probably does
not indicate sterilizer malfunction but the spore test should be
repeated immediately. If the spore tests remain positive, use of
the sterilizer should be discontinued until it is serviced.
Similarly, AORN states that a single positive spore test does not
necessarily indicate a sterilizer failure. If the test is positive,
the sterilizer should immediately be rechallenged for proper use and
function. Items, other than implantable ones, do not necessarily
need to be recalled unless a sterilizer malfunction is found. If a
sterilizer malfunction is discovered, the items must be considered
nonsterile, and the items from the suspect load(s) should be
recalled, insofar as
possible, and reprocessed.
A more conservative approach also has been recommended
in which any positive spore test is assumed to represent sterilizer
malfunction and requires that all materials processed in that
sterilizer, dating from the sterilization cycle having the last
negative biologic indicator to the next cycle showing satisfactory
biologic indicator challenge results, must be considered nonsterile
and retrieved, if possible, and reprocessed. This more conservative
approach should be used for sterilization methods other than steam
(e.g., ETO, hydrogen peroxide gas plasma). However, no action is
necessary if there is strong evidence for the biological indicator
being defective or the growth medium contained a Bacillus
contaminant. See the complete
recommendations on sterilizer and disinfection at
www.cdc.gov
“Guideline for Disinfection and Sterilization in Healthcare
Facilities, 2008”.
|
|
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). |
