Biological indicators
are a device to monitor the
sterilization process that consists of
a standardized population of bacterial spores known to
be resistant to the mode of sterilization being
monitored. Biological indicators indicate that all the
parameters necessary for sterilization were present.
As per the FDA, “a
biological sterilization process indicator is a device
intended for use by a health care provider to accompany
products being sterilized through a sterilization
procedure and to monitor adequacy of sterilization. The
device consists of a known number of microorganisms, of
known resistance to the mode of sterilization, in or on
a carrier and enclosed in a protective package.
Subsequent growth or failure of the microorganisms to
grow under suitable conditions indicates the adequacy of
sterilization.” [21 CFR 880.2800(a)(1)]
Biological indicators
are recognized by most authorities as being closest to
the ideal monitors of the sterilization process because
they measure the sterilization process directly by using
the most resistant microorganisms (i.e., Bacillus
spores), and not by merely testing the physical and
chemical conditions necessary for sterilization. Since
the Bacillus spores used in biological indicators are
more resistant and present in greater numbers than are
the common microbial contaminants found on patient-care
equipment, the demonstration that the biological
indicator has been inactivated strongly implies that
other potential pathogens in the load have been killed.
ATS, Inc. provides high
quality, FDA approved, biological indicators for
sterilizer monitoring using either a
Mail-In or
In-Office
testing system.
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.
