4-1
Techniques of Sterilization
Operator Manual
P129394-020
4.1 General
The information in this section is intended as a general guide to
steam sterilization techniques. Also recommended is reference to
the standards of the Association for the Advancement of Medical
Instrumentation (AAMI ST-79), comprehensive guide to steam
sterilization and sterility assurance in health care facilities.
•
Prior to sterilization, all materials and articles must be thoroughly
cleaned.
•
After sterilization, goods should be stored in conditions that will
not compromise the barrier quality of their wrapping materials.
Important:
Applicable cycles have been validated to satisfy the
requirements outlined in
(page-iv). If
cycle parameters (sterilize time, dry time, temperature) other than
those listed are required, it is the responsibility of the healthcare
facility to consult and follow the device manufacturer’s written
instructions.
NOTE: Contact STERIS for information on a wide range of education/
training programs designed to meet the educational needs of
healthcare industries.
As part of the operator’s verification of the sterilization process,
biological indicators may be used to demonstrate that sterilization
conditions have been met.
NOTE: Contact STERIS for information on specific biological
indicators recommended for use with this sterilizer.
4.2 Immediate Use
Each of the sterilizers is programmed with one or more sterilization
cycles intended to process items for “immediate use.” Immediate
use can be defined as the shortest possible time between a
sterilized item’s removal from the sterilizer and its aseptic transfer to
the sterile field.
•
A sterilized item intended for immediate use must not be stored.
•
An item sterilized for immediate use cannot be held for use on a
future case.
•
The Prevac immediate use cycle is the preferred immediate use
cycle to use. The Gravity immediate use cycle is only safe for
simple instruments that contain no hinges or other features that
could trap air.
4.3 Control Measures
for Verifying
Sterilization Process
A live spore test utilizing
G. stearothermophilus
is the most reliable
form of biological monitoring. This type of product utilizes controlled
populations of a controlled resistance, so that survival time and kill
time can be demonstrated.
To verify the process, insert the biological indicator in a test pack
and place pack on the bottom shelf. Run test pack through a typical
cycle. On completion, forward test pack and monitor to appropriate
personnel for evaluation. Refer to AAMI guidelines to conduct routine
biological monitoring.
WARNING: The liquid cycle is
for non-patient contact use
only.
!
TECHNIQUES OF STERILIZATION
4
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