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Packaging - Genesis Containerized Systems
Follow the instructions provided with the Genesis container.
Sterilization
All devices must be processed in the completely open position
(i.e. flushports, jaws, etc.) to allow sterilant contact of all
surfaces. Note that applicable device disassembly should not
require any mechanical tooling (i.e. screwdriver, pliers etc.)
unless otherwise indicated.
All devices with concave surfaces shall be configured so that
water pooling does not occur.
Note: These instruments have not been validated for
sterilization using Ethylene Oxide (EO).
When using a Genesis sterilization container please refer to the
full instructions for use for Genesis Sterilization Containers.
Recommended Sterilization Cycle Parameters
The following recommendations may include sterilization
temperature/exposure parameters and maximum loads different
than those which your institution commonly uses. Since
individual sterilizers may perform differently it is important to
conduct individual sterilizer testing of instrument sets using
biological and chemical indicators to verify exposure times and
to determine adequate sterilizing parameters in your particular
facility.
These recommendations represent specific validated settings,
but are not inclusive of all possible combinations of settings
and variables which could produce acceptable results. The
recommendations below were generated to cover a worst case
instrument set with typical load contents. The end user is
ultimately responsible for establishing and following protocols
to ensure properly sterilized and dried sets.
Sterilizers vary in design and performance characteristics. It is
strongly recommended that the user verify the cycle parameters
for the specific sterilizer prior to use. It is important to verify
the parameters in conjunction with the sterilizer, load contents
and any other processing accessories that may be used.
Adjusted cycle times or dry times may be required to properly
sterilize and dry desired loads.
Sterilization for United States Market
PREVACUUM STEAM STERILIZATION CYCLES
Prevacuum Steam Sterilization Cycle (U.S. "FDA
Compliant – WRAPPED")
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F)
• Exposure Time: 4 minutes
• Dry Time: 30 minutes
• Sterilization Configuration: FDA Cleared Sterilization Wrap
(2 layer-1 ply, or 1 layer -2 ply – examples: cellulose,
polypropylene, muslin)
Prevacuum Steam Sterilization Cycle – Immediate Use
Steam Sterilization (U.S. "FDA Compliant – WRAPPED")
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F)
• Exposure Time: 4 minutes
• Sterilization Configuration: FDA Cleared Sterilization Wrap
(2 layer-1 ply, or 1 layer -2 ply – examples: cellulose,
polypropylene, muslin)
Note: Devices must be used immediately and cannot be
stored for later use.
Immediate Use Steam Sterilization is not recommended as
a routine practice. Refer to ANSI/AAMI ST79 for
requirements on when to perform and how to control
immediate use steam sterilization.
Reference: ANSI/AAMI ST79: (current revision)
Comprehensive guide to steam sterilization and sterility
assurance in health care facilities.
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