Cleaning Inspection
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Inspect all instruments before sterilization or storage to ensure the complete removal of soil from
surfaces, lumens, holes, and moveable parts.
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If areas are difficult to inspect visually, check for blood by immersing or flushing the instrument in
a 3% hydrogen peroxide solution. If bubbling is observed, blood is present. Rinse instruments for
a minimum of 1 minute with warm, 85°F – 104°F (30°C – 40°C), tap water after using hydrogen
peroxide solution.
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If soil is still present, re-clean the instrument.
Disinfection
Instruments must be terminally sterilized prior to surgical use. See Sterilization instructions.
Maintenance
Carefully inspect instruments between uses to verify proper functioning. Send damaged instruments
to a supplier of authorized repair or refurbishment services.
Inspection and Functional Testing
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Visually inspect the instruments for damage and wear.
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The dilators should be free of bending and distortion.
Packaging
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If desired, use instrument trays to contain instruments that are provided in sets.
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Double wrap instruments in accordance with local procedures, using standard wrapping techniques
such as those described in the current revision of ANSI/AAMI ST79.
Sterilization
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Use a validated, properly maintained and calibrated steam sterilizer.
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Effective steam sterilization can be achieved using the following cycle:
Cycle Type
Pre-Vacuum
Pre-Vacuum*
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Post-sterilization drying of the sterilization load within the sterilization vessel is standard practice
in hospitals. ANSI/AAMI ST79:2006, "Comprehensive guide to steam sterilization and sterility
assurance in health care facilities" provides guidance to hospitals for selecting appropriate drying
parameters based on the sterilization cycle that is being conducted. Sterilizer manufacturers also
typically provide recommendations for drying parameters for their specific equipment.
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Only legally marketed, FDA cleared sterilization wrap, pouches, or DePuy Synthes Reusable
Sterilization Containers should be used by the end-user for packaging terminally sterilized devices.
The manufacturer's instructions for use for the sterilization wrap, pouches, or DePuy Synthes
Reusable Sterilization Containers are to be followed. The use of DePuy Synthes Reusable
Temperature
270°F (132°C)
273°F (134°C)
9 of 152
Exposure Time
4 minutes
3 minutes
Dry Time
30 minutes
30 minutes