This document is valid only on the date printed. If unsure of the print date, please
re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com).
The onus resides with the user to ensure that the most up-to-date IFU is used.
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Following automated drying, inspect the device for residual
moisture. Any residual moisture identified should be dried
manually (as described below).
For manual drying:
•
Ensure each device is dried and inspected thoroughly.
•
For external surfaces, use a clean, soft, lint-free cloth to avoid
damage to the surface.
•
Open and close any applicable devices during drying. Pay
special attention to any device threads, ratchets and hinges or
areas where fluid can accumulate. Clean, compressed air (e.g.,
medical grade) may be used to facilitate surface drying.
•
Dry all lumen/cannulated parts using clean compressed air
(e.g., medical grade).
Step 6: Maintenance and Inspection
Instruments should be visually inspected under ambient lighting,
to verify that the devices do not have visible soil, damage or
moisture.
Inspect devices for:
•
Lack of moisture. If moisture is detected, manually drying
should be performed.
•
Cleanliness. If any residual soil is discovered during inspection,
repeat the cleaning steps on those devices until all visible soil is
removed from the device.
•
Damage, including but not limited to, corrosion (rust, pitting),
discoloration, excessive scratches, flaking, cracks and wear
•
Proper function, including but not limited to, sharpness of
cutting tools, bending of flexible devices, movement of hinges/
joints/box locks and moveable features such as handles,
ratcheting and couplings and missing or removed part numbers
Improperly functioning devices, devices with unrecognizable
markings, missing or removed (buffed off) part numbers,
damaged and worn devices should be discarded.
Disassembled devices should be reassembled prior to sterilization
when specified.
Lubricate any moving parts with a water-soluble surgical
instrument lubricant. The lubricant should be approved for use on
medical devices and provided with data to ensure biocompatibility
and compatibility with steam sterilization.
Step 7: Packaging
Place cleaned, dry devices into the specified locations within the
cases provided, if applicable.
Only legally marketed, and locally approved sterilization barriers
(e.g. wraps, pouches or containers) should be used for packaging
terminally sterilized devices, in compliance to the manufacturer’s
instructions.
Step 8. Sterilization
Steam (moist heat) sterilization shall be performed in a locally
approved, pre-vacuum (forced air removal) cycle. The steam
sterilizer should be validated to the requirements of any local
standards and guidance such as EN 285 or AAMI/ANSI ST8. The
steam sterilizer should be installed and maintained in compliance
to manufacturer’s instructions and local requirements. Ensure
that the steam sterilizer cycle is chosen that is designed to
remove air from porous or lumened device loads in accordance
to manufacturer’s instructions and does not exceed the criteria for
sterilizer load.
The following steam sterilization cycles are examples of validated
cycles:
Condition-
ing Phase
Minimum Steril-
ization Exposure
Time (minutes)
Minimum
Sterilization
Exposure
Temperature
Dry Time*
Prevacuum
4
132°C (270°F) 30 minutes
Prevacuum
3
134°C (274°F) 30 minutes
Extended steam exposure cycle can be used to meet local
requirements such as 134°C (274°F) for 18 minutes.
The efficiency of steam sterilizer drying can range considerably
depending on the sterilizer design, loading, packaging and steam
supply during the sterilization process. The user should employ
verifiable methods (e.g. visual inspections) to confirm adequate
drying. Extended drying within the sterilizer or in an external
drying cabinet in accordance with manufacturer’s instructions may
be necessary. Do not exceed 140°C (284°F) during drying.
Step 9: Storage
Sterilized products should be stored in a dry, clean environment,
protected from direct sunlight, pests, and extremes of temperature
and humidity.
Refer to sterilization wrap or rigid container manufacturer’s IFU for
limits on sterile product storage time and storage requirements for
temperature and humidity.
ADDITIONAL INFORMATION
Cleaning agent information: Examples of detergents that have
been used during cleaning validations include Prolystica
TM
2X Concentrate Enzymatic Cleaner, Prolystica
TM
2X Neutral
Detergent, Enzol
TM
, Endozime
TM
, Neodisher Medizym
TM
,
Terg-A-Zyme
TM
, and NpH-Klenz
TM
.
2018-03-09 04:03:33