Depuy Synthes EXPEDIUM SFX Handbuch Seite 7

Recircula-
tion Time
Phase (mins)
Rinse 2
Rinse 0.25
Step 4: Thermal Disinfection
Thermal disinfection is recommended to render devices safe for
handling prior to steam sterilization. Thermal disinfection should
be conducted in a washer-disinfector compliant to ISO 15883-1
and-2, or to an equivalent standard. Thermal disinfection in
the washer-disinfector shall be validated to provide an A
least 600 (e.g., 90°C (194°F) for 1 min). Higher levels of A
be achieved by increasing the exposure time and temperature
(e.g., A of 3000 at > 90°C (194°F) for 5 min, in accordance
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with local requirements). Load the device components in
the washer-disinfector in accordance with manufacturer's
instructions, ensuring that the devices and lumens can drain
freely. Lumened devices should be placed in a vertical position.
If this is not possible due to space limitations within the washer-
disinfector, use an irrigating rack /load carrier with connections
designed to ensure an adequate flow of process fluids to the
lumen or cannulation of the device if provided.
The following automated cycles are examples of validated
cycles:
Recircula-
tion Time
Phase (mins)
Thermal
Disinfec- 1
tion
Thermal
Disinfec- 5
tion
Step 5: Drying
It is recommended that drying is conducted in a washer-
disinfector compliant to ISO 15883-1 and-2, or to an
equivalent standard. Drying efficiency in washer-disinfectors
can range considerably based on the automated system
design and load configuration.
The following automated cycle is an example of a validated
cycle:
Recircula-
tion Time
Phase (mins)
Dry 7
Water Detergent/
Temp Water Type
> 40°C
Tap water
(104°F)
Critical water
Ambient (RO, deionized or
distilled water)
Water
Temp Water Type
Critical water
> 90°C
(RO, deionized or
(194°F)
distilled water)
Critical water
> 90°C
(RO, deionized or
(194°F)
distilled water)
Air Temp Air Type
115°C (239°F) Medical grade
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).
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Step 6: Maintenance and Inspection
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can
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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 inspec-
tion, 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.
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