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9. Remove the devices and repeat the rinsing using in ambient,
< 40°C (104°F) critical water (high purity water generated by
processes such as RO, deionization or distillation) for at least
15 seconds.
10. Remove and dry device using a clean, soft, lint-free cloth or
clean compressed air. Ensure that all lumens and articulated
areas are dried using compressed air.
Cleaning: Automated
1. Prepare a neutral or mild alkaline cleaning solution (pH 7 to 9)
in accordance to the detergent manufacturer’s instructions.
The temperature of the solution should be
≤
40°C (104°F) for
manual cleaning.
NOTE:
The cleaning solution may contain enzymes. Aluminum-
safe alkaline cleaners can be used, but can vary in material
compatibility overtime based on their formulation. Material com-
patibility should be confirmed with the detergent manufacturer.
2. Immerse devices and parts in the detergent solution, and soak
for a minimum of 5 minutes.
3. While immersed, use a soft non-metallic bristle brush (plastic
bristles, like nylon) or sponge to thoroughly scrub all traces of
blood and debris from all device surfaces for at least one minute.
4. Ensure all lumens are thoroughly brushed. Push the brush
through the entire length of the lumen using a twisting motion
to remove debris from both ends for at least one minute
5. During cleaning, actuate joints, handles and other movable
device features to expose all areas to the detergent solution, if
applicable. Ensure all lumens are flushed for at least one minute.
6. Load the device components in the washer-disinfector in
accordance with manufacturer’s instructions, ensuring that the
devices and lumens can drain freely.
7. Automated washing shall be conducted in a validated washer-
disinfector in compliance to ISO 15883-1 and-2, or to an
equivalent standard. Automated washing can be included as
part of a validated washing, disinfection, and/or drying cycle
in accordance to manufacturer’s instructions. An example of a
validated cycle used for cleaning validation include:
Phase
Recirculation
Time
Water Temp
Detergent/Water
Type
Pre-wash
2:00
Cold Tap
Water
N/A
Enzyme
wash
1:00
< 40°C
(104°F)
Neutral, Enzymatic
Cleaner
Wash
5:00
66°C
(151°F)
Neutral pH
Detergent
Phase
Recirculation
Time
Water Temp
Detergent/Water
Type
Rinse
2:00
> 40°C
(104°F)
Tap water
Rinse
0:15
Ambient
Critical water
(RO, deionized or
distilled water)
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
0
of at
least 600 (e.g., 90°C (194°F) for 1 min). Higher levels of A
0
can
be achieved by increasing the exposure time and temperature
(e.g., A
0
of 3000 at >90°C (194°F) for 5 min, in accordance
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:
Phase
Recircula-
tion Time
Water
Temp
Water Type
Thermal
Disinfection
1:00
> 90°C
(194°F)
Critical water
(RO, deionized or
distilled water)
Thermal
Disinfection
5:00
> 90°C
(194°F)
Critical water
(RO, deionized or
distilled water)
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:
Phase
Recirculation
Time
Air Temp
Air Type
Dry
7:00
115°C (239°F) Medical grade
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