aesculap_validated_instrument_reprocessing_procedur.pdf
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Aesculap®
Validated Reprocessing Procedures
AVA-V6
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Validated Reprocessing Procedures
Preface
Premium quality instruments are a valuable commodity that deserve to be treated with care and respect.
The surgical instrumentation of a hospital represents a
considerable proportion of its fixed assets. In view of
this, it is essential that the functionality and value of
reusable medical devices, particularly surgical instruments, are preserved for the long term through professional reprocessing. The measures recommended here
should be implemented in accordance with the manufacturer's instructions, hygiene requirements, and
health and safety regulations.
Instrument reprocessing is becoming increasingly regulated by the German Medical Devices Act, a global
harmonization of standards, and specific national laws
and regulations (such as the MPBetreibVO (Medical
Devices Operator Ordinance) as part of the MPG (Medical Devices Act) within Germany), which explicitly
demand validation measures for reprocessing. The best
way to comply with such requirements, and demonstrate compliance, is to implement a dedicated quality
management system incorporating these measures.
This brochure provides details of the validated reprocessing procedures used for Aesculap AG products.
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Contents
1.
About these instructions for use
4
2.
Product-specific characteristics
4
3.
Validated instrument reprocessing procedure
5
3.1
General safety instructions
5
3.2
General information
5
3.3
Validated cleaning and disinfecting procedure
6
3.4
Preparations at the place of use
6
3.5
Preparations before cleaning
6
3.6
Cleaning/Disinfection
6
3.7
Wipe disinfection for electrical devices without sterilization
7
3.8
Manual cleaning/disinfection
7
3.8.1
Manual cleaning and wipe disinfecting
8
3.8.2
Manual cleaning with immersion disinfection
3.8.3
Manual cleaning with ultrasound and immersion disinfection
11
3.9
Mechanical cleaning/disinfection
13
3.9.1
Mechanical alkaline cleaning and thermal disinfecting
13
3.9.2
Mechanical neutral or mild alkaline cleaning and thermal disinfecting
14
3.10
Mechanical cleaning/disinfection with manual pre-cleaning
15
3.10.1
Manual pre-cleaning with a brush
15
3.10.2
Manual pre-cleaning with ultrasound and brush
16
3.10.3
Mechanical alkaline cleaning and thermal disinfecting
17
3.10.4
Mechanical neutral or mild alkaline cleaning and thermal disinfecting
18
3.11
Steam sterilization
19
3.12
Sterilization for the US market
19
9
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Validated Reprocessing Procedures
1.
About these instructions for use
These instructions for use:
■ contain information about the various validated
reprocessing procedures and notes on sterilization
for all Aesculap products.
■ do not replace the instructions for use of the product being reprocessed.
Note
Before reprocessing, take note of the product-specific
characteristics.
2.
Product-specific characteristics
► Before each clean, take note of any restrictions on
handling the product.
If product-specific instructions for use are available,
the following proscriptions/restrictions may have to be
observed:
■ Reprocessing
■ Oxidizing chemicals
■ Immersion/insertion
■ Disassembling
■ Chemicals and temperature
■ Ultrasonic cleaning
■ Positioning aids
■ Cleaning
■ Cleaning brush and other accessories
■ Medical compressed air
■ Sterilization
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3.
3.1
Validated instrument reprocessing procedure
General safety instructions
Note
Adhere to national statutory regulations, national and
international standards and directives, and local, clinical hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing
of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.
Note
Successful processing of this medical device can only
be ensured if the processing method is first validated.
The operator/sterile processing technician is responsible for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For the latest information on reprocessing and material
compatibility see also the Aesculap extranet at
www.extranet.bbraun.com
The validated steam sterilization procedure was carried
out in the Aesculap sterile container system.
3.2
General information
Dried or affixed surgical residues can make cleaning
more difficult or ineffective and lead to corrosion.
Therefore, the time interval between application and
reprocessing should not exceed 6 hours; also, neither
fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/
alcohols) should be used.
Excessive dosages of neutralizing agents or basic
cleaners may result in a chemical attack and/or fading
and the laser marking on stainless steel becoming
unreadable either visually or by machine.
Residues containing chlorine or chlorides, e.g., in surgical residues, medicines, saline solutions, and in the
service water used for cleaning, disinfection, and sterilization, will cause corrosion damage (pitting, stress
corrosion) and result in the destruction of stainless
steel products. These must be removed by rinsing thoroughly with demineralized water and then drying.
Perform additional drying, if necessary.
Only process chemicals that have been tested and
approved (e.g., VAH/DGHM or FDA approval or CE
mark) and which are compatible with the product’s
materials according to the chemical manufacturer's
recommendations may be used for processing the
product. All the chemical manufacturer's application
specifications must be strictly observed. Failure to do
so can result in the following problems:
■ Optical changes in materials, e.g., fading or discoloration of titanium or aluminum. For aluminum,
the application/process solution only needs to be
of pH >8 to cause visible surface changes
■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling
► Do not use metal cleaning brushes or other abrasives that would damage the product surface and
could cause corrosion
► For further detailed advice on hygienically safe and
material-/value-preserving
reprocessing, see
www.a-k-i.org Publications, Red Brochure – Proper
maintenance of instruments
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Validated Reprocessing Procedures
3.3
Validated cleaning and disinfecting
procedure
3.5
Preparations before cleaning
► Carry out non-fixating/NaCl-free pre-cleaning
Note
See the instructions for use pertaining to the instrument in question for product-specific information
about appropriate equipment.
3.4
Preparations at the place of use
immediately after use.
► During disassembly, take note of the product-spe-
cific characteristics described in the corresponding
instructions for use.
3.6
Cleaning/Disinfection
► If applicable, rinse non-visible surfaces (preferably
► Observe the product-specific safety notes relating
with deionized water), using a disposable syringe,
for example.
► Remove any visible surgical residues as much as
possible with a damp, lint-free cloth.
► Place the dry product in a sealed waste container
and forward it on for cleaning and disinfection
within 6 hours.
to the reprocessing procedure contained in the
corresponding instructions for use.
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3.7
Wipe disinfection for electrical devices without sterilization
Phase
Step
T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I
Wipe disinfection
RT
≥1
-
-
Meliseptol HBV wipes 50 %
Propan-1-ol
RT:
Room temperature
Phase I
► Remove any visible residues with a disposable dis-
infectant wipe.
► Wipe all surfaces of the optically clean product
with a fresh, disposable disinfectant wipe.
► Observe the specified application time (1 min min-
imum).
3.8
Manual cleaning/disinfection
► Prior to manual disinfection, allow water to drip off
for a sufficient length of time to prevent dilution of
the disinfecting solution.
► After manual cleaning/disinfection, visually check
visible surfaces for residues.
► Repeat the cleaning/disinfection process if necessary.
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Validated Reprocessing Procedures
3.8.1
Manual cleaning and wipe disinfecting
Phase
Step
T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I
Cleaning
RT
(cold)
-
-
D–W
-
II
Drying
RT
-
-
-
-
III
Wipe disinfection
-
>1
-
-
Meliseptol HBV wipes 50 % Propan-1-ol
IV
Final rinse
RT
(cold)
0.5
-
FD-W
-
V
Drying
RT
-
-
-
-
D–W:
FD–W:
RT:
Drinking water
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
Room temperature
Phase I
Phase IV
► Clean the product under running faucet water,
► After the specified exposure time (at least 1 min),
using a suitable cleaning brush until all visible residues have been removed from the surfaces.
► Mobilize non-rigid components, such as set screws,
links, etc. during cleaning.
rinse the disinfected surfaces under running FD
water.
► Drain any remaining water fully.
Phase II
► Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Validated cleaning and disinfecting procedure.
Phase III
► Wipe all surfaces of the product with a single-use
disinfectant wipe.
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Phase V
► Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Validated cleaning and disinfecting procedure.
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3.8.2
Manual cleaning with immersion disinfection
Phase
Step
T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I
Disinfecting
cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
II
Intermediate rinse
RT (cold)
1
-
D–W
-
III
Disinfection
RT (cold)
15
2
D–W
Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
IV
Final rinse
RT (cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
D–W:
FD–W:
Drinking water
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
RT:
Room temperature
*Recommended:BBraun Stabimed
► Note the information on appropriate cleaning
► Mobilize non-rigid components, such as set screws,
brushes and disposable syringes, see Validated
cleaning and disinfecting procedure.
► Thoroughly rinse through these components with
Phase I
► Fully immerse the product in the cleaning/disinfec-
tant for at least 15 min. Ensure that all accessible
surfaces are moistened.
► Clean the product with a suitable cleaning brush in
the solution until all discernible residues have been
removed from the surface.
► If applicable, brush through non-visible surfaces
with an appropriate cleaning brush for at least
1 min.
links, etc. during cleaning.
the cleaning disinfectant solution (at least five
times), using a disposable syringe.
Phase II
► Rinse/flush the product thoroughly (all accessible
surfaces) under running water.
► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
► Drain any remaining water fully.
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Validated Reprocessing Procedures
Phase III
► Fully immerse the product in the disinfectant solu-
tion.
► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
► Rinse lumens at least 5 times at the beginning of
the exposure time using an appropriate disposable
syringe. Ensure that all accessible surfaces are
moistened.
Phase IV
► Rinse/flush the product thoroughly (all accessible
surfaces).
► Mobilize non-rigid components, such as set screws,
joints, etc. during final rinse.
► Rinse lumens with an appropriate disposable
syringe at least five times.
► Drain any remaining water fully.
Phase V
► Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Validated cleaning and disinfecting procedure.
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3.8.3
Manual cleaning with ultrasound and immersion disinfection
Phase
Step
T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I
Ultrasonic cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
II
Intermediate rinse
RT (cold)
1
-
D–W
-
III
Disinfection
RT (cold)
15
2
D–W
Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
IV
Final rinse
RT (cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
D–W:
FD–W:
Drinking water
Fully desalinated water (demineralized, low microbiological contamination: drinking water
quality at least)
RT:
Room temperature
*Recommended: BBraun Stabimed
► Note the information on appropriate cleaning
brushes and disposable syringes, see Validated
cleaning and disinfecting procedure.
Phase I
► Clean the product in an ultrasonic cleaning bath
►
►
►
►
(frequency 35 kHz) for at least 15 min. Ensure that
all accessible surfaces are immersed and acoustic
shadows are avoided.
Clean the product with a suitable cleaning brush in
the solution until all discernible residues have been
removed from the surface.
If applicable, brush through non-visible surfaces
with an appropriate cleaning brush for at least
1 min.
Mobilize non-rigid components, such as set screws,
links, etc. during cleaning.
Thoroughly rinse through these components with
the cleaning disinfectant solution (at least five
times), using a disposable syringe.
Phase II
► Rinse/flush the product thoroughly (all accessible
surfaces) under running water.
► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
► Drain any remaining water fully.
Phase III
► Fully immerse the product in the disinfectant solu-
tion.
► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
► Rinse lumens at least five times at the beginning of
the exposure time with an appropriate disposable
syringe. Ensure that all accessible surfaces are
moistened.
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Validated Reprocessing Procedures
Phase IV
► Rinse/flush the product thoroughly (all accessible
surfaces) under running water.
► Mobilize non-rigid components, such as set screws,
joints, etc. during final rinse.
► Rinse lumens with an appropriate disposable
syringe at least five times.
► Drain any remaining water fully.
Phase V
► Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Validated cleaning and disinfecting procedure.
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3.9
Mechanical cleaning/disinfection
Note
The cleaning and disinfection device must be of tested
and approved effectiveness (e.g. FDA approval or CE
mark according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
3.9.1
Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
Phase
Step
T
[°C/°F]
t
[min]
Water
quality
Chemical/Note
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■
Concentrate, alkaline:
– pH = 13
– <5 % anionic surfactant
■
0.5 % working solution
– pH = 11*
III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning
and disinfection device
D–W:
FD–W:
Drinking water
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
*Recommended:BBraun Helimatic Cleaner alkaline
► Check visible surfaces for residues after mechani-
cal cleaning/disinfecting.
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Validated Reprocessing Procedures
3.9.2
Mechanical neutral or mild alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
Phase
Step
T
[°C/°F]
t
[min]
Water
quality
Chemical
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
Neutral:
■ Concentrate:
– pH neutral
– <5 % anionic surfactant
■ 0.5 %* working solution
Mildly alkaline:
■ Concentrate:
– pH = 9.5
– <5 % anionic surfactant
■
0.5 % solution
III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for
cleaning and disinfection device
D–W:
FD–W:
Drinking water
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
*Recommended:BBraun Helimatic Cleaner neutral
► Check visible surfaces for residues after mechani-
cal cleaning/disinfecting.
► Repeat the cleaning/disinfecting process if neces-
sary.
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3.10
Mechanical cleaning/disinfection with manual pre-cleaning
Note
The cleaning and disinfection device must be of tested
and approved effectiveness (e.g. FDA approval or CE
mark according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
3.10.1 Manual pre-cleaning with a brush
Phase
Step
T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I
Disinfectant
cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
II
Rinsing
RT (cold)
1
-
D–W
-
D–W:
Drinking water
RT:
Room temperature
*Recommended:BBraun Stabimed
► Note the information on appropriate cleaning
► Thoroughly rinse through these components with
brushes and disposable syringes, see Validated
cleaning and disinfecting procedure.
the cleaning disinfectant solution (at least five
times), using a disposable syringe.
Phase I
Phase II
► Fully immerse the product in the cleaning/disinfec-
► Rinse/flush the product thoroughly (all accessible
tant for at least 15 min. Ensure that all accessible
surfaces are moistened.
► Clean the product with a suitable cleaning brush in
the solution until all discernible residues have been
removed from the surface.
► If applicable, brush through non-visible surfaces
with an appropriate cleaning brush for at least
1 min.
► Mobilize non-rigid components, such as set screws,
links, etc. during cleaning.
surfaces) under running water.
► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
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Validated Reprocessing Procedures
3.10.2 Manual pre-cleaning with ultrasound and brush
Phase
Step
T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I
Ultrasonic cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
II
Rinsing
RT (cold)
1
-
D–W
-
D–W:
Drinking water
RT:
Room temperature
*Recommended:BBraun Stabimed
► Note the information on appropriate cleaning
brushes and disposable syringes, see Validated
cleaning and disinfecting procedure.
Phase I
► Clean the product in an ultrasonic cleaning bath
►
►
►
►
(frequency 35 kHz) for at least 15 min. Ensure that
all accessible surfaces are immersed and acoustic
shadows are avoided.
Clean the product with a suitable cleaning brush in
the solution until all discernible residues have been
removed from the surface.
If applicable, brush through non-visible surfaces
with an appropriate cleaning brush for at least
1 min.
Mobilize non-rigid components, such as set screws,
links, etc. during cleaning.
Thoroughly rinse through these components with
the cleaning disinfectant solution (at least five
times), using a disposable syringe.
Phase II
► Rinse/flush the product thoroughly (all accessible
surfaces) under running water.
► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
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3.10.3 Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
Phase
Step
T
[°C/°F]
t
[min]
Water
quality
Chemical
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■
Concentrate, alkaline:
– pH = 13
– <5 % anionic surfactant
■
0.5 % working solution
– pH = 11*
III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning
and disinfection device
D–W:
FD–W:
Drinking water
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
*Recommended:BBraun Helimatic Cleaner alkaline
► Check visible surfaces for residues after mechani-
cal cleaning/disinfecting.
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Validated Reprocessing Procedures
3.10.4 Mechanical neutral or mild alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
Phase
Step
T
[°C/°F]
t
[min]
Water
quality
Chemical
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
Neutral:
■ Concentrate:
– pH neutral
– <5 % anionic surfactant
■ 0.5 %* working solution
Mildly alkaline:
■ Concentrate:
– pH = 9.5
– <5 % anionic surfactant
■
0.5 % solution
III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning
and disinfection device
D–W:
FD–W:
Drinking water
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
*Recommended:BBraun Helimatic Cleaner neutral
► Check visible surfaces for residues after mechani-
cal cleaning/disinfecting.
► Repeat the cleaning/disinfecting process if neces-
sary.
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3.11
Steam sterilization
► Take note of the product-specific characteristics
►
►
►
►
relating to sterilization described in the corresponding instructions for use, such as whether or
not the product needs to be disassembled.
To prevent breakage due to stress corrosion, sterilize the instruments with the locking mechanism
open, or locked on the first ratchet tooth.
Check to ensure that the sterilizing agent will come
into contact with all external and internal surfaces
(e.g., by opening any valves and faucets).
Validated sterilization process
– Steam sterilization through fractionated vacuum process
– Steam sterilizer according to DIN EN 285 and
validated according to DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding time 5 min
When sterilizing several instruments at the same
time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified
by the manufacturer is not exceeded.
3.12
Sterilization for the US market
■
Aesculap advises against sterilizing the device by
flash sterilization or chemical sterilization.
■ Sterilization may be accomplished by a standard
prevacuum cycle in a steam autoclave.
To achieve a sterility assurance level of 10-6, Aesculap
recommends the following parameters:
Aesculap Orga Tray/Sterile container (perforated
bottom)
Minimum cycle parameters*
Sterilization method
Temp.
Time
Minimum
drying
time
Prevacuum
270 °F/
275 °F
4 min
20 min
*Aesculap has validated the above sterilization cycle
and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA
for the sterilization and storage of these products.
Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative
method using appropriate laboratory techniques. Use
an FDA cleared accessory to maintain sterility after
processing, such as a wrap, pouch, etc.
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Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany
Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com
Technical alterations reserved
Aesculap – a B. Braun company
Brochure No. C63402
11/11
V6