Validated 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 oper-
ator/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.
Single-use products
The following products must not be reprocessed:
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 processing should not exceed 6 h; also, neither fixating pre-cleaning temper-
atures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used.
Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the
laser marking becoming unreadable visually or by machine for stainless steel.
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.
Additional drying, if necessary.
Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are
compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used
for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Fail-
ure to do so can result in the following problems:
■
Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the applica-
tion/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 surfaces and could cause
corrosion.
►
Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-
k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
Disassembling the product before carrying out the reprocessing procedure
►
Disassemble the product immediately after use, as described in the respective instructions for use.
Preparations at the place of use
►
If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example.
►
Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.
►
Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
Preparation before cleaning
►
Dismantle the product prior to cleaning, see Disassembling.
Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
►
Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-
tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the
product thoroughly with running water.
►
Carry out ultrasound cleaning:
–
as an effective mechanical supplement to manual cleaning/disinfection.
–
as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/
disinfection.
–
as an integrated mechanical support measure for mechanical cleaning/disinfection.
–
for additional cleaning of products with residues left after mechanical cleaning/disinfection.
Validated cleaning and disinfection procedure
Manual cleaning/disinfection
►
Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution.
►
After manual cleaning/disinfection, check visible surfaces visually for residues.
►
Repeat the cleaning /disinfection process if necessary.
Manual cleaning with immersion disinfection
D–W:
Drinking water
FD–W:
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 dis-
infection procedure.
Phase I
►
Fully immerse the product in the cleaning/disinfectant 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.
►
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 solution.
►
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 disinfection procedure.
WARNING
Infection hazard for patients and/or users and impairment of product functional-
ity due to reuse. Risk of injury, illness or death due to contamination and/or
impaired functionality of the product!
►
Do not reprocess the product!
Art. no.
Designation
FW851SU
activ C lockable offset distraction screw, 12 mm
FW852SU
activ C lockable offset distraction screw, 14 mm
FW853SU
activ C lockable offset distraction screw, 16 mm
FW854SU
activ C lockable offset distraction screw, 18 mm
FW855SU
activ C lockable distraction screw, 16 mm
FW856SU
activ C lockable distraction screw, 18 mm
FW861SU
activ C lockable distraction screw, 12 mm
FW862SU
activ C lockable distraction screw, 14 mm
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
►
Use cleaning and disinfecting agents according to the manufacturer’s instruc-
tions which
–
are approved for the material in question (e.g., aluminum, plastics, high-
grade steel),
–
do not attack softeners (e.g. in silicone).
►
Observe specifications regarding concentration, temperature and exposure
time.
►
Do not exceed the maximum permitted cleaning temperature of 60 °C.
Validated procedure
Specific requirements
Reference
Manual cleaning with
immersion disinfection
■
FW848R-FW850R
■
Brush length: 30 mm/
∅
: 5.5 mm,
e.g., TA006874
■
20 ml disposable syringe
■
When cleaning instruments with movable
hinges, ensure that these are in an open
position and, if applicable, move the joint
while cleaning.
■
Drying phase: Use a lint-free cloth or
medical compressed air
Chapter Manual cleaning/disinfec-
tion and sub-chapter:
■
Chapter Manual cleaning with
immersion disinfection
Manual pre-cleaning
with brush and subse-
quent mechanical alka-
line cleaning and ther-
mal disinfection
■
FW848R-FW850R
■
Brush length: 30 mm/
∅
: 5.5 mm,
e.g., TA006874
■
20 ml disposable syringe
■
Place the instrument in a tray that is suit-
able for cleaning (avoiding rinsing blind
spots).
■
Connect components with lumens and
channels directly to the rinsing port of the
injector carriage.
■
Place instruments in the tray with their
hinges open.
Chapter Mechanical cleaning/disin-
fection with manual pre-cleaning
and sub-chapter:
■
Chapter Manual pre-cleaning
with a brush
■
Chapter Mechanical alkaline
cleaning and thermal disinfect-
ing
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
-
-
-
-
