6.
Validated reprocessing pro-
cedure
6.1
General safety information
Note
Adhere to national statutory regulations, national and
international standards and directives, and local, clini-
cal hygiene instructions for reprocessing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), sus-
pected CJD, or possible variants of CJD, observe the rel-
evant national regulations concerning the reprocessing
of products.
Note
Mechanical reprocessing should be favored over man-
ual cleaning as it gives better and more reliable results.
Note
It should be noted that successful reprocessing of this
medical device can only be guaranteed following prior
validation of the reprocessing method. The opera-
tor/reprocessor is responsible for this.
The recommended chemical was used for validation.
Note
If there is no final sterilization, then a virucidal disinfec-
tant must be used.
Note
For the latest information on reprocessing and material
compatibility see also the Aesculap extranet at
https://extranet.bbraun.com
The validated steam sterilization procedure was carried
out in the Aesculap sterile container system.
6.2
General notes
Dried or affixed surgical residues can make cleaning
more difficult or ineffective and lead to corrosion.
Therefore, no more than 6 hours should be left between
use and preparation, pre-clean temperatures >45 °C
liable to fusing should not be employed and disinfec-
tants liable to fusing (aldehyde or alcohol-based)
should not be used.
Excessive neutralizing agents or basic cleaners may
result in a chemical attack and/or fading and the laser
marking becoming unreadable either visually or by
machine in case of non stainless steel.
On stainless steel, residues containing chlorine or chlo-
ride (such as surgical residues, drugs, saline solutions in
water for cleaning, disinfection and sterilization) may
lead to corrosion (pitting corrosion, tensile corrosion)
and thus to the destruction of the product. 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 or FDA approval or CE mark) and
which are compatible with the product's materials
according to the chemical manufacturers' recommen-
dations may be used for reprocessing the product. All
the chemical manufacturer's application specifications
must be strictly observed. Failure to do so can result in
the following problems:
■
Visual material changes (such as fading or color
changes in titanium or aluminum). For aluminum,
the application/process solution only needs to be
pH >8 to cause visible surface changes.
■
Material damage (such as corrosion, cracks, breaks,
premature aging or swelling).
►
Do not use metal cleaning brushes or other abra-
sives that would damage the product surface and
could cause corrosion.
►
Further detailed advice on hygienically safe and
material-/value-preserving reprocessing can be
found at www.a-k-i.org, section Publications, Red
Brochure – Proper maintenance of instruments.
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