FujiFilm medwork LIT2-D-HAN Instructions page 5

Processing instructions
Specifications for the reprocessing of endoscopic instru-
ments
In order to guarantee functional reliability and a long service life, reusable endoscopic
instruments must be processed after every examination in accordance with the
applicable guidelines and standards. These specifications are based on DIN EN ISO
17664 and "Hygiene requirements for the reprocessing of flexible endoscopes and
endoscopic additional instruments" published by the Robert Koch Institute (RKI).
The automatic reprocessing process in the washer-disinfector (WD) for reusable
FUJIFILM medwork products as described below has been validated by FUJIFILM
medwork and constitutes the specifications for the operator. Please note that the
operator is solely responsible for carrying out and monitoring the correct and proper
reprocessing.
Products
The specifications published here contain important information for the reliable and
effective reprocessing of FUJIFILM medwork products and apply in conjunction with
the respective instructions for use of the products.
The type and scope of reprocessing depends on the application of the medical device.
Therefore, the operator is responsible for the correct classification of the medical
devices and as a result for specifying the type and scope of reprocessing (see
KRINKO/BfArM recommendation, Section 1.2.1 Risk assessment and classification of
medical devices before reprocessing). It must particularly be ensured that standar-
dised and validated processes are applied. If reusable FUJIFILM medwork products
are used for patients suffering from a variant of Creutzfeld-Jakob disease, they must
not be processed after use. The particular recommendations of the RKI are applicable
here.
FUJIFILM medwork products that are labelled as single use devices (
not be prepared or resterilised for reuse. Reuse, reprocessing or resterilisation can
alter product properties, resulting in functional failure that can endanger the patient's
health, or result in illness, injury or death. Reuse, reprocessing and resterilisation also
present the additional risk of patient or product contamination, as well as the risk of
cross contamination including the transmission of infectious diseases. Product
contamination can result in patient illness, injury or death. All instruments must be
cleaned, disinfected and sterilised before every use. This is particularly important
when using an instrument for the first time after delivery, because all instruments are
supplied in unsterile condition (cleaning and disinfection after removal of protective
shipping packaging;
sterilisation after packing). Particular care is required for cleaning instruments with
hollow bodies. A special rack with provision for rinsing cavities is required for machine
cleaning and disinfection of such instruments, e.g. racks for micro-invasive instru-
ments (MIC trolley). The equipment of these racks varies depending on the manufac-
turer. The cleaning performance depends on the equipment and adaptability of the
instruments to the rack and must be confirmed by validation of the processes. Please
follow the manufacturer's information on the compatibility of materials for cleaning,
disinfection and sterilisation. For ultrasonic cleaning use only cleaners approved for
the process and maintain the temperature range recommended by the manufacturer.
Premises
The reprocessing must only be conducted in suitable rooms specially equipped for this
purpose and that comply with the requirements of the Committee for Hospital Hygiene
and Infection Prevention of the RKI.
Personnel
Please note that additional endoscopic instruments must only be processed by trained
persons (Category IV) who have the necessary training, level of knowledge and
experience for this work. You should wear a face mask, safety glasses, an operating
gown impervious to liquids and cut-resistant gloves for protection from potential
contamination with pathogenic germs and potentially hazardous cleaning chemicals.
Equipment for precleaning:
Disposable cloth or sponge:
-symbol) may
lint-free disposable cloth or sponge
Step 1: Precleaning:
Clean used instruments as soon as possible after endoscopy (after no more than 2
hours) with a lint-free disposable cloth or sponge in order to minimise as much as
possible drying on of organic material and chemical residues and contamination of the
environment. For the protection of personnel and the environment, transport the
contaminated instrument only in closed containers from the examination room to the
conditioning room. We recommend reprocessing of the instruments as soon as
possible, but in any case no later than 2 hours after use. Temporary storage of used
instruments with impurities such as blood residues may cause corrosion.
Equipment for manual cleaning:
Cleaning agent: non-protein-fixing VAH-listed instrument disinfectant with
cleaning action, validated: gigasept AF forte
Mayr GmbH, article number: 125603)
Plastic brushes for 1st brush: brush head length 30 mm, brush head diameter
LIT2-D-HAN: 2.5 mm
2nd brush: brush head length 13 mm, brush head length
diameter 1.6 mm
Disposable syringe: 20 ml syringe, validated: B. Braun, article number:
4606205V
Ultrasonic bath: validated: Bandelin, Sonorex RK1028
Mains water: running water, temperature 20 +/- 2°C, minimum potable
water quality
Sink: sink for mains water
Transport box: lockable transport container
Step 2: Manual cleaning
ATTENTION! Special Instructions
The instruments must be disassembled for cleaning and disinfection depending on the
device. Follow the instructions for disassembly in the instructions for use. Do not use
any solutions containing aldehydes as these can fix proteins and thus adversely affect
the success of the cleaning.
Prepare the cleaning solution (e.g.: gigasept AF forte®2%) as directed by the manu-
facturer and place it in an ultrasonic bath. If possible, place the instruments immedia-
tely after use in the cleaning solution prepared strictly in accordance with the concent-
rations, interactions and exposure times specified by the manufacturer. Carry out all
following cleaning steps below the surface of the liquid in order to prevent spraying of
contaminated liquid. Use only cleaning solutions whose suitability and effectiveness
have been documented and declared accordingly in the expert reports of the repro-
cessing and equipment manufacturers. The cleaning solution must be replaced at
least daily and immediately in the case of visible contamination.
During the soaking time brush the thread and the parts of the immersed instrument
that are difficult to access with a soft brush. (validated brush 1: brush head length: 30
mm, brush head diameter: 2.5 mm and brush 2: brush head length 100 mm, brush
head diameter 7.0 mm)).
Pay particular attention to the critical, difficult to access parts where visual inspection
of the cleaning effect is not possible. Then rinse the lumen once with the cleaning
solution using a 20 ml syringe.
Fill the lumen with cleaning solution with no air bubbles.
Run the ultrasonic bath with the instruments for at least 5 minutes (5 minutes has
been validated). Then rinse the lumen at least once with cleaning solution using a 20
ml syringe to remove dissolved impurities. The total time in the cleaning solution must
be at least 15 minutes. After that remove the instrument from the cleaning solution and
place it in a sink with water (minimum potable water quality) for at least 1 minute.
Rinse the lumen at least once with cleaning solution using a 20 ml syringe to flush out
completely the cleaning solution residue.
ATTENTION! Special Instructions
Please inspect the instrument after manual conditioning to make sure that it is clean. If
you can still see visible impurities, please repeat the above procedures.
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