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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
medwork products as described below has been validated by medwork and constitu-
tes the specifications for the operator. Please note that the operator is solely respon-
sible 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 medwork products and apply in conjunction with the respecti-
ve 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 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.
medwork products that are labelled as single use devices (
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 contaminati-
on 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.
Machine reprocessing
Equipment for precleaning and manual cleaning:
Cleaning agent:
non-protein-fixing VAH-listed instrument disinfectant with
cleaning action, e.g. based on quaternary compounds,
Plastic brushes
Disposable cloth or sponge: lint-free disposable cloth or sponge, validated: B. Braun,
Disposable syringe:
Ultrasonic bath:
Mains water:
Sink:
Transport box:
Step 1: Precleaning:
Clean used instruments as soon as possible after endoscopy with a lint-free disposab-
le cloth or sponge in order to minimise drying on of organic material and chemical
residues as much as possible and prevent contamination of the environment. For the
protection of personnel and the environment, transport the contaminated instrument
only in a lockable container 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.
Step 2: Manual cleaning:
-symbol) may not be
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. Insert the instrument
with a diameter of 20 cm into the basket. Wipe the wires thoroughly with a lint-free
cloth soaked in cleaning solution. Finally, brush the wires for at least 1 minute (1
minute has been validated) with the cleaning brush (validated brush head length: 100
mm, brush head diameter: 7.0 mm). During the soaking time brush the parts of the
immersed instrument that are difficult to access with a soft brush (validated brush
head diameter 2.5 mm). Pay particular attention to the critical, difficult to access parts
where visual inspection of the cleaning effect is not possible. Brush the Luer-Lock
attachment and the cavities with a soft brush (validated brush head diameter 2.5 mm).
Insert the brush head into the lumen, push the brush carefully through the lumen and
then pull it out carefully. Finally, push the brush into the lumen from the distal end and
pull it out carefully.
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.
guanidine/guanidine derivatives, gigasept AF forte
(Schülke & Mayr GmbH) is validated
1st brush: brush head diameter 2.5 mm
2nd brush: brush head length 100 mm, brush head diame-
ter: 7.0 mm
article number: 19726
20 ml syringe, validated: B. Braun, article number:
4606205V
validated: Bandelin, Sonorex RK1028
running water, temperature 20 +/- 2°C, minimum potable
water quality
sink for mains water
lockable transport container
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