General Information
Warning:
The flexible endoscope is delivered non-sterile and must be thoroughly cleaned and high- level
disinfected (as a minimum) or sterilized before initial and subsequent uses. The FDA recommends sterilization over
high-level disinfection, if available.
Warning:
Occupational safety guidelines must be observed and applied when cleaning contaminated flexible
endoscopes and instruments. Ensure appropriate Personal Protective Equipment (PPE) is used by all staff during
reprocessing.
Warning:
Ensure adequate ventilation is used for manual High-Level Disinfection (HLD) as per the HLD
manufacturer’s instructions.
Warning:
: Sterilization/high-level disinfection can only be performed successfully if:
• The instruments are freed of organic materials and residues of pharmaceutical products and cleaning products
(i.e. thoroughly cleaned).
• The recommended sterilization and high-level disinfection parameters are maintained.
• Sterilization equipment is properly maintained and calibrated.
CAUTION:
High-level disinfection is the minimum requirement for “semi-critical” devices that only come in contact
with intact mucous membranes or non-intact skin.
CAUTION:
The maximum permitted temperature is 65° C (149° F) for decontamination and sterilization.
CAUTION:
Personal Protective Equipment (PPE) is required to ensure safety of the operator when cleaning any
contaminated medical device. Follow occupational safety guidelines and your institution’s policies for PPE
requirements.
CAUTION:
The flexible endoscope must be protected from objects that could cause damage to the device such as
wire bristle brushes, sharp objects etc. Soft, lint-free cloths and/or sponges along with ONLY the correct KARL
STORZ cleaning brush(es) should be used to clean the flexible endoscope.
CAUTION:
To prevent biofilm formation it is critical that flexible endoscopes be thoroughly dried prior to storage.
Biofilm formation will interfere with sterilization and high level disinfection of the flexible endoscope and could lead to
infection transmission.
Note:
The soft, lint-free cloths should be disposed of after a single use (i.e. use separate cloths for the detergent
cleaning, water rinsing and drying phases).
Note:
When preparing cleaning and disinfecting solutions, follow the manufacturer's instructions for proper exposure
time, dilution and temperatures.
Cleaning and Sterilization/Disinfection Instructions
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