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4-2. ENDOSCOPIC ACCESSORY INSTRUMENT (EAIs) AND ENDOSCOPE COMPONENTS
4-2-1 CLEANING
1) Reusable endoscopic accessory instruments (such as biopsy forceps, needle, etc.) and removable scope com-
ponents (such as suction valve) should be cleaned immediately after each use since dried blood, mucous, or
other debris may cause damage to the instrument and render the mechanism inoperable, or may interfere with
the ability of the user to reprocess the device or component.
2) Place the EAIs and/or components in a basin with fresh enzymatic detergent solution for the time period
recommended by the manufacturer of the detergent being careful not to tightly coil or kink the flexible shaft.
3) Clean the handle and flexible shaft by gently wiping with a soft gauze or the like. Removable components
such as suction valve should be manipulated and detergent injected directly into/onto component surfaces
and then brushed clean.
4) Rinse all residual detergent from the EAIs by immersing the entire EAIs under clean water and manipulating
the handle mechanism. Similarly rinse component surfaces.
5) Ultrasonic cleaning of forceps and similar accessories is then recommended, provided the manufacturer’s
instructions and the parameters below are followed: Heavily soiled and/or difficult-to-manually clean compo-
nents such as valve mechanisms, inlet seals, etc. should be ultrasonically cleaned prior to subsequent high-
level disinfection or sterilization.
Frequency Range 44 kHz ± 6%
Time 5 minutes
DO NOT use caustic or abrasive solutions in the ultrasonic cleaner.
CAUTION:
Use appropriate heat process indicators and/or biological monitors as recommended by the manufac-
turer of the sterilizer.
WARNING:
In addition to efficacy claims always check with the manufacturer of the sterilizer/disinfector to confirm
their specific product claims including compatibility and confirm that they have test data supporting their
claims and demonstrating that no harmful levels of any residues (active/inert ingredients, their byprod-
ucts or derivatives of the processed devices) remain on any instrument or lumened surfaces that may
pose a risk to patient and users.
WARNING:
Current infection control guidelines require that biopsy forceps and similar endoscopic accessory instru-
ments which enter sterile tissue or the vascular system or break the mucosal barrier must be sterilized
before each patient use. For patient contact endoscopic accessories, follow the specific and detailed
reprocessing instructions supplied with each product.
CAUTION:
Not all manufacturers of Automated Endoscope Reprocessors (AERs) and Washer-Disinfectors (WDs) make
specific claims nor provide special instructions for reprocessing all of the removable scope components that
are integral to the safe and effective operation of flexible endoscopes. Therefore, should the AER/WD manu-
facturer’s instructions not specifically address reprocessing of any particular scope component (air/water
valve, suction valve, inlet seal, etc.) in the AER/WD, then those components must be reprocessed manually as
described in PENTAX instructions/labeling. Prior to use, check with each AER/WD manufacturer as to their
specific claims with respect to reprocessing individual endoscope components as well as any endoscopic
accessory instrument.