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REPROCESSING
ofPENTAX ENDOSCOPES
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General infectioncontrol/reprocessing issues
Reprocessing, more specific toPentax endoscopes
Automated Endoscope Reprocessors(AERs)
Critical Elements to Reprocessing
Topics of Discussion
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The POTENTIAL fortransmission of infection
by flexible endoscopes isan area of much concern
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It is extremely important thatappropriate precautions be taken to
minimize the risk of infection to bothpatient and healthcare professional
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Reprocessing of flexibleendoscopes
means the complete cleaning,high-level disinfection (or
sterilization) and removalofresidual chemical agents from all
instrument surfaces
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Cleaning
Removal, usually with detergent and water,of adherent visible soil (e.gblood, protein
substances, and other debris) from thesurfaces, crevices, serrations joints, and
lumens of instruments, device orequipment by a manual or mechanicalprocess that prepare the items safe for
handling and/or further decontamination
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HIGH-LEVEL DISINFECTION
Process designed toremove or destroyMOST forms ofmicrobial life,including SOMEbacterial endospores
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STERILIZATION
Process designed to remove or destroy ALL
viable forms of microbial life, includingbacterial spores, to an acceptable sterilityassurance level.
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CLEANING
Requires special cleaning agents(detergents) and manual action(washing, scrubbing, brushing, etc.)to be effective
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ENZYMATIC DETERGENTS
Incorporate enzymes thatact as catalysts to
accelerate chemical
reactions in the breakingdown of organic materialsinto simpler water solublecompounds which can be
rinsed away
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Different enzymes effect different
types of organic material
Protease Proteins (blood, mucous, feces,etc.)
Amylase Starch
Lipase Fat (adipose tissue)
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Current reprocessing guidelines statethat flexible GI endoscopes require
HIGH-LEVEL DISINFECTION
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Dr. Spaulding grouped medicaldevices into 3 categories and
suggested that the selection of a
disinfection or sterilization processdepends upon the RISK of INFECTION
associated with the devices use
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Spauldings Classification System
Category
Critical
Semi-critical
Non-critical
Process
Sterilization
Sterilization, desirable
High-Level Disinfection, acceptable
Intermediate-Level Disinfection to
Cleaning, depending upon patientcontact & type/amount ofcontamination
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CRITICAL DEVICES
Enter sterile tissue orbody cavitiesex. Choledochoscope
Break mucosal barrierex. biopsy forceps
Enter vascular systemex. angioscope
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SEMI-CRITICAL DEVICES
Normally come intocontact with intactmucous membranes
or non-intact skin
ex. gastroscopes,colonoscopes,
endotracheal tubes,etc....
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NON-CRITICAL DEVICES
Normally come intocontact with intact
skin
ex. stethoscope,blood pressure cuffs
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High-Level Disinfection can be achievedby using a liquid chemical sterilant witha High-Level Disinfection claim cleared
(by the FDA)
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Various professionalorganizations and
governmental agencies havedeveloped reprocessingguidelines for complex
devices, such as flexible GIendoscopes
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Reprocessing Guidelines
1. ASTM
2. ASGE
3. SGNA4. APIC
5. Multi-Society
Guidelines includingFDA and CDC
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Participating organizations includeASGE & SGNA, FDA & CDC, and APIC.
Working with device & sterilantmanufacturers, they have developed
the ASTM F1518 document
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ASGE & SGNAendorsed the ASTM reprocessing
document
along with other professionalorganizations (AGA, AGC & APIC)
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The elevator wire/channel
requires special reprocessingtechniques including
manual injection of disinfectant water rinse after disinfection
70% alcohol flush
(ASGE/SGNA White Paper)
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...after meticulous MANUALCLEANING, a 20 minute exposure
time at 20C to a 2%glutaraldehyde... which is above itsMEC, is adequate for disinfection...
(ASGE/SGNA White Paper)
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New APIC Guideline
Latest guideline recommends
Meticulous cleaning of the endoscopeimmediately after use
The irrigation of all internal channels and thecleaning by brushof ALLaccessible channelsto remove particulate matter
Leak test before immersion
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New APIC Guideline
Use only an FDA-clearedsterilant/disinfectant
Onlycompatibleproducts/methods should be
used for cleaning and disinfection/sterilization
Non-immersibleendoscopes should no longer bein service
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New APIC Guideline
Waterborne microorganisms (Pseudomonas,Mycobacteria) can be found in ordinary tap water
Rinsing should be done with sterilewater
If sterile water is not used, an alcohol rinsefollowedby forced air to facilitate drying is essential(especially for internal channels) between each
patient use
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Multi-Society Guideline
Emphasized importance of cleaning
Recommends routine use of alcohol
Dr. Douglas Nelson
the guidance is now crystal clear that everyoneshould be using an alcohol flush between everypatient no matter what the water quality
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Specifics onReprocessing Pentax
Endoscopes
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Manual Reprocessing Policy
PAMC sales representatives are only permitted to instructcustomers on the manualreprocessing of Pentaxproducts following recommendations described in Pentaxreprocessing manuals and/or supporting Pentax trainingaids such as PAMC released reprocessing videos, charts,etc.
Non-authorized Pentax reprocessing instructions, that is,those not officially developed and released by either PCor PAMC should not be provided to any end user andshould not be used by any PAMC sales representative.
PAMC personnel are NOT allowed to abbreviate and/orprovide their own (or any other non-Pentax)reprocessing instructions to customers
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Reprocessing Guidelines forPentax GI Endoscopes
1. Pre-cleaning (in examination room)
2. Leak Testing (in reprocessing area)
3. Cleaning (in reprocessing area)
4. High-Level Disinfection (reproc area)
5. After HLD Prepare for storage and inspect before reuse
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MANUAL PRE-CLEANING
Immediately after the procedure:
Wipe insertion tube
Purge air & water channels ... using HIGHpressure setting
Alternate aspiration of detergent & air tocreate agitation
Place removable components in detergent
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LEAK TESTING
Ensure detachable componentsare removed (valves, inletseals, etc.)
Attach Soaking Cap
Perform Dry Leak Test
Perform Wet Leak Test
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CLEANING
After confirming absence of leak:
Soak in fresh enzymatic detergent
Scrub with cleaning brushes
Includes components, valve cylinders, inlet seals, etc.
Manipulate valve mechanisms during cleaning
Scope components may be ultrasonically cleaned
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CLEANING 70K-series
Disposable tri-bristledcleaning brush
Pass blunt end (bluetip) through channelfirst, then pull bristledend
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Attach channel cleaning adapters
Expose ALLinternal channel surfacesto
detergent
Rinse with clean water and Dry
Forced air, up to 24 psi, may be used
CLEANING
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HIGH-LEVEL DISINFECTION
...after meticulous MANUALCLEANING, a 20 minute exposure
time at 20C to a 2%glutaraldehyde... which is above itsMEC, is adequate for disinfection...
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HIGH-LEVEL DISINFECTION
Soak in disinfectant
Immerse scope andcomponents
Expose ALLinternal channelsurfaces to disinfectant byusing channel cleaningadapters
Avoid introduction of airbubbles into channelsduring process
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Purge disinfectant from ALL channels
RINSE entire scope, ALL internal channel surfacesand components with STERILE water
Use a final alcohol rinse and followed by forced air(up to 24 psi) to facilitate drying
DRY ALL surfaces.
HIGH-LEVEL DISINFECTION
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AFTER DISINFECTION
If for STORAGE
- Detach removableparts**
- Hang scope/keepstraight
- Avoid dark, humid orpoorly ventilated areas
(**Follow owners manual)
If for REUSE
- Inspect scope
- Follow owners manualnf,
d d
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Manual
Manual ou Lavadora
1. Pre Cleaning
6. High-Level Desinfection(Expose all external and internal
surfaces in contact with HLD)
5. Dry of
external and
internal
surfaces
8. Final Rinse 70% Alcohol
of all internal channels
9. Final Drying of all internal
channels by compressed air (notgreater than 165 Kpa)
Immediately
Interrupt the
Use
2. Leak
Testing
positive
3. Manual Cleaning with
Detergent Solution(Brushing of channels, superficial
areas and removal parts)
negative
4. Water Rinse(Rigorously)
Contact Local
Technical
Service
7. Water Rinse(Rigorously)
8. Dry of external and internal
surfaces
(by compressed air not greater than 165 Kpa)
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Internal Schematics of
Various Pentax Endoscopes
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Water Feeding Channel
Air Feeding Channel
Air Water Nozzle
Channel Inlet A/WFeeding Valve Suction Control Valve
Instrument Channel
Suction Tube
Water Feeding
Tube
Air Feeding Tube
Air/Water Port
Suction Nipple
Suction Source
Internal Schematics of a Pentax30-Series Video Gastroscope
Air
Water
Suction
Color Codes
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Water Feeding Channel
Air Feeding Channel
Channel Inlet A/WInstrument channel cleaning Adapter OF-B115
Instrument Channel
Forward Water Jet Channel
Suction Tube
Water Feeding Tube
Air Feeding Tube
Water Jet lrrigation Tube
OF-B113
Suction Nipple
Cleaning/Disinfecting the Internal Channels of aPentax 40-Series Video Colonoscope*
* Drawing illustrates a two-c hanne l colonosco pe.
OF-G17A/W Channel Cleaning Adapter
Air/Water Port
Luer-Slip Syringewith
Cleaning/Disinfecting
Solution
Air
Water
Suction
Forward Water Jet
Color Codes
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Compatible Reprocessing Agents
The term compatible is not an endorsement of
a solutions effectiveness. Compatible simplymeans when these solutions are used accordingto product labeling/instructions, the materialsused in Pentax endoscopes will not be damaged.
ibl
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Pentax CompatibleEnzymatic Detergents
ENDOZIME RUHOF CORP
KLENZYME STERIS CORP
METRIZYME METREX
ENZOL ASP (J & J Medical)
ENZY-CLEAN BURNISHINE
TERGAL 800* CUSTOM ULTRASONICS
*NOT an enzymatic detergent
Pentax Compatible
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Pentax CompatibleHigh-Level Disinfectants
CIDEX OPA ASP (J & J MEDICAL)
CIDEX ASP (J & J MEDICAL)
METRICIDE * METREX
WAVICIDE- 01 WAVE ENERGY
SPORICIDIN SPORICIDIN INTERNTL
RAPICIDE** MEDIVATORS, INC.
* = Omnicide NS, CidaSteryl 14, abcoCIDE NS, Medica 14,Glutaraldehyde NS, MaxiCide NS and StarCide NS
** = cleared ONLY for use in legally marketed AER
Hi h L l Di i f t t
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High-Level DisinfectantsNOT Considered Compatible
Sporox Sultan
CIDEX PA* ASP (J&J MEDICAL)
Compliance** METREX
Sterilox*** STERILOX Technologies
* = Originally marketed as Peract 20 (by Unitrol)
** = Originally marketed as EndoSpor Plus (by Cottrell)
*** = Requires application of E-Wipe to protect endoscope
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Pentax CompatibleSterilization Agents
ETO GAS STERILIZATION
STERIS20 sterilant (used in STERISSYSTEM 1)
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Automated Endoscope
Reprocessors(AERs)
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AERscan provide a consistent and oftenless time consuming method to reprocess
flexible endoscopes
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AERs are not infallible.Caution and special care to explicitly
follow AER manufacturers instructionsmust be exercised
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In July 1999, CDC publication MMWRreported several infection outbreaks
associated with bronchoscopes
inadequately reprocessed by an AER
(during a period from 1996-98)
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Report identified 3 clusters in New YorkState (each at a different facility)
involving 4, 7 & 18 patients
In one cluster 3 patients became seriously ill and onepatient apparently died after becoming infected withpseudomonas aeruginosa
(during a period from 1996-98)
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An investigation concluded that therewere inconsistenciesin instructions
supplied by both device & AERmanufacturer
(MMWR July 99)
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Incorrect channeladapters were used with
the AER during
reprocessing of thebronchoscopes
(MMWR July 99)
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Another possible cause for theseoutbreaks has been suggested by
Dr. Lawrence Muscarella ofCustom Ultrasonics, Inc
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There is a strong possibility that thefiltered rinse water in the AER
recontaminated the processed instruments
with waterborne microorganisms
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The FDA/CDC reminded users that AERmanufacturers are required in their
labeling to provide device specificreprocessing instructions
(PHA Sept. 99)
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AER manufacturer-supplied instructionsare supposed to be based upon validation
studiesperformed on specific
brand/modelinstruments
(PHA Sept. 99)
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FDA Guidance Document for AERmanufacturers recommends:
List all brands and models of endoscopescompatiblewith each AER
Identify any limitationsto process certainbrands, models and/or features ofscopes/accessories
Be compatible with the scope manufacturersreprocessing instructions
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FDA/CDC made specificrecommendations to health care
facilities:Carefully clean instruments as per scope manufacturersinstructions
Ask AER manufacturer if specific (model/ brand) endoscopesyou are using have been tested with their system
If conflicting instructions between AER and scopemanufacturer, work with AER manufacturers staff to resolve
conflicts
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FDA/CDC made specificrecommendations to health care
facilities:In the absence of specificinstructions onautomated reprocessing of eachmodel scope, followendoscope manufacturers instructions for manual
reprocessing
Whether reprocessing manually or an AER,consider the use of an alcohol rinse, followed by
forced air as a final drying step
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Automated Endoscope Reprocessors
Pentax endoscope owners manuals contain astatement about AERs
all reprocessing claims, instructions, validation
studies, compliance with local regulationsand/or guidelines are the responsibility of theAER manufacturer
Any questions regarding the use of AERs withPentax endoscopes should be directed to theAER manufacturer
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Regardless of brand or type of AER, checkwith AER manufacturer to confirm their
specific claims for reprocessing the
endoscope and removable scopecomponents
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Four AER Manufacturers
1. Custom Ultrasonics
2. ASP (Unitrol AER)
3. MediVators (Olympus)
4. Steris
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Custom Ultrasonics
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ASP
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MediVators
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BHT Innova 3
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Steris
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Steris Reliance EPS
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ASP EvoTech
i i f
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AERs - Disinfectors
1. Custom Ultrasonics *
2. ASP (Unitrol AER)
3. MediVators (Olympus)
* Only AER with FDA clearance as a washer and
disinfector
S i S 1
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Steris System 1
1. Sterile Processing System
2. Just -In -Time or Point of Use Process
3. After processing, scopes are notintended to be stored
4. If stored overnight, scopes should bereprocessed prior to use
AER 70K Cl i
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AER 70K ClaimsCustom Ultrasonics
Issued compatibility letter in June 2004
Released CU Scope Adaptation chart inJuly 2004
Issued 2ndcompatibility statement inDecember 2004
Note: CU # 17016 for 70K FWJ
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AER 70K Claims
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AER 70K Claims
Advanced Sterilization Products
Informal compatibility email in March 2004
Acknowledged problems with FWJ
Written ASP instructions March 05
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Minntech/MediVators
Compatibility released Feb. 8, 2005
Pending Application Guide
Pending written Minntech instructions
AER 70K Claims
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l i
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AER 70K Claims
Steris System 1Released QC adapters for 70K scopes
QPC 1670 EB-70Ks (May 03)
QPC 1702 70K/80Ks with FWJ (May 04)
QPC 1713 70K/80Ks without FWJ (July 04)
No QPCs (no compatibility claims) for
EC-3870TLK
EE/EG-1580Ks
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NEW AER 70K Cl i
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NEW AER 70K Claims
Steris Reliance EPS
Claim yes, but no Reliance instructions received
ASP EvoTech/AdaptaScopeClaim yes, but no EvoTech instructions received
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Critical Elements ofReprocessing
GI Endoscopes
Critical Elements of
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Critical Elements ofReprocessing GI Endoscopes
Wear appropriateprotective attire
Immediatelyafter the
procedurebegin pre-cleaning
Wipe insertion tube
Purgeair & waterchannels
Aspirate detergent
Expose ALL surface areasand scope components toan enzymaticdetergent
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Cleaning is thesingle most
important stepto efficientreprocessing
C itical Elements
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Critical Elements
Always Leak Test prior toimmersion
Not only to prevent MAJOR scopedamage
To reduce potential for cross-
contamination from acompromised instrument whichcould harbor microorganisms
Rigorous mechanical cleaningisimperativeto remove organic soil...
Residual detergent should be rinsedto prevent dilution &/or adulterationof the disinfectant
Critical Elements
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Critical Elements
Always use an effective disinfectant Aim; to achieve High-Level Disinfection
Iodophors, Quats, Alcohol, are NOTconsidered HLD
Check theMEC of disinfectant via test stripsto ensure potency
Avoid introduction of air bubbles into internal
channels during flushing...
Adhere to recommended exposure times forbothdisinfectant & detergent
C iti l El t
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Critical Elements
Minimize personnel exposure toglutaraldehyde vapors by using abasin with tight fitting lid or asealed automated endoscopereprocessor
Adequate ventilation isrequired8-10 room exchanges of airper hour is typicallyrecommended
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Critical Elements
Channel cleaning adapters mustbe used to allow chemicalagents to reach all areas
Complete immersion ONLYis notenough to ensurecontact ...
Thoroughly rinseresidual disinfectant to prevent patientexposure to toxic chemicals
Ideally, rinse with sterilewater
Follow byfresh 70% alcohol rinse and forced air
Critical Elements
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Critical Elements
Do not neglect to reprocess specialfeature areassuch as
Exposed elevator wire/channel
F. water jet channel Balloon filling channels
(ultrasound scopes)
Secondary biopsy/suctionchannels
If an automated unit can notreprocess any special feature area,that channel mustbe reprocessedmanually
C i i l El
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Prior to use, check with the AERmanufacturerto confirm that theyhave validated reprocessing
instructions for the device-specific(brand and model) endoscopes youintend to reprocess
Critical Elements
C iti l El t
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Critical Elements
Regardless of AER, use a final alcoholrinse followed by forced air to facilitatedrying of endoscope surfaces
L t t SGNA id li th
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Latest SGNA guideline on theuse of HLDs and sterilants
Irrespective of quality of rinse water, the entireendoscope should be dried, with each internal
channel being flushed with 70% alcohol followedby forced air drying, both between patient
procedures and prior to storage
C iti l El t
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Prior to storage, removablescope components should bedetached
Reusable biopsy forceps & otherdevices which break the mucosalbarrier must be meticulouslycleaned and sterilizedbeforeEACHuse
The entire water bottle assemblyshould be sterilized, at leastdaily. Only sterilewatershould be used in the procedure
Critical Elements
Pentax Steam
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Pentax SteamSterilization Parameters
Sterilizer Type: Prevacuum
Temperature: 132-135C(270-275F)
Time: 5 minutes
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By strictly adheringto thereprocessing recommendations
developed by ASTM, ASGE & SGNA,as well as device & sterilant
manufacturers, end-users shouldfeel confident that they areconsistently providing the standard
level of patient care.
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There have been no published reportsof infection when established
reprocessing guidelines are followed
Handouts
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Handouts
Multi-Society GuidelinesASTM
APIC
ASGE
SGNA
HLDs and Sterilants
Reprocessing valves
Reprocessing water bottles
Reprocessing SUDs
Handouts
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Handouts
CDC/FDA Public Health Advisory
MMWR Infection Outbreak
Steris Letter on Reprocessing Valves
Steris User Notes
Decontamination Letter
Internal Schematics
Handouts
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Summary of Pentax Reprocessing Instructions (70K)
Summary of Pentax Reprocessing Instructions (30/31K)
70K Cleaning Chart
30/31/30K/31K Cleaning Chart
List of Compatible Reprocessing Agents
Irrigator Reprocessing Instructions
Water Bottle Reprocessing Instructions
Handouts
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Thank You