Reprocessing of Pentax Endoscopes

7/21/2019 Reprocessing of Pentax Endoscopes

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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



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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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...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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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.



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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

Reprocessing of Pentax Endoscopes

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