REPROCESSING

of
PENTAX ENDOSCOPES

Topics of Discussion
General infection
control/reprocessing issues
Reprocessing, more specific to
Pentax endoscopes
Automated Endoscope Reprocessors
(AERs)
Critical Elements to Reprocessing

The POTENTIAL for

transmission of infection
by flexible endoscopes is
an area of much concern

It is extremely important that

appropriate precautions be taken to
minimize the risk of infection to both
patient and healthcare professional

Reprocessing of flexible
endoscopes
means the complete cleaning,
high-level disinfection (or
sterilization) and removal of
residual chemical agents from all
instrument surfaces

Cleaning
Removal, usually with detergent and water,
of adherent visible soil (e.gblood, protein
substances, and other debris) from the
surfaces, crevices, serrations joints, and
lumens of instruments, device or
equipment by a manual or mechanical
process that prepare the items safe for
handling and/or further decontamination

HIGH-LEVEL DISINFECTION
Process designed to
remove or destroy
MOST forms of
microbial life,
including SOME
bacterial endospores

STERILIZATION

Process designed to remove or destroy ALL

viable forms of microbial life, including
bacterial spores, to an acceptable sterility
assurance level.

CLEANING
Requires special cleaning agents
(detergents) and manual action
(washing, scrubbing, brushing, etc.)
to be effective

ENZYMATIC DETERGENTS
Incorporate enzymes that
act as catalysts to
accelerate chemical
reactions in the breaking
down of organic materials
into simpler water soluble
compounds which can be
rinsed away

Different enzymes effect different

types of organic material
Protease Proteins (blood, mucous, feces,etc.)

Amylase Starch
Lipase Fat (adipose tissue)

Current reprocessing guidelines state

that flexible GI endoscopes require

HIGH-LEVEL DISINFECTION

Dr. Spaulding grouped medical

devices into 3 categories and
suggested that the selection of a
disinfection or sterilization process
depends upon the RISK of INFECTION
associated with the devices use

Spauldings Classification System

Category
Critical

Process
Sterilization

Semi-critical

Sterilization, desirable
High-Level Disinfection, acceptable

Non-critical

Intermediate-Level Disinfection to
Cleaning, depending upon patient
contact & type/amount of
contamination

CRITICAL DEVICES
Enter sterile tissue or
body cavities
ex. Choledochoscope
Break mucosal barrier
ex. biopsy forceps
Enter vascular system
ex. angioscope

SEMI-CRITICAL DEVICES
Normally come into
contact with intact
mucous membranes
or non-intact skin

ex. gastroscopes,
colonoscopes,
endotracheal tubes,
etc....

NON-CRITICAL DEVICES
Normally come into
contact with intact
skin
ex. stethoscope,
blood pressure cuffs

High-Level Disinfection can be achieved

by using a liquid chemical sterilant with
a High-Level Disinfection claim cleared
(by the FDA)

Various professional
organizations and
governmental agencies have
developed reprocessing
guidelines for complex
devices, such as flexible GI
endoscopes

Reprocessing Guidelines
1. ASTM
2. ASGE
3. SGNA
4. APIC
5. Multi-Society
Guidelines including
FDA and CDC

Participating organizations include

ASGE & SGNA, FDA & CDC, and APIC.
Working with device & sterilant
manufacturers, they have developed
the ASTM F1518 document

ASGE & SGNA

endorsed the ASTM reprocessing
document
along with other professional
organizations (AGA, AGC & APIC)

The elevator wire/channel

requires special reprocessing
techniques including
manual injection of disinfectant
water rinse after disinfection
70% alcohol flush
(ASGE/SGNA White Paper)

...after meticulous MANUAL

CLEANING, a 20 minute exposure
time at 20C to a 2%
glutaraldehyde... which is above its
MEC, is adequate for disinfection...
(ASGE/SGNA White Paper)

New APIC Guideline

Latest guideline recommends

Meticulous cleaning of the endoscope

immediately after use
The irrigation of all internal channels and the
cleaning by brush of ALL accessible channels
to remove particulate matter
Leak test before immersion

New APIC Guideline

Use only an FDA-cleared sterilant/disinfectant

Only compatible products/methods should be

used for cleaning and disinfection/sterilization

Non-immersible endoscopes should no longer be

in service

New APIC Guideline

Waterborne microorganisms (Pseudomonas,

Mycobacteria) can be found in ordinary tap water

Rinsing should be done with sterile water

If sterile water is not used, an alcohol rinse followed

by forced air to facilitate drying is essential
(especially for internal channels) between each
patient use

Multi-Society Guideline

Emphasized importance of cleaning

Recommends routine use of alcohol

Dr. Douglas Nelson

the guidance is now crystal clear that everyone
should be using an alcohol flush between every
patient no matter what the water quality

Specifics on
Reprocessing Pentax
Endoscopes

Manual Reprocessing Policy

PAMC sales representatives are only permitted to instruct

customers on the manual reprocessing of Pentax
products following recommendations described in Pentax
reprocessing manuals and/or supporting Pentax training
aids such as PAMC released reprocessing videos, charts,
etc.

Non-authorized Pentax reprocessing instructions, that is,

those not officially developed and released by either PC
or PAMC should not be provided to any end user and
should not be used by any PAMC sales representative.

PAMC personnel are NOT allowed to abbreviate and/or

provide their own (or any other non-Pentax)
reprocessing instructions to customers

Reprocessing Guidelines for

Pentax GI Endoscopes
1.

Pre-cleaning

(in examination room)

2.

Leak Testing

(in reprocessing area)

3.

Cleaning

4.

High-Level Disinfection

5.

After HLD

(in reprocessing area)

(reproc area)

Prepare for storage and inspect before reuse

MANUAL PRE-CLEANING
Immediately after the procedure:

Wipe insertion tube

Purge air & water channels ... using HIGH

pressure setting

Alternate aspiration of detergent & air to

create agitation

Place removable components in detergent

LEAK TESTING

Ensure detachable components

are removed (valves, inlet
seals, etc.)

Attach Soaking Cap

Perform Dry Leak Test

Perform Wet Leak Test

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

CLEANING 70K-series
Disposable tri-bristled
cleaning brush

Pass blunt end (blue

tip) through channel
first, then pull bristled
end

CLEANING
Attach channel cleaning adapters
Expose ALL internal channel surfaces to
detergent

Rinse with clean water and Dry

Forced air, up to 24 psi, may be used

HIGH-LEVEL DISINFECTION
...after meticulous MANUAL
CLEANING, a 20 minute exposure
time at 20C to a 2%
glutaraldehyde... which is above its
MEC, is adequate for disinfection...

HIGH-LEVEL DISINFECTION
Soak in disinfectant
Immerse scope and
components
Expose ALL internal channel
surfaces to disinfectant by
using channel cleaning
adapters
Avoid introduction of air
bubbles into channels
during process

HIGH-LEVEL DISINFECTION
Purge disinfectant from ALL channels
RINSE entire scope, ALL internal channel surfaces
and components with STERILE water
Use a final alcohol rinse and followed by forced air
(up to 24 psi) to facilitate drying
DRY ALL surfaces.

AFTER DISINFECTION
If for STORAGE
- Detach removable
parts**
- Hang scope/keep
straight
- Avoid dark, humid or
poorly ventilated areas
(**Follow owners manual)

If for REUSE
- Inspect scope
- Follow owners manualnf,
dd

1. Pre Cleaning

Manual
Manual ou Lavadora

2. Leak
Testing

Immediately
Interrupt the
Use

positive

Contact Local
Technical
Service

negative

3. Manual Cleaning with

Detergent Solution

4. Water Rinse
(Rigorously)

(Brushing of channels, superficial

areas and removal parts)

6. High-Level Desinfection
(Expose all external and internal
surfaces in contact with HLD)

7. Water Rinse
(Rigorously)

5. Dry of
external and
internal
surfaces

8. Dry of external and internal

surfaces
(by compressed air not greater than 165 Kpa)

8. Final Rinse 70% Alcohol

of all internal channels

9. Final Drying of all internal

channels by compressed air (not
greater than 165 Kpa)

Internal Schematics of
Various Pentax Endoscopes

Internal Schematics of a Pentax

30-Series Video Gastroscope
Channel Inlet

A/WFeeding Valve

Suction Control Valve

Water Feeding Channel

Air Water Nozzle
Air Feeding Channel

Instrument Channel

Air/Water Port
Water Feeding
Tube

Air Feeding Tube

Color Codes
Air
Water
Suc tion

Suction Tube
Suction Nipple

Suction Source

Cleaning/Disinfecting the Internal Channels of a

Pentax 40-Series Video Colonoscope*
Channel Inlet

A/WInstrument channel cleaning Adapter OF-B115

Water Feeding Channel

Air Feeding Channel

Water Jet lrrigation Tube

OF-B113
Instrument Channel
Forward Water Jet Channel

Suction Tube
OF-G17
A/W Channel Cleaning Adapter

Water Feeding Tube

Air/Water Port

Air Feeding Tube

Color Codes
Air
Water
Suction
Forward Water Jet

Suction Nipple
Luer-Slip Syringe
with
Cleaning/Disinfecting
Solution

* Dra wing illustra tes a two-c ha nnel c olo nosc op e.

Compatible Reprocessing Agents

The term compatible is not an endorsement of
a solutions effectiveness. Compatible simply
means when these solutions are used according
to product labeling/instructions, the materials
used in Pentax endoscopes will not be damaged.

Pentax Compatible
Enzymatic Detergents
ENDOZIME
KLENZYME
METRIZYME
ENZOL
ENZY-CLEAN
TERGAL 800*

RUHOF CORP
STERIS CORP
METREX
ASP (J & J Medical)
BURNISHINE
CUSTOM ULTRASONICS

*NOT an enzymatic detergent

Pentax Compatible
High-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

High-Level Disinfectants
NOT Considered Compatible
Sporox
CIDEX PA*
Compliance**
Sterilox***

Sultan
ASP (J&J MEDICAL)
METREX
STERILOX Technologies

* = Originally marketed as Peract 20 (by Unitrol)

** = Originally marketed as EndoSpor Plus (by Cottrell)

*** = Requires application of E-Wipe to protect endoscope

Pentax Compatible
Sterilization Agents
ETO GAS STERILIZATION
STERIS 20 sterilant (used in STERIS SYSTEM 1)

Automated Endoscope
Reprocessors
(AERs)

AERs can provide a consistent and often

less time consuming method to reprocess
flexible endoscopes

AERs are not infallible.

Caution and special care to explicitly
follow AER manufacturers instructions
must be exercised

In July 1999, CDC publication MMWR

reported several infection outbreaks
associated with bronchoscopes
inadequately reprocessed by an AER
(during a period from 1996-98)

Report identified 3 clusters in New York

State (each at a different facility)
involving 4, 7 & 18 patients
In one cluster 3 patients became seriously ill and one
patient apparently died after becoming infected with
pseudomonas aeruginosa
(during a period from 1996-98)

An investigation concluded that there

were inconsistencies in instructions
supplied by both device & AER
manufacturer
(MMWR July 99)

Incorrect channel
adapters were used with
the AER during
reprocessing of the
bronchoscopes
(MMWR July 99)

Another possible cause for these

outbreaks has been suggested by
Dr. Lawrence Muscarella of
Custom Ultrasonics, Inc

There is a strong possibility that the

filtered rinse water in the AER
recontaminated the processed instruments
with waterborne microorganisms

The FDA/CDC reminded users that AER

manufacturers are required in their
labeling to provide device specific
reprocessing instructions
(PHA

Sept. 99)

AER manufacturer-supplied instructions

are supposed to be based upon validation
studies performed on specific
brand/model instruments
(PHA

Sept. 99)

FDA Guidance Document for AER

manufacturers recommends:
List all brands and models of endoscopes
compatible with each AER

Identify any limitations to process certain

brands, models and/or features of
scopes/accessories
Be compatible with the scope manufacturers
reprocessing instructions

FDA/CDC made specific

recommendations to health care
facilities:
Carefully clean instruments as per scope
instructions

manufacturers

Ask AER manufacturer if specific (model/ brand) endoscopes

you are using have been tested with their system
If conflicting instructions between AER and scope
manufacturer, work with AER manufacturers staff to resolve
conflicts

FDA/CDC made specific

recommendations to health care
facilities:
In the absence of specific instructions on
automated reprocessing of each model scope, follow
endoscope 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

Automated Endoscope Reprocessors

Pentax endoscope owners manuals contain a
statement about AERs
all reprocessing claims, instructions, validation
studies, compliance with local regulations
and/or guidelines are the responsibility of the
AER manufacturer
Any questions regarding the use of AERs with
Pentax endoscopes should be directed to the
AER manufacturer

Regardless of brand or type of AER, check

with AER manufacturer to confirm their
specific claims for reprocessing the
endoscope and removable scope
components

Four AER Manufacturers

1. Custom Ultrasonics
2. ASP (Unitrol AER)
3. MediVators (Olympus)

4. Steris

Custom Ultrasonics

ASP

MediVators

BHT Innova 3

Steris

Steris Reliance EPS

ASP EvoTech

AERs - Disinfectors
1. Custom Ultrasonics *
2. ASP (Unitrol AER)

3. MediVators (Olympus)
* Only AER with FDA clearance as a washer and
disinfector

Steris System 1
1.

Sterile Processing System

2. Just -In -Time or Point of Use Process

3. After processing, scopes are not
intended to be stored
4. If stored overnight, scopes should be
reprocessed prior to use

AER 70K Claims

Custom Ultrasonics
Issued compatibility letter in June 2004

Released CU Scope Adaptation chart in

July 2004

Issued 2nd compatibility statement in

December 2004

Note: CU # 17016 for 70K FWJ

AER 70K Claims

Advanced Sterilization Products

Informal compatibility email in March 2004

Acknowledged problems with FWJ

Written ASP instructions March 05

AER 70K Claims

Minntech/MediVators
Compatibility released Feb. 8, 2005

Pending Application Guide

Pending written Minntech instructions

AER 70K Claims

Steris System 1
Released 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

NEW AER 70K Claims

Steris Reliance EPS
Claim yes, but no Reliance instructions received
ASP EvoTech/AdaptaScope
Claim yes, but no EvoTech instructions received

Critical Elements of
Reprocessing
GI Endoscopes

Critical Elements of
Reprocessing GI Endoscopes
Wear appropriate
protective attire
Immediately after the
procedurebegin precleaning
Wipe insertion tube
Purge air & water
channels
Aspirate detergent
Expose ALL surface areas
and scope components to
an enzymatic
detergent

Cleaning is the
single most
important step
to efficient
reprocessing

Critical Elements
Always Leak Test prior to
immersion
Not only to prevent MAJOR scope
damage
To reduce potential for crosscontamination from a
compromised instrument which
could harbor microorganisms
Rigorous mechanical cleaning is
imperative to remove organic soil...

Residual detergent should be rinsed

to prevent dilution &/or adulteration
of the disinfectant

Critical Elements
Always use an effective disinfectant
Aim; to achieve High-Level Disinfection
Iodophors, Quats, Alcohol, are NOT
considered HLD
Check the MEC of disinfectant via test strips
to ensure potency
Avoid introduction of air bubbles into internal
channels during flushing...
Adhere to recommended exposure times for
both disinfectant & detergent

Critical Elements
Minimize personnel exposure to
glutaraldehyde vapors by using a
basin with tight fitting lid or a
sealed automated endoscope
reprocessor

Adequate ventilation is
required
8-10 room exchanges of air
per hour is typically
recommended

Critical Elements
Channel cleaning adapters must be used to allow chemical
agents to reach all areas
Complete immersion ONLY is not enough to ensure
contact ...

Thoroughly rinse residual disinfectant to prevent patient

exposure to toxic chemicals
Ideally, rinse with sterile water
Follow by fresh 70% alcohol rinse and forced air

Critical Elements
Do not neglect to reprocess special
feature areas such as
Exposed elevator wire/channel
F. water jet channel
Balloon filling channels
(ultrasound scopes)
Secondary biopsy/suction
channels

If an automated unit can not

reprocess any special feature area,
that channel must be reprocessed
manually

Critical Elements
Prior to use, check with the AER
manufacturer to confirm that they
have validated reprocessing
instructions for the device-specific
(brand and model) endoscopes you
intend to reprocess

Critical Elements
Regardless of AER, use a final alcohol
rinse followed by forced air to facilitate
drying of endoscope surfaces

Latest SGNA guideline on the

use of HLDs and sterilants
Irrespective of quality of rinse water, the entire
endoscope should be dried, with each internal
channel being flushed with 70% alcohol followed
by forced air drying, both between patient
procedures and prior to storage

Critical Elements
Prior to storage, removable
scope components should be
detached
Reusable biopsy forceps & other
devices which break the mucosal
barrier must be meticulously
cleaned and sterilized before
EACH use
The entire water bottle assembly
should be sterilized, at least
daily. Only sterile water
should be used in the procedure

Pentax Steam
Sterilization Parameters
Sterilizer Type: Prevacuum
Temperature: 132-135C
(270-275F)
Time: 5 minutes

By strictly adhering to the

reprocessing recommendations
developed by ASTM, ASGE & SGNA,
as well as device & sterilant
manufacturers, end-users should
feel confident that they are
consistently providing the standard
level of patient care.

There have been no published reports

of infection when established
reprocessing guidelines are followed

Handouts
Multi-Society Guidelines
ASTM
APIC
ASGE
SGNA
HLDs and Sterilants
Reprocessing valves
Reprocessing water bottles
Reprocessing SUDs

Handouts
CDC/FDA Public Health Advisory
MMWR Infection Outbreak
Steris Letter on Reprocessing Valves
Steris User Notes

Decontamination Letter
Internal Schematics

Handouts
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

Thank You