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Slide 1
1 Contact Hour CNE Presentation
MK-234 Rev. a
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Slide 2
Successful completion:
Participants must attend the entire program, including any resulting Q & A,
and submit required documentation.
Conflict of interest:
Planners disclose no conflict of interest. The speaker, as an employee of the
commercial support entity, hereby declares a conflict of interest.
Commercial company support: Fees are underwritten by education funding and
commercial support provided by PENTAX Medical.
Non-commercial company support: None.
Non-endorsement of products: Educational Dimensions, the Accredited
Provider for this activity, is dedicated to the provision of quality CNE and does
not endorse products or services provided by the speaker's company.
Off-label product use: None
Alternative/Complementary Therapy :None
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Slide 3
Upon completion of this presentation, participants will be
able to:
Apply standards and regulations from recognized
agencies to safe endoscope reprocessing
Examine safety considerations in the reprocessing
environment
Analyze reprocessing activities which will
contribute to the development of best practices
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Slide 4
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Slide 5
Dr. Earle H. Spaulding, Temple University, Philadelphia
1939 paper serves as basis for FDA, CDC and EPA
guidelines
Strategy for sterilization and disinfection of inanimate
objects is based on the degree of risk involved in using
them
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Slide 6
Critical Items Semi-critical Items Non-critical Items
Penetrate skin or mucous membrane
Contact intact mucous membrane
Contact intact skin
Must be sterilized Require minimum high-level disinfection
Require intermediate-or low-level disinfection
Surgical instruments, biopsy forceps
Endoscopes BP cuff
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Slide 7
Kills all microorganisms including bacterial spores
Sterilization expressed as Sterility Assurance Level
(SAL)
◦ Probability of an item being contaminated is equal to or
less than one in a million
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Slide 8
Timeline for Heat/Gas/Chemical Sterilization
Number Log
1,000,000 6
100,000 5
10,000 4
1,000 3
100 2
10 1
1 0
0.1 -1 1 in 10
0.01 -2 1 in 100
0.001 -3 1 in 1,000
0.0001 -4 1 in 10,000
0.00001 -5 1 in 100,000
0.000001 -6 1 in 1,000,000
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Slide 9
Kills all microorganisms except high numbers of
bacterial spores
Time, temperature, minimum effective concentration
(MEC)
Manual or automated cycles
Relatively short (5-20 min.) exposure time
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Slide 10
Intermediate-level disinfection
◦ Kills viruses, Mycobacteria, fungi, vegetative
bacteria
◦ Does not kill bacterial spores
Low-level disinfection
◦ Kills vegetative bacteria, some fungi, lipid viruses
◦ Does not destroy Mycobacteria, nonlipid viruses or
bacterial spores
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Slide 11
BACTERIAL SPORESBacillus subtilisClostridium sporogenes
MYCOBACTERIAMycobacterium tuberculosis
NONLIPID OR SMALL VIRUSESPolio virus, Rhinovirus
FUNGITrichophytonCandida albicansCryptococcus
VEGETATIVE BACTERIAPseudomonas, Staphylococci,Enterococci (MRSA, VRE)
LIPID OR MEDIUM-SIZED VIRUSESHBV, HCV, HIV, HSV, EBOLA, CMV, SARS
STER
HLD
ILD
LLD
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Slide 12
Association for the Advancement of Medical
Instrumentation (AAMI)
Association of PeriOperative Registered Nurses
(AORN)
Society of Gastroenterology Nurses and Associates
(SGNA)
Multi-Society Guideline on Reprocessing Flexible
Gastrointestinal Endoscopes: 2011
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Slide 13
Association for the Advancement of Medical
Instrumentation (AAMI) ST79
“Comprehensive Guide to Steam Sterilization and
Sterility Assurance in Health Care Facilities”
Addresses work area design, cleaning and
decontamination, personnel considerations
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Slide 14
Association of PeriOperative Registered Nurses
(AORN)
“AORN Standards and Recommended Practices”
The standards address high-level disinfection, cleaning
and processing of flexible endoscopes, and safe
environment of care
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Slide 15
Society of Gastroenterology Nurses and Associates
(SGNA)
“SGNA Practice Guidelines and Position Statements”
Guidelines address standards of infection control in
reprocessing of flexible gastrointestinal endoscopes and
the use of high level disinfectants and sterilants for
flexible scopes
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Slide 16
“Multi-Society Guideline on Reprocessing Flexible
Gastrointestinal Endoscopes: 2011”
Published in Gastrointestinal Endoscopy
Input and endorsement from eleven professional
organizations
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Slide 17
More than 20 million endoscopy procedures are
performed in the US each year. Patient outcomes are
not routinely tracked, however reports of pathogen
transmission resulting from these procedures are rare.
Between 1966 and 1992, the 281 cases of pathogen
transmission were associated with a reprocessing
guidelines breach.
Since the adoption of specific reprocessing guidelines
from 1988 to 1992, the incidence of pathogen
transmission was approximately 1 in 1.8 million
procedures.
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Slide 18
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Slide 19
Environment
◦ HVAC moves air from clean side of the room to
contaminated area
◦ Minimum 10 air exchanges per hour
◦ 16o to 18o C (60o to 65o F), 30 to 60% humidity
◦ Storage of supplies
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Slide 20
Personal Protective Equipment
◦ PPE – gown or apron, goggles or face shield, masks,
heavy duty gloves
◦ Cleaning supplies– brushes of various sizes and
diameters, lint-free cloths, solutions
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Slide 21
Water
◦ Separate handwash area
◦ Use potable water unless specified by the
manufacturer
◦ Seasonal differences in water quality
◦ Deionized or softened water removes detergent more
efficiently
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Slide 22
Eyewash station
◦ American National Standards Institute (ANSI)
◦ Accessible to workers within 10 seconds
◦ Continuous flush 0.4 gallons per minute for 15
minutes
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Slide 23
1 2 3 4 5 6 7 8 9 10 11 12 13 14pH
Neutral
Best for
inorganic soil
Best for
organic soil
Best for
stainless steel
instruments
Acid Alkaline
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Slide 24
Detergent solutions
◦ pH, enzymes, foaming/surfactant, temperature, rinsing
Dilution
Usage
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Slide 25
Different types of enzymes
◦ Breakdown of proteins
◦ Several types of enzymes -- action against blood,
protein, fats, carbohydrates
◦ Multiple enzymes – addition of synthetic lipids
remover
Other cleaners
◦ Multipurpose cleaner and degreaser
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Slide 26
Pressure to turn rooms around quickly
Failure to leak test or failure to correctly leak test
Failure to dilute the detergent or properly dilute the
detergent
Failure to fully immerse the endoscope
Failure to clean all channels or to fill all channels with
detergent
Failure to time the detergent contact
Failure to rinse the endoscope completely
Failure to purge all channels with air prior to disinfection
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Slide 27
Monitoring the cleaning process: is visual inspection
adequate?
The effectiveness of the cleaning process is dependent on adherence to the cleaning procedures and protocols established by SGNA and your facility.
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Slide 28
◦ EndoCheck®: Swab inner surface of channel
◦ ChannelCheck®: Irrigate channel and check fluid
Products of Healthmark, used with permission, for information purposes only
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Slide 29
Disinfectants
◦ Selection criteria
◦ Usage
◦ MEC test strips
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Slide 30
Commonly used types
◦ Aldehydes
Glutaraldehyde (GA)
Ortho-phthalaldehyde (OPA)
◦ Peracetic acid
◦ Hybrid formulations
Glutaraldehyde and alcohol (Aldahol)
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Slide 31
70% Isopropyl Alcohol
◦ Every endoscope, every time
◦ Air flush, alcohol flush, air flush
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Slide 32
OSHA Bloodborne Pathogens Standard
◦ Part of Annual Safety Review
Staff training
Competencies
Material Safety Data Sheets (MSDS)
◦ All chemicals
Environmental cleaning
Spill-containment plans
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Slide 33
Damage prevention
Clean endoscopes
◦ Transport to patient room
Contaminated endoscopes
◦ Transport to Decontamination Area
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Ergonomics -- OSHA
◦ “Ergonomics is the science of fitting workplace
conditions and job demands to the capabilities of the
working population.”
◦ Risks for injury
Work station design
Posture and position
Personal Protective Equipment
◦ Level of risk based on intensity, frequency, duration
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Slide 35
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Slide 36
Pre-cleaning
◦ Wipe outside surfaces
◦ Aspirate
◦ Purge
◦ Special channels
◦ Disconnect
Transport
◦ Impervious container
◦ Horizontal
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Slide 37
Air channel 0.7 mm
Water channel 0.7 mm
Biopsy channel 4.2 mm
Suction channel 4.2 mm
CO2 channel 0.7 mm
Water jet channel 0.7 mm
Elevator channel 0.15 mm
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Slide 38
Auxiliary water channel and water jet channel
Elevator channel
(source:Johns Hopkins Endoscopy)
Dual biopsy channels
(source:Pentax)
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Slide 39
Manual pre-cleaning at bedside
Leak test
Cleaning
Rinsing
Disinfection
Rinsing
Drying
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Slide 40 Pre-clean
Leak test
Mechanically
Clean
RinseDisinfect
Rinse
Alcohol flush
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Slide 41
Pressure to turn rooms around quickly
Failure to use disinfectant compatible with scopes
Failure to perform MEC test
Failure to use a disinfectant that has potency above its
MEC
Failure to fully immerse endoscope and accessories
Failure to fill all channels with disinfectant
Failure to time disinfectant contact (no clock in the room)
Failure to use disinfectant at proper temperature
Lack of written competencies, personnel training and periodic review
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Slide 42
An automated endoscope reprocessor can replace part
or all of the manual process
◦ Does not replace bedside cleaning
Advantages
◦ Patient
◦ Staff
◦ Standardization
Inspection and maintenance
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Slide 43
Validate compatibility
◦ Endoscope manufacturers must validate the compatibility of
the reprocessing solutions used on the endoscopes
◦ Medical facilities should confirm that the endoscope
manufacture has validated all model endoscopes which will be
reprocessed in the chemicals used by the AER the customer is
considering.
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Slide 44
EVOTECH® ECR
◦ First automated cleaning cycle
◦ 2 basins run asynchronously
◦ Cycle time 33 minutes
◦ Computerized leak and channel
blockage test, channel connection
security, channel pressure
◦ Alcohol flush automatic
◦ Solutions
CIDEZYME® GI Enzymatic Detergent Solution
CIDEX® OPA-C Solution
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Slide 45
System 83 PlusTM 9
◦ Ultrasonic wash cycle
◦ Can reprocess 2 endoscopes
◦ Cycle time 28 minutes with GTA
◦ Keyboard and video monitor
◦ Manual alcohol flush
◦ Solutions
Tergal® 800 Detergent
Disinfectant
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Slide 46
Medivators® Advantage Plus
◦ Automated cleaning cycle
◦ 2 asynchronous basins
◦ Cycle time 28 minutes
◦ Computerized cycle
◦ Continuous leak test and
programmable alcohol flush
◦ Solutions
Intercept® Detergent
Rapicide® PA
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Slide 47
OER-Pro®
◦ Modified manual cleaning
Bedside cleaning and leak test
◦ One basin for 2 endoscopes
◦ Cycle time 29 minutes
◦ RFID technology for endoscope
serial number, and data
◦ Alcohol flush automated
◦ Solutions
FlexClean® 895
Aldahol®
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Slide 48
RelianceTM EPS
◦ Manual cleaning
◦ P rocess 2 scopes in single basin
◦ Cycle time 30 mins
◦ Touch-button controls
◦ Alcohol flush manual
◦ Solutions
Klenzyme® Detergent
RelianceTM DG Dry Germicide
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Slide 49
System 1ETM
◦ Manual cleaning
◦ One scope in basin
◦ Cycle time 23 minutes
◦ Microprocessor controls
◦ Manual alcohol flush
◦ Solutions
S40TM Sterilant Concentrate
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Slide 50
ASP Evotech®
Custom
Ultrasonics
System 83
PlusTM 9
Medivators®
Advantage Plus
Olympus OER-Pro®
Steris RelianceTM
EPS
Automatic
wash
yes Yes yes yes no
Solutions CIDEZYME® GI,
CIDEX®
OPA
Tergal®800,
Disinfectant
Intercept®,
Rapicide® PA
FlexClean®
895,
Aldahol®
Klenzyme®
Reliance®
DG
Automatic
alcohol
flush
yes No yes yes no
Cycle time 33 mins 28 mins with
GA
28 mins 29 mins 30 mins
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Slide 51
Manual cleaning of endoscope not performed when
indicated by reprocessor manufacturer
Channels not rinsed and dried prior to placing
endoscope into reprocessor
Endoscope connectors or cleaning adapters not applied
correctly
All channels not connected
Endoscope incompatible with disinfectant
Water filters not changed as required
Alcohol flush omitted
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Slide 52
Clean, well-ventilated area
Distal tip hanging free
SecurityStorage cabinetTransport cart
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Slide 53
The Spaulding Classification System says that any
instrument that penetrates the mucous membrane (like
biopsy forceps) must be sterile.
Biopsy forceps, snares or other devices that pass through
an endoscope channel become contaminated
immediately upon entering channel.
Is it necessary to sterilize such devices or can they be
reprocessed by high-level disinfection?
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Slide 54
How long can reprocessed endoscopes be stored without
requiring repeat high-level disinfection just prior to
patient use?
Refer to the High Level Disinfectant manufacturers
instructions for soaking times.
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Slide 55
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Slide 56
The Case:
Veterans Administration Hospitals
◦ Blood in auxiliary water system tubing
◦ Investigation revealed errors
One-way valve missing
2 system components not being disinfected properly
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Slide 57
Discussion
Communications
◦ Patients from December 1
◦ Colonoscopy patients since endoscope received
◦ Other VA facilities
Actions taken
◦ Standard Operating Procedures (SOP)
◦ Competency evaluations
◦ Training by manufacturer
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Slide 58
The Outcomes
Follow-up visits
◦ 3 months after STEP UP WEEK
◦ Unannounced inspections in 42 facilities
◦ Low compliance
Clinical Risk Assessment Advisory Board
◦ Recommendations
2010 Update
◦ Over 50 cases of infection
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Slide 59
Apply standards and regulations from recognized
agencies to safe endoscope reprocessing
Examine safety considerations in the reprocessing
environment
Analyze reprocessing activities which will contribute to
the development of best practices
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Slide 60
Prepared by: Educational Dimensions, Claire Maguire,
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