Transcript Standards & Guidelines for Creating Presentations using

Cleaning, Disinfection and
Sterilization
APIC Chapter 26
November 11, 2008
Rosie Fardo RN, BSN, CIC
1
Program Objectives
1. Review the Chain of Infection
2. Define and discuss common cleaning,
disinfection sterilization terminology
3. Discuss and review the “chemistry” of
cleaning , disinfection, sterilization and
Spaulding Classifications-medical devices
4. Discuss sterilization methods and
monitoring
5. Describe components of instrument loaner
protocol
3
Breaking the Chain of Infection by Effective
Cleaning
Causative
Agent
Mode of
Transmission
4
Causative Agent
Pathogen
• The right antibiotic can control the pathogen
inside or on the body
• The right disinfectant, properly used, can
control or destroy most pathogens almost
everywhere else
5
Reservoir
• The medical staff cares for living
reservoirs- the human body
• The environmental staff cares for the
living reservoirs by managing and
cleaning the inanimate environment
6
Portal of Exit
• Reservoirs (humans) expel
pathogens
• Keeping the inanimate environment
clean is essential for this reason
7
Mode of Transmission
The chain of transmission is broken when:
• Appropriate PPE is used
• Public surfaces that are contaminated by direct
or indirect contact are cleaned with hospital
grade EPA approved products
• Waste is properly handled and discarded
• Hand hygiene
8
Portal of Entry
• Appropriate PPE is used
• Covering injured skin, not touching mucous
membranes
• Hand hygiene
9
Susceptible Host
• Maintain personnel health
• Immunizations
• Antibiotic stewardship
• Proper use of PPE
• Hand hygiene
10
Cleaning/Disinfection Terminology
• Antiseptic - substance that tends to inhibit the
growth and reproduction of microorganisms in
or on humans or animals
• Clean - removal of all visible dust, soil and any
other foreign material
• Decontaminate - remove disease producing
microbes rendering safe for handling
• Disinfectant - kills or destroys nearly all
disease-producing organisms, except spores
(used on inanimate objects)
11
Cleaning/Disinfection Terminology
• Germicide - an agent capable of killing
microorganisms (germs). Applies to
compounds used both on living tissue and
inanimate objects
• Sanitize - reduce microbes on surfaces to a
safe or relatively safe level
• Sterilize - all organic and inorganic soils,
microorganisms and spores are destroyed
• Vegetative- the stage of a cell that is not
replicating or forming spores
12
The Chemistry of Cleaning
• The first and most important step in infection
prevention and control is cleaning
• Microbes hide in soil
• Often simple cleaning will remove soil and the
microbes along with it
• Cleaning ensures that your disinfectant cleaner
will be able to reach the microscopic
contamination underneath and destroy microbes
You can’t kill microbes if you don’t clean first!
13
The Chemistry of Cleaning
A detergent is a liquid or solid chemical that can
do one or more of the following:
1. Wet or penetrate soil
2. Break apart the soil
3. Surround and emulsify greasy soils
4. Suspend the soil in the scrubbing water
14
The Chemistry of Cleaning
The surface-active agent or surfactant is the active
ingredient in a detergent
• The surfactant increases the wetting power of
scrub water by reducing its surface tension,
helping water spread out and better penetrate
the soil
• A detergent molecule has two distinct ends,
each with a special job- hydrophobic and
hydrophilic
15
Selecting the Right Detergent
Types of detergents fall into three
categories:
1. Anionic detergents
2. Cationic detergents
3. Nonionic detergents
16
Three Basic Elements in
Determining and Managing
Cleaning Operations
1. Detergents, solutions and/or chemicals
needed to clean and/or disinfect the
surface
2. The tools and/or equipment needed
3. Labor resources needed to properly
execute the process
17
The Factors of Cleaning Success- T.A.C.T.
• Time or labor involved
• Agitation
• Concentration of the chemical
• Temperature of the cleaning solution
18
Chemical Cleaning
There are five basic elements involved in
cleaning with chemicals:
1. Contact time
2. Temperature
3. Concentration
4. Mechanical action
5. pH (potential hydrogen)
19
Tools and Equipment for Cleaning
• Using the proper tool or equipment with the
proper chemical products is the most effective
and productive method of cleaning
• Factors to consider:
–
–
–
–
Initial price (acquisition cost)
Useful life
Suitable for the task
Labor cost to use the item
20
Introduction of New Tools and
Equipment
Microfiber System
• Microfibers are densely constructed polyester
and nylon fibers that are approximately 1/16
the thickness of human hair
• The density holds 6 times its weight in water,
making it more absorbent than conventional
cotton mops
• The Microfiber System demonstrated superior
microbial removal compared to cotton-string
mops with detergent
Rutala et. al. Microbiologic evaluation of microfiber. Mops for surface disinfection. AM J Infect
Control 2007
21
The Cleaning Process
• Environmental Services should
approach cleaning in a methodical
fashion
• Clock or counter clockwise
• Working from top to bottom
• Cleanest to the dirtiest
22
The “Chemistry” of
Cleaning
• One can clean without disinfecting, but
one can not disinfect without cleaning
• It may not be a failure of the cleaning
and disinfecting agents but rather a
failure to completely follow the
cleaning and disinfecting process
23
Foundation and Principles of
Environmental Services
Maintaining the built environment of a healthcare facility
or an environment where healthcare services are
delivered is driven largely by regulations set forth by:
1. OSHA
2. JCAHO
3. CDC
4. EPA
5. APIC
6. AORN
7. ASHES
24
Decreasing Order of Resistance of
Microorganisms to
Disinfectants/Sterilants
Prions
Spores
Mycobacterium
Non-Enveloped Viruses
Fungi
Bacteria
Enveloped Viruses
25
Spaulding Classification for
Medical Devices
Dr. Earle H. Spaulding devised a rational
approach to disinfection and sterilization of
patient-care items or equipment
He believed that the nature of disinfection could
be understood more readily if instruments and
items for patient care were divided into three
categories based on the degree of risk of
infection involved in the use of the item
26
Disinfection and Sterilization
Levels
STERILE
HIGH - LEVEL
INTERMEDIATELEVEL
LOW- LEVEL
27
Processing Non-Critical Items
NON-CRITICAL - objects will not come in
contact with mucous membranes or skin that
is not intact. Objects that touch only intact
skin can be expected to be contaminated
with some microorganisms and only require
low-level disinfection.
Examples: Bedpans; crutches; bed rails;
EKG leads; bedside tables; walls, floors and
furniture.
28
Low-Level Disinfection
Effective against:
Vegetative bacteria
Fungi
Low-Level
Lipid viruses
Not Effective against:
Spores
Non-critical devices
Environ. surfaces
Non-lipid viruses
Less active against Pseudomonas and Mycobacterium
Quaternary compounds (Quats) are low level disinfectants and
equivalent to an EPA hospital disinfectant (hospital grade),
not registered effective against Mycobacterium
29
Intermediate-Level Disinfection
Effective against:
Vegetative bacteria,
Fungi
Intermediate-Level
Non-critical devices
Lipid and non-lipid viruses
Mycobacterium
Environ. surfaces
Not effective against:
Spores
Phenolics, alcohols, and iodophors are examples of
intermediate-level disinfectants
30
Processing Semi-Critical Items
SEMI-CRITICAL - objects that touch mucous
membranes or skin that is not intact require a
disinfection process that kills microorganisms
except high numbers of bacterial spores requires
high-level disinfection.
Examples:
Respiratory therapy
Anesthesia equipment
GI endoscopes
Endocavitary probes
Tonometers
31
High-Level Disinfection
Effective against:
Vegetative bacteria
Fungi
Lipid and non-lipid viruses
Mycobacterium
Some spores
High-Level
Semi-Critical Devices
Instrumentation
Not effective against:
Large numbers or all bacterial spores
•
Compounds include aldehydes, hydrogen peroxide,
•
peracetic acid
32
Terminology
• Sterilize - is the highest level of clean in the
health care facility in which all organic and
inorganic soils, microorganisms and spores are
destroyed
• Sterilization is required for surgical procedures
• Sterilization requires heat or extended contact
with the strongest chemicals to control both
microbes and spores
• Sterilization is not practical or required for
environmental services housekeeping
procedures
33
Processing Critical Items
CRITICAL - objects which enter normally sterile
tissue or the vascular system or through which
blood flows should be free from ALL
microorganisms, including bacterial spores and
must be STERILE.
Examples
Surgical instruments
Cardiac catheters
Urinary catheters
Implants
Probes used in sterile body sites
34
Chemical Sterilants
Chemicals used to destroy all forms of:
Microbiological life
Fungal and bacterial spores
Prolonged exposure times (6-10 hours)
High-level disinfectants when used as a sterilant
may not convey the same level of sterility assurance
as other methods (sterilizers)
Sterile
35
Minimum Effective Concentration
(MEC) Test Strips
Dilution of chemical occurs during routine use
Test strips depends on frequency use of chemical
e.g. use daily, then test daily
Do not use test strips beyond expiration date.
Test & document when opening a new bottle;
refer to manufacturer’s protocol
36
Types of Sterilizers
37
Types of Sterilizers
Thermal (Heat)
Moist (Tabletop, Gravity, & High Speed Vacuum)
Dry
Chemical
ETO
HLD Chemicals
Ozone
Radiation
38
Dry Heat Sterilization
Gravity Convection- heated air rises and
displaces cooler air- temperatures within the
chamber tend to be inconsistent
Mechanical Convection – blower actively
forces heated air through-out the chambers so
it is more efficient than gravity and the
temperature is more uniform
39
Steam Pre-vacuum Sterilization
or High Speed Vacuum
Low cost, quick turnover, no
toxic chemicals,
accommodates large loads
Air is removed by a pump
then steam is rapidly
introduced
Example of an Electronic High Speed pre-and
post-vacuum autoclave.
40
Steam Gravity Sterilization
Low cost, quick turnover, no toxic chemicals,
accommodates large loads
Steam enters the chamber by gravity &
displaces air (so steam can penetrate load)
Takes longer for steam to reach required
temperature
4 key parameters; steam, pressure,
temperature, time
41
Flash Sterilization
Acceptable only for items:
Urgently needed
Cleaned well
Used close to point of sterilization
Adequately covered or protected from contamination
AAMI guidelines for implants (do not approve)
AORN guidelines for implants (do not approve)
Single instruments only (not trays)
42
Flash Sterilization
Considerations:
Risk of pt. burns from hot instruments
Recontamination of instruments during
transport
Keep logs of all flashing
Monitor times used, procedures, who, and
why – use as Performance Improvement
Monitor staff performance
43
Low Temperature Sterilization
Ethylene oxide (EtO);
Used for heat & moisture sensitive devices
Lengthy aeration time must follow each cycle to allow
removal of harmful residuals before opening chamber
doors
EtO is a carcinogen
Alarms, ventilation, and training of staff promote safe use of
this agent
44
Sterilization is Complex!
Human Factor Variables
+
Sterilizer Equipment Performance
Variables
=
Inconsistent Processes
45
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Reasons for Testing the Sterilization
Process
Ensure probability of sterility of processed
medical devices
Detect sterilization failure ASAP: quarantine
medical devices until final BI result known
Verify a corrected failure ASAP…… get sterilizer
back into service
Remove medical devices involved in failures before
patient use
Control costs
47
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Reasons for Testing the Sterilization
Process:
Quality Control
 Helps determine if events
during sterilization process
met parameters
 Provides verification of
adherence to
policies/procedures
48
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Variables Affecting the Outcome of
Steam Sterilization Process
Equipment
malfunction
10%
Utilities
5%
Human
error
85%
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49
ANSI/AAMI ST79
Comprehensive guide to steam sterilization and
sterility assurance in health care facilities
ANSI/AAMI ST46
ANSI/AAMI ST42
ANSI/AAMI ST37
Steam sterilization
and sterility
assurance in health
care facilities
Steam sterilization
and sterility
assurance using
table-top sterilizers in
office & amb facilities
Flash sterilization:
Steam sterilization
of patient care
items for immediate
use
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ANSI/AAMI ST35
ANSI/AAMI ST33
Safe handling
and biological
decontamination of
devices in facilities &
nonclinical settings
Guidelines for
reusable rigid
sterilization containers
for EO and steam
sterilization in facilities
50
Association of PeriOperative
Registered Nurses
 Recommended Practices for Sterilization
in Perioperative Practice Setting
 Recommended Practices for Selection and
Use of Packaging Systems for
Sterilization
51
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Sterilization Monitoring Systems
• Mechanical Indicators- Charts for time,
temperature, pressure
• Chemical Indicators- Internal and External;
Bowie Dick
• Biological Indicators
52
Sterilization Monitoring:
Mechanical Indicators
Cycle time, temperature, &
pressure is displayed on
the sterilizer gauges with
each instrument load
Printout or graph also
measures these indicators
53
Sterilization Monitoring:
Chemical Indicators (CI)
The CI is a temperature indicator that signals
the item has been exposed to sterilization
process
A CI is affixed to outside of package and used
with every load
An indicator is also placed inside the pack to
verify steam penetration
54
Chemical Indicator (CI) placed in the
tray prior to sterilization
55
Examples of Bowie Dick Tests
56
Integrators (Class 5)
Emulators (Class 6)
• Integrating indicator- chemical indicator
designed to react to all critical parameters over
a specified range of sterilization cycles
• Emulating indicators- cycle verification
indicators which shall be designed to react to all
critical variables for specified sterilization
cycles
57
Sterilization Monitoring:
Biological Indicators (BI)
Challenges the sterilization process against a Bacillus
spore
Use BI daily if sterilizer is used frequently
Use a BI for every implant and EtO
Placement
Procedures: notification, instruments, used,
documentation & report
58
Biological Indicators (BI)
Following the autoclave cycle,
the BI is placed in an incubator
Rapid readout 1-3 hours, or 24
hours
Control positive
Positive test = sterilization
process has failed
Pull instruments
59
3M™ Attest™ Rapid Readout Biological
Monitoring Products for Steam
Sterilization
1291
270°F/121°C, gravity
1296/1296F PCD/test
pack
270°F/131°C, dynamic-airremoval, ≥4 min
250°F/121°C, gravity, ≥40 min
1292
270°F/131°C,
dynamic-air-removal
250°F/121°C, gravity
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41382/41382F PCD/test pack
270°F/131°C, dynamic-airremoval, ≥4 min
250°F/121°C, gravity, ≥30 min
60
BI Monitoring Frequency
Some facilities are moving
to a higher standard of
patient care by monitoring
every sterilization load
with a biological indicator.
61
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BI Monitoring Frequency
Why monitor every load?
 Universal standard of patient care
 Cost and impact of a recall
 To be certain all implants, including those in
loaners, are appropriately monitored
 Ensure every type of sterilization cycle used is
monitored
 Ensure every type of packaging used in flash
sterilization is monitored
 Reduce risk and cost of healthcare-associated
infections (HAIs)
62
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Time Related vs. Event Related
Sterilization
Time related- expiration date
Event related sterilization –package must be
intact, dry, clean
63
Storage of Clean/Sterile supplies
Store at least 8-10
inches from the
floor & 18
inches from the
ceiling
Solid bottom shelf
64
Continuous Quality Improvement
(CQI)
AAMI ST79
 CQI programs are used to assess and
improve all components of the
sterilization process
– Desired outcome of improving patient
care by consistently delivering sterile
product to the user
 No single “right way” to implement CQI
 Team approach
65
Managing Loaner Instrumentation
Use of loaners has become common practice
across U.S.
 Increasing need to borrow instruments,
implants and other devices from vendors
and/or neighboring facilities
66
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Why Do Hospitals “Borrow” So
Much?
 Ever-changing technology
 Multiple cases in the same
day: block scheduling
 Procedures done infrequently
 Specialty procedures (e.g.,
pediatrics)
 Cannot afford to purchase
everything
 Space/storage issues
67
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Loaner Instrumentation Issues




Patient Safety
Timelines (flashing is not recommended)
Communication (OR, SPD, Vendor)
Quality
– MDM Reprocessing Guidelines
– Adequate time
– Implants
 Potential for lost items
68
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Managing Loaner Instrumentation
– AORN
“A
formalized program between
health care organizations and
health care industry
representatives should be
established for the receipt and
use of loaner instruments”
AORN, 2008
69
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Managing Loaner Instrumentation
– AORN
Loaner Process should include
70
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Managing Loaner Instrumentation
– AORN
Allow sufficient time for conventional sterilization
methods: “…circumvent the need for flash
sterilization”
Have loaner instruments delivered to
decontamination
Sterilize implantable devices with a BI and a
Class 5 integrating indicator
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71
Resources for Loaner
Instrumentation
 Joint position paper created and adopted by
ASHCSP and IAHCSMM
http://www.iahcsmm.org/current_issues_Joint_
paper_loaner_instrumentation.htm
– AORN Recommended Practice
– Managing Infection Control Journal inservice “Loaner Instrumentation: Keeping
Patient Safety First” by Rose Seavey, April,
2007
72
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Summary
1. Defined and discussed common cleaning,
disinfection sterilization terminology
2. Reviewed the Chain of Infection
3. Discussed and reviewed the “chemistry” of
cleaning , disinfection, sterilization and
Spaulding Classifications-medical devices
4. Discussed sterilization methods and
monitoring
5. Described components of instrument loaner
protocol
73
References
Guidelines:
Association for the Advancement of Medical
Instrumentation (AAMI)
Association of periOperative Registered Nurses
(AORN)
American Society for Healthcare Environmental
Services (ASHES)
74
References
• CDC Guidelines for Environmental Infection
Control in Health-Care Facilities
• International Association of Healthcare Central
Service Materials Management (IAHCSMM)
• (Rutala, William A.) Disinfection, Sterilization and
Antisepsis
75
Thank You
76