Cleaning, Disinfection and Sterilization APIC Chapter 26 November 11, 2008 Rosie Fardo RN, BSN, CIC...
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Transcript of Cleaning, Disinfection and Sterilization APIC Chapter 26 November 11, 2008 Rosie Fardo RN, BSN, CIC...
Cleaning, Disinfection and Sterilization
APIC Chapter 26
November 11, 2008
Rosie Fardo RN, BSN, CIC
Cleaning, Disinfection and Sterilization
APIC Chapter 26
November 11, 2008
Rosie Fardo RN, BSN, CIC
1
2
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
Portal of Entry
Suscep
tible
Hos
t
Causative Agent R
eservoir
Porta
l of
Exit
Mode of Transmissio
n4
• 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
Causative AgentPathogen
5
• 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
Reservoir
6
• Reservoirs (humans) expel pathogens
• Keeping the inanimate environment clean is essential for this reason
Portal of Exit
7
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
Mode of Transmission
8
• Appropriate PPE is used
• Covering injured skin, not touching mucous membranes
• Hand hygiene
Portal of Entry
9
• Maintain personnel health
• Immunizations
• Antibiotic stewardship
• Proper use of PPE
• Hand hygiene
Susceptible Host
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
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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. ASHES24
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
STERILESTERILE
LOW- LEVELLOW- LEVEL
INTERMEDIATE- INTERMEDIATE- LEVEL LEVEL
HIGH - LEVELHIGH - LEVEL
27
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.
Processing Non-Critical Items
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Low-Level Disinfection Effective against:
Vegetative bacteria
Fungi
Lipid viruses
Not Effective against:
Spores
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
Lipid and non-lipid viruses
Mycobacterium
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 equipmentGI endoscopesEndocavitary probesTonometers
31
High-Level Disinfection
Effective against:Vegetative bacteria
Fungi
Lipid and non-lipid viruses
Mycobacterium
Some spores
Not effective against:
Large numbers or all bacterial spores
•Compounds include aldehydes, hydrogen peroxide,
•peracetic acid32
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 ItemsCRITICAL - 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.
ExamplesSurgical instrumentsCardiac cathetersUrinary cathetersImplantsProbes 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)
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
Radiation38
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 Sterilizationor 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
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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
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Variables Affecting the Outcome of Steam Sterilization Process
Equipment malfunction
10%
Utilities5%
Human error85%
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ANSI/AAMI ST79
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST46
Steam sterilization and sterility
assurance in health care facilities
ANSI/AAMI ST37
Flash sterilization: Steam sterilization
of patient care items for immediate
use
ANSI/AAMI ST35 ANSI/AAMI ST33
Safe handlingand biological
decontamination of devices in facilities & nonclinical settings
Guidelines for reusable rigid
sterilization containers for EO and steam
sterilization in facilities
ANSI/AAMI ST42
Steam sterilization and sterility
assurance using table-top sterilizers inoffice & amb facilities
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Association of PeriOperative Registered Nurses
Recommended Practices for Sterilization in Perioperative Practice Setting
Recommended Practices for Selection and Use of Packaging Systems for Sterilization
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Sterilization Monitoring Systems
• Mechanical Indicators- Charts for time, temperature, pressure
• Chemical Indicators- Internal and External; Bowie Dick
• Biological Indicators
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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
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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
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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
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3M™ Attest™ Rapid Readout Biological Monitoring Products for Steam Sterilization1291
270°F/121°C, gravity
1296/1296F PCD/test pack
270°F/131°C, dynamic-air-removal, ≥4 min
250°F/121°C, gravity, ≥40 min1292
270°F/131°C, dynamic-air-removal250°F/121°C, gravity
41382/41382F PCD/test pack
270°F/131°C, dynamic-air-removal, ≥4 min250°F/121°C, gravity, ≥30 min
60
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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
Time Related vs. Event Related Sterilization
Time related- expiration date
Event related sterilization –package must be intact, dry, clean
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Storage of Clean/Sterile supplies
Store at least 8-10 inches from the floor & 18 inches from the ceiling
Solid bottom shelf
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Continuous Quality Improvement (CQI)
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
AAMI ST79
65
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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
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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
71
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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 in-
service “Loaner Instrumentation: Keeping Patient Safety First” by Rose Seavey, April, 2007
72
Summary
1. Defined and discussed common cleaning, disinfection sterilization terminology
2. Reviewed the Chain of Infection3. 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
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