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

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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

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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

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• 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

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• Reservoirs (humans) expel pathogens

• Keeping the inanimate environment clean is essential for this reason

Portal of Exit

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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

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• Appropriate PPE is used

• Covering injured skin, not touching mucous membranes

• Hand hygiene

Portal of Entry

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• Maintain personnel health

• Immunizations

• Antibiotic stewardship

• Proper use of PPE

• Hand hygiene

Susceptible Host

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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)

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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!

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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

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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

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Selecting the Right Detergent

Types of detergents fall into three categories:

1.Anionic detergents

2.Cationic detergents

3.Nonionic detergents

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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

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The Factors of Cleaning Success- T.A.C.T.

• Time or labor involved

• Agitation

• Concentration of the chemical

• Temperature of the cleaning solution

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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)

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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

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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

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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

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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

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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

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Disinfection and Sterilization Levels

STERILESTERILE

LOW- LEVELLOW- LEVEL

INTERMEDIATE- INTERMEDIATE- LEVEL LEVEL

HIGH - LEVELHIGH - LEVEL

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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

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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

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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

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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

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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

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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)

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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

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Types of Sterilizers

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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

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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.

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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

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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

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Sterilization is Complex!

Human Factor Variables +

Sterilizer Equipment Performance Variables

=Inconsistent Processes

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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

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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

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Chemical Indicator (CI) placed in the tray prior to sterilization

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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

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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

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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

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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.

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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

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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

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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

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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

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Managing Loaner Instrumentation – AORN

Loaner Process should include

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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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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

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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

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References

Guidelines:

Association for the Advancement of Medical Instrumentation (AAMI)

Association of periOperative Registered Nurses (AORN)

American Society for Healthcare Environmental Services (ASHES)

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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

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Thank You

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