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![Page 1: Guarantee of the Steam Sterilization Process: Practice Based on CDC Evidence William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational.](https://reader035.fdocuments.net/reader035/viewer/2022062519/5697bfa61a28abf838c98790/html5/thumbnails/1.jpg)
Guarantee of the Steam Sterilization Process: Practice
Based on CDC EvidenceWilliam A. Rutala, PhD, MPH
Director, Hospital Epidemiology, Occupational Health and Safety; Professor of Medicine and
Director, Statewide Program for Infection Control and Epidemiology; University of North Carolina at
Chapel Hill, NC, USA
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Guarantee of the Steam Sterilization Process
Steam Sterilization: Advantages and disadvantages Functional workflow Cleaning and decontamination Preparation and Packaging Monitoring
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Disinfection and SterilizationRutala , Weber. www.cdc.gov
EH Spaulding believed that how an object will be disinfected depended on the object’s intended use.
CRITICAL - objects which enter normally sterile tissue or the vascular system or through which blood flows should be sterile.
SEMICRITICAL - objects that touch mucous membranes or skin that is not intact require a disinfection process (high-level disinfection [HLD]) that kills all microorganisms but high numbers of bacterial spores.
NONCRITICAL -objects that touch only intact skin require low-level disinfection .
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Processing “Critical” Patient Care ObjectsClassification: Critical objects enter normally sterile tissue or
vascular system, or through which blood flows.
Object: Sterility.Level germicidal action: Kill all microorganisms, including bacterial
spores.Examples: Surgical instruments and devices; cardiac
catheters; implants; etc.Method: Steam, gas, hydrogen peroxide gas plasma,
vaporized hydrogen peroxide, ozone or chemical sterilization.
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Sterilization of “Critical Objects”
Steam sterilizationHydrogen peroxide gas plasma
Ethylene oxideVaporized hydrogen peroxide
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Guarantee of the Steam Sterilization Process
Steam Sterilization: Advantages and disadvantages Functional workflow Cleaning and decontamination Preparation and Packaging Monitoring
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Steam Sterilization Advantages
Non-toxic Cycle easy to control and monitor Inexpensive Rapidly microbicidal Least affected by organic/inorganic soils Rapid cycle time Penetrates medical packing, device lumens
Disadvantages Deleterious for heat labile instruments Potential for burns
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Minimum Steam Sterilization Times Time at 132oC in Prevacuum Sterilizer
Item Minimum exposure Minimum drying time
Wrapped instruments 4 min 30 min
Textile packs 4 min 5 min
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Steam Sterilization
• Saturated steam is used to sterilize 80-85% of reusable medical devices in healthcare facilities.
“Steam is the preferred method for sterilizing critical medical and surgical instruments that are not damaged by heat, steam, pressure, or moisture.”*
*Rutala, Weber. CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
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Guarantee of the Steam Sterilization Process
Steam Sterilization: Advantages and disadvantages Functional workflow Cleaning and decontamination Preparation and Packaging Monitoring
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Central ProcessingPhysical Facilities
Facility ideally divided into three areas: Decontamination-reusable items are received, sorted, and
decontaminated; negative pressure; 6AC/hr. Personnel wear gloves when handling contaminated instruments; face masks, eye protection, and gowns/aprons when splashing may occur.
Packaging-used for inspecting, assembling, and packaging clean, but not sterile, material.
Sterilization and storage-limited access area with a controlled temperature and relative humidity.
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Staging/Preparation
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Preparation
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Sterilization
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Storage of Sterile Surgical Instruments
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Guarantee of the Steam Sterilization Process
Steam Sterilization: Advantages and disadvantages Functional workflow Cleaning and decontamination Preparation and Packaging Monitoring
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Cleaning Mechanical cleaning machines-automated equipment may
increase productivity, improve cleaning effectiveness, and decrease worker exposure Utensil washer-sanitizer Ultrasonic cleaner Washer sterilizer Dishwasher Washer disinfector
Manual
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Cleaning Items must be cleaned using water with detergents or
enzymatic cleaners before processing. Cleaning reduces the bioburden and removes foreign
material (organic residue and inorganic salts) that interferes with the sterilization process.
Cleaning and decontamination should be done as soon as possible after the items have been used as soiled materials become dried onto the instruments.
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Cleaning Purpose: remove all adherent debris from an item and to
reduce the number of particulates, microorganisms, and pyrogens. Removes debris such as blood, mucus, oil, salts or other
foreign matter interferes with the sterilization process Reduces the bioburden and enhances the probability of
sterilization
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Bioburden on Surgical Devices Bioburden on instruments used in surgery (Nystrom, 1981)
62% contaminated with <101
82% contaminated with <102
91% contaminated with <103
Bioburden on surgical instruments (Rutala, 1997) 72% contained <101
86% contained <102
Bioburden on surgical instruments (50)submitted to CP (Rutala, 2014) 58% contained <10 20% contained < 102
16% contained <5x102
6% contained <103
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Washer/DisinfectorRutala WA, Gergen MF, Weber DJ, ICHE. In press
Five Chambers Pre-wash: water/enzymatic is circulated over the load for 1 min Wash: detergent wash solution (150oF) is sprayed over load for 4 min Ultrasonic cleaning: basket is lowered into ultrasonic cleaning tank
with detergent for 4 min Thermal and lubricant rinse: hot water (180oF) is sprayed over load
for 1 min; instrument milk lubricant is added to the water and is sprayed over the load
Drying: blower starts for 4 min and temperature in drying chamber 180F
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Washer/DisinfectorRemoval/Inactivation of Inoculum (Exposed) on Instruments
WD Conditions Organism Inoculum Log Reduction Positives
Routine MRSA 2.6x107 Complete 0/8
Routine VRE 2.6x107 Complete 0/8
Routine P aeruginosa 2.1x107 Complete 0/8
Routine M terrae 1.4x108 7.8 2/8
Routine GS spores 5.3x106 4.8 11/14
No Enz/Det VRE 2.5x107 Complete 0/10
No Enz/Det GS spores 8.3x106 5.5 8/10
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Washer/disinfectors are very effective (>5 log10 reduction) in removing/inactivating
microorganisms from instruments
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IS THERE A STANDARD TO DEFINE WHEN A DEVICE IS CLEAN?
There is currently no standard to define when a device is “clean”, cleanliness controlled by visual
Potential methods: level of detectable bacteria; protein (6µg/cm2); endotoxin; ATP; lipid
This is due in part to the fact that no universally accepted test soils to evaluate cleaning efficiency and no standard procedure for measuring cleaning efficiency
At a minimum, a cleaning process should: reduce the natural bioburden; remove organic/inorganic contaminants; provide devices that when sterilized have a SAL 10-6
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Cleaning Indicators for Washer Disinfector Monitor the automated
washer and instrument cleaning chemistry functionaiity
Indicator includes proteins, lipids, and polysaccharides to mimic common challenging test soils
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Guarantee of the Steam Sterilization Process
Steam Sterilization: Advantages and disadvantages Cleaning and decontamination Functional workflow Preparation and Packaging Monitoring
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Packaging Once items are cleaned, dried, and inspected, items are
wrapped or placed in a rigid container Arranged in tray/basket according to guidelines
Hinged instruments opened Items with removable parts should be disassembled Heavy items positioned not to damage delicate items
Several choices to maintain sterility of instruments: rigid containers, peel pouched; sterilization wraps
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PackagingSterilization Wraps
An effective sterilization wrap would: Allow penetration of the sterilant Provide an effective barrier to microbial penetration Maintain the sterility of the processed item after sterilization Puncture resistant and flexible Drapeable and easy to use
Multiple layers are still common practice due to the rigors of handling
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Loading All items to be sterilized should be arranged so all
surfaces will be directly exposed to the sterilizing agent Other basic principles:
Allow for proper steam/gas circulation Nonperforated containers should be placed on their edge Peel packs should be placed on edge
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Packaging/Load Configuration Packaging materials should be compatible with the
sterilization process Packaging (rigid containers, peel pouches, wraps) should
provide a barrier to microorganisms and moisture and should be sufficiently strong to resist punctures and tears.
Items should be placed loosely into the basket, shelf, or cart so as not to impede contact between the sterilant and the microorganism.
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Objectives of Monitoring the Sterilization Process
Assures probability of absence of all living organisms on medical devices being processed
Detect failures as soon as possibleRemoves medical device involved in failures
before patient use
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Guarantee of the Steam Sterilization Process
Steam Sterilization: Advantages and disadvantages Cleaning and decontamination Functional workflow Preparation and Packaging Monitoring
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Sterilization Process Monitoring
Monitoring Tools• Physical monitors• Chemical indicators• Biological indicators• Process challenge devices (PCDs) test packs or challenge packs
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Sterilization MonitoringSterilization monitored routinely by combination of
mechanical, chemical, and biological parameters Physical - cycle time, temperature, pressure. Monitors
one location in the sterilizer. Chemical - heat or chemical sensitive inks that change
color when germicidal-related parameters present. Identifies processed from unprocessed medical devices.
Biological - Bacillus spores that directly measure sterilization. Integrates all parameters of the process.
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ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 , Section 10.5.1
Physical Monitors
• Marked with correct date and sterilizer identification at beginning of cycle• Read & verified by initialing at end of cycle• If not correct, do not release load
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Chemical Indicators
ANSI/AAMI/ISO 11140-1:2005 /(R)2010 (Mfrs. Standard)ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.2.1
• Class 1 Process Indicators
• Class 2 Indicators for use in Specific Tests
• Class 3 Single Variable Indicators
• Class 4 Multi-variable Indicators
• Class 5 Integrating Indicators
• Class 6 Emulating Indicators
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Class 1 Chemical Indicators
ANSI/AAMI/ISO 11140-1:2005 /(R)2010 (Mfrs. Standard)ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.2.1
Process IndicatorsUse with individual units to indicate that the unit has been directly exposed to the sterilization process • Exposure Control/External CIs• Distinguish between processed and unprocessed
units• Designed to react to one or more of the
critical process variables
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Class 2 Chemical Indicators
Indicators for Specific Tests• Equipment Control• Testing sterilizer performance
Bowie-Dick Test monitors efficacy of air removal and steam penetration in 270-
275ºF (132-135ºC) dynamic-air removal sterilizers (i.e., vacuum-assisted sterilizers)
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.2.1,10.7.6
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Class 2 Chemical Indicators
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 , Section 10.7.6
Bowie-Dick tests can detect: • Air leaks• Inadequate air removal• Inadequate steam penetration• Presence of non-condensable gases: air or gases from boiler additives
•Used for routine daily testing and qualification testing
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ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.7.6.5 and 10.8.1
• Uniform color change • If not uniform, shut down and report to
supervisor• Remain in use• Retest• Call for repair
• Re-qualify if major repair
Class 2 Chemical Indicators Bowie-Dick Test
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Class 5 Chemical Indicators
Integrating Indicators (Internal CIs, Load Control)• Designed to react to all critical variables • Stated values equivalent to the performance requirements for BIs (ISO 11138
series)
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.2.1
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Monitoring of Sterilizers Use physical, chemical and biological monitors to ensure
the effectiveness of the sterilization process Each load should be monitored with physical and chemical
indicators. If the physical, chemical or biological indicators suggest inadequate processing, the items should not be used
Biological indicators should be used at least weekly (in CP at least daily, sometimes every load) with spores intended specifically for the type of sterilizer
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Monitoring of Sterilizers
Internal Chemical IndicatorValidates the sterilant penetrated the pack or trayAdvantage of the pack control monitor is that it is
inside each pack in multiple locationsDetect local problem
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Biological Monitors Steam - Bacillus stearothermophilus Dry heat - B. subtilis ETO - B. subtilis New low temperature sterilization technologies
Plasma sterilization (Sterrad) - B. stearothermophilus
Peracetic acid - B. stearothermophilus
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Process Challenge Device (PCD)
“A PCD is a device used to assess the effective performance of a sterilization process by providing a challenge to the process that is equal or greater than the challenge posed by the most difficult item routinely processed.”
•PCD may be:
• User-assembled test pack
• Commercially available, FDA cleared preassembled test pack
•ST41 describes two types of PCDs
• Routine BI test pack
• Challenge BI test pack
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Rapid Readout BIs for Steam Now Require a 1-3h Readout Compared to 24-48h
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Super Rapid Readout Biological IndicatorsCommercially available in early 2013
1491 BI (blue cap)• Monitors 270°F and 275°F gravity –displacement steam sterilization cycles• 30 minute result (from 1 hour)
1492V BI (brown cap)• Monitors 270°F and 275°F dynamic-air-removal (pre-vacuum) steam sterilization cycles• 1 hour result (from 3 hours)
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RecommendationsMonitoring of Sterilizers
Following a single positive biological indicator used with a method other than steam, treat as non-sterile all items that have been processed in that sterilizer, dating back to last negative biological indicator. These non-sterile items should be retrieved, if possible, and reprocessed.
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Storage Time-related shelf life-safe storage times for sterile packs
vary with the porosity of the wrapper and storage conditions (e.g., 1 year, plastic wrapped pack)
Event-related shelf life-product remains sterile until some event causes the item to become contaminated (e.g., tear in packaging, packaging become wet)
Closed or covered cabinets are ideal but open shelving may be used for storage
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Storage of Sterile Items Event-related shelf life recognizes that the product
remains sterile until an event causes it to become contaminated (e.g., tear, wetness). Packages should be evaluated before use for lose of integrity.
Time-related shelf life (less common) considers items remain sterile for varying periods depending on the type of material used to wrap the item/tray. Once the expiration date is exceeded the pack should be reprocessed.
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Storage of Sterile Items Sterile storage area should be well-ventilated area that
provides protection against dust, moisture, and temperature and humidity extremes.
Sterile items should be stored so that packaging is not compromised
Sterilized items should be labeled with a load number that indicates the sterilizer used, the cycle or load number, the date of sterilization, and the expiration date (if applicable)
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Quality Control Provide comprehensive and intensive training for all staff
assigned to reprocess medical/surgical instruments To achieve and maintain competency, staff should:
hands-on training all work supervised until competency is documented competency testing should be conducted at commencement
of employment and regularly review written reprocessing instructions to ensure
compliance
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Immediate Use Steam SterilizationIssues
Over-used…intended for immediate use only
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Immediate Use Steam Sterilization “Flash” originally defined as sterilization of an unwrapped
object at 132oC for 3 min at 27-28 lbs pressure in gravity “Flash” used for items that must be used immediately and
cannot be packaged, sterilized and stored before use “Flash” is an antiquated term and replaced by “immediate
use steam sterilization” The same critical reprocessing steps (such as cleaning,
decontaminating, and transporting) must be followed
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Immediate Use Steam Sterilization “Immediate Use” is defined as the shortest possible time
between a sterilized item’s removal from sterilizer and aseptic transfer to sterile field
A sterilized item intended for immediate use is not stored for future use.
Sterilization process monitoring is essential Instruments inventories should be adequate to meet
surgical volumes and permit the time to complete all critical elements of reprocessing
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Sterilization Practices in Healthcare Facilities
Overview Physical facilities Cleaning, Packaging, Loading, Storage Monitoring
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Conclusions All sterilization processes effective in killing spores Cleaning removes salts and proteins and must precede
sterilization Delivery of sterile products for use in patient care
depends not only on the effectiveness of the sterilization process but also on cleaning, disassembling and packaging of the device, loading the sterilizer, and monitoring
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www.disinfectionandsterilization.org