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Chapter 15 high temperature sterilization
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- 2. Objectives: • As aresult of successfully completing this chapter, students will be able to: • Discuss factors that impact the effectiveness of sterilization and the methods of heat transfer associated with high temperature sterilization. • Discuss the advantages of steam sterilization. • Explain the anatomy of a steam sterilizer and identify the function of each major component. • Sizes of steam sterilizers • Jacket • Door, Gasket, and Chamber Drain • Thermostatic Trap • Gauges and Controls
- 3. Objectives:• Provide basicinformation about the types of steam sterilizers • Tabletop • Gravity Air Displacement • Dynamic Air Removal • Steam Flush and Pressure Pulse • Special Purpose Sterilizer (Flash) • Special Purpose Sterilizer (Instrument Washer Sterilizer) • Provide basic information about the phases in a steam sterilizer cycle: • Conditioning • Exposure • Exhaust • Drying
- 4. Objectives:• Describe theconditions necessary for an effective steam sterilization process: • Contact • Time • Temperature • Moisture • Explain basic work practices for steam sterilization: • Preparing devices and packs for steam sterilization • Loading a sterilizer • Unloading a sterilizer • Controlling wet packs • Cleaning and maintaining sterilizers
- 5. Objectives: • Explain thebasics of dry heat sterilization: • When dry heat is appropriate. • Advantages and disadvantages of dry heat sterilization. • Types of hot-air convection sterilizers. • Dry heat sterilization procedures. • Explain the need for quality control and review sterilization process indicators that help assure quality control: • Need for quality control • Chemical indicators. • Sterilization load control information. • Physical and mechanical monitors. • Biological indicators. • Bowie-Dick tests • Validation and Verification processes • Review the basics of three special high temperature sterilization concerns: • D-values and sterilization effectiveness • Creutzfeldt-Jakob disease (CJD) • Solutions
- 6. Common Methods ofHeat Transfer • Conduction – Heat transfer from one part of an item to another • Convection – Heat transfer from one point to another as gas or liquid circulates
- 7. Factors and Conditionsthat Impact Sterilization • Type of microorganisms present • Number of microorganisms present. (Bioburden) • Amount and type of soil present • Amount of protection the medical device provides
- 8. BIOBURDEN The number ofmicroorganisms on a contaminated object; also called bioload or microbial load
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- 10. Advantages of Steam Sterilization •Low Cost • Fast Cycles • Relatively Simple Technology • Leaves No Chemical Residues or By- products Behind
- 11. Steam Sterilizers come inMany Sizes
- 12. ANATOMY of a SteamSterilizer
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- 17. Gauges, Controls, andMonitors Provide a Visual and Written Record of Sterilizer Cycles
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- 19. TABLE TOP STERILIZERS Frequentlyused in Clinics and Dental Offices
- 20. Water Port ona Tabletop Sterilizer
- 21. GRAVITY AIR DISPLACEMENT STERILIZERS Steamsterilizer that uses gravity to remove air from the chamber. As steam enters the gravity sterilizer chamber, cooler air is forced out through the chamber drain
- 22. DYNAMIC AIR REMOVAL STERILIZERS Steamsterilizers that use a vacuum pump or ejector system to mechanically remove air from the chamber
- 23. GRAVITY AND DYNAMIC AIRREMOVAL STERILIZERS Differ in their methods of air removal
- 24. STEAM FLUSH- PRESSURE PULSESTERILIZERS Steam sterilizers that use a repeated sequence of steam flushes and pressure pulses to remove air from the chamber
- 25. SPECIAL PURPOSE PRESSURE STERILIZERS (FLASHSTERILIZERS) Steam sterilizers that are surgical instrument located at point-of-use. They are intended to be used in emergencies when there is no time for terminal sterilization.
- 26. SPECIAL PURPOSE PRESSURE STERILIZERS (INSTRUMENTWASHER STERILIZERS) Combination units that wash and sterilize instruments to make them safe for handling by processing personnel
- 27. Terminology • Terminal Sterilization– The process of sterilizing an item that is packaged • Flash Sterilization – The process of sterilizing an item that is not packaged
- 28. Steam Sterilizer Cycle Phases •Conditioning • Exposure • Exhaust • Drying
- 29. Steam Enters theChamber
- 30. Steam Passes throughthe Thermostatic Trap
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- 32. Steam is Exhausted fromthe Chamber
- 33. DRYING Begins at thecompletion of the exhaust phase if packaged items are in the load Flash (unwrapped) loads have minimal drying times and in some cases, no dry time at all
- 34. Conditions Necessary for EffectiveSteam Sterilization • Contact • Time • Temperature • Moisture
- 35. Frequent Causes of SteamContact Failures • Failure to adequately clean the object being sterilized • Packages wrapped too tightly • Loads that are too crowded • Containers that are positioned incorrectly • Clogged drain strainer • Mechanical malfunctions
- 36. Temperature Requirements • Steamsterilization must take place at specific temperatures in order to destroy heat resistant bacteria • The two most common temperatures used are: • 2500 F (1210 C) • 2700 F-2750 F (132.20 C-1340 C)
- 37. TIME In order forsteam sterilization to be effective, all items within the load need to be exposed to a specific temperature for an adequate amount of time
- 38. MOISTURE Adequate moisture isrequired for steam sterilization to be effective
- 39. SATURATED STEAM Steam thatcontains the maximum amount of water vapor. The moisture content of saturated steam should possess a Relative Humidity of 97% to 100%
- 40. Preparing Devices andPacks for Steam Sterilization
- 41. Preparing Items forSteam Sterilization • Use instrument trays that are large enough to evenly distribute that metal mass • Use only non-linting materials when assembling sets and trays • Remove stoppers and tubes from drainage bottles and tubing from hemostats and clamps • Position items to allow for sterilant contact • Disassemble all multi-part instruments • Do not hold instruments together with rubber bands • Open all jointed instruments
- 42. • Items withconcave or broad, flat surfaces should be placed on edge • Heavy instruments should be arranged to they will not damage more delicate items • Complex instruments should be prepared and sterilized following manufacturers’ instructions • Central Service Technicians must test and evaluate protective organizing cases sterilization and drying • Instruments must be inspected to ensure that they are clean • Instruments should be dry, with the exception of lumens which should be moistened Preparing Items for Steam Sterilization
- 43. Catheters, Tubing, Rubber, andOther Goods • Due to it’s rough molecular structure, rubber is difficult to clean • Rubber can break down when exposed to heat, light, acids, solvents, petroleum products, ether and hot metal • Most rubber items are single-use items • When processing reusable rubber items, follow manufacturer’s guidelines carefully for cleaning and sterilization
- 44. WOOD AND CORK Cannotbe sterilized by any hospital sterilization method
- 45. OILS AND POWDERS Cannotbe sterilized by steam
- 46. NO ITEM SHOULDBE STERILIZED… Without written instructions from the manufacturer
- 47. Paper/Plastic Pouches • Should beused for small, lightweight items
- 48. Small Perforated Boxes •Should be used to contain small items within instrument sets • Paper/Plastic pouches should not be used in trays
- 49. Textile Packs • Shouldbe made of materials that allow adequate air removal and steam penetration • The manufacturer should be consulted for recommendations on package size and density
- 50. Basins and Basin Sets•Graduated, nested basins should differ in diameter by at least 1 inch • Basin sets should be prepared so all basins are in the same direction to facilitate drainage and air removal • Non-linting absorbent material should be used to separate the basins • Basin sets should not exceed 7 pounds in weight
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- 52. Lumens • Moisten withdistilled or demineralized water • Do not moisten more than 2 hours prior to sterilization
- 53. Loading the Steam Sterilizer •Allow for proper steam circulation
- 54. Allow Adequate Spaceto Facilitate Air Removal and Drying
- 55. Position solid bottomeditems so that water and air are not trapped inside
- 56. When using Paper/PlasticPouches • Remember that only the paper side allows air removal, steam penetration, and drainage
- 57. Stand Paper/Plastic Laminateon Edge (Use a holder if necessary)
- 58. Do Not LayPaper/Plastic Laminate Pouches Flat
- 59. Lay items with perforatedbottoms flat
- 60. Where Water CannotFlow, Steam Cannot Go
- 61. Position Textile Packsso Layers within them are Perpendicular to the Shelf
- 62. Unloading the SteamSterilizer • Open the sterilizer door according to protocol • The load should be free from any visible liquid • Wet items should be considered contaminated • Do not touch items that have just been removed from the sterilizer • Do not handle packages until they are cool
- 63. Controlling Wet Packs • Packagesare considered wet when moisture in the form of dampness or puddles of water are found on or within a pack • Wet packs are considered contaminated
- 64. Causes of WetPacks • Wet packs may be the result of improper placement or positioning of packs or their contents • Pack density can also increase the incidence of wet packs.
- 65. Assembling and Wrapping InstrumentSets • Use only instrument trays with mesh or perforated bottoms to reduce the risk of wet packs • Use lint-free tray liners to help absorb moisture and facilitate drying • Evenly distribute set weight
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- 68. Clogged Drain Strainers CanImpede Air Removal
- 69. Wipe the DoorGasket. Inspect for Signs of Wear and Defects
- 70. Sterilizer Cleaning andMaintenance • Routinely clean sterilizer carts, carriages, and baskets • Inspect recording devices, paper charts and printer paper
- 71. Sterilizer Cleaning and Maintenance •Clean the sterilizer chamber according to manufacturer’s recommendations to prevent residue build up • Check the Chamber Drain Strainer at least daily • Clean and Check the Door Gasket Daily • Clean the inside of the chamber with a non-abrasive cleaner • Follow Manufacturer’s Specific Instructions
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- 73. Dry Heat Advantages • Sterilizessome items that Steam cannot sterilize • Can sterilize assembled instruments because of conduction heating • Will not erode the surface of glass • Is not corrosive to metals Disadvantages • Difficult to Control • High Temperature • Slow and Uneven Penetration • Requires Long Exposure Times • Limited Packaging Materials Available • Not suitable to sterilize fabrics and rubber
- 74. Types of DryHeat Sterilizers •Gravity Convection •Mechanical Convection
- 75. Gravity Convection Sterilizers •Prone to air layering which causes temperatures to be uneven
- 76. Mechanical Convection Sterilizers • Utilizea blower system to insure even heating thrughout the cycle.
- 77. CONVECTION The process ofheat transfer by the circulation of currents from one area to another
- 78. Dry Heat CyclePhases •Heat Up •Exposure •Cool Down
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- 81. Oils and Powders •Both Oils and Powders should be packaged less than 1 ounce and less that .25” deep • The required sterilization temperature should be based on manufacturer’s recommendations
- 82. Impregnated Gauze Strips •Strips should be placed in a stainless steel container and covered with petroleum jelly or other oil-based liquid • Depth should not exceed .5”
- 83. Syringes and Needles •Mustbe thoroughly Dry •May be assembled
- 84. Instruments • Must bethoroughly Dry • May be assembled • Ratchets and Boxlocks may be closed • Screws may be tightened as necessary
- 85. Dry Heat PackagingMaterials • Heat Resistant Glass • Stainless Steel Trays • Cotton Muslin (if the chamber temperature does not exceed 400 degrees F.) • Aluminum Foil • Nylon Films • Certain Sterilization Containers (Check Manufacturers’ Recommendations)
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- 87. PROCESS INDICATOR Devices intendedfor use with individual units (for example, packs or containers) to demonstrate that the unit has been exposed to the sterilization process, and to distinguish between processed and unprocessed units
- 88. External Chemical IndicatorTape Before Processing After Processing
- 89. Examples of Internal ChemicalIndicators
- 90. Examples of Internal ChemicalIntegrators
- 91. LOAD CONTROL NUMBER Label informationon sterilization packages, trays, and containers that identifies the sterilizer, cycle run, and date of sterilization
- 92. Load Control Information* Sterilizer Number Load Number DateSterilized *Must be placed on each item Sterilized in the Central Service Department S-1 L-5 05-03-07
- 93. Example of aLabel Applicator Gun for Load Control Information
- 94. JULIAN DATE The Julianday or Julian day number (JDN) is the number of days that have elapsed since January 1st
- 95. Sterilization Logging Information •Date and time of the sterilizer load control number (sometimes called the lot number) which includes sterilizer information. • Specific items sterilized including: • Quantity of items • User (destination) department • Complete item description • Exposure time and temperature • Sterilizer operator identification • Results of biological testing (if applicable) • Response of the CI placed in the BI test pack (if applicable) • Results of the Bowie-Dick testing, if performed
- 96. Physical (Mechanical) Monitoring • Includesinformation from time, temperature, and pressure recorders • Must be checked after each load before the load is released
- 97. BIOLOGICAL INDICATORS (BIS) Provide ameasure of sterilization process lethality
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- 99. BI Process ChallengeDevice (PCD) Placement BI Test pack
- 100. Process Challenge Devices • Guidelinesfor Process Challenge Devices are discussed in detail on pages 318 – 320 of the text
- 101. BOWIE-DICK TESTS Tests usedto evaluate the efficacy of air removal in dynamic air removal sterilizers
- 102. Examples of Bowie-Dick (AirRemoval) Tests
- 103. VALIDATION Procedures used byequipment manufacturers to obtain, record, and interpret test results required to establish that a process consistently produces a sterile product
- 104. VERIFICATION Procedures used byhealthcare facilities to confirm that the validation undertaken by the equipment manufacturer is applicable to the specific setting Specific information about verification recommendations is discussed in detail on pages 321 – 322 of the text
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- 106. D-VALUE The amount oftime required to kill 90% of the microorganisms present
- 107. Creutzfeldt-Jakob Disease • Specificinformation regarding procedures for CJD are discussed on pages 324 – 325 of the text.
- 108. SOLUTION PREPARATION ANSI/AAMI ST79:2006, section8.5.7 states: “Primarily for personnel safety reasons, inhospital preparation of and sterilization of parenteral and irrigation solutions is discouraged. When solutions are processed in the hospital (i.e. emergency situations), processing should be performed by trained personnel”
- 109. Types of Solutions Parental Solutions •Solutionsthat are administered to patients intravenously External Solutions •Solutions that are normally used for irrigating, topical application, and surgical use that are given orally or by inhalation
- 110. Flasking Technique • Useonly Borosilicate Glass Bottles • Fill with freshly distilled water • Use only vented closures that will allow air and steam to escape • Overfill by 3% - 5% to allow for evaporation during sterilization
Editor's Notes
- #14 The red depicts the steam as it travels from it ’ s source INTO THE JACKET SPACE as seen in a cut away view of a sterilizer.
- #16 It ’ s the heart of the system. If this is blocked there is no other exit point for air at the beginning of the cycle (remember that air is the biggest enemy to sterilization), or steam to exit the chamber at the end of the cycle, therefore wet loads will result.