Chapter 15 high temperature sterilization


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  • 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.
  • 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.
  • Chapter 15 high temperature sterilization

    2. 2. Objectives: • As a result 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. 3. Objectives:• Provide basic information 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. 4. Objectives:• Describe the conditions 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. 5. Objectives: • Explain the basics 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. 6. Common Methods of Heat 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. 7. Factors and Conditions that 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. 8. BIOBURDEN The number of microorganisms on a contaminated object; also called bioload or microbial load
    9. 9. Steam Sterilization
    10. 10. Advantages of Steam Sterilization • Low Cost • Fast Cycles • Relatively Simple Technology • Leaves No Chemical Residues or By- products Behind
    11. 11. Steam Sterilizers come in Many Sizes
    12. 12. ANATOMY of a Steam Sterilizer
    13. 13. Door Gasket
    14. 14. Chamber Drain
    16. 16. Gauges, Controls, and Monitors Provide a Visual and Written Record of Sterilizer Cycles
    18. 18. TABLE TOP STERILIZERS Frequently used in Clinics and Dental Offices
    19. 19. Water Port on a Tabletop Sterilizer
    20. 20. GRAVITY AIR DISPLACEMENT STERILIZERS Steam sterilizer 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
    21. 21. DYNAMIC AIR REMOVAL STERILIZERS Steam sterilizers that use a vacuum pump or ejector system to mechanically remove air from the chamber
    22. 22. GRAVITY AND DYNAMIC AIR REMOVAL STERILIZERS Differ in their methods of air removal
    23. 23. STEAM FLUSH- PRESSURE PULSE STERILIZERS Steam sterilizers that use a repeated sequence of steam flushes and pressure pulses to remove air from the chamber
    24. 24. SPECIAL PURPOSE PRESSURE STERILIZERS (FLASH STERILIZERS) 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.
    25. 25. SPECIAL PURPOSE PRESSURE STERILIZERS (INSTRUMENT WASHER STERILIZERS) Combination units that wash and sterilize instruments to make them safe for handling by processing personnel
    26. 26. Terminology • Terminal Sterilization – The process of sterilizing an item that is packaged • Flash Sterilization – The process of sterilizing an item that is not packaged
    27. 27. Steam Sterilizer Cycle Phases • Conditioning • Exposure • Exhaust • Drying
    28. 28. Steam Enters the Chamber
    29. 29. Steam Passes through the Thermostatic Trap
    30. 30. Closed Thermostatic Trap
    31. 31. Steam is Exhausted from the Chamber
    32. 32. DRYING Begins at the completion 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
    33. 33. Conditions Necessary for Effective Steam Sterilization • Contact • Time • Temperature • Moisture
    34. 34. Frequent Causes of Steam Contact 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
    35. 35. Temperature Requirements • Steam sterilization 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)
    36. 36. TIME In order for steam sterilization to be effective, all items within the load need to be exposed to a specific temperature for an adequate amount of time
    37. 37. MOISTURE Adequate moisture is required for steam sterilization to be effective
    38. 38. SATURATED STEAM Steam that contains the maximum amount of water vapor. The moisture content of saturated steam should possess a Relative Humidity of 97% to 100%
    39. 39. Preparing Devices and Packs for Steam Sterilization
    40. 40. Preparing Items for Steam 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
    41. 41. • Items with concave 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
    42. 42. Catheters, Tubing, Rubber, and Other 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
    43. 43. WOOD AND CORK Cannot be sterilized by any hospital sterilization method
    44. 44. OILS AND POWDERS Cannot be sterilized by steam
    45. 45. NO ITEM SHOULD BE STERILIZED… Without written instructions from the manufacturer
    46. 46. Paper/Plastic Pouches • Should be used for small, lightweight items
    47. 47. Small Perforated Boxes • Should be used to contain small items within instrument sets • Paper/Plastic pouches should not be used in trays
    48. 48. Textile Packs • Should be made of materials that allow adequate air removal and steam penetration • The manufacturer should be consulted for recommendations on package size and density
    49. 49. 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
    50. 50. Glass Syringes
    51. 51. Lumens • Moisten with distilled or demineralized water • Do not moisten more than 2 hours prior to sterilization
    52. 52. Loading the Steam Sterilizer • Allow for proper steam circulation
    53. 53. Allow Adequate Space to Facilitate Air Removal and Drying
    54. 54. Position solid bottomed items so that water and air are not trapped inside
    55. 55. When using Paper/Plastic Pouches • Remember that only the paper side allows air removal, steam penetration, and drainage
    56. 56. Stand Paper/Plastic Laminate on Edge (Use a holder if necessary)
    57. 57. Do Not Lay Paper/Plastic Laminate Pouches Flat
    58. 58. Lay items with perforated bottoms flat
    59. 59. Where Water Cannot Flow, Steam Cannot Go
    60. 60. Position Textile Packs so Layers within them are Perpendicular to the Shelf
    61. 61. Unloading the Steam Sterilizer • 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
    62. 62. Controlling Wet Packs • Packages are 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
    63. 63. Causes of Wet Packs • 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.
    64. 64. Assembling and Wrapping Instrument Sets • 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
    65. 65. CLEANING AND MAINTAINING Steam Sterilizers
    66. 66. Routine Sterilizer Maintenance
    67. 67. Clogged Drain Strainers Can Impede Air Removal
    68. 68. Wipe the Door Gasket. Inspect for Signs of Wear and Defects
    69. 69. Sterilizer Cleaning and Maintenance • Routinely clean sterilizer carts, carriages, and baskets • Inspect recording devices, paper charts and printer paper
    70. 70. 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
    71. 71. Dry Heat Sterilization
    72. 72. Dry Heat Advantages • Sterilizes some 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
    73. 73. Types of Dry Heat Sterilizers •Gravity Convection •Mechanical Convection
    74. 74. Gravity Convection Sterilizers • Prone to air layering which causes temperatures to be uneven
    75. 75. Mechanical Convection Sterilizers • Utilize a blower system to insure even heating thrughout the cycle.
    76. 76. CONVECTION The process of heat transfer by the circulation of currents from one area to another
    77. 77. Dry Heat Cycle Phases •Heat Up •Exposure •Cool Down
    78. 78. Items must be: •Clean •Dry •Packaged
    79. 79. Preparation of Specialty Items
    80. 80. 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
    81. 81. 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”
    82. 82. Syringes and Needles •Must be thoroughly Dry •May be assembled
    83. 83. Instruments • Must be thoroughly Dry • May be assembled • Ratchets and Boxlocks may be closed • Screws may be tightened as necessary
    84. 84. Dry Heat Packaging Materials • 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)
    85. 85. STERILIZATION Quality Control
    86. 86. PROCESS INDICATOR Devices intended for 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
    87. 87. External Chemical Indicator Tape Before Processing After Processing
    88. 88. Examples of Internal Chemical Indicators
    89. 89. Examples of Internal Chemical Integrators
    90. 90. LOAD CONTROL NUMBER Label information on sterilization packages, trays, and containers that identifies the sterilizer, cycle run, and date of sterilization
    91. 91. Load Control Information* Sterilizer Number Load Number Date Sterilized *Must be placed on each item Sterilized in the Central Service Department S-1 L-5 05-03-07
    92. 92. Example of a Label Applicator Gun for Load Control Information
    93. 93. JULIAN DATE The Julian day or Julian day number (JDN) is the number of days that have elapsed since January 1st
    94. 94. 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
    95. 95. Physical (Mechanical) Monitoring • Includes information from time, temperature, and pressure recorders • Must be checked after each load before the load is released
    96. 96. BIOLOGICAL INDICATORS (BIS) Provide a measure of sterilization process lethality
    97. 97. Examples of Biological Indicators
    98. 98. BI Process Challenge Device (PCD) Placement BI Test pack
    99. 99. Process Challenge Devices • Guidelines for Process Challenge Devices are discussed in detail on pages 318 – 320 of the text
    100. 100. BOWIE-DICK TESTS Tests used to evaluate the efficacy of air removal in dynamic air removal sterilizers
    101. 101. Examples of Bowie-Dick (Air Removal) Tests
    102. 102. VALIDATION Procedures used by equipment manufacturers to obtain, record, and interpret test results required to establish that a process consistently produces a sterile product
    103. 103. VERIFICATION Procedures used by healthcare 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
    105. 105. D-VALUE The amount of time required to kill 90% of the microorganisms present
    106. 106. Creutzfeldt-Jakob Disease • Specific information regarding procedures for CJD are discussed on pages 324 – 325 of the text.
    107. 107. SOLUTION PREPARATION ANSI/AAMI ST79:2006, section 8.5.7 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”
    108. 108. Types of Solutions Parental Solutions •Solutions that 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
    109. 109. Flasking Technique • Use only 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