Chapter 16 low temperature sterilization

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  • 1. Low TemperatureLow Temperature SterilizationSterilization Chapter 16
  • 2. Objectives:Objectives: As a result of successfully completing this chapter, students will be able to: Discuss basic requirements important for any type of low temperature sterilization system Explain specific requirements for the three low temperature sterilization methods: ethylene oxide, hydrogen peroxide (gas plasma), and ozone Review (compare) important parameters of the three low temperature sterilization methods commonly used by health care facilities
  • 3. Basic Sterilization RequirementsBasic Sterilization Requirements Effectiveness Safety Monitoring Quality Assurance Penetration Material Compatibility Adaptability Approval
  • 4. Ethylene OxideEthylene Oxide Used commonly in Hospitals since the 1960s Excellent Penetration Capabilities Kills microorganisms by alkylation
  • 5. AlkylationAlkylation The process of destroying microorganisms by making the cell unable to metabolize and/or reproduce
  • 6. Ethylene Oxide ProcessEthylene Oxide Process ParametersParameters Time Temperature Concentration of EtO Relative Humidity
  • 7. TerminologyTerminology  Residual- The amount of EtO that remains inside of materials after they have been sterilized  Aeration- A process in which a device is actively subjected to moving air. For example, items that have been sterilized with EtO  Sterility Assurance Level (SAL)- The probability of a viable microorganism being present on a product after sterilization  Permissible Exposure Limits (PELs)- Limits developed by OSHA to indicate the maximum concentration of a contaminant to which an employee may be exposed over the duration assigned to that contaminant  Time Weighted Average (TWA)- The employee’s average airborne exposure in any 8-hour work shift of a 40 hour work week  Parts Per Million (PPM)- Parts Per Million (PPM) is the term used to measure the volume of gas in a vapor
  • 8. EtO SystemsEtO Systems 100% EtO Gas Blends
  • 9. Employee SafetyEmployee Safety Employees should receive instruction on: ◦ Hazards of EtO ◦ Procedures to reduce employee exposure ◦ Principles of EtO monitoring and interpretation of results ◦ Use of protective equipment ◦ OSHA Standards ◦ MSDS Sheets ◦ EtO Emergency Plans ◦ Processing procedures ◦ Storage and handling of EtO gas containers
  • 10. EtO SafetyEtO Safety EtO is a Toxic Gas EtO Sterilizers should be located in a well- ventilated area with a room air exchange rate of 10 air exchanges per hour Additional information about EtO safety is included in Chapter 21, Safety, pages 405 – 408 of the text
  • 11. Personnel MonitoringPersonnel Monitoring Personal devices worn with 1 foot of the employee’s breathing zone ◦ Provide delayed results Area monitors continuously monitor airborne EtO ◦ Provide real-time information
  • 12. Education Should also include:Education Should also include: Specific training from the manufacturers of the gas containers and the sterilizer
  • 13. Aeration of EtO SterilizedAeration of EtO Sterilized ItemsItems Minimum recommendations for aeration: ◦ 8 hours at 1400 F (600 C) ◦ 12 hours at 1220 F (500 C) *Some items require significantly longer aeration. Consult device manufacturer’s recommendations for specific guidelines
  • 14. Loading the EtO SterilizerLoading the EtO Sterilizer  Do not overload  When possible use metal carts or baskets  Do not let items come in contact with chamber walls  Place peel pouches on edge  Do not stack items on top of one another
  • 15. Unloading the EtO SterilizerUnloading the EtO Sterilizer  If possible aerate before handling  When transferring loads to the aerator, pull, don’t push the load  Follow your specific facility's safety protocols  Once a load has been placed in the aerator, new groups of sterilized items should not be added
  • 16. EtO Sterilizer PerformanceEtO Sterilizer Performance MonitorsMonitors Physical Monitors (Charts, Printout Tapes and Graphs Chemical Indicators Biological Indicators (Bacillus atrophaeus)
  • 17. Hydrogen Peroxide (Gas Plasma)Hydrogen Peroxide (Gas Plasma)  Popular because of its short cycle times  Uses H2O2 vapor and low temperature gas plasma doe rapid inactivation of microorganisms  Is widely compatible with different materials  Is not compatible with powders and strong absorbers like paper and linen made of cellulose  There are some restrictions regarding the sterilization of lumens (diameter and length). Consult device manufacturer recommendations for specific parameters
  • 18. Staff Safety Education:Staff Safety Education: Hazards of H2O2 MSDS Sheets OSHA PEL Process for changing vapor plates Storage, handling and disposal of cassettes
  • 19. MonitoringMonitoring Physical Monitors (Printout) Chemical Indicators Biological Indicators (Geobacillus stearothermophilus)
  • 20. OzoneOzone Newest low temperature process No purchase of sterilant needed. The system generates the O3 needed Process parameters: ◦ Time ◦ Temperature ◦ O3 Concentration ◦ Relative Humidity
  • 21. Overview of LowOverview of Low Temperature ProcessesTemperature Processes A comparison chart of the low temperature sterilization methods covered in this unit is located on page 341 of the text.