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What is the preferred time and temperature combination for sterilizing devices that can withstand it?
What is the preferred time and temperature combination for sterilizing devices that can withstand it?
What is the primary requirement for effective steam sterilization?
What is the primary requirement for effective steam sterilization?
Which of the following statements about Ethylene Oxide (EO) sterilizers is true?
Which of the following statements about Ethylene Oxide (EO) sterilizers is true?
What does 'functionality' refer to in the context of medical devices and sterilization?
What does 'functionality' refer to in the context of medical devices and sterilization?
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Which process is essential for air removal during steam sterilization?
Which process is essential for air removal during steam sterilization?
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What is a characteristic of the operating conditions for Ethylene Oxide sterilizers?
What is a characteristic of the operating conditions for Ethylene Oxide sterilizers?
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Why are Ethylene Oxide (EO) sterilizers banned in many hospital settings?
Why are Ethylene Oxide (EO) sterilizers banned in many hospital settings?
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What is the initial step in a typical Ethylene Oxide sterilization cycle?
What is the initial step in a typical Ethylene Oxide sterilization cycle?
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What is a key characteristic of dry heat sterilization compared to other methods?
What is a key characteristic of dry heat sterilization compared to other methods?
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Which of the following is NOT a consideration for low temperature sterilization?
Which of the following is NOT a consideration for low temperature sterilization?
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What is the typical operating temperature range for gas plasma sterilization?
What is the typical operating temperature range for gas plasma sterilization?
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Which statement about the cycle process of gas plasma sterilization is true?
Which statement about the cycle process of gas plasma sterilization is true?
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In which situation is the risk/benefit ratio typically higher?
In which situation is the risk/benefit ratio typically higher?
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What is a common reason instruments undergo immediate use steam sterilization (IUSS)?
What is a common reason instruments undergo immediate use steam sterilization (IUSS)?
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What condition must an instrument meet to be valid for flash sterilization?
What condition must an instrument meet to be valid for flash sterilization?
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What is the main consequence of finding wet packs on removal from the sterilizer?
What is the main consequence of finding wet packs on removal from the sterilizer?
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What impact does a heavy item, such as an orthopedic mallet, have on cooling time after sterilization?
What impact does a heavy item, such as an orthopedic mallet, have on cooling time after sterilization?
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What environmental conditions should be avoided during the cooling process of sterilized items?
What environmental conditions should be avoided during the cooling process of sterilized items?
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What is the primary requirement for a sterilization method to be used for reusable invasive medical devices (RMD)?
What is the primary requirement for a sterilization method to be used for reusable invasive medical devices (RMD)?
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Which sterilization method is characterized by having a cycle time of approximately 40–60 minutes?
Which sterilization method is characterized by having a cycle time of approximately 40–60 minutes?
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Which of the following statements best describes the main disadvantage of steam sterilization?
Which of the following statements best describes the main disadvantage of steam sterilization?
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In the context of sterilization, what is the significance of device compatibility?
In the context of sterilization, what is the significance of device compatibility?
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What is the primary function of low temperature steam and formaldehyde vapor sterilization?
What is the primary function of low temperature steam and formaldehyde vapor sterilization?
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What does the Spaulding classification primarily assess?
What does the Spaulding classification primarily assess?
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Which type of sterilization process has a cycle time that can take up to 2 hours?
Which type of sterilization process has a cycle time that can take up to 2 hours?
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What should be ensured when providing sterile devices for patient procedures?
What should be ensured when providing sterile devices for patient procedures?
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What is the minimum sterilization time at 134°C in a typical sterilization cycle?
What is the minimum sterilization time at 134°C in a typical sterilization cycle?
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Which of the following compounds can cause stress corrosion and pitting in RMDs?
Which of the following compounds can cause stress corrosion and pitting in RMDs?
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What is the recommended orientation for placing non-perforated trays in the sterilizer?
What is the recommended orientation for placing non-perforated trays in the sterilizer?
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What is the first step to take after a sterilization cycle is complete?
What is the first step to take after a sterilization cycle is complete?
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Which of the following is NOT a recommended method for loading sterilizers?
Which of the following is NOT a recommended method for loading sterilizers?
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Which of the following should be visually checked after removing the sterilized load?
Which of the following should be visually checked after removing the sterilized load?
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What should be done with the printed records after each sterilization cycle?
What should be done with the printed records after each sterilization cycle?
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What should be done with sterile packs after the cycle is complete?
What should be done with sterile packs after the cycle is complete?
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What is a mandatory prerequisite for using an IUSS sterilizer?
What is a mandatory prerequisite for using an IUSS sterilizer?
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Which factor is critical in ensuring the effectiveness of IUSS sterilization?
Which factor is critical in ensuring the effectiveness of IUSS sterilization?
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Why is the surgical theatre not suited for washing and cleaning instruments?
Why is the surgical theatre not suited for washing and cleaning instruments?
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In what situation is the use of IUSS sterilizers justified?
In what situation is the use of IUSS sterilizers justified?
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What happens if IUSS sterilizers are used for implants or non-validated products?
What happens if IUSS sterilizers are used for implants or non-validated products?
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What is a significant disadvantage of using the operating theatre for instrument preparation?
What is a significant disadvantage of using the operating theatre for instrument preparation?
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What is a potential risk of using IUSS in the operating theatre?
What is a potential risk of using IUSS in the operating theatre?
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Why should IUSS sterilizers not be used routinely for instrument sets?
Why should IUSS sterilizers not be used routinely for instrument sets?
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Study Notes
Sterilization Techniques
- Sterilization is the complete destruction of microorganisms, including bacterial spores, crucial for reusable invasive medical devices (RMDs).
- Ideal sterilization methods feature rapid throughput, ease of validation, and ability to process wrapped items without environmental contamination.
Methods of Sterilization
- Steam (Moist Heat): High-pressure steam, typically at 115-121°C for 15-60 minutes, is reliable and easily monitored and validated but unsuitable for heat-sensitive items.
- Dry Heat: Similar to an oven, often used for glassware, metal items, and heat-stable powders (longer cycle times). Temperatures can range from 160°C to 180°C for varying durations.
- Ethylene Oxide (EO): Suitable for heat-sensitive items like flexible endoscopes and cardiac devices. However, it's less common for hospital operation due to cost implications on equipment and operating costs
- Gas Plasma: Operates at 55°C, suitable for heat-sensitive items and often has short cycles but requires non-cellulose wrapping.
Sterilization Validation
- Validation ensures a process consistently produces an end result that meets specifications and quality attributes.
- Critical parameters such as temperature, time, pressure, and load configuration are crucial to validation processes
- Proper protocols, cleaning, functionality, packing, and wrapping also need to be validated.
Sterilizer Testing
- Steam sterilizer testing: Daily, weekly, quarterly, and yearly testing is required to confirm proper sterilization (ISO 17665).
- Daily testing: Bowie-Dick test for steam penetration (air removal).
- Weekly testing: Safety checks, vacuum leak test, air detector function test (if equipped), and automatic control tests.
- Quarterly testing: Including the above, thermo-metric test, and surgical instrument calibration verification.
- Yearly testing: All previous tests plus steam superheat, non-condensable gas, endotoxins, thermocouple test, dry heat sterilizer testing, biological indicators, and chemical indicators are required for annual testing.
- EO sterilizer testing: Testing includes physical parameters (temperature, pressure, and humidity). Chemical and biological indicators are used.
- Gas Plasma sterilizer testing: Physical parameters (temperature, pressure, and humidity). Chemical and biological indicators are required.
Loading, Unloading, and Cool-Down
- Loading: Sterilizers should be loaded correctly to ensure steam contact and penetration, avoiding overloading, and placement that could block steam penetration.
- Unloading: Review sterilization parameters, verify cycle number with load label, examine items for moisture and integrity, retain records for local policy.
- Cool-down: Allow sufficient cool-down time for sterilized items to avoid damage and ensure safe handling in a traffic-free area.
Wet Pack Problems
- Wet packs indicate a compromised sterilization process and possible contamination.
- Handling requirements and rejection criteria should be established for wet packs.
Types of Steam Sterilization
- Gravity displacement: Dependent on gravity (slower penetration) and not suitable for wrapped items with narrow channels
- Porous load (Vacuum assisted): Incorporates a vacuum stage to improve penetration and suitable for items with channels.
- Flash (Immediate Use Steam Sterilization (IUSS)): Fast sterilization at high temperatures (134°C for 3-10 minutes) for urgent needs. Focuses on non-porous instruments with use restrictions.
Sterilization Recommendations
- IUSS (immediate use steam sterilization) is best for emergencies only, when it's the only viable option.
- Devices meant for implants, suction tubing, and cannulas should not be sterilized using IUSS.
- For other situations, standard steam sterilization/another suitable method should be used.
- Sterility procedures should be in place for any process, and properly validated.
Dry Heat Considerations
- Dry heat methods are suitable for specific materials (glassware, metals) not affected by moisture.
- Sterilization times are typically much longer in dry heat processes, compared to standard steam method sterilization.
- Temperature ranges between 160°C and 180°C.
Low Temperature Sterilization
- Suitable methods for particular devices, ensuring compatibility with items being processed
- Evaluate cycle time against workload/turnaround time
- Assess equipment availability
- Follow validation requirements
Gas Plasma Sterilization
- Suitable method for specific devices
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Description
This quiz explores various sterilization techniques critical for ensuring the safety of reusable invasive medical devices. Topics include steam sterilization, dry heat, ethylene oxide, and gas plasma methods, focusing on their applications and suitability. Test your knowledge on the ideal practices and principles behind sterilization methods.