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Questions and Answers
A failed sterilization indicator may only be caused by a true sterilizer failure.
A failed sterilization indicator may only be caused by a true sterilizer failure.
False
All packages from a failed sterilization load can be reused after completing the investigation.
All packages from a failed sterilization load can be reused after completing the investigation.
False
If a chemical indicator indicates a failure, the sterilizer must be removed from service.
If a chemical indicator indicates a failure, the sterilizer must be removed from service.
True
Biological indicators must always be checked after a single chemical indicator failure.
Biological indicators must always be checked after a single chemical indicator failure.
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Once a cause of failure has been identified, it is not necessary to repackage items before reprocessing.
Once a cause of failure has been identified, it is not necessary to repackage items before reprocessing.
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Following the MDR protocols is optional when managing an indicator failure.
Following the MDR protocols is optional when managing an indicator failure.
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If the second sterilization cycle after an indicator failure passes, the sterilizer can continue to be used.
If the second sterilization cycle after an indicator failure passes, the sterilizer can continue to be used.
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It is important to notify your supervisor immediately when a sterilization indicator fails.
It is important to notify your supervisor immediately when a sterilization indicator fails.
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Visible moisture on the outside of packages is an indicator of possible sterilization failure.
Visible moisture on the outside of packages is an indicator of possible sterilization failure.
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Biological indicators are typically used to confirm that the sterilization process has been successful.
Biological indicators are typically used to confirm that the sterilization process has been successful.
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Chemical indicators are commonly used in the sterilization of most reusable medical devices.
Chemical indicators are commonly used in the sterilization of most reusable medical devices.
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Reports of adverse events related to sterilization must be submitted to the supervisor.
Reports of adverse events related to sterilization must be submitted to the supervisor.
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Ethylene Oxide gas is a method used for low temperature sterilization of devices that cannot withstand steam.
Ethylene Oxide gas is a method used for low temperature sterilization of devices that cannot withstand steam.
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A package feeling moist to the touch is a normal indicator of successful sterilization.
A package feeling moist to the touch is a normal indicator of successful sterilization.
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Unidentified stains on devices are considered inconsequential and do not require reporting.
Unidentified stains on devices are considered inconsequential and do not require reporting.
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Once a product recall is initiated, all indicators related to the sterilization process must be assessed by the supervisor.
Once a product recall is initiated, all indicators related to the sterilization process must be assessed by the supervisor.
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All items from a failed sterilization load must be quarantined until the results of a re-test are known.
All items from a failed sterilization load must be quarantined until the results of a re-test are known.
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If a biological indicator fails a test, the sterilizer does not need to be serviced by a qualified technician unless the second test is also positive.
If a biological indicator fails a test, the sterilizer does not need to be serviced by a qualified technician unless the second test is also positive.
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Once a biological indicator retest is negative, it is safe to assume that the initial failure was a false positive.
Once a biological indicator retest is negative, it is safe to assume that the initial failure was a false positive.
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Three consecutive biological indicator tests must always be performed in an empty chamber before a sterilizer is returned to service.
Three consecutive biological indicator tests must always be performed in an empty chamber before a sterilizer is returned to service.
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Packages from a positive biological indicator load must be rewrapped and re-sterilized before being used.
Packages from a positive biological indicator load must be rewrapped and re-sterilized before being used.
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Chemical indicators do not need to be replaced for non-PCD packages if the biological indicator tests are negative.
Chemical indicators do not need to be replaced for non-PCD packages if the biological indicator tests are negative.
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Documentation of failures must exclude any type of failure and focus solely on corrective actions taken.
Documentation of failures must exclude any type of failure and focus solely on corrective actions taken.
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For a Prevac sterilizer, three consecutive Bowie Dick air removal tests must be performed after a biological indicator failure.
For a Prevac sterilizer, three consecutive Bowie Dick air removal tests must be performed after a biological indicator failure.
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Study Notes
Module 9: Sterilization
- Sterilization is the process of removing all viable microorganisms from a device
- Patient safety requires effective sterilization processes and device compatibility
- Sterilization process validation is performed by the manufacturer to ensure effectiveness
- Medical device compatibility ensures the device can withstand the sterilization process without damage
- Steam sterilization is the most common sterilization method
- Effective steam sterilization depends on temperature, moisture, and time
- Air removal is crucial for efficient steam sterilization
- Steam sterilizers have various components including the chamber, door, drain, and steam trap
- Different types of steam sterilizers exist with varying operational procedures
- Different types of sterilization cycles exist, each with specific requirements
Requirements for Steam Sterilization
- Steam sterilization effectiveness relies on temperature, moisture, and the time the device is exposed to steam.
- Air must be removed completely before sterilization begins
- Microorganisms are protein-based, and their protein structure is denatured (or coagulated) by heat.
- Moist heat kills microorganism(s) significantly faster than dry heat.
Temperature and Pressure in Steam Sterilization
- Steam at sea level boils at 100°C, but this temperature is not sufficient to kill all microorganisms
- Raising the pressure of the steam increases its temperature.
- A predictable relationship exists between steam pressure and temperature.
- The specific parameters for steam sterilization, including pressure and temperature, depend entirely on the sterilizer model.
Parts of a Steam Sterilizer
- The chamber is where sterilization takes place, must withstand high pressures
- The door is part of the chamber, and is locked during the cycle for safety.
- The jacket surrounds the chamber and contains steam
- A baffle inside the chamber directs steam for even heating
- The drain or air outlet removes air before and during the cycle
- The steam trap controls the release of steam at the end of the sterilization period.
Types of Steam Sterilizers
- Gravity displacement sterilizers rely on the principle that air is denser than steam, thus causing air to be removed as steam enters the chamber.
- Dynamic air removal sterilizers use active means to extract the air from the chamber, these methods include pre-vacuum, and steam flushing methods.
Sterilizing Liquids
- Some sterilizers have specific cycles to sterilize liquids, these cycles are slower than standard cycles to avoid damaging the glassware.
Managing a Steam Sterilization Cycle
- Sterilization cycle selection must be appropriate for the items being sterilized.
- Proper loading techniques and procedures prevent air trapping and ensure adequate penetration for sterilization to occur.
Quality Assurance for Steam Sterilization
- Physical indicators, chemical indicators, and biological indicators are used in steam sterilization cycle verification.
- The physical indicators provide information about the conditions inside the sterilizer chamber, during the cycle
- Chemical indicators demonstrate exposure to sterilization, and give feedback if parameters were met.
- Biological indicators show if all microorganisms have been killed during the cycle; also a control is necessary to determine if the machine is performing as required.
Managing Adverse Sterilization Events
- If a failed indicator/cycle results, the investigation of the probable cause and corrective actions should be performed.
- The appropriate documentation regarding these events and any corrective actions must be retained.
Low Temperature Sterilization Methods
- Lower temperatures are used for specific types of devices that would be damaged in steam
- Three specific chemical methods are used occasionally: hydrogen peroxide vapor, ethylene oxide gas, and peracetic acid
- Each method has advantages and disadvantages.
Ozone-Hydrogen Peroxide Vapor Sterilization
- This is a newer method of sterilization that avoids the higher temperatures of steam
- This method uses ozone and hydrogen peroxide vapor, and equipment for generating the vapor and controlling the process
- H2O2 sterilizers have various components, including the process chamber, and safety features.
Peracetic Acid Immersion (Steris)
- This is a liquid-based sterilization process.
- Devices are immersed in a PAA solution inside a chamber, and then rinsed and ventilated to ensure safe removal.
- Peracetic acid is an active sterilization agent that destroys microorganisms.
- The process is generally fast, and does not require large chambers and ventilation to complete the cycle.
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Description
Test your knowledge on sterilization indicators and their implications in medical settings. This quiz covers key practices in responding to sterilization failures and the actions required following indicator malfunctions. Ideal for healthcare professionals involved in sterilization processes.
