Questions and Answers
The FDA classifies sterilization packaging as a?
Which of the following is NOT an acceptable sterilization packaging material?
Wicking material is used to:
When arranging plastic-paper pouches in the sterilizer, the pouches should be arranged:
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The relative humidity of the Central Service department should be:
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Some plastics including formulations of spun-bonded polyolefin are intended for use solely in these sterilization processes:
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When placing ring-handled instruments in an instrument tray, you should:
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Gauze squares are the wicking material of choice for instrument sets.
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Temperatures in a sterile storage area should be 55°F-60°F.
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Sterile packages should be stored no lower than 8-10 inches from the floor.
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All rigid sterilization containers have tamper evident seals.
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Cellulose materials cannot be processed within a gas plasma sterilizer.
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Reusable textile packaging requires less labor than disposable packaging.
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Aluminum foil is an acceptable packaging material for dry heat sterilization.
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Because shelf-life is event-related, stock rotation is no longer necessary.
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Study Notes
FDA Classification
- Sterilization packaging is classified as a Class II Medical Device by the FDA.
Sterilization Packaging Materials
- Muslin, Barrier Cloth, and Twills are acceptable sterilization packaging materials.
- Canvas is NOT an acceptable sterilization packaging material.
Wicking Material Functionality
- Wicking material facilitates air removal, steam penetration, and drying during the sterilization process.
Arrangement of Pouches
- Plastic-paper pouches should be arranged in the sterilizer with paper facing plastic to ensure effective sterilization.
Relative Humidity Standards
- The relative humidity in the Central Service department should be maintained at less than 75%.
Plastics in Sterilization Processes
- Certain plastics, such as spun-bonded polyolefin, are designated for use in low-temperature sterilization processes.
Arrangement of Ring-Handled Instruments
- Ring-handled instruments should be unlocked and opened when placed in an instrument tray to prevent damage during sterilization.
Wicking Material for Instrument Sets
- Gauze squares are NOT the preferred choice for wicking material in instrument sets.
Sterile Storage Area Temperatures
- Temperatures in sterile storage areas should not be limited to 55°F-60°F, as this statement is false.
Storage Protocol for Sterile Packages
- Sterile packages must be stored at least 8-10 inches above the floor to maintain sterility.
Rigid Sterilization Containers
- All rigid sterilization containers come with tamper-evident seals to ensure safety and integrity.
Cellulose Material Restrictions
- Cellulose materials are not suitable for processing within a gas plasma sterilizer.
Labor Requirements for Packaging
- Reusable textile packaging requires more labor than disposable packaging, making the statement that it requires less false.
Acceptable Packaging for Dry Heat Sterilization
- Aluminum foil is an acceptable material for use in dry heat sterilization processes.
Stock Rotation and Shelf-Life
- Despite shelf-life being event-related, stock rotation remains necessary to ensure the quality and safety of sterilized items.
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Description
Test your knowledge on sterilization packaging and protocols as defined by the FDA. This quiz covers acceptable materials, humidity standards, and arrangements for effective sterilization processes. Make sure you're familiar with the key concepts and best practices in medical sterilization.
