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#1. How does the FDA classify a sterilization packaging system?

Correct Answer: Class II medical device

Explanation: Sterilization packaging is regulated as a Class II medical device because it plays a critical role in maintaining sterility.

#2. Before sterilizing hinged instruments, how should they be prepared?

Correct Answer: Open the jaws and unlock the handles

Explanation: Opening hinged instruments allows the sterilant to reach all surfaces.

#3. Instruments should be placed into trays in what condition?

Correct Answer: Dry

Explanation: Instruments must be completely dry before packaging to help prevent contamination and sterilization problems.

#4. When loading paper/plastic peel pouches into a sterilizer, how should they be placed?

Correct Answer: Paper side facing plastic

Explanation: Alternating the paper and plastic sides promotes proper sterilant penetration and drying.

#5. How often should the insulation on electrosurgical instruments be tested?

Correct Answer: Every time the instrument is processed

Explanation: Routine testing helps detect insulation damage before the instrument is used on a patient.

#6. What information should always be included on an instrument count sheet?

Correct Answer: A detailed list of tray contents

Explanation: A complete tray list helps ensure every instrument is present during assembly and inspection.

#7. Which item should not be placed inside an instrument tray?

Correct Answer: Plastic peel packs

Explanation: Peel pouches are designed to be processed separately and should not be placed inside instrument sets.

#8. Which material should not be used for sterilization packaging?

Correct Answer: Canvas

Explanation: Canvas does not provide an appropriate sterile barrier and is not approved for sterilization packaging.

#9. Which tape is approved for sealing sterilization packages?

Correct Answer: Sterilization indicator tape

Explanation: Sterilization indicator tape helps secure the package while providing visual confirmation that it has been processed.

#10. Which sterilization process is commonly used for many plastic medical devices?

Correct Answer: Hydrogen peroxide sterilization

Explanation: Heat-sensitive plastics are often sterilized using low-temperature hydrogen peroxide systems.

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