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AAMI guidelines necessitate that terminal sterilized tissue be released based on?

a. 10% destructive sterility testing
b. Random selective destructive testing
c. 100% swab cultures
d. None of the above

1 Answer

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Final answer:

AAMI guidelines do not prescribe a specific type of sterility testing but suggest a combination including random selective destructive testing and other validation methods to ensure safety and efficacy of sterilized tissues.

Step-by-step explanation:

The AAMI (Association for the Advancement of Medical Instrumentation) guidelines for tissue sterilization do not specifically mandate a release of terminally sterilized tissue based on a fixed percentage of destructive sterility testing, such as 10%, nor do they require 100% swab cultures.

Instead, the guidelines recommend a combination of methods for quality assurance, including validation of the sterilization process, routine controls, and product testing, which may include random selective destructive testing (where applicable) and sterility test methods that are designed to ensure the tissue is free from viable microorganisms. AAMI suggests that each sterilization process should be thoroughly evaluated to determine the appropriate acceptance activities, including sterility testing, bioburden testing, process validations, and other relevant parameters critical for ensuring the safety and efficacy of the sterilized tissues.

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