Regulatory Compliance and Standards Flashcards
6 cards from real CIS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Regulatory Compliance and Standards flashcards as text
Which organization publishes ANSI/AAMI ST79, the primary US guideline for steam sterilization in healthcare?
Answer: Association for the Advancement of Medical Instrumentation (AAMI)
AAMI (Association for the Advancement of Medical Instrumentation) develops and publishes ANSI/AAMI ST79, the comprehensive guide for steam sterilization in health care facilities.
The OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030) primarily protects CS/SPD workers from:
Answer: Exposure to blood and other potentially infectious materials during instrument handling
OSHA's Bloodborne Pathogens Standard requires engineering controls, PPE, and training to protect workers from exposure to blood and OPIM encountered during decontamination and instrument processing.
Which regulatory body must clear or approve medical devices, including surgical instruments, before they can be marketed in the United States?
Answer: U.S. Food and Drug Administration (FDA)
The FDA regulates medical devices under the Federal Food, Drug, and Cosmetic Act; surgical instruments require FDA 510(k) clearance or PMA approval before being sold in the US.
What is the purpose of a Biological Indicator (BI) in sterilization validation?
Answer: To confirm that the sterilization process achieved a sufficient kill of the most resistant microorganisms
BIs contain highly resistant spore-forming bacteria (G. stearothermophilus for steam) and directly demonstrate that the sterilization process was lethal enough to destroy even the most resistant organisms.
According to AAMI guidelines, how often must a biological indicator be run in a steam sterilizer used for implants?
Answer: Every load containing implants, with results reviewed before implant release
AAMI ST79 requires that every load containing implants include a BI, and the implants should not be released until the BI result is confirmed negative (no growth).
Which accrediting body surveys hospitals and includes sterile processing standards as part of its Environment of Care requirements?
Answer: The Joint Commission (TJC)
The Joint Commission accredits hospitals and evaluates sterile processing practices through its Infection Control and Environment of Care standards during surveys.