CIS Regulatory Compliance and Standards 1 — Questions and Answers
Question 1: Which organization publishes ANSI/AAMI ST79, the primary US guideline for steam sterilization in healthcare?
- Association for the Advancement of Medical Instrumentation (AAMI) (Correct answer)
- Occupational Safety and Health Administration (OSHA)
- Centers for Disease Control and Prevention (CDC)
- The Joint Commission (TJC)
Correct 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.
Question 2: The OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030) primarily protects CS/SPD workers from:
- Exposure to blood and other potentially infectious materials during instrument handling (Correct answer)
- Chemical burns from sterilant gases
- Radiation exposure from sterilization equipment
- Hearing damage from loud processing equipment
Correct 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.
Question 3: Which regulatory body must clear or approve medical devices, including surgical instruments, before they can be marketed in the United States?
- U.S. Food and Drug Administration (FDA) (Correct answer)
- Centers for Medicare & Medicaid Services (CMS)
- The Joint Commission (TJC)
- American National Standards Institute (ANSI)
Correct 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.
Question 4: What is the purpose of a Biological Indicator (BI) in sterilization validation?
- To confirm that the sterilization process achieved a sufficient kill of the most resistant microorganisms (Correct answer)
- To measure the temperature inside the sterilizer chamber
- To verify that chemical indicator tape changed color
- To test the cleanliness of instruments before sterilization
Correct 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.
Question 5: According to AAMI guidelines, how often must a biological indicator be run in a steam sterilizer used for implants?
- Every load containing implants, with results reviewed before implant release (Correct answer)
- Once per week during routine load testing
- Once per day at the beginning of each shift
- Every other load, alternating with chemical indicators
Correct 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).
Question 6: Which accrediting body surveys hospitals and includes sterile processing standards as part of its Environment of Care requirements?
- The Joint Commission (TJC) (Correct answer)
- OSHA
- FDA
- EPA
Correct 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.
CIS Regulatory Compliance and Standards 1
Which organization publishes ANSI/AAMI ST79, the primary US guideline for steam sterilization in healthcare?