CIS Regulatory Compliance and Standards

Question 1

Which organization publishes ANSI/AAMI ST79, the primary US guideline for steam sterilization in healthcare?

Accepted Answer

Association for the Advancement of Medical Instrumentation (AAMI)

Answer

Occupational Safety and Health Administration (OSHA)

Answer

Centers for Disease Control and Prevention (CDC)

Answer

The Joint Commission (TJC)

Question 2

The OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030) primarily protects CS/SPD workers from:

Accepted Answer

Exposure to blood and other potentially infectious materials during instrument handling

Answer

Chemical burns from sterilant gases

Answer

Radiation exposure from sterilization equipment

Answer

Hearing damage from loud processing equipment

Question 3

Which regulatory body must clear or approve medical devices, including surgical instruments, before they can be marketed in the United States?

Accepted Answer

U.S. Food and Drug Administration (FDA)

Answer

Centers for Medicare & Medicaid Services (CMS)

Answer

The Joint Commission (TJC)

Answer

American National Standards Institute (ANSI)

Question 4

What is the purpose of a Biological Indicator (BI) in sterilization validation?

Accepted Answer

To confirm that the sterilization process achieved a sufficient kill of the most resistant microorganisms

Answer

To measure the temperature inside the sterilizer chamber

Answer

To verify that chemical indicator tape changed color

Answer

To test the cleanliness of instruments before sterilization

Question 5

According to AAMI guidelines, how often must a biological indicator be run in a steam sterilizer used for implants?

Accepted Answer

Every load containing implants, with results reviewed before implant release

Answer

Once per week during routine load testing

Answer

Once per day at the beginning of each shift

Answer

Every other load, alternating with chemical indicators

Question 6

Which accrediting body surveys hospitals and includes sterile processing standards as part of its Environment of Care requirements?

Accepted Answer

The Joint Commission (TJC)

Answer

OSHA

Answer

FDA

Answer

EPA