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

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:

Accepted Answer

Exposure to blood and other potentially infectious materials during instrument handling

Answer

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?

Accepted Answer

U.S. Food and Drug Administration (FDA)

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

Every load containing implants, with results reviewed before implant release

Answer

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).

CIS - Certified Instrument Specialist Practice Test

CIS - Certified Instrument Specialist Practice Test

CIS Regulatory Compliance and Standards