CIS CIS - Certified Instrument Specialist Regulatory Compliance and Standards Questions and Answers 2

Question 1

Which AAMI document provides guidance specifically on the design and qualification of sterilization process monitoring using biological indicators?

Accepted Answer

ST79

Answer

AAMI ST79 is the comprehensive steam sterilization standard that includes guidance on biological indicator use, placement, and interpretation for process monitoring.

Question 2

Under CDC Guidelines for Disinfection and Sterilization, which Spaulding classification applies to surgical instruments that enter sterile tissue?

Accepted Answer

Critical

Answer

The Spaulding Classification defines items that enter sterile tissue or the vascular system as 'critical' items, requiring sterilization before use.

Question 3

What does CMS (Centers for Medicare and Medicaid Services) Condition of Participation require regarding reprocessing of surgical instruments in accredited hospitals?

Accepted Answer

Facilities must follow nationally recognized guidelines for sterilization and disinfection

Answer

CMS Conditions of Participation require accredited hospitals to follow nationally recognized infection control guidelines, which includes AAMI and CDC standards for instrument reprocessing.

Question 4

Which OSHA standard requires healthcare employers to implement an Exposure Control Plan for employees who handle contaminated instruments?

Accepted Answer

29 CFR 1910.1030 (Bloodborne Pathogens)

Answer

OSHA 29 CFR 1910.1030 (Bloodborne Pathogens Standard) requires employers to establish an Exposure Control Plan to protect workers from bloodborne pathogen exposure during instrument handling.

Question 5

What is the regulatory definition of 'immediate use steam sterilization' (IUSS) as referenced in AAMI ST79?

Accepted Answer

Sterilization of an item intended for immediate use without being stored after the cycle

Answer

IUSS (formerly called 'flash sterilization') refers to sterilization of an item intended for immediate use without drying, storage, or transport in a covered or enclosed container.

CIS - Certified Instrument Specialist Practice Test

CIS - Certified Instrument Specialist Practice Test

CIS CIS - Certified Instrument Specialist Regulatory Compliance and Standards Questions and Answers 2