CIS CIS - Certified Instrument Specialist Regulatory Compliance and Standards Questions and Answers 1

Question 1

Which organization publishes the ST79 standard that serves as the primary guidance document for steam sterilization in US healthcare facilities?

Accepted Answer

AAMI

Answer

CDC

Answer

OSHA

Answer

The Joint Commission

Question 2

Under OSHA's Bloodborne Pathogen Standard (29 CFR 1910.1030), which personal protective equipment is required when handling contaminated surgical instruments?

Accepted Answer

Gloves, gown, mask, and eye protection

Answer

Safety glasses only

Answer

Gloves only

Answer

Respirator and full-body suit only

Question 3

Which federal agency classifies medical devices and regulates reprocessing instructions for surgical instruments in the United States?

Accepted Answer

FDA

Answer

CDC

Answer

OSHA

Answer

CMS

Question 4

What is the significance of an instrument manufacturer's Instructions for Use (IFU) in a sterile processing department?

Accepted Answer

IFUs are legally binding instructions that must be followed exactly for safe reprocessing

Answer

IFUs are optional guidelines that may be followed at the facility's discretion

Answer

IFUs apply only to robotic instruments

Answer

IFUs are only required for single-use devices

Question 5

Which accrediting body surveys US hospitals for compliance with sterile processing standards and can require immediate corrective action for deficiencies?

Accepted Answer

The Joint Commission (TJC)

Answer

IAHCSMM

Answer

AAMI

Answer

APIC

Question 6

What is the purpose of maintaining a sterilization log in a sterile processing department?

Accepted Answer

To provide documentation for regulatory compliance, traceability, and investigation of sterilization failures

Answer

To track employee vacation schedules

Answer

To record the cost of sterilization supplies used

Answer

To schedule preventive maintenance only