CIS Regulatory Compliance and Standards 2

Question 1

What does the term 'IFU' mean in the context of instrument reprocessing?

Accepted Answer

Instructions for Use — the manufacturer's directions for cleaning, disinfection, and sterilization

Answer

IFU (Instructions for Use) are mandatory manufacturer-provided documents that specify validated methods for reprocessing each device; following the IFU is required by AAMI, TJC, and the FDA.

Question 2

A facility reprocesses a single-use device (SUD) against the manufacturer's labeling. Who then bears regulatory responsibility for that device?

Accepted Answer

The reprocessing facility becomes the manufacturer and must comply with FDA device regulations

Answer

Under FDA policy, when a facility reprocesses a SUD, it becomes the legal manufacturer and must comply with FDA's 21 CFR 820 quality system regulations for that device.

Question 3

Which AAMI standard specifically addresses high-level disinfection and liquid chemical sterilization processes?

Accepted Answer

ANSI/AAMI ST58

Answer

ANSI/AAMI ST58 provides guidance on chemical sterilization and high-level disinfection in health care facilities, covering glutaraldehyde, OPA, peracetic acid, and other agents.

Question 4

What does the Spaulding Classification System categorize?

Accepted Answer

Medical devices by the level of disinfection or sterilization required based on their risk of infection transmission

Answer

The Spaulding Classification System divides medical devices into Critical, Semi-critical, and Non-critical categories, each requiring a corresponding level of reprocessing to prevent infection.

Question 5

According to OSHA, which PPE is REQUIRED when handling contaminated instruments in the decontamination area?

Accepted Answer

Heavy-duty gloves, fluid-resistant gown, face shield or mask and eye protection

Answer

OSHA's Bloodborne Pathogens Standard requires appropriate PPE including puncture-resistant gloves, fluid-resistant gown, and face/eye protection when handling contaminated instruments.

CIS - Certified Instrument Specialist Practice Test

CIS - Certified Instrument Specialist Practice Test

CIS Regulatory Compliance and Standards 2