CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 4

Question 1

Under FDA regulations, which classification applies to flexible endoscopes used for diagnostic procedures?

Accepted Answer

Class II medical device

Answer

Flexible endoscopes are generally classified as Class II medical devices under FDA regulations, subject to special controls.

Question 2

Which ANSI/AAMI standard specifically addresses the reprocessing of flexible and rigid endoscopes?

Accepted Answer

ANSI/AAMI ST91

Answer

ANSI/AAMI ST91 is the comprehensive standard specifically dedicated to the flexible and semi-rigid endoscope reprocessing process.

Question 3

The Joint Commission requires facilities to follow endoscope reprocessing guidelines primarily from which source?

Accepted Answer

Professional society guidelines and manufacturer IFU

Answer

The Joint Commission requires facilities to follow manufacturer Instructions for Use (IFU) and relevant professional society guidelines for endoscope reprocessing.

Question 4

When a high-level disinfectant reaches its minimum effective concentration (MEC) limit, what action must be taken?

Accepted Answer

Discard it immediately per manufacturer instructions

Answer

When a disinfectant falls below its minimum effective concentration, it must be discarded immediately because it can no longer achieve high-level disinfection.

Question 5

Under OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030), endoscope reprocessors are required to have access to which item?

Accepted Answer

Personal protective equipment (PPE)

Answer

OSHA's Bloodborne Pathogens Standard mandates that employers provide appropriate PPE to workers exposed to potentially infectious materials, including those reprocessing endoscopes.

CER - Certified Endoscope Reprocessor Practice Test

CER - Certified Endoscope Reprocessor Practice Test

CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 4