CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 2

Question 1

The Spaulding Classification system categorizes flexible endoscopes that contact only mucous membranes (e.g., GI scopes) as:

Accepted Answer

Semi-critical devices requiring high-level disinfection

Answer

Semi-critical devices contact intact mucous membranes and require at minimum high-level disinfection per the Spaulding Classification framework.

Question 2

Which organization accredits ambulatory surgery centers (ASCs) and surveys endoscope reprocessing practices as part of its accreditation process?

Accepted Answer

The Joint Commission (TJC)

Answer

The Joint Commission surveys ASCs and hospitals and evaluates infection control programs including endoscope reprocessing as part of its accreditation reviews.

Question 3

AORN's Guideline for Care and Cleaning of Flexible Endoscopes recommends that what be performed within how many minutes of scope use?

Accepted Answer

Point-of-use pre-cleaning within 60 minutes

Answer

AORN recommends point-of-use pre-cleaning (wiping and flushing) begin within 60 minutes of scope use to prevent biofilm formation before formal reprocessing.

Question 4

Under FDA regulations, a reprocessed single-use device (SUD) must bear a label that includes:

Accepted Answer

Name and address of the third-party reprocessor and original OEM device name

Answer

FDA requires reprocessed SUDs to be labeled with the name and address of the reprocessor and the original OEM labeling information for traceability.

Question 5

Which ANSI/AAMI standard provides requirements for steam sterilization used on endoscope components that are heat-stable?

Accepted Answer

ANSI/AAMI ST79

Answer

ANSI/AAMI ST79 is the comprehensive guide to steam sterilization and sterility assurance in health care facilities, applicable to heat-stable endoscope accessories.

CER - Certified Endoscope Reprocessor Practice Test

CER - Certified Endoscope Reprocessor Practice Test

CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 2