CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 2 — Questions and Answers
Question 1: The Spaulding Classification system categorizes flexible endoscopes that contact only mucous membranes (e.g., GI scopes) as:
- Semi-critical devices requiring high-level disinfection (Correct answer)
- Critical devices requiring sterilization
- Non-critical devices requiring low-level disinfection
- Non-critical devices requiring intermediate-level disinfection
Correct answer: Semi-critical devices requiring high-level disinfection
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?
- The Joint Commission (TJC) (Correct answer)
- OSHA
- FDA
- AORN
Correct answer: The Joint Commission (TJC)
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?
- Point-of-use pre-cleaning within 60 minutes (Correct answer)
- Full manual cleaning within 30 minutes
- Immersion in HLD solution within 10 minutes
- Drying with 70% alcohol within 5 minutes
Correct answer: Point-of-use pre-cleaning within 60 minutes
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:
- Name and address of the third-party reprocessor and original OEM device name (Correct answer)
- Only the expiration date
- Patient's name and treating physician
- Manufacturing lot number of original device only
Correct answer: Name and address of the third-party reprocessor and original OEM device name
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?
- ANSI/AAMI ST79 (Correct answer)
- ANSI/AAMI TIR34
- ANSI/AAMI ST58
- ANSI/AAMI ST41
Correct answer: ANSI/AAMI ST79
ANSI/AAMI ST79 is the comprehensive guide to steam sterilization and sterility assurance in health care facilities, applicable to heat-stable endoscope accessories.
Question 6: Which regulatory body has the authority to issue a 483 Observation or Warning Letter to an endoscope reprocessing facility?
- FDA (Correct answer)
- OSHA
- CMS
- The Joint Commission
Correct answer: FDA
FDA Form 483 Observations and Warning Letters are issued by the FDA following inspections that identify deviations from current Good Manufacturing Practices or device regulations.
CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 2
The Spaulding Classification system categorizes flexible endoscopes that contact only mucous membranes (e.g., GI scopes) as: