CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 4 — Questions and Answers
Question 1: Under FDA regulations, which classification applies to flexible endoscopes used for diagnostic procedures?
- Class I medical device
- Class II medical device (Correct answer)
- Class III medical device
- Exempt from classification
Correct answer: Class II medical device
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?
- ANSI/AAMI ST58
- ANSI/AAMI ST79
- ANSI/AAMI ST91 (Correct answer)
- ANSI/AAMI ST65
Correct answer: ANSI/AAMI ST91
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?
- CDC only
- FDA only
- Professional society guidelines and manufacturer IFU (Correct answer)
- OSHA standards only
Correct answer: Professional society guidelines and manufacturer IFU
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?
- Continue using it for 24 more hours
- Dilute it with water to extend use
- Discard it immediately per manufacturer instructions (Correct answer)
- Test it again after 30 minutes
Correct answer: Discard it immediately per manufacturer instructions
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?
- Lead aprons
- Personal protective equipment (PPE) (Correct answer)
- Radiation dosimeters
- Noise-canceling headphones
Correct answer: Personal protective equipment (PPE)
OSHA's Bloodborne Pathogens Standard mandates that employers provide appropriate PPE to workers exposed to potentially infectious materials, including those reprocessing endoscopes.
Question 6: Which federal agency has regulatory authority over the chemical high-level disinfectants used in endoscope reprocessing?
- OSHA
- CDC
- EPA (Correct answer)
- AAMI
Correct answer: EPA
The EPA regulates disinfectants and sterilants used on medical devices, including high-level disinfectants used for endoscope reprocessing, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Question 7: What is the primary purpose of documenting the lot number of the high-level disinfectant used during endoscope reprocessing?
- To track purchase costs
- To enable product recall traceability (Correct answer)
- To record staff overtime hours
- To satisfy insurance requirements
Correct answer: To enable product recall traceability
Documenting lot numbers enables traceability in the event of a product recall, allowing facilities to identify which patients may have been affected.
CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 4
Under FDA regulations, which classification applies to flexible endoscopes used for diagnostic procedures?