CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 5 — Questions and Answers
Question 1: Which organization publishes the 'Multi-Society Guideline on Reprocessing Flexible GI Endoscopes' widely referenced in U.S. endoscopy practice?
- APIC alone
- SGNA and ASGE jointly (Correct answer)
- The Joint Commission
- OSHA
Correct answer: SGNA and ASGE jointly
The Society of Gastroenterology Nurses and Associates (SGNA) and the American Society for Gastrointestinal Endoscopy (ASGE) jointly publish the multi-society guideline on GI endoscope reprocessing.
Question 2: A facility discovers that an automated endoscope reprocessor (AER) was used without its door seal functioning properly. According to regulatory guidance, the first step is to:
- Continue use until the next scheduled maintenance
- Remove the AER from service and notify the biomedical engineering team (Correct answer)
- Double the exposure time to compensate
- Increase the chemical concentration
Correct answer: Remove the AER from service and notify the biomedical engineering team
A malfunctioning AER must be taken out of service immediately to prevent inadequately reprocessed endoscopes from being used on patients.
Question 3: FDA's 2015 and 2018 safety communications regarding duodenoscopes specifically highlighted the risk of which pathogen transmission?
- Clostridium difficile
- Carbapenem-resistant Enterobacteriaceae (CRE) (Correct answer)
- Hepatitis C virus
- Pseudomonas aeruginosa
Correct answer: Carbapenem-resistant Enterobacteriaceae (CRE)
FDA safety communications identified carbapenem-resistant Enterobacteriaceae (CRE) transmission linked to contaminated duodenoscopes, prompting enhanced reprocessing guidance.
Question 4: Under CMS Conditions of Participation, hospitals must ensure that endoscope reprocessing policies are reviewed at minimum how often?
- Every 5 years
- Annually (Correct answer)
- Every 6 months
- Only when incidents occur
Correct answer: Annually
CMS Conditions of Participation require hospitals to review infection control policies, including endoscope reprocessing procedures, at least annually.
Question 5: Which statement best describes the regulatory status of endoscope reprocessing chemicals labeled 'sterilants/high-level disinfectants' in the United States?
- They are regulated solely by the FDA
- They require dual registration with both the FDA and EPA (Correct answer)
- They are only regulated by state health departments
- They require no federal registration if used in hospitals
Correct answer: They require dual registration with both the FDA and EPA
Liquid chemical sterilants and high-level disinfectants used on medical devices require dual registration — FDA clears them for use on devices while the EPA regulates them as pesticides under FIFRA.
Question 6: Which accreditation standard requires a facility to conduct and document a patient notification process following identification of an endoscope reprocessing breach?
- ISO 13485
- The Joint Commission NPSG.07.05.01 (Correct answer)
- ANSI/AAMI ST91 Section 12
- OSHA 1910.1450
Correct answer: The Joint Commission NPSG.07.05.01
The Joint Commission's National Patient Safety Goal 07.05.01 addresses healthcare-associated infection prevention and supports requirements for patient notification following reprocessing failures.
Question 7: According to AAMI ST91, what is the recommended action when the biological burden on an endoscope channel exceeds acceptable post-cleaning benchmarks during surveillance testing?
- Proceed to high-level disinfection with an extended soak time
- Remove the endoscope from service and investigate the cleaning process (Correct answer)
- Report the finding to the manufacturer only
- Re-test using a different swab technique
Correct answer: Remove the endoscope from service and investigate the cleaning process
AAMI ST91 recommends removing the endoscope from service and conducting a root cause investigation of the cleaning process when surveillance testing reveals unacceptable bioburden levels.
CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 5
Which organization publishes the 'Multi-Society Guideline on Reprocessing Flexible GI Endoscopes' widely referenced in U.S. endoscopy practice?