CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 5

Question 1

Which organization publishes the 'Multi-Society Guideline on Reprocessing Flexible GI Endoscopes' widely referenced in U.S. endoscopy practice?

Accepted Answer

SGNA and ASGE jointly

Answer

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:

Accepted Answer

Remove the AER from service and notify the biomedical engineering team

Answer

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?

Accepted Answer

Carbapenem-resistant Enterobacteriaceae (CRE)

Answer

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?

Accepted Answer

Annually

Answer

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?

Accepted Answer

They require dual registration with both the FDA and EPA

Answer

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.

CER - Certified Endoscope Reprocessor Practice Test

CER - Certified Endoscope Reprocessor Practice Test

CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 5