CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 1

Question 1

Which federal agency is responsible for clearing automated endoscope reprocessors (AERs) as medical devices in the United States?

Accepted Answer

FDA (Food and Drug Administration)

Answer

EPA (Environmental Protection Agency)

Answer

CDC (Centers for Disease Control)

Answer

CMS (Centers for Medicare and Medicaid Services)

Question 2

The SGNA (Society of Gastroenterology Nurses and Associates) publishes standards for endoscope reprocessing that are classified as:

Accepted Answer

Professional practice guidelines, not legally binding regulations

Answer

Federal law enforceable by CMS

Answer

OSHA-mandated safety standards

Answer

FDA-required labeling specifications

Question 3

Under Joint Commission standards, what must be documented after every endoscope reprocessing cycle?

Accepted Answer

Scope identifier, reprocessing method, operator, date, and MEC test results

Answer

Only the scope serial number and date

Answer

Operator name and time only

Answer

Patient name associated with prior use

Question 4

Which CDC Guideline is the primary federal reference document for endoscope reprocessing practices in US healthcare facilities?

Accepted Answer

Guideline for Disinfection and Sterilization in Healthcare Facilities (2008, updated 2019)

Answer

Guideline for Hand Hygiene in Healthcare Settings

Answer

Guideline for Prevention of Surgical Site Infections

Answer

Guideline for Isolation Precautions

Question 5

AAMI TIR34 provides guidance on which specific aspect of endoscope reprocessing?

Accepted Answer

Water quality for reprocessing of medical devices

Answer

Chemical sterilant efficacy testing

Answer

Endoscope channel diameter specifications

Answer

Staff competency assessment tools

Question 6

CMS Conditions of Participation (CoP) require hospitals to follow endoscope reprocessing standards. What happens if a facility is found non-compliant?

Accepted Answer

Loss of Medicare and Medicaid reimbursement eligibility

Answer

Mandatory criminal prosecution of staff

Answer

Immediate facility closure by FDA order

Answer

Civil fines only with no operational impact