CER CER - Certified Endoscope Reprocessor Regulatory Compliance and Standards Questions and Answers 2

Question 1

The Spaulding Classification system categorizes flexible endoscopes that contact only mucous membranes (e.g., GI scopes) as:

Accepted Answer

Semi-critical devices requiring high-level disinfection

Answer

Critical devices requiring sterilization

Answer

Non-critical devices requiring low-level disinfection

Answer

Non-critical devices requiring intermediate-level disinfection

Question 2

Which organization accredits ambulatory surgery centers (ASCs) and surveys endoscope reprocessing practices as part of its accreditation process?

Accepted Answer

The Joint Commission (TJC)

Answer

OSHA

Answer

FDA

Answer

AORN

Question 3

AORN's Guideline for Care and Cleaning of Flexible Endoscopes recommends that what be performed within how many minutes of scope use?

Accepted Answer

Point-of-use pre-cleaning within 60 minutes

Answer

Full manual cleaning within 30 minutes

Answer

Immersion in HLD solution within 10 minutes

Answer

Drying with 70% alcohol within 5 minutes

Question 4

Under FDA regulations, a reprocessed single-use device (SUD) must bear a label that includes:

Accepted Answer

Name and address of the third-party reprocessor and original OEM device name

Answer

Only the expiration date

Answer

Patient's name and treating physician

Answer

Manufacturing lot number of original device only

Question 5

Which ANSI/AAMI standard provides requirements for steam sterilization used on endoscope components that are heat-stable?

Accepted Answer

ANSI/AAMI ST79

Answer

ANSI/AAMI TIR34

Answer

ANSI/AAMI ST58

Answer

ANSI/AAMI ST41

Question 6

Which regulatory body has the authority to issue a 483 Observation or Warning Letter to an endoscope reprocessing facility?

Accepted Answer

FDA

Answer

OSHA

Answer

CMS

Answer

The Joint Commission