CER Chapter 14 Review Quiz Flashcards
Regulations, Standards and Resources
Endoscopes should only be reprocessed using equipment that has been approved by the:
a. OSHA
b. CDC
c. US FDA
d. AAMI
US Food and Drug Administration
The document “Essential Elements of a Reprocessing Program for Flexible Endoscopes” was published by:
a. US FDA
b. US EPA
c. CDC
d. ECRI
Centers for Disease Control and Prevention
Regulations and standards establish:
a. effective processing guidelines
b. minimum levels of quality and safety
c. a method that has consistently shown superior results
d. all the above
Minimum levels of quality and safety
This action is taken by the US FDA when a medical device is defective or poses a health risk:
a. validation
b. citation
c. 510 (K)
d. Recall
Recall
This agency requires manufacturers to provide IFU’s with each product:
a. OSHA
b. AAMI
c. FDA
d. AORN
FDA
This regulatory department issues registration numbers for disinfectants:
a. US FDA
b. US EPA
c. APIC
d. AAMI
US Environmental Protection Agency
A method or technique that has consistently shown results superior to other means is a :
a. regulation
b. official protocol
c. best practice
d. requirement
Best practice
Individual states may have regulations that are more, or less, stringent than federal regulations, however, when federal and state regulations differ, facilities must follow:
a. the most stringent regulation
b. whichever regulation the facility’s IP chooses
c. the most recent regulation
c. whichever regulation fits with manufacturers IFU
The most stringent regulation
The agency responsible for the bloodborne pathogen standard:
a. OSHA
b. CDC
c. APIC
d. AAMI
OSHA
The non-profit organization that writes standards and technical information reports:
a. CDC
b. AORN
c. APIC
d. AAMI
AAMI