CER Chapter 14 Review Quiz Flashcards

Regulations, Standards and Resources

1
Q

Endoscopes should only be reprocessed using equipment that has been approved by the:
a. OSHA
b. CDC
c. US FDA
d. AAMI

A

US Food and Drug Administration

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2
Q

The document “Essential Elements of a Reprocessing Program for Flexible Endoscopes” was published by:
a. US FDA
b. US EPA
c. CDC
d. ECRI

A

Centers for Disease Control and Prevention

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3
Q

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

A

Minimum levels of quality and safety

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4
Q

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

A

Recall

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5
Q

This agency requires manufacturers to provide IFU’s with each product:
a. OSHA
b. AAMI
c. FDA
d. AORN

A

FDA

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6
Q

This regulatory department issues registration numbers for disinfectants:
a. US FDA
b. US EPA
c. APIC
d. AAMI

A

US Environmental Protection Agency

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7
Q

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

A

Best practice

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8
Q

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

A

The most stringent regulation

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9
Q

The agency responsible for the bloodborne pathogen standard:
a. OSHA
b. CDC
c. APIC
d. AAMI

A

OSHA

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10
Q

The non-profit organization that writes standards and technical information reports:
a. CDC
b. AORN
c. APIC
d. AAMI

A

AAMI

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