fda regulations Flashcards
Pacemakers and life support equipment are examples of
a) Class I medical device
b) Class II medical device
c) Class III medical device
c) Class III medical device
What class are elastic bandages, dental floss, enemas?
a) Class I medical device
b) Class II medical device
c) Class III medical device
a) Class I medical device
What class are condoms, pregnancy testing kits, powered wheelchairs?
a) Class I medical device
b) Class II medical device
c) Class III medical device
b) Class II medical device
What class are implantable pacemakers and breast implants?
a) Class I medical device
b) Class II medical device
c) Class III medical device
c) Class III medical device
Acupuncture needles are an example of
a) Class I medical device
b) Class II medical device
c) Class III medical device
b) Class II medical device
Hypodermic needles are
a) Class I medical device
b) Class II medical device
c) Class III medical device
b) Class II medical device
A suction cup used in snake bite kit is an example of a
a) Class I medical device
b) Class II medical device
c) Class III medical device
b) Class II medical device
For any of the Class III medical devices the acupuncturist should
a) document supportive evidence for use; not advertise claims to the public; get signed consent from pt that device is not cleared by the FDA
b) do not advertise claims to the public; get signed consent from pt that device is not cleared by the FDA
a) document supportive evidence for use; not advertise claims to the public; get signed consent from pt that device is not cleared by the FDA
The FDA classifies cupping as a
a) unclassified device
b) class III device
b) class III device
To disinfect a blood contaminated cup one can use
a) endospore
b) isopropyl alcohol
a) endospore
If one wants to use cupping to draw blood, what is the amount of blood to be drawn in to a cup?
a) not more than a teaspoon
b) not more than 10 ml
a) not more than a teaspoon
When cupping an area over an inserted needle, it is best to use a cup the size of
a) 30 mm at the base
b) 40 mm at the base
b) 40 mm at the base
If you plan to both needle and cup an area, which would be the most risk free procedure?
a) needle first and cup afterwards
b) cup first and then needle afterwards
b) cup first and then needle afterwards
True or False
For adults 911 should be called after initiating cpr
False
For adults you call 911 first
A needle is stuck and cannot be removed. What should you do?
a) puncture another nearby point to relax the muscle
b) use cupping over the needle
a) puncture another nearby point to relax the muscle
