Adverse Reactiond Flashcards
1
Q
Expectations of dental materials?
A
Easy to use
Biocompatible
Safe
Cost-effective
2
Q
What does safe mean regarding biocompatible material?
A
Doesn’t irritate surrounding structures
Doesn’t promote inflammatory response
Don’t incite allergic reaction
Doesn’t cause cancer
3
Q
How can adverse reactions be reported?
A
UK ARPP
adverse reaction reporting project
4
Q
How is risk of dental materials reduced?
A
Pre-market testing: in vitro, in vivo, clinical trials
CE mark
Post-market surveillance
5
Q
What does award of CE mark mean?
A
Enables goods to be sold throughout EEA (European economic area) - given as result risk management exercise
6
Q
Does CE mark mean 100% safe?
A
No, no amount experimental study can guarantee absolute safety
