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- Safe Medical Device Act
- If a medical device suspected to have caused a serious patient
injury or death, incident reportable by law within 10 days
- Purpose – initiate corrective action, prevent or minimize
occurrence of similar incidents
- “Serious Injury” (FDA Guidelines)
- Life-threatening
- Permanent impairment of body function or structure, or prolongation
of hospital stay
- Significant, persistent or permanent change, impairment, damage
or disruption in body function or structure, physical activities
or quality of life
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