Page 20 - 2020 ARE eGuide for Nonclinical at Bethesda
P. 20
Safe Medical Device Act
The Safe Medical Device Act requires reporting of incidents involving
medical devices or equipment within 10 days to the manufacturer
and/or the FDA.
Examples of devices are: entity beds, heart valves, catheters,
ventilators, restraints, X-Ray machines, and defibrillators.
Incidents to be reported include:
• Device failure
• Improper use of device
• Injury or harm involving a device
• Additional medical or surgical intervention is required
• Death
