- Choosing an FDA-approved AED is crucial because it ensures the device meets strict safety, effectiveness, and quality standards.
- The FDA evaluates AEDs through a rigorous premarket review, monitors device performance, and investigates failures.
- Non-approved devices have been linked to malfunctions, injuries, and even deaths, prompting recalls.
- Using an FDA-approved AED reduces the risk of failure during a cardiac emergency, giving users greater confidence that the device will work properly when it’s needed most.
