(RxWiki News) The US Food and Drug Administration (FDA) is encouraging consumers to check that their AED is FDA-approved.
AEDs (automated external defibrillators) are lifesaving portable devices designed to treat people whose hearts stop beating (cardiac arrest). After several years of work to ensure the safety of AEDs, the FDA is now recommending that consumers determine whether their devices have been approved by the FDA.
As a result of a final order from the FDA in February of 2015, all manufacturers of AED accessories must file a premarket approval application by Feb. 3, 2020. If an application is not filed by this date, the manufacturer has to stop marketing its accessories by Feb. 3, 2021.
Even before this deadline, there are already FDA-approved AEDs. And the FDA is encouraging consumers to check that their device is approved.
If it is not approved, the FDA said it’s time to start planning to purchase an FDA-approved AED.
The following AEDs have been approved:
Cardiac Science Corporation
- Powerheart G3 AED, Powerheart G3 Plus AED and Powerheart G3 PRO AED
- Powerheart G5 AED
- Lifeline/ReviveR DDU-100
- Lifeline/ReviveR AUTO DDU-120
- Lifeline/ReviveR VIEW DDU-2300
- Lifeline/ReviveR VIEW AUTO DDU-2200
- Lifeline/ReviveR ECG DDU-2450
- Lifeline/ReviveR ECG+ DDU-2475
HeartSine Technologies, LLC
- SAM 350P; SAM 360P; SAM 450P (Samaritan Public Access Automated External Defibrillator)
Philips Medical Systems
- HeartStart Home and OnSite
- HeartStart FR3
- HeartStart FRx
- LIFEPAK CR Plus Defibrillator
- LIFEPAK EXPRESS Defibrillator
- LIFEPAK CR2 Defibrillator
- LIFEPAK 15 Monitor/Defibrillator
- LIFEPAK 20 Defibrillator/Monitor and LIFEPAK 20E Defibrillator/Monitor
- LIFEPAK 1000 Defibrillator
ZOLL Medical Corporation
- AED Plus and Fully Automatic AED Plus
- X Series Defibrillator
- R Series Defibrillator
- AED Pro Defibrillator
- AED 3 BLS Defibrillator
The FDA said it will add to this list as more AEDs are approved. You can check the updated list on the FDA’s website.
If you are not sure whether your AED is FDA-approved, the FDA recommends contacting the manufacturer of your AED.
Because AEDs are lifesaving devices, the FDA recommends that you keep your unapproved AED available for use until you get an FDA-approved AED.
If you have any questions about AEDs, speak with your health care provider.
Written by Anyssa Garza, PharmD, BCMAS