Check your AED: Is it FDA approved? 

Annually, more than 356,000 Americans suffer an out-of-hospital cardiac arrest. The key to survival is immediate cardiopulmonary resuscitation (CPR) and defibrillation from an AED. To ensure that AEDs are safe and effective, the U.S. Food and Drug Administration (FDA) recently added more stringent regulations for manufacturers. All AEDs and accessories must now undergo rigorous evaluation and obtain FDA approval in order to be sold in the U.S. In addition, manufacturers are not allowed to sell accessories for non-FDA approved AEDs, which will essentially make these devices obsolete. Continue reading to check if your AED is on the FDA-approved list. 

Are Your Facility's Defibrillators FDA Approved?

The table below lists all AEDs that have received approval from the FDA. If your AED is listed below, no matter your purchase date, the AED is considered FDA-approved. 

DF028345-SA | Cardiac Science Powerheart G5 AED ✅

DF028343-SA | Cardiac Science Powerheart G3 AED ✅

DF152055 | Defibtech Lifeline VIEW AED ✅

DF029701 | Defibtech Lifeline AED ✅

DF152051 | HeartSine Samaritan 350P ✅

DF152066 | HeartSine Samaritan 450P ✅

EM090142 | HeartSine AED 350P Bundle ✅

EM090139 | HeartSine On the Go AED 450P Bundle ✅

DF026203 | Philips HeartStart FRx AED ✅

EM049904 | Philips FRx Responder Bundle ✅

DF152069 | Philips HeartStart Onsite AED ✅

EM049905 | Philips HeartStart Onsite Responder Bundle✅

EM090141 | Philips HeartStart OnSite AED Bundle ✅

DF026201 | Philips HeartStart Onsite AED M5066A ✅

DF026301 | Physio-Control LIFEPAK CR Plus AED ✅

DF152062 | Physio-Control LIFEPAK CR2 AED ✅

DF152067 | Physio-Control LIFEPAK 1000 AED Graphic ✅

DF152068 | Physio-Control LIFEPAK 1000 AED ECG ✅

DF152052 | ZOLL AED 3 ✅

DF028302 | ZOLL AED Plus semi-automatic ✅

DF152079 | ZOLL AED Plus automatic ✅

EM090143 | ZOLL AED Plus Bundle ✅

EM090140 | ZOLL AED Plus Outdoor Bundle ✅

What if my AED is not FDA approved? 

If your AED has not received approval from the FDA, no batteries, pad electrodes, adapters, or other accessories will be manufactured for it after February 2022. Since this deadline has already elapsed, critical parts for your unit might already be gone from the market, with no way to resupply. For that reason, DiaMedical USA advises their customers to make plans to replace their AEDs as soon as budgets permit. In the meantime, these AEDs should not be removed from service until they are replaced with FDA-approved devices. 

Key takeaway

Your AED is one of the most important safety tools in your facility. In a cardiac emergency, it could save a life - but only if it performs as intended. A wide variety of FDA-approved AEDs are available and it can be difficult to decide which one is best suited for your facility. The DiaMedical USA team is ready to help customers balance cost and functionality in order to find the right crash cart to meet their needs. For more information, reach out to a DiaMedical USA expert at 877-593-6011 or info@diamedicalusa.com.