FDA Approved AEDs
FDA Approved AEDs
The Food and Drug Administration or FDA is responsible for the protection of public health by passing a certification of safety, efficiency and security of both human and veterinary drugs, biological products and medical devices.
The FDA is also responsible for helping to advance public health by assisting in the innovation of beneficial medical products. Their contribution helps to make this a speedier process, whilst still ensuring the newly developed products are safer and affordable to give the public the most effective health solutions possible and the scientific information to increase awareness and ability to use the products.
What is FDA approval?
When a particular product is “approved” by the FDA, this marks the pass in the premarket approval (or PMA) application of a particular product which has been submitted to the FDA.
To receive approval of a device through a PMA application, the applicant in question must provide reasonable assurance of the device’s safety and effectiveness which is then challenged by the FDA before being approved.
Why choose FDA?
Whilst all AEDs can be used to increase chances of survival and even save a life in the event of a cardiac arrest, FDA approved devices provide that extra piece of mind that the specific unit being used has undergone vigorous and substantial testing to ensure that that particular piece of equipment operates just as it should and provides the most effective care possible.
Many manufacturers perform their own tests on products, but not all defibrillators will undergo the same premarket approval as FDA approved devices and there is no guarantee or stamp of certification if testing has taken place with non-FDA approved products.
Does FDA approved mean better?
In the event of a cardiac arrest, no one can be sure of the outcome. The only chance of survival a victim has is the actions of bystanders which must include effective CPR and the shock from a defibrillator. The chances of a particular AED saving the life of a casualty in comparison of another device would be impossible to determine, an FDA approval simply guarantees the ability of certain products and ensures the effectiveness of its life-saving functions.
So, should you choose FDA approved? The choice is entirely up to you. FDA approval does not affect price or promise, just extra confidence in the effectiveness and ability in a particular device should it need to be used in an emergency.
If you have any questions regarding our FDA approved products, or would like to learn more about what this means, you can call our friendly and knowledgeable defibshop team on 0845 071 0830 who will be happy to assist you in any way they can.