What is Pre-Market Approval for AED’s?
Pre-Market Approval for AED’s is something that has been in the works since 2015. The FDA wanted to be more stringent on AED reliability and make sure that manufacturers were keeping up with their AEDs while assuring quality. Medical equipment, and AED’s need to go through rigorous testing before being put on the market. Because of this, the FDA came up with PMA- Pre-Market Approval- and manufacturers of the AEDs and AED accessories are required to submit a PMA application for their product.
Pre Market Approval Application Process:
The Pre-Market Approval process has several steps involved in it. There are certain AED units where manufacturers decided it was not worth their time to go through all the requirements by the FDA. These manufacturer’s never submitted a PMA application for their AED device that was sold prior to this requirement. Because of this, you may have an AED that is not PMA approved or never received a PMA.
Having an AED without PMA, does not inhibit you from using your AED, however it means that if you try to purchase another one it will no longer be available on the market. This includes the accessories as well: pads and batteries. Because pads and batteries usually have no more than a two to three year shelf life, you are going to be forced to have to find a new AED unit altogether.
It is possible to still find some AED’s and accessories without PMA for sale. Distributors are still able to sell what they have already purchased but can not purchase more. So, if you’re lucky enough to find what you need- that’s great. However, once the products are gone, they are gone. This may force you to upgrade your device. You can find a cost comparison chart of all AED’s with PMA and their accessories here.
How Will I Know If My AED is approved or not?
There’s a whole list of AEDs that you can find online of approved ones and you can find unapproved lists as well. Some of the more common AED units that are on the unapproved list are going to be the Lifepak 500, the Welch-Allen 10 and
20 series, the Phillips FR2 and the HeartSine 300, as well as some old Cardiac Science units as well. Pay attention to the series numbers behind the unit because most manufacturers have come out with new units that have the same name but a different series number.
If you think you might not have a PMA approved AED, you should go ahead and check and be aware if you may have to purchase a new unit in the next six months to a year. This will help you start planning and saving towards that. AED Source offers some really affordable options as well as financing.
The Heartsine Samaritan PAD 350 is one of the most popular on the market recently. It is very compact and ideal for schools, churches, or people who may be traveling with an AED. The next most popular AED with Pre Market Approval is the ZOLL AED Plus. You’ve probably seen this one at your local gym, airport, or community center. They are large and very visible. The Zoll tends to be a fan favorite with it’s bells and whistles!
Watch this video to learn more about PMA:
https://www.youtube.com/watch?v=8cP0W1N7jgY
