AED Compliance Notice:
The U.S. Food and Drug Administration (FDA) notified all AED and defibrillator manufacturers, distributors, owners, users, and prescribers that effective February 3, 2022, all accessories for non-FDA approved AEDs and professional defibrillators must no longer be supported by manufacturers. A unit is non-FDA approved if the manufacturer did not file for a premarket approval application (PMA) by the revised deadline of February 3, 2022. No entity can manufacture accessories, such as pads and batteries, for non-FDA approved AEDs & defibs in the United States after February 3, 2022, effectively killing non-approved AEDs and defibrillators.
Which units does this affect?
This regulation will impact the following defibrillators and AEDs. In accordance with FDA requirements, accessories (including batteries, cables, pads, and parts) and service will be in end-of-life supply after February 3, 2022. Master Medical Equipment will continue to support these legacy units as accessory availability allows, until February 3, 2022.
- Welch Allyn AED 10
- Cardiac Science 9200
- Heartsine 300P
- Philips FR2/FR2+
- Philips Forerunner
- Physio-Control Lifepak 12
- Physio-Control Lifepak 20
- Physio-Control Lifepak 500
- Philips Heartstart XL
- Philips Heartstart MRx
- Zoll M Series Defibrillator
- Zoll E Series Defibrillator
What should you do if your AED/Defib is out of compliance?
- If your unit is no longer FDA approved, you have a few options. As an MME customer, you deserve a cost-effective solution.
If you need new pads or batteries, try to purchase them as soon as possible. Once stock runs out, there will be no more pads or batteries available to purchase anywhere, so act quickly. This will buy you time to budget for a compliant AED.
- Upgrade to a recertified AED or defibrillator that satisfies compliance regulations. Call our customer service line at 866.468.9558 and talk to an AED expert that can help you transition to the best AED for your situation, giving you the lowest cost-of-ownership over the long term. You can purchase a compliant AED for as little as $495.
- Worried about the cost? We offer easy, flexible financing through our partnership with JEM Financial. Break up payments over a period that suits your budgetary needs, with no hidden fees or out-of-pocket costs. We even offer trade-in credit after February 3, 2022.
- The sooner you contact us, the better! The longer you wait, the more scarce your accessories will be, and you run the risk of not being able to find them at all. Additionally, we will offer a higher trade-in value now than we will closer to February 3, 2022. Proper preparation will save your budget in the long run.