Automated external defibrillators are among the most advanced medical equipment available on the consumer market, so you may be wondering: Can anyone buy an AED? Or are they for medical personnel only?
These life-saving devices are legal for most individuals and organizations to possess—as long as the device is managed and purchased in accordance with the law. With that in mind, you will usually need:
- A physician’s prescription for your AED device
- Medical oversight and direction
- AED registration through your state or jurisdiction
- Ongoing AED maintenance in accordance with state and federal law
It sounds like a lot, but once you break it down, it’s less complicated than it seems.
An AED Unit Requires a Prescription
AED units must be sold and operated according to strict FDA guidelines because a defibrillator is a medical device. On the consumer end, this means you will need a physician’s prescription[mfn]fda.gov[/mfn] before you buy one. If you own multiple AED devices, every device must have its own prescription. The only exception is the Philips Heartstart OnSite AED. It’s currently the only AED machine that is available for personal use without a prescription, though use within an organization, or outside of ‘personal’ use (usually considered within a private home) still requires a prescription.
An AED prescription isn’t like a drug prescription. Whereas a drug prescription requires a pre-existing condition, an AED prescription isn’t intended to weed out ineligible users but rather to ensure that the device is properly labeled and responsibly maintained.
You don’t need a pre-existing condition to obtain an AED prescription because sudden cardiac arrest can happen to anyone. Every home, business, and facility can benefit from having at least one automated external defibrillator and the corresponding AED supplies.
To obtain a prescription, you must speak with a licensed physician and identify the specific model you intend to purchase. Your physician should hopefully be able to help you in providing the prescription, which you’ll want to keep for your records. These days, several of the AED manufacturers also include an initial prescription shipped along with your AED, though this prescription does not meet the requirement for continued physician or medical oversight, as required in most states.
Which AEDs Are Subject to FDA Guidelines?
There are currently six FDA-approved AED brands:
- Cardiac Defibrillators (formerly Cardiac Science), owned by ZOLL
- Defibtech
- HeartSine (owned by Stryker)
- Philips
- Physio-Control (owned by Stryker)
- ZOLL
Devices produced by these manufacturers have undergone the FDA’s stringent premarket approval process and are subject to the regulations and guidelines set forth by the Federal Drug Administration.
Do not purchase any defibrillation device that hasn’t been approved by the FDA. If you use such a device, and its operation results in injury or death, you likely won’t be protected by Good Samaritan laws. You may even face criminal prosecution. Always stick with the approved brands.
An AED Requires Medical Oversight and Direction
Ongoing physician oversight is required[mfn]cpr.heart.org[/mfn] for all AEDs in most states (view our summary of AED regulations by state). This is to ensure quality control and optimal maintenance, and it’s required for any device used by a layperson for medical treatment.
Once you have your prescription, your physician’s job is to help you implement an AED program. They will work with you to establish protocols and quality-control measures to keep you in compliance with the FDA.
For example, the physician may oversee or facilitate training in CPR and AED best practices in addition to helping you establish the installation location and maintenance procedures. The physician is also responsible for collecting and reviewing any data compiled when the AED is used—such as EKG readings.
The precise medical oversight requirements can vary from state to state. For example, some states require regular AED inspections while others only require a prescription. Your prescribing physician should notify you of all applicable laws where you live.
An AED Must Be Registered
Again, this is a requirement that varies depending on the state and jurisdiction, but it should always be a priority regardless of the law—especially if you’re maintaining the AED on behalf of a business or public facility.
Registering your device provides local law enforcement and emergency personnel with valuable information in the event of an emergency. For example, suppose someone in your vicinity calls 9-1-1 to report a cardiac arrest. In that case, the operator can immediately determine where your AED is located and then direct the caller to your location to retrieve the lifesaving device—but only if your device is registered.
There is no single organization or database for AED registration. There are many AED registration programs available, and local municipalities often have their own AED registration requirements. So you will need to do a bit of research to determine what’s required in your area.
You Must Maintain Your AED
This goes hand-in-hand with the registration requirement. When you register your AED, you should receive notifications when it’s time to replace the pads and batteries. You will also receive notifications about any product recalls or warranty expirations.
As the AED owner, you are required to keep track of all expiration dates and ensure that the device is always up-to-date and emergency-ready. That means that any alerts or errors on the device must be addressed immediately and that pads and batteries must always be current. Failure to properly maintain the device may render you vulnerable to legal liability if an emergency occurs and the AED is unsafe or unavailable.
Stay in Compliance With AED Program Management
If this sounds like a lot of complicated information (and a lot of work), there is an easier way: AED program management. You should never try to keep track of all compliance requirements on your own. When you sign up for an AED program, everything is handled by experts. You get:
- The AED prescription
- The AED registration
- The physician oversight
- Expiration alerts and reminders
- Replacement parts and components as needed
- AED tracking
- Post-emergency assistance
- Ongoing customer support
When investing in a new AED, the first thing you should do is sign up for program management with a service like AED Total Solution. All your needs will be covered, so you won’t have to worry about all the details.
Yes, You Can Buy an AED
So can anyone buy an AED? The short answer is yes. As long as you’re diligent about remaining in compliance with the law, you’re free to own and maintain an AED. It doesn’t matter what your training or background happens to be.
To be as prepared as possible, it’s essential to maintain your AED properly, place it in a visible and easily accessible location, and brush up on cardiopulmonary resuscitation. You might just save a life!
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