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
- 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 Requires a Prescription
AEDs must be sold and operated according to strict FDA guidelines. On the consumer end, this means you will need a physician’s prescription before you buy. If you own multiple AEDs, every device must have its own prescription. The only exception is the Philips Heartstart OnSite AED, currently the only AED 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 cardiac arrest can happen to anyone. Every home, business, and facility can benefit from having at least one automated external defibrillator.
To obtain a prescription, all you have to do is 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 Science (owned by ZOLL)
- Defibtech
- HeartSine (owned by Stryker, formerly Medtronic)
- Philips
- Physio Control (owned by Stryker, formerly Medtronic)
- 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 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 for all AEDs in most States. Click here to see a quick summary of the legal requirements for each 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 the policies and quality control measures that 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 optimal location and maintenance procedures. The physician is also responsible for collecting and reviewing any data that’s 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.
Regardless of whether or not your state requires in-person oversight, the American Heart Association recommends that you always have a physician present when purchasing and placing a defibrillator.
An AED Must Be Registered
Your defibrillator must be registered. This requirement 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, if someone in your vicinity calls 9-1-1 to report a cardiac arrest, 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. You’ll need to do a bit of research to determine what’s required in your area.
You Must Maintain Your AED in Accordance With Local and Federal Law
This goes hand-in-hand with the registration requirement. When you register your AED, you should receive notifications when it’s time to replace your pads and batteries. You’ll also receive notifications about any product recalls or warranty expiration.
As the AED owner, you are required to keep track of all expiration dates and ensure that the device is always 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.
Compliance Is Easy 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
After buying a new AED, the next step you should take 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 the details.
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 no matter what your training or background happens to be.