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An Automated External Defibrillator is a portable medical device that analyzes a person's heart rhythm during cardiac arrest, adnd, if necessary delivers a shock to help the heart re-establish a correct heart rhythm. All AEDs on the market today are intuitive, easy-to-use, and can save a life.
An AED device is used in combination with cardiopulmonary resuscitation (CPR) in the treatment of sudden cardiac arrest including the irregular heart rhythms caused by ventricular fibrillation. An AED defibrillator can be found in fully or semi-automatic forms and are usually purchased in combination with various AED supplies such as batteries, pads, cabinets, and signs.
The machine being used is called a defibrillator, and its use isn't limited to a hospital setting. Devices called automated external defibrillators (AEDs) can be used at home and in schools and are also found in a number of public places. These lightweight, portable devices are available without a prescription.
Deciphering AED features and deciding what device to purchase can be overwhelming. What are the most affordable AEDs? What even is an IP rating? We hope to clarify your questions, share important facts, and help you find what AED unit is right for you!
Automated external defibrillators (AEDs) are portable, life-saving devices designed to treat people experiencing sudden cardiac arrest, a medical condition in which the heart stops beating suddenly and unexpectedly.
The table below lists all AEDs that have received premarket approval from the FDA. If your AED is listed below, no matter your purchase date, the AED is considered FDA-approved. The FDA will update this table when new AEDs are approved. For descriptions of these devices, their indications for use, and related information, follow the Premarket Database links.
The FDA expects that necessary AED accessories will be labeled for use with an FDA-approved AED device (on the list above). Manufacturers submitting a premarket approval application (PMA) for necessary AED accessories should be aware that they can continue to market those accessories while the PMA is pending until the FDA issues a decision (approval, not approvable, or denial decision). After a PMA decision is made, only FDA-approved accessories can continue to be marketed.
The FDA's premarket approval of new and existing AEDs and AED accessories is based on a determination that the application contains sufficient valid scientific evidence to reasonably assure the device is safe and effective for its intended use. This regulatory pathway requires manufacturers to receive FDA approval before initiating design, manufacturing, or labeling changes to the device, and imposes certain annual reporting requirements.
Once the AEDs and AED accessories are on the market, the FDA proactively monitors their safety and reliability by reviewing the manufacturers' manufacturing and design changes, performance reports, and medical device reports (MDRs). When a company initiates a correction or removal action, the FDA posts information about the action in the public Medical Device Recall database. Once classified, the FDA monitors the recall to ensure the recall strategy has been effective.
The FDA recognizes the importance of AEDs as life-saving devices. Problems associated with AEDs include design and manufacturing issues, such as inadequate control of components purchased from suppliers or inadequate validation of manufacturing processes. When this occurs, an AED can malfunction and may contribute to patient harm or prevent the rescue of the patient.
Heartsmart is proud to be a leading provider of Automated External Defibrillators, also referred to as AEDs, AED devices and AED machines. We have an AED for sale from all manufacturers including ZOLL, Defibtech, Philips, HeartSine, Cardiac Science and Physio-Control. You can also purchase AED supplies, AED accessories, AED training, and AED program management, along with other emergency medical and CPR related products and services. Heartsmart is a top AED retailer like AED Superstore.
Sudden cardiac arrest is a serious medical emergency that requires immediate first aid from first responders. SCA is treated with a portable defibrillator known as an automated external defibrillator. The AED device provides a shock through special AED pads placed on the victim's chest. These electrode pads allow the portable AED to restore a normal heart rhythm when needed. Used with CPR, an AED defibrillator is the only way to prevent death or long-term damage from an SCA event.
Having a home AED machine in the first aid kit is becoming more common. These machines, now highly developed for use by lay rescuers, are becoming well known for treating events of sudden cardiac arrest (SCA). If you have decided to purchase a personal AED device for home use, you are making an excellent choice. This is especially true if there is a family member at risk of sudden cardiac arrest due to irregular heart rhythms, etc.
There are a number of considerations to make when choosing a home AED. Which is the best home AED unit to buy varies according to the circumstances of the particular home. Study of the AED device options available and time spent seeking advice of medical professionals, educators, and expert sales representatives is advisable. It is important to take the shopping process for the best AED seriously. Remember that having a good quality unit that functions well is what can make a life-or-death difference should a cardiac arrest occur.