AED Laws and Regulations

What is a AED?

Automated external defibrillators (AEDs) are devices used to deliver electric shocks to the heart to restore its normal rhythm in case of sudden cardiac arrest. AEDs are becoming more widely available in public places such as schools, airports, and sports venues, but there are laws and regulations in place to ensure that they are used effectively and safely.

Here are some key things to know about AED laws and regulations:

  • There is no federal law that requires AEDs to be placed in public spaces, but many states have passed AED laws.
  • AED laws in the U.S. typically require certain types of public spaces, such as schools, gyms, and airports, to have AEDs and trained personnel available in case of cardiac emergencies.
  • The specific requirements for AED placement and training vary by state, so it's important to check the laws in your area.
  • Many states offer legal protection for those who use AEDs in good faith to save a life. This means that if you use an AED to help someone in cardiac arrest, you are protected from liability as long as you acted in good faith and within the scope of your training.
  • Some states require AEDs to be registered with the state or local EMS authority.
  • AEDs must be maintained and tested regularly to ensure that they are functioning properly.
  • The FDA regulates AEDs as medical devices and sets standards for their safety and effectiveness.
  • The American Heart Association provides guidelines for AED use and training, which many states use as a basis for their own AED laws and regulations.

FDA Regulations

  • AEDs must be labeled and advertised for use in emergency treatment of victims of sudden cardiac arrest.
  • AEDs must meet performance standards set by the FDA, which include accuracy of rhythm analysis, energy output, and shock delivery time.
  • AED manufacturers must submit their devices to the FDA for review and approval before they can be sold in the United States. This process includes clinical testing to demonstrate the safety and effectiveness of the device.
  • AED manufacturers must comply with FDA regulations for labeling and post-market surveillance. This includes providing instructions for use and warnings about potential risks, as well as monitoring and reporting any adverse events or malfunctions.

AED laws and regulations are important to ensure that these lifesaving devices are used effectively and safely. If you're interested in purchasing an AED for your business or organization, it's important to familiarize yourself with the laws and regulations in your area to ensure that you're in compliance. With the proper training and equipment, AEDs can make a big difference in the survival rate of cardiac arrest victims.