Which AEDs are approved by the FDA?

Automated External Defibrillators (AEDs) are pivotal in saving lives during sudden cardiac arrests. The FDA, recognizing their significance, has laid down stringent guidelines and recommendations to ensure their efficacy and safety. Here's an overview of what you need to know:

What Are AEDs?

AEDs are portable devices designed to analyze the heart rhythm of individuals experiencing sudden cardiac arrest. They deliver an electrical shock to restore the heart's normal rhythm. There are two types: public access AEDs for laypeople and professional use AEDs for first responders.

Important Information for AED and AED Accessory Manufacturers

To ensure the quality and reliability of AEDs, the FDA requires manufacturers to obtain premarket approval for all AEDs and AED accessories.

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's Continued Efforts to Keep AEDs Reliable

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.

Given this, the FDA has taken several actions to assure that current and future AEDs and necessary accessories are safe and reliable. These actions include:

  • November 2022: The FDA sent letters to AED accessory manufacturers who did not submit a PMA for their AED accessories as required by the final order reminding them that they can no longer market their AED accessories.   
  • By February 3, 2022: Manufacturers of previously-cleared necessary accessories (such as batteries, pad electrodes, adapters) for the operation of AED systems that are FDA-approved were required to file a premarket approval application (PMA).
  • October 27, 2020: FDA revised its compliance policy regarding the deadline for filing a PMA for previously-cleared necessary AED accessories until February 3, 2022. This revised compliance policy allowed health care facilities and manufacturers to remain focused on public health needs related to the COVID-19 public health emergency, while allowing time to transition to FDA-approved AEDs.
  • By February 3, 2020: Original date manufacturers of previously-cleared necessary accessories (such as batteries, pad electrodes, adapters) for AED systems that are FDA-approved were to file a PMA.
  • April 2019: The FDA sent letters to all AED manufacturers, who did not submit a PMA for their AEDs as required by the final order, reminding them they can no longer market their AED; the letters also informed the manufactures that necessary AED accessories may not be marketed after February 3, 2020, if a PMA is not filed. Manufacturers were asked to provide a plan for these AEDs and necessary AED accessories, including a timeline for servicing and phase-out activities, a plan for communicating with their customers, and an estimate of the volume of AEDs and accessories that remain in the field.
  • November 1, 2017: The FDA and Philips Medical Systems LLC entered a consent decree of permanent injunction prohibiting Philips Medical Systems, Philips Healthcare, and those individually named from manufacturing, processing, packing, holding, or distributing AEDs from two facilities until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • February 2015: The FDA published a final order in February 2015 requiring premarket approval (PMA) applications for new and existing AEDs and necessary AED accessories.
  • December 2013: The FDA issued a Safety CommunicationExternal Link Disclaimer alerting all users of the Philips HeartStart FRx, HS1 Home and HS1 OnSite AEDs manufactured between 2005 and 2012 that these devices may fail to deliver a shock in the event of an emergency.
  • March 2013: The FDA published a proposed order to allow for notice and comment regarding the FDA's recommendation to require premarket approval (PMA) applications for AEDs and necessary AED accessories.
  • January 2011: The FDA convened a public meeting of the Circulatory System Device Panel of the Medical Devices Advisory Committee where the FDA presented its comprehensive assessment of AEDs. The panel of independent experts considered the FDA's assessment of AEDs and its recommendation that more stringent FDA oversight be applied to reduce future AED problems. The panel agreed with the FDA's recommendation to require PMA applications for AEDs.

Check Your AED and AED Accessories: Are They FDA Approved?

It's crucial to ensure that your AED and its accessories are FDA-approved for reliability and safety. Here's what you should do:

  • Verify if your AED and accessories are FDA-approved using the linked tables.
  • Contact the manufacturer for clarification if needed.
  • Purchase accessories only from authorized retailers to guarantee FDA approval.
  • Keep your AED available for use, even if not FDA-approved, until you obtain an approved one.

Source: FDA Blogpost
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