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Automated External Defibrillators (AEDs)

Automated External Defibrillators (AEDs)

On 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 automatic external defibrillators (AEDs) from two facilities until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act). More information in the FDA Press Release.

An automated external defibrillator (AED) is a device that automatically analyzes the heart rhythm in victims of cardiac arrest, and delivers an electrical shock to the heart to restore its normal rhythm. AEDs are important tools in providing a rapid response to victims of cardiac arrest.

An AED system consists of an AED device, battery, pad electrode, and if applicable, an adapter.

AEDs are found in airports, community centers, schools, government buildings, and other public locations. These devices are intended for use by the general public.

AEDs can save lives – but the devices have been associated with manufacturing problems and many devices have been recalled.

The FDA issued a Final Order: Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems; Republication on February 3, 2015, which represents a tailored approach to help manufacturers assure the quality and reliability of AEDs. AEDs can be highly effective in saving the lives of people suffering cardiac arrest when used in the first few minutes following collapse from cardiac arrest. To help to assure the quality and reliability of AEDs, the FDA is requiring manufacturers to obtain premarket approval for all future and currently-marketed AEDs and necessary AED accessories (e.g., pad electrodes, batteries, adapters and hardware keys for pediatric use).

The PMA process allows the FDA to review quality systems and manufacturing information; conduct pre-approval inspections; review changes in manufacturing facilities where devices are made; and review design and manufacturing changes that affect safety and effectiveness to ensure that the changes are adequately evaluated and tested prior to implementation. We believe these actions will help address the problems that have been of concern for AEDs.

Given the importance of these devices in emergency situations, AEDs currently on the market will remain available while manufacturers work to meet the new PMA requirements. See Press Release: FDA takes steps to improve reliability of automated external defibrillators for more information.

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