Automated External Defibrillators (AEDs) - FDA

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.

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The combination of CPR and early defibrillation is effective in saving lives when used in the first few minutes following a collapse from sudden cardiac arrest.

On this page

• What Are AEDs?
• Check Your AED and AED Accessories: Are They FDA Approved?
• FDA-Approved AEDs
• FDA-Approved AED Accessories
• Important Information for AED and AED Accessory Manufacturers
• The FDA's Continued Efforts to Keep AEDs Reliable

What Are AEDs?

AEDs are a type of computerized defibrillator that automatically analyzes the heart rhythm in people who are experiencing cardiac arrest. When appropriate, it delivers an electrical shock to the heart to restore its normal rhythm. The AED system includes accessories, such as a battery and pad electrodes, that are necessary for the AED to detect and interpret a person's heart rhythm and deliver an electrical shock if one is needed. There are two main types of AEDs: public access and professional use.

• Public access AEDs can be found in airports, community centers, schools, government buildings, hospitals, and other public locations. They are intended to be used by laypeople who have received minimal training.
• Professional use AEDs are used by first responders, such as emergency medical technicians (EMTs) and paramedics, who receive additional AED training.

AEDs can be semi-automated or fully automated.

• Semi-automated defibrillators analyze the heart's rhythm, and if an abnormal heart rhythm is detected that requires a shock, then the device prompts the user to press a button to deliver a defibrillation shock.
• Fully automated defibrillators analyze the heart's rhythm and deliver a defibrillation shock if commanded by the device software without user intervention.

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

There are FDA-approved AEDs and AED accessories available, and we encourage you to ensure your AED and AED accessories are FDA-approved; if they are not, we encourage you to transition to FDA-approved AEDs and AED accessories.

If you or your organization owns an AED system, the FDA recommends you:

• Check the tables below to see if your AED system and AED accessories are FDA-approved.
  • FDA-Approved AEDs
  • FDA-Approved AED Accessories
• Contact the manufacturer of your AED or necessary AED accessories if:
  • You are not sure if your AED or AED accessories are FDA-approved or
  • They are not FDA-approved and you have not received a letter from the manufacturer.
• Select and purchase necessary AED accessories directly from authorized retailers to help ensure that you are purchasing an FDA-approved device.
• Locate the unique device identifier (UDI) on the AED or AED accessory product labels before you purchase them and consider searching the UDI in the AccessGUDID Database. The Global Unique Device Identification Database (GUDID) lists most medical devices legally sold in the U.S. from manufacturing through distribution to patient use.
• Continue to keep your AED available for use, even if it is not FDA-approved, until you obtain an FDA- approved AED, given the importance of these devices in emergency situations.
• Be aware that if your AED is not FDA-approved, compatible necessary AED accessories may no longer be available to support your AED after February 3, .
• Report problems with AEDs and AED accessories to the FDA by submitting a voluntary report online at MedWatch.

FDA-Approved AEDs

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.

Important: If your AED is not listed in this table, please contact the manufacturer of your AED for more information about your device.

Manufacturer Device Name Approval Date Premarket Database Avive Solutions, Inc. Avive Automated External Defibrillator (AED) System 10/31/ P Cardiac Science Corporation Powerheart G3 AED 12/07/ P Cardiac Science Corporation Powerheart G3 Plus AED 12/07/ P Cardiac Science Corporation Powerheart G5 AED 12/07/ P Cardiac Science Corporation Powerheart G3 PRO AED 12/06/ P Defibtech, LLC Lifeline/ReviveR DDU-100 02/01/ P Defibtech, LLC Lifeline/ReviveR AUTO DDU-120 02/01/ P Defibtech, LLC Lifeline/ReviveR VIEW DDU- 02/01/ P Defibtech, LLC Lifeline/ReviveR VIEW AUTO DDU- 02/01/ P Defibtech, LLC Lifeline/ReviveR ECG DDU- 02/01/ P Defibtech, LLC Lifeline/ReviveR ECG+ DDU- 02/01/ P HeartSine Technologies, LLC SAM 350P (Samaritan Public Access Automated External Defibrillator) 01/12/ P HeartSine Technologies, LLC SAM 360P (Samaritan Public Access Automated External Defibrillator) 01/12/ P HeartSine Technologies, LLC SAM 450P (Samaritan Public Access Automated External Defibrillator) 01/12/ P HeartSine Technologies, Ltd. samaritan 350P (SAM350P) Automated External Defibrillator 06/23/ P Philips Medical Systems HeartStart Home 06/06/ P Philips Medical Systems HeartStart OnSite 06/06/ P Philips Medical Systems HeartStart FR3 05/11/ P Philips Medical Systems HeartStart FRx 05/11/ P Physio-Control, Inc. LIFEPAK CR Plus Defibrillator 12/21/ P Physio-Control, Inc. LIFEPAK EXPRESS Defibrillator 12/21/ P Physio-Control, Inc. LIFEPAK CR2 Defibrillator 12/21/ P Physio-Control, Inc. LIFEPAK 15 Monitor/Defibrillator 07/02/ P Physio-Control, Inc. LIFEPAK 20E Defibrillator/ Monitor 07/02/ P Physio-Control, Inc. LIFEPAK Defibrillator 07/02/ P ZOLL Medical Corporation AED Plus and Fully Automatic AED Plus 05/26/ P ZOLL Medical Corporation X Series Defibrillator 12/27/ P ZOLL Medical Corporation R Series Defibrillator 12/27/ P ZOLL Medical Corporation AED Pro Defibrillator 12/27/ P ZOLL Medical Corporation AED 3 BLS Defibrillator 12/27/ P ZOLL Medical Corporation Propaq MD Defibrillator 12/27/ P ZOLL Medical Corporation AED 3 Defibrillator 02/28/ P/S001

FDA-Approved AED Accessories

The table below lists all necessary AED accessories that have received premarket approval from the FDA and the FDA-approved AED for which it is compatible. The FDA will update this table when new AED accessories are approved.

For more information about the FDA approval of these accessories, their indications for use, and related information, follow the Premarket Database links.

Important: If your AED accessory is not listed in this table, please contact the manufacturer of your accessories for more information about your device.

Manufacturer Accessory Name Compatible AEDs Approval Date Premarket Database AED Battery Exchange -ABE Cardiac Science (now ZOLL) Powerheart G3 02/02/ P AED Battery Exchange G5-ABE Cardiac Science (now ZOLL) Powerheart G5 02/02/ P AED Battery Exchange -ABE Philips HeartStart Onsite/Home (HS1), FRx 02/02/ P AED Battery Exchange FR3-ABE Philips HeartStart FR3 02/02/ P Avive Solutions, Inc. Avive Pad Cartridge Avive AED 10/31/ P Cardiac Science (now ZOLL) Intellisense Lithium Battery (Model , Model -201-TSO) Cardiac Science (now ZOLL) Powerheart G3, G3 Plus 12/07/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Adult (Model ) Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro 12/07/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Pediatric (Model ) Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro 12/07/ P Cardiac Science (now ZOLL) Intellisense Lithium Battery (ModelXBAED001A, XBTAED005A, XBTAED005A-TSO) Cardiac Science (now ZOLL) Powerheart G5 12/07/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Adult (Model XELAED001A, XELAED001B, XELAD001C) Cardiac Science (now ZOLL) Powerheart G5 12/07/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Pediatric (Model XELAD003A, XELAD003C) Cardiac Science (now ZOLL) Powerheart G5 12/07/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - ICPR Adult (Model XELAD002B, XELAED002C) Cardiac Science (now ZOLL) Powerheart G5 12/07/ P Cardiac Science (now ZOLL) Intellisense Lithium Battery (Model ) Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro 12/06/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Adult (Model ) Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro 12/06/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Adult - Polarized (Model ) Cardiac Science (now ZOLL) Powerheart G3 Pro 12/06/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Pediatric (Model ) Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro 12/06/ P Cardinal Health Kendall Adult Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 15, 20, 20E, , CR Plus, and Express 08/07/ P Cardinal Health Kendall Adult Multi-Function Defibrillation Electrodes ZOLL R Series, X Series, Propaq MD 08/07/ P Cardinal Health Medi-Trace A Cadence Adult Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 15, 20, 20E, , CR Plus, and Express 08/07/ P Cardinal Health Medi-Trace P Cadence Pediatric Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 15, 20, and 20E 08/07/ P Cardinal Health Medi-Trace PC Cadence Adult Multi-Function Defibrillation Electrodes Pre-Connect Physio-Control LIFEPAK 15, 20, 20E, , CR Plus, and Express 08/07/ P Cardinal Health Medi-Trace R Cadence Adult Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 15, 20, 20E, , CR Plus, and Express 08/07/ P Cardinal Health Medi-Trace P Cadence Pediatric Multi-Function Defibrillation Electrodes ZOLL R Series, X Series, Propaq MD 08/07/ P Cardinal Health Medi-Trace PC Cadence Adult Multi-Function Defibrillation Electrodes Pre-Connect ZOLL R Series, X Series, Propaq MD 08/07/ P Cardinal Health Medi-Trace R Cadence Adult Multi-Function Defibrillation Electrodes ZOLL R Series, X Series, Propaq MD 08/07/ P Cardinal Health Kendall P Adult Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 20 and 20E 08/07/ P Cardinal Health Kendall P Adult Multi-Function Defibrillation Electrodes Physio-Control LIFPEAK 15, 20, 20E, , CR Plus, and Express 08/07/ P Cardinal Health Kendall Adult Multi-Function Defibrillation Electrodes ZOLL R Series, X Series, Propaq MD 08/07/ P Cardinal Health QUIK-COMBO Radiotransparent Physio-Control Defibrillation Electrode Physio-Control LIFEPAK 15, 20, and 20E 08/07/ P Cardinal Health QUIK-COMBO Physio-Control Defibrillation Electrode Physio-Control LIFEPAK 15, 20, and 20E 08/07/ P Cardinal Health QUIK-COMBO Redi-Pak Preconnect Medtronic Defibrillation Electrode Physio-Control LIFEPAK 15, 20, 20E, , CR Plus, and Express 08/07/ P Cardinal Health QUIK-COMBO RTS Pediatric Defibrillation Electrode Physio-Control LIFEPAK 15, 20, and 20E 08/07/ P Conmed Adult/Child (radiotransparent) and (radiotranslucent) Physio-Control LIFEPAK 15, 20, and 20E; ZOLL R Series, X Series, Propaq MD 09/26/ P Conmed Adult/Child Model (Sterile) Physio-Control LIFEPAK 15, 20, and 20E; ZOLL R Series, X Series, Propaq MD 09/26/ P Conmed Infant Model and Mini-Infant Model Physio-Control LIFEPAK 15, 20, and 20 E; ZOLL R Series, X Series, Propaq MD 09/26/ P Conmed PadPro Multi-Function Electrode Adaptors (ZMUF, ZMMF) ZOLL R Series, X Series, Propaq MD 09/26/ P Conmed PadPro Multi-Function Electrode Adaptors (MMUF, MMZF) Physio-Control LIFEPAK 15, 20, and 20E 09/26/ P Defibtech DDP-100 Adult Defibrillation Pads Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120 06/10/ P/S005 Defibtech DDP-200P Pediatric Defibrillation Pads Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120 06/10/ P/S005 Defibtech DBP- 5 year non-rechargeable battery pack Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120 06/10/ P/S005 Defibtech DBP- 7 year non-rechargeable battery pack Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120 06/10/ P/S005 Defibtech DDP- Adult Defibrillation Pads Defibtech Lifeline/ReviveR VIEW DDU-, VIEW AUTO DDU-, ECG DDU-, ECG+ DDU- 06/10/ P/S005 Defibtech DDP- Pediatric Defibrillation Pads Defibtech Lifeline/ReviveR VIEW DDU-, VIEW AUTO DDU-, ECG DDU-, ECG+ DDU- 06/10/ P/S005 Defibtech DBP- 4 year non-rechargeable battery pack Defibtech Lifeline/ReviveR VIEW DDU-, VIEW AUTO DDU-, ECG DDU-, ECG+ DDU- 06/10/ P/S005 Defibtech DBP- 4 year non-rechargeable TSO battery pack Defibtech Lifeline/ReviveR VIEW DDU-, VIEW AUTO DDU-, ECG DDU-, ECG+ DDU- 06/10/ P/S005 HeartSine Pad-Pak-01 (Adult) HeartSine samaritan PAD 350P, 360P, and 450P 01/12/ P HeartSine Pad-Pak-02 (Pediatric) HeartSine samaritan PAD 350P, 360P, and 450P 01/12/ P HeartSine Pad-Pak-7 (Aviation/TSO) HeartSine samaritan PAD 350P, 360P, and 450P 01/12/ P Philips Primary Battery (Model MA) Philips HeartStart Onsite/Home (HS1), FRx 06/06/ P Philips SMART Pads Cartridges (Adult Model MA) Philips HeartStart Onsite/Home (HS1) 06/06/ P Philips SMART Pads Cartridges (Pediatric Model MA) Philips HeartStart Onsite/Home (HS1) 06/06/ P Philips Primary Battery (Models , ) Philips HeartStart FR3 05/11/ P Philips Rechargeable Battery (Model ) Philips HeartStart FR3 05/11/ P Philips Charger for the Rechargeable Battery (Model ) Philips HeartStart FR3 05/11/ P Philips SmartPads III (Models , ) Philips HeartStart FR3 05/11/ P Philips Pediatric Key (Model ) Philips HeartStart FR3 05/11/ P Philips Primary Battery (MA) Philips HeartStart Onsite/Home (HS1), FRx 05/11/ P Philips Aviation FRx Battery () Philips HeartStart FRx 05/11/ P Philips SMART Pads II () Philips HeartStart FRx 05/11/ P Philips Infant/Child Key () Philips HeartStart FRx 05/11/ P Physio-Control CHARGE-PAK Battery Charger Physio-Control LIFEPAK CR Plus and Express 12/21/ P Physio-Control QUICK-STEP Pacing/ECG Defibrillation Electrodes Physio-Control LIFEPAK CR2 12/21/ P Physio-Control LIFEPAK CR2 Lithium Battery Physio-Control LIFEPAK CR2 12/21/ P Physio-Control LIFEPAK Defibrillator Lithium-Ion Rechargeable Battery Physio-Control LIFEPAK 07/02/ P Physio-Control LIFEPAK Defibrillator Non-Rechargeable Battery Physio-Control LIFEPAK 07/02/ P Physio-Control LIFEPAK Lithium-ion Rechargeable Battery Physio-Control LIFEPAK 15 07/02/ P Physio-Control QUIK-COMBO Therapy Cable - Lifepak 20e Physio-Control LIFEPAK 20e 07/02/ P Physio-Control QUIK-COMBO Therapy Cable - Lifepak 15 Physio-Control LIFEPAK 15 07/02/ P Physio-Control QUIK-PAK Electrodes Physio-Control LIFEPAK CR Plus and Express 11/29/ P/S002 Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes Physio-Control LIFEPAK , CR Plus, and Express 07/08/ P/S003 (bundled) Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes Physio-Control LIFEPAK , CR Plus, and Express 07/08/ P/S015 (bundled) ZOLL CPR-D-Padz Electrode ZOLL AED Plus, AED 3 05/26/ P ZOLL CPR Stat-Padz Electrode ZOLL AED Plus, AED 3 05/26/ P ZOLL Stat-Padz II Electrode ZOLL AED Plus, AED 3 05/26/ P ZOLL Pedi-Padz II Electrode ZOLL AED Plus, AED 3 05/26/ P ZOLL AED Plus Aviation Battery Assembly ZOLL AED Plus 05/26/ P ZOLL Pro-Padz Radiotransparent Electrode ZOLL R Series, X Series 12/27/ P ZOLL SurePower Battery Pack ZOLL R Series, AED Pro 12/27/ P ZOLL SurePower II Battery Pack ZOLL X Series, Propaq MD 12/27/ P ZOLL AED Pro Non-Rechargeable Lithium Battery Pack ZOLL AED Pro 12/27/ P ZOLL AED 3 Battery Pack ZOLL AED 3, AED 3 BLS 12/27/ P ZOLL SurePower Charger ZOLL R Series, X Series, Propaq MD, AED Pro 12/27/ P ZOLL SurePower Single Bay Charger ZOLL R Series, X Series, Propaq MD, AED Pro 12/27/ P ZOLL CPR Uni-Padz electrode ZOLL AED 3, AED Plus 02/28/ P/S001 ZOLL AED 3 Battery Pack ZOLL AED 3, AED 3 BLS 02/28/ P/S001 Graphic Controls d.b.a. Nissha Medical Technologies, Vermed, Biomedical Innovations HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads Physio-Control LIFEPAK 15, 20/20e, and ; ZOLL R-Series, X-Series; Cardiac Science (now ZOLL) PowerHeart AED G3 Plus, G3 Pro 06/23/ P ZOLL Pro-padz Sterile Electrodes X Series, Propaq MD, R Series 12/20/ P/S014 ZOLL Stat-padz Electrodes X Series, Propaq MD, R Series, 12/20/ P/S014 ZOLL Stat-padz Deployment Readiness Pack Electrodes X Series, Propaq MD, R Series 12/20/ P/S014 ZOLL Pedi-padz Electrodes X Series, Propaq MD, R Series 12/20/ P/S014 ZOLL Pedi-padz II Electrodes X Series, Propaq MD, R Series, AED Pro, AED 3 BLS, AED Plus 12/20/ P/S014 ZOLL Stat-padz II Electrodes X Series, Propaq MD, R Series, AED Pro, AED 3 BLS, AED Plus 12/20/ P/S014 ZOLL OneStep CPR Cable R Series 12/20/ P/S014 ZOLL X Series/Propaq MD Multifunction Therapy Cable X Series, Propaq MD 12/20/ P/S014 ZOLL X Series OneStep Cable X Series, Propaq MD 12/20/ P/S014 ZOLL Multifunction Therapy Cable with CPR-D Connector X Series, Propaq MD 12/20/ P/S014 ZOLL OneStep CPR Complete Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep CPR Complete Adult-Child Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep Basic Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep Pacing Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep Pediatric Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep Pediatric CPR Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep CPR II Electrodes R Series 06/21/ P/S015 ZOLL OneStep CPR A/A (Anterior/Anterior) Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep CPR Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL X Series OneStep Cable X Series, Propaq MD 06/21/ P/S015 ZOLL OneStep CPR Cable R Series 06/21/ P/S015 ZOLL R Series OneStep Pacing Cable R Series 06/21/ P/S015 ZOLL X Series/Propaq MD Multifunction Therapy Cable X Series, Propaq MD 06/21/ P/S015 ZOLL Pedi-padz Liquid Gel Electrodes X Series, Propaq MD, R Series 12/19/ P/S016 ZOLL Adult Liquid Gel Electrodes X Series, Propaq MD, R Series 12/19/ P/S016 ZOLL Pro-padz Radiolucent Liquid Gel Electrodes X Series, Propaq MD, R Series 12/19/ P/S016 ZOLL Pro-padz Radiolucent Electrodes X Series, Propaq MD, R Series 12/19/ P/S016 ZOLL Pedi-padz Radiolucent Electrodes X Series, Propaq MD, R Series 12/19/ P/S016 ZOLL CPR-D-padz Electrodes X Series, Propaq MD, R Series, AED Pro, AED 3 BLS, AED Plus 12/19/ P/S016 ZOLL CPR Stat-padz Electrodes X Series, Propaq MD, R Series, AED Pro, AED 3 BLS, AED Plus 12/19/ P/S016 ZOLL CPR Dura-padz Reusable Electrodes X Series, Propaq MD, R Series, AED Pro 12/19/ P/S016 ZOLL OneStep Cable R Series 12/19/ P/S016 ZOLL OneStep Pacing Cable R Series 12/19/ P/S016 ZOLL R Series MFC (Multifunction Cable) R Series 12/19/ P/S016 ZOLL Multifunction Therapy Cable CPRD Adapter (MFC to CPRD Connector) R Series 12/19/ P/S016 ZOLL CPR Connector X Series, Propaq MD 12/19/ P/S016

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.

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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 : 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, : 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, : FDA revised its compliance policy regarding the deadline for filing a PMA for previously-cleared necessary AED accessories until February 3, . 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, : 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 : 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, , 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, : 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 : The FDA published a final order in February requiring premarket approval (PMA) applications for new and existing AEDs and necessary AED accessories.
• December : The FDA issued a Safety Communication alerting all users of the Philips HeartStart FRx, HS1 Home and HS1 OnSite AEDs manufactured between and that these devices may fail to deliver a shock in the event of an emergency.
• March : 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 : 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.

Differences between Hospital Defibrillator and Public AED

The hospital defibrillator in this context refers to a specialized manual external defibrillator (MED) used in hospitals to restore a patient's normal heart rate. It is designed for trained medical personnel to detect different heart problems and treat them appropriately, as it requires doctors to assess how much shock energy should be delivered to the patient and decide when and how often to administer the shock. This is what is defined as manual defibrillation.

A public AED, on the other hand, is an SCA rescue device that anyone can access, designed for non-medical personnel outside the hospital. Some are equipped with voice prompts, pictorial instructions, and a buzzer to indicate when the user should administer an AED shock. The AED equipment is typically wall-mounted with a special AED box and placed in public places outside hospitals, such as airports, stations, office buildings, stadiums, etc., to provide the fastest response time for out-of-hospital SCA rescue. They are fundamentally different in appearance, operation, and functionality.

• Appearance

In terms of appearance, most people think of the manual defibrillator in hospitals as two hand paddles connected by wires to a larger monitor. They are typically used in acute hospital settings, have oversized dimensions, and are stored in a crash cart. While a public AED is a portable device the size of a regular lady’s handbag and is very light in weight. A complete portable AED kit includes an AED machine, a pair of AED replacement pads, and a battery. In use, the public AED is powered by the battery without the need for socket power; thus, it is the perfect solution for out-of-hospital SCA.

• Operation

In terms of operation, a hospital defibrillator is more complicated than a public AED. Doctor has to turn on the device at first, then switch to the correct treatment mode, since most of the manual external defibrillators are designed with several treatment modes. After that, it’s time to select the proper energy level based on clinical condition, press the charge button and deliver the shock by pressing the shock button. Even in words, the whole process is not easy, especially for those people who haven’t got any professional training before. Public AED, on the other hand, is relatively foolproof to operate because essentially every public AED on the market is equipped with comprehensive automated voice prompts explaining subsequent steps. During operation, the public AED informs you how to place the pads, when to perform CPR, when to administer an AED shock and when you should back off. Moreover, public AEDs deliver AED shocks at a pre-set energy of 200 joules each time, without the need for responder tuning. These are extremely important features of a public AED because it ensures that everyone is available to help in an emergency.

For public AEDs, there are fully automatic AED and semi-automatic AED. A fully automatic external defibrillator simply requires the responder to attach the AED pads to the correct location (as for the attachment method, the AED machine will have voice guidance, and some AED brands, such as Mindray, also have detailed diagrams on the AED pads). It will automatically analyze the patient's heart rate and deliver the AED shock automatically after a shock indicator is given under the right condition. In the case of a semi-automatic external defibrillator, it is necessary for the responder to press the shock button to deliver an AED shock. 

• Functionality

In terms of functionality, a hospital defibrillator can not only deliver the shock as an AED, but also has functions that a public AED does not support, such as pacing (providing electrical pulses to stimulate the heart to contract), synchronized cardioversion and patient monitoring. 

While defibrillators used in professional medical settings rely on the understanding and knowledge of physicians to defibrillate patients promptly, the intervention of public AED devices becomes necessary in public places where SCA occurs due to the lack of obvious symptoms and guidance from professional medical personnel. However, in many areas, the survival rate of out-of-hospital SCA remains low due to the lack of public AEDs or improper use of AED devices that cause patients to miss the best time for rescue. Therefore, it is of great significance to further emphasize the importance of public AED equipment and the use of an AED device.

How to Use an AED Device?

Studies have shown that the survival rate of SCA patients increases 2.62 times when bystanders are able to effectively use public AEDs.[1] Managers of communities, office buildings, gyms, stadiums, and other places with a high incidence of SCA should take on the responsibility of popularizing the use of public AED equipment in addition to actively deploying AED devices to improve the survival rate of out-of-hospital SCA. 

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