Proposed Order on AEDs

Automated external defibrillators (AEDs) can save the lives of individuals suffering from a cardiac arrest event. Sudden cardiac arrest can happen to anyone and at any time. According to the American Red Cross, over 350,000 people will suffer from sudden cardiac arrest this year.¹

AEDs can be found nearly anywhere; from airports, shopping malls, restaurants, and schools, to casinos, amusement parks, and movie theaters. AEDs are placed in general public areas, because they are portable, easy to operate, and are an effective method of re-establishing normal heart rhythms of a sudden cardiac arrest victim.

An AED system device consists of three main components: AED device, battery, and electrode pads.² In the case of a cardiac emergency, the AED operator turns the device on and follows the step-by-step instructions (typically a voice prompt on a screen).³ The operator applies the electrodes to the dry, bare chest of the victim; the AED analyzes the electrical output from the victim’s heart and determines if the victim is in ventricular fibrillation or ventricular tachycardia. If the medical device determines that shock is necessary, the AED will charge and indicate to the operator to press a button to deliver the charged shock.

Although AEDs save lives, there are still risks involved. Around 45,000 adverse event reports submitted to the FDA between the years 2005 and 2012 are associated with the failure of AED devices.⁴ There have also been many AED recalls by AED manufacturers. Many of the issues that are being reported involve the design and manufacture of the devices and inadequate supplier purchasing controls of the AED components.

Last month, FDA issued a proposed order that aims to improve the quality and reliability of AEDs.^4-6 If this proposed order is finalized, manufacturers will be required to submit PMA applications. Comments on the proposed order are now being accepted by the FDA and comments, either electronic or written, must be submitted by 24 June 2013.⁶ If you would like to make a comment regarding the proposed order, please visit www.regulations.gov and search for Docket No. FDA-2013-N-0234.

If finalized, how will this proposed order impact the access to AEDs? If you are a manufacturer and the proposed order is finalized, what impact will having to submit a PMA, instead of a 510(k), have on your business? How would the PMA requirement impact the price of AED devices?

Please leave your thoughts and comments!

-RSpelich ^_^

For further information, please contact:

Melissa Burns

Center for Devices and Radiological Health, Food and Drug Administration

10903 New Hampshire Ave., Bldg. 66, rm. 1646

Silver Spring, MD 20993-0002

(301) 796-5616

Melissa.Burns@fda.hhs.gov⁵

References

1.) American Red Cross. Learn About Automated External Defibrillators. Available at: http://www.redcross.org/prepare/location/workplace/easy-as-aed. Accessed on 23 April 2013.

2.) FDA. Automated External Defibrillators (AEDs). Last updated 4 April 2013. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/ucm344669.htm. Accessed on 22 April 2013.

3.) NIH and NHLBI. How to Use an Automated External Defibrillator. Available at: http://www.nhlbi.nih.gov/health/health-topics/topics/aed/howtouse.html. Accessed on 23 April 2013.

4.) FDA. FDA News Release: FDA issues proposal to improve the quality of automated external defibrillators. Last updated 22 March 2013. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345062.htm. Accessed on 22 April 2013.

5.) FDA. Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System. Federal Register 78(57);17890-5. Available at: http://www.gpo.gov/fdsys/pkg/FR-2013-03-25/html/2013-06723.htm. Accessed on 22 April 2013.

6.) FDA. Effective Dates of Requirements for Premarket Approvals: Automated External Defibrillator System. Available at: http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-0234-0001. Accessed on 23 April 2013.