FDA launches program to develop new AEDs
November 15th, 2010
05:26 PM ET

FDA launches program to develop new AEDs

The Food and Drug Administration wants to strengthen automated external defibrillators, or AEDs.  They are the lifesaving devices used to treat sudden cardiac arrest. The FDA plan, dubbed the "External Defibrillator Improvement Initiative", aims to improve the safety and effectiveness of AEDs currently available and to work with manufacturers to create newer models that are more effective.

"There have been more than 28,000 adverse event reports [associated with AEDs]," says Dr. Jeffrey Shuren, Director of the FDA's Center for Devices and Radiological Health. There also have been more than 700 deaths, although Shuren cautions that it's difficult to link cause of death to external defibrillators because the patients being treated with them are already extremely ill.

 In addition, there have been dozens of recalls of AEDs according to the FDA. Unlike other medical devices, the issues being identified in external defibrillators span across all types of the device, from all manufacturers. That's why the first step of the FDA's three-step initiative calls on all manufacturers of AEDs to innovate better devices.

The plans also calls on the FDA to identify flaws in the models currently on the market. One shortcoming the FDA has already identified is that in one AED model, a button needs to be pushed in order to give a person an electric charge. But that button has a cover over it that sometimes prevents it from being pushed and thus, the charge from ever being delivered. The FDA hopes issues like this can be done away with in future models.

"By working together [with manufacturers], we hope to propel the next generation of these devices to work safely and effectively," says Dr. Shuren.

Despite this initiative, the FDA says people should not stop using external defibrillators when they're needed.

"We consider these to be life-saving technologies and we're not taking any of them off the market," says Dr. Shuren. "But we think they can be improved."

soundoff (13 Responses)
  1. DumbestStoriesOf2010

    1)Debt is the new slavery
    2)Soledad's battle against a photographer who asked if she was black
    3)Elliot Spitzer .....becoming the moral compass of CNN...The new 8 p.m.
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    November 15, 2010 at 20:02 | Report abuse | Reply
    • AC360

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      November 15, 2010 at 20:13 | Report abuse |
    • CnnReally

      Soledad and the race card with Jesse Jackson...Poor poor Soledad she has overcome so much!!!!...I thought it was a punked/pranked episode...I thought she was a decent reporter and anchor on Msnbc ...Now all the people who worked with her in her past are not saying complimentary things about her work ethic.....Soledad is running out of stations!!

      November 16, 2010 at 18:22 | Report abuse |
  2. andrew

    Great Article. My company, In Case Of Emergency, has put together a new HeartSafe AED Product package that comes with a HeartSine AED, alarmed wall storage cabinet, 3D AED wall sign, first aid kit, first aid/cpr/aed training for up to 12 people, and a 2 year AED management program all for the price of $1,895.00. There are also some other smaller accessories included in the package. Also check out the local Delaware County PA school AED video contest we have put together that kicks off January 1st, 2011. Check out our website http://www.iceems.com for the package info or give us a call!

    November 17, 2010 at 13:19 | Report abuse | Reply
    • MJ

      Your self-promotion is pathetic and this is NOT a "Great Article"; this is a stupid article. The statement: "There also have been more than 700 deaths, although Shuren cautions that it's difficult to link cause of death to external defibrillators because the patients being treated with them are already extremely ill". Holy Christ, not only are these patients "extremely ill already', they're EXTREMELY DEAD, and without an AED they will remain extremely dead.

      The U.S. FDA shirked their responsibility years ago by not doing a more thorough and thoughtful job when considering the 510(K) substantial equivalence applications of companies throwing crappy AEDs on the market for the sole purpose of cashing in on what has become a commodity market in the medical industry. It is now standard operating procedure to require AEDS in pulbic places (schools, airports, arenas, casinos, etc), and a lot of cheap junk has gone out there at equally cheap prices because no one wants to pay for better quality devices from more consciencious companies. And now the FDA is going to step in as some kind of authortiy when frankly they couldn't collectively box their way out of a paper bag when it comes to anything regarding technology. This is rich!

      I've spent 30 years in this part of the medical business and I can assure that when the FDA says they're here to help, run, run fast and far away!

      November 17, 2010 at 20:02 | Report abuse |
  3. Joy

    Hi Dr.Gupta, Do these new body scanners at airports that use low frequency radio waves affect the human body physiologically? Can that radiation cause skin cancer or sterility or impact human DNA adversely? I fly through airports every week and I am concerned about physiological damage if I go through these body scanners.
    Thank you for your counsel in advance.

    November 21, 2010 at 07:46 | Report abuse | Reply
  4. Cece and Mark

    Pertinent to this article is the following quote:
    "Never talk when you can nod. And never nod when you can wink. And never write email because its death. You’re giving prosecutors all the evidence we need." -Elliot Spitzer, February 2006
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    November 23, 2010 at 09:01 | Report abuse | Reply
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    November 29, 2010 at 10:07 | Report abuse | Reply
  6. Dinak

    All the media is ignoring the life-altering news about a Harvard-based experiment that replenished enzymes in rat cells that protect the cells' DNA. After doing that, rats that were "old" began to rejuvenate; brain capacity that was 75% returned to normal, grey hair started growing in dark again, and other remarkable fountain-of-youth-type physical responses occurred. This is the biggest news in medicine since the discovery of antibiotics. And NOTHING from the media on it. It's because embryonic stem cells are not the cause of this breakthrough, that's why. Also, the gov't may not want us hanging around healthier, as it would affect the population. I say there's still plenty of land for everyone, and death will still come, we'll just suffer less from the effects of aging.

    December 1, 2010 at 21:29 | Report abuse | Reply
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    December 2, 2010 at 10:40 | Report abuse | Reply
  8. Greg

    If you have private insurance, it is CRUCIAL that you switch to one of the new plans made available after September 23, 2010 because they include free preventative care (like flu shots), they have no annual or lifetime maximums, and kids don't have to go through underwriting and must be accepted up to age 26 regardless of pre-existing conditions. If you bought your health insurance before September 23, you can get a free quote at usabg.net/ghovey/quote

    December 7, 2010 at 08:08 | Report abuse | Reply
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  10. Jeffrey Knaak

    I’m amazed, I must say. Seldom do I encounter a blog that’s both equally educative and amusing, and let me tell you, you've hit the nail on the head. The problem is something that not enough folks are speaking intelligently about. I'm very happy I found this in my search for something relating to this.


    April 1, 2021 at 05:00 | Report abuse | Reply

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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.

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