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| T01-21 | Print Media: 301-827-6242 |
| May 4, 2001 | Consumer Inquiries: 888-INFO-FDA |
FDA has cleared for marketing the first automatic external defibrillator system for use on infants and young children who experience cardiac arrest.
AEDs are life saving devices used when the heart is beating irregularly and ineffectively (fibrillating) and the patient will die without treatment. The AED administers an external electric shock through the chest wall to the heart via conductive adhesive pads in an effort to restore normal heart rhythm.
The AEDs currently marketed are restricted to use on adults and children over eight years of age. The new device, made by Agilent Technologies, Inc., of Palo Alto, Calif., can be used on infants and children up to age eight and/or weighing up to 55 lbs.
Agilent's AED was previously cleared by FDA for use on adult and adolescents and has been used thousands of times to save lives. The new version can be equipped with specially designed pediatric defibrillation pads in order to deliver less electrical shock.
Standard AEDs deliver 150 joules of energy to the patient; the new product, when equipped with the pediatric pads, delivers 50 joules of energy.
FDA cleared the device for young children based on laboratory and animal testing performed by Agilent and on reports in medical literature which showed successful use of AEDs on both adults and young children.
The firm will conduct a follow-up study of up to 50 children worldwide to evaluate how well the device performs in actual use.
AEDs are prescription devices and are intended for use by or under the supervision of a physician or by other trained and certified persons.
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Web page created by jch 2001-MAY-04.