US Food and Drug Administration recently issued a proposed order
aimed at helping manufacturers improve the quality and reliability of automated
external defibrillators (AEDs). The proposed order, if finalized, will require
manufacturers of AEDs to submit premarket approval (PMA) applications that contain clinical data to support the product's
these devices have saved lives over the years, the FDA has received
approximately 45,000 adverse event reports between 2005 and 2012 associated
with the failure of AEDs. Manufacturers also have conducted dozens of recalls.
FDA says the problems it is seeing are "preventable and correctable."
The most common issues involve the design and manufacture of the devices and
inadequate control of components purchased from other suppliers.
addition to the clinical safety and effectiveness data, a PMA must also include
a review of a manufacturer's quality systems information and an inspection of
its manufacturing facilities. After approval, manufacturers must submit to the
FDA any significant manufacturing changes made to the devices and annual
reports of the device’s performance.
For information on APTA's position on
cardiopulmonary resuscitation certification and use of AEDs, and acquiring an
AED for a physical therapy practice, click here.
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