FDA Proposes Efforts to Improve Automated External Defibrillators’ Safety

Although automated external defibrillators (AEDs) can save someone’s life when they are experiencing cardiac arrhythmia, AEDs have also been linked to significant rates of failure. From 2005 to 2012, the FDA has received about 45,000 reports of adverse events associated with failures of these medical devices.

According to a 2011 study published in the Annals of Emergency Medicine, about 23 percent of AED failures may be caused by problems with power or the batteries. Meanwhile, about 45 percent of AED failures happened while the device was attempting to charge and deliver the shock. In about 24 percent of the cases, pads and connectors were the issue.

Now the Food and Drug Administration (FDA) has proposed that the manufacturers of these devices be required to undergo a review process that carefully monitors the design and manufacturing of AEDs. Makers would need to submit a pre-market approval (PMA) application.

The PMA will need to include: 

  • clinical data that supports approval of device;
  • inspection of the manufacturing facility; and
  • review of manufacturer’s’ qualify systems info.

Filing a Defective Product Claim Stemming from Injuries Caused By a Medical Device

In order to file a claim against a manufacturer, there are some elements that must be established. First is proving the device was defective. One of the best pieces of evidence would be the product itself.

Of course, the source of the defect must also be determined. It could have been designed correctly but manufactured incorrectly and vice versa. Or it could be that both the design and the manufacturing of the device were flawed.

Another element is proving that as a result of the defect, serious or fatal injuries were sustained.

Establishing evidence for a defective product claim helps in determining who can be held liable when filing for damages, which means that more than one party could potentially be named. These types of cases can be complex and victims or their families may consult an attorney for legal help. The law firm of Gacovino, Lake & Associates can help clients with defective product claims involving medical equipment.

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