FDA Increases Regulations on Defibrillators as Recalls and Malfunctions Mount

Dangerous device lawyers at Pintas & Mullins Law Firm report that the FDA recently proposed new requirements for automated external defibrillators (AEDs) manufacturers, which will include increased premarket approval requirements. This action is the result of the numerous AED malfunctions and recalls in recent years, which the FDA says proves that the current rules are unsuccessful.

AEDs are portable devices that are often seen in offices, schools, and shopping malls, and are always carried by emergency response crews. They are used to shock hearts back into rhythm that have experienced a sudden cardiac arrest, and are made by companies like Royal Philips Electronics NV, which is based in Amsterdam.

Between 2005 and 2012, reports of AEDs malfunctioning numbered about 45,000 and 88 different products were recalled. The chief scientist of the FDA’s Center for Devices and Radiological Health stated that the agency does not have confidence in the AEDs currently on market.

Sudden cardiac arrest stops the human heart completely, and typically causes death within just a few minutes, before emergency response teams can arrive at the scene. In the U.S. alone there are about 300,000 sudden cardiac deaths each year.

Once the new FDA regulations are made final, manufacturers will be required to complete pre-market applications and submit clinical data with the findings of the risks of illness or injury. If a premarket approval is not filed for an AED within 90 days after the final order, the device will be deemed defective, and may not be placed into distribution. However, because AEDs are so widespread and critical to saving lives, the FDA proposed that the devices may be accepted as long as the manufacturer notifies the agency within 90 days saying it intends to file a premarket approval. The FDA will wait 15 months after the final order to exercise enforcement.

The FDA believes that most AED distributors already have enough clinical data to support a premarket approval, and it is not expecting any AED shortages throughout the country. The new requirements will become official at the end of 2014, and manufacturers will be required to pay more than $245,000 per application for the FDA to review before it can be placed back on the market.

In 2012, many AEDs were recalled because they contained a defect that would cause the device to not deliver defibrillation. Because of the seriousness of this, the FDA initiated a Class I recall to numerous devices, meaning the defects pose significant risk of severe injury or death.

External defibrillators are not the only heart devices experiencing mass malfunctions. St. Jude recently recalled two of its Riata Defibrillator Leads, which are implanted internally. Unfortunately, due to delays and miscommunications, nearly 80,000 patients are still living with the recalled devices inside them.

If a defibrillator malfunctions, several serious outcomes may occur, all of which will require immediate medical attention. The lead wires connect directly to the heart, and if they malfunction, detach, or break, the device is then unable to sense irregular heartbeats, and will be completely unable to provide the electric shocks required to keep the patient alive. Like AEDs, the lead wires in internal defibrillators were never required to undergo any human testing before they were released onto markets.

In 2009, a recalled Medtronic defibrillator implanted in a nine-year-old girl started firing electronic shocks throughout her body uncontrollably, at a rate of nearly 20 times per hour. The Medtronic devices were responsible for more than 2,000 injuries and 13 deaths that year, and her parents switched her over to a St. Jude Riata device. Those too were recalled in 2011, however. In 2012, the New York Times reported on research that found that at least 20 deaths were associated with the Riata products. St. Jude later recalled more than 35,000 of its Eon and Eon Mini implantable pulse generators, which treat chronic back pain by providing stimulation to the spinal cord.

Product liability lawyers at Pintas & Mullins Law Firm hope the increase in FDA regulation leads to higher quality AEDs, devoid of defects and malfunctions. Significant compensation may be available to those patients who suffered serious complications from AEDs or implanted defibrillators, such as St. Jude’s Riata or Medtronic devices.


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