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FDA Strengthening Oversight Over Defibrillators

Automated external defibrillators (AEDs) can save lives. However, they don’t always work when you need them.

From January 2005 through September 2014, the U.S. Food and Drug Administration received approximately 72,000 reports of device failure. Over the same time period, manufacturers have conducted 111 recalls involving more than two million AEDs.

According to the FDA, the recalls and reports were frequently linked to design and manufacturing issues, such as inadequate control of components purchased from other suppliers. In some cases, the AED defects may have led to severe injuries or even deaths.

To address the quality and reliability of these important medical devices, the FDA recently issued a final order that will require AED manufacturers to submit premarket approval applications (PMAs) for the devices, which must pass more stringent review than what was previously required. According to the agency, the changes will allow it to more closely monitor how AEDs are designed and manufactured.

Previously, AEDs were approved through an accelerated approval pathway designed for low-risk devices, which range from hospital beds to artificial hips. The so-called 510(k) system allows speedy approval of devices that are similar to products already on the market.

Under the new standards, the FDA will inspect AED makers’ manufacturing facilities prior to approval. Once the devices are on the market, manufacturers will be required to notify the FDA regarding any changes that affect safety or effectiveness and file annual reports on device performance.