FDA reports RF ablation deaths

Dec 11, 2007

The U.S. Food and Drug Administration (FDA) has issued a Public Health Notification regarding reported deaths following radiofrequency (RF) ablation of lung tumors.

In the December 11 notification, the FDA said it has received reports of patient deaths, and similar reports have appeared in the literature. Patient selection, subsequent treatment, and technical use of the RF device, including placement operation, may have contributed to the fatalities, according to the FDA.

While the FDA said it has cleared many RF ablation devices as tools for general ablation of soft tissue by thermal coagulation necrosis, the devices have not been cleared specifically for lung tumor ablation. As a result, the FDA recommends that special caution be used when operating RF ablation devices, adhering strictly to information contained in the labeled operating instructions, operator's manual, manufacturer's instructions for use, and any provided training.

If an RF ablation device is to be used to treat patients with lung tumors, the FDA said healthcare providers should consider enrolling them in an approved clinical study, in which training is available. More information on clinical trials can be found here. For additional information on adverse events due to lung tumor ablation, search the FDA's MAUDE database here.

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