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U.S. Department of Health and Human Services

Safety

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Radio Frequency Ablation Devices December 2007

Audience: Thoracic Surgeons, hospital administrators, other healthcare professionals

[UPDATE 09/26/2008] FDA issued a clarification to the December 11, 2007 Public Health Notification. The clarification discusses the regulatory status of radiofrequency (RF) ablation devices used to treat lung tumors, the regulatory basis for FDA’s clearance of these devices for the indication of general soft tissue ablation, and the public health concerns related to the specific use of RF ablation to treat lung tumors.

[Posted 12/12/2007] FDA alerted healthcare professionals of reports of patient deaths associated with the use of radio frequency (RF) ablation devices during lung tumor ablation. Patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the fatalities. While RF ablation devices have been cleared for general indications- ablation of soft tissue by thermal coagulation necrosis- the devices have not been cleared specifically for lung tumor ablation. Healthcare professionals should use caution when operating RF ablation devices, adhering strictly to information contained in the labeled operating instructions, Operators Manual, the Manufacturer's Instructions for Use and any training provided. Additionally, if healthcare professionals plan to use RF ablation devices to treat patients with lung tumors, they should consider enrolling patients in an approved clinical study, where training is available.

[September 24, 2008 - Public Health Notification - FDA]
[December 11, 2007 - Public Health Notification - FDA]