Radio Frequency Ablation Devices
Radio Frequency (RF) Ablation devices, used during lung tumor ablation, have been linked to patient injury and death, and the FDA released a warning to doctors on December 11, 2007 about the risks.
Ablation devices are used to remove soft tissue from lesions and lesions involving bone. A small needle is inserted through the skin and directly into the tumor. The ablation device emits radiofrequency energy into the tumor, causing the tissue to heat up and kill nearby cancer cells.
However, RF ablation devices have not been cleared by FDA specifically for lung tumor ablation, although they are used frequently for this purpose. Clinical data concerning their safety and effectiveness for lung tumor ablation has not been established.
The FDA advises doctors to use special caution when using RF ablation devices, and to adhere to operating instructions. If patients need to be treated for lung tumors, they should be enrolled in approved clinical studies, in which training is available for RF ablation.


