The U. S. Food and Drug Administration issued a Public Health Notification on Dec. 11 alerting the public on reported deaths associated with radiofrequency ablation of lung tumors.
Selection of patients, their subsequent treatment, and placement and use of the RF device, may have contributed to the deaths, according to the FDA.
Many RF ablation devices have received FDA clearance as tools for general ablation of soft tissue by thermal coagulation necrosis. However, the FDA said the devices have not been specifically cleared for lung tumor ablation because clinical data establishing product safety and effectiveness for this purpose have not been submitted to the agency.
The FDA warned healthcare providers to use special caution when operating RF ablation devices and adhere strictly to labeled operating instructions and any training provided. For those who wish to use an RF ablation device to treat patients with lung tumors, the FDA recommends enrollment in an approved clinical study, where training is available.
