• E-mail
• Print
• RSS

FDA warns of deaths after radio frequency ablation for lung tumors

Device Regulation Alert: Safety, Compliance and Reimbursement News, January 7, 2008

The FDA issued a public health notification on December 11, 2007, alerting the public to deaths relating to radio frequency ablation devices used on lung tumors. According to the notification, the ablation devices have been cleared for certain uses such as for non-resectable liver tumors, but have not been cleared for use on lung tumors.

The FDA states manufacturers cannot market the devices for use on lung tumors. The FDA advises using "special caution" with radio frequency ablation devices and "adhering strictly" to the operating instructions, manufacturer's instructions, and operating manuals. Further, the FDA recommends that if healthcare professionals want to use a radio frequency ablation device to treat a lung tumor, they should enroll the patient in an approved clinical study.

The notification provides links to additional information about adverse events relating to ablation of lung tumors. The FDA also provided a link to information about FDA-cleared indications for radio frequency ablation devices.

Click here to read the FDA's public notification.

• Comment
• E-mail to a Colleague
• Print
• RSS
• Archive

Comments