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FDA issues alert on radio frequency ablation devices due to patient deaths.


FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 alerted health care professionals of reports of patient deaths associated with the use of radio frequency (RF) ablation ablation /ab·la·tion/ (-shun)
1. separation or detachment; extirpation; eradication.

2. removal or destruction, especially by cutting.


ab·la·tion
n.
 devices during lung tumor tumor: see neoplasm.  ablation, the agency stated Dec. 12.

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 coagulation (kōăg'ylā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or  necrosis--the devices have not been cleared specifically for lung tumor ablation, officials said.

The agency advises healthcare professionals to use caution when operating RF ablation devices, adhering ADHERING. Cleaving to, or joining; as, adhering to the enemies of the United States.
     2. The constitution of the United States, art. 3, s 3, defines treason against the United States, to consist only in levying war against them or in adhering to their enemies,
 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.
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Article Details
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Title Annotation:Medical Devices
Publication:Adverse Event Reporting News
Article Type:Brief article
Geographic Code:1USA
Date:Dec 17, 2007
Words:143
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