Issued: September 24, 2008
Dear Healthcare Practitioner:
This is to clarify the message conveyed in the Public Health Notification entitled “Deaths Reported Following Radiofrequency Ablation of Lung Tumors,” which was issued on December 11, 2007. It is intended to inform you about 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.
FDA has cleared RF ablation devices for the general indication of soft tissue cutting, coagulation, and ablation by thermal coagulation necrosis. This clearance was based only on bench testing data or animal testing performance data. Under this general indication, RF ablation can be used as a tool to ablate tumors, including lung tumors.
Some RF ablation devices have been cleared for additional specific treatment indications, including partial or complete ablation of non-resectable liver lesions, and palliation of pain associated with metastatic lesions involving bone. In order for an ablation device to obtain clearance for specific treatment indications, clinical data are necessary to justify the indications by showing that the device, when used on a well-defined target population, consistently achieves the desired treatment effect.
FDA has not cleared any RF ablation devices for the specific treatment indication of partial or complete ablation of lung tumors. Manufacturers of RF ablation devices cannot legally market them for this treatment indication until they have presented to FDA clinical data sufficient to establish safety and effectiveness for this purpose. Manufacturers have asked that they be allowed to provide training for clinicians related to this ablation of pulmonary tumor use. FDA cannot permit manufacturer-sponsored training for a specific indication that has not been cleared. This does not apply to training that may be available from other sources.
FDA has received reports of death and serious injuries associated with the use of RF ablation devices in treatment of lung tumors. Since we have not reviewed any pre-market clinical data in support of this specific treatment use, we do not know the actual adverse event rate. Therefore, we cannot say if these deaths or injuries are occurring more frequently than with other forms of treatment for lung tumors. These adverse events could be related to a number of factors, including patient selection and management, technical use of the RF device, post procedural treatments, and management of complications.
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of an RF ablation device, you should follow the reporting procedure established by your facility.
Reporting adverse events is everyone’s responsibility, even if the procedure involves off-label usage of medical devices.
To report your experience regarding the devices in this Notification, please use MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.
For the most recent information on adverse events due to lung tumor ablation please check the MAUDE database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm?searchoptions=1
Enter the Event Type – Death and Product Code – GEI for all reported deaths caused by electrosurgical, cutting and coagulation devices and accessories for various indications. To determine which of these adverse events may be related to lung tumor ablation, please read the detailed adverse event description.
The level of evidence required to obtain FDA clearance for general claims as compared to a specific claim related to general and specific indications of use of a device can be found in FDA’s published industry guidance: Guidance for Industry: General/Specific Intended Use – November 4, 1998 (http://www.fda.gov/cdrh/modact/genspec.pdf)
The FDA cleared indications for use of a particular RF ablation device can be found in the FDA 510(k) database:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. The Product Code for these devices, GEI, includes electrosurgical, cutting and coagulation devices and accessories for various indications. Each cleared device will be associated with a specific 510(k) number, as will the indication for use that FDA has cleared for each cleared device. The database is updated as new products are cleared. FDA requires medical device manufacturers to provide sufficient data to demonstrate that the device is safe and effective for each stated indication. FDA will clear each device for the stated indication once they have reviewed this data and the appropriate training programs for these indications are available from the manufacturer.
In February 2003, FDA’s General and Plastic Surgery Devices Advisory Committee met and discussed the subject of thermal ablation of lung tumors. Concerns were raised about the safety and adverse event reporting associated with RF Ablation of lung tumors. To read a transcript of the FDA Panel’s deliberations, please refer to FDA Panel meeting Emphysema and Ablation devices Clinical Issues Discussion Session, February 28, 2003. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=385
If you have questions about this notification, please contact the Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, by Fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. You may also leave a voicemail message at 240-276-3357 and we will return your call as soon as possible.
FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through email on the day the safety notification is released by subscribing to our list server. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.
Sincerely,
Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration
Updated September 24, 2008
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