February 2003 Bulletin

FDA issues alert regarding diathermy

Diathermy interactions with implanted leads and implanted systems with leads

The Food and Drug Administration (FDA) issued an alert concerning the risk of serious injury or death if patients with implanted electrical leads are administered diathermy treatments. The FDA has received reports of patients with implanted deep brain stimulators who died after receiving diathermy therapy. Shortwave and microwave diathermy, in both heating and non-heating modes, can result in serious injury or death to patients with implanted devices with leads. This kind of interaction is not expected with ultrasound diathermy; electrocautery devices are not included in this notification.

The FDA recommends that shortwave or microwave diathermy should not be used on patients who have an implanted metallic lead, or any implanted system that may contain a lead. Both the heating and non-heating modes of operation pose a risk of tissue destruction.

Physicians who implant or monitor patients with leads or implanted systems with leads should explain what diathermy is and advise that the patient is prohibited from receiving shortwave or microwave diathermy therapy. Examples of implanted systems that may contain a lead include cardiac pacemakers and defibrillators, cochlear implants, bone growth stimulators, deep brain stimulators, spinal cord stimulators, and other nerve stimulators.

Health care professionals who use shortwave or microwave diathermy should be certain to ask patients about possible implants before deciding to administer these therapies. If the patient has an implanted lead or an implant containing a lead, diathermy therapy should not be used, even if the implant has been turned off. Shortwave or microwave diathermy therapy should not be administered to a patient who has had an implant in the past unless you are absolutely certain that the implant and all leads have been removed in their entirety. Read more about the notice at the FDA’s Web site.


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