Guest guest Posted December 21, 2002 Report Share Posted December 21, 2002 ----- Original Message ----- From: " Kathi " <pureheart@...> Sent: Friday, December 20, 2002 6:00 PM Subject: TOXIC DISCOVERY ALERT > TOXIC DISCOVERY ALERT > > > _________________________________________ > > FDA Public Health Notification: > Diathermy Interactions with Implanted Leads and > Implanted Systems with Leads > (You are encouraged to copy and distribute this information) > > December 19, 2002 > > > Dear Colleague: > > This is to alert you to the risk of serious injury or death if patients > with implanted electrical leads are exposed to diathermy treatments. > > > BACKGROUND > > > Adverse events > > FDA has received reports in which patients with implanted deep brain > stimulators (DBS) died after receiving diathermy therapy. One patient > received diathermy following oral surgery, > the other for treatment of chronic scoliosis. In both cases, the > interaction of the diathermy with the implanted device caused severe > brain damage in the area where the lead electrodes > were implanted. > > Types of diathermy affected > > There are three types of diathermy equipment used by physicians, > dentists, physical therapists, chiropractors, sports therapists, and > others: radio frequency (shortwave) diathermy, > microwave diathermy and ultrasound diathermy. 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. > > > Medical devices affected > > Laboratory testing has shown that patients with any implanted metallic > lead are at risk of serious injury when exposed to shortwave or > microwave diathermy therapy. This is true even > if the implanted device is not turned on, and even if the lead is no > longer connected to an implanted system. Interaction of the diathermy > energy with the implanted lead causes > excessive heating in the tissue surrounding the lead electrodes. > Insufficient testing has been done to determine whether there is a safe > distance between the diathermy applicator and > the implant system that might allow patients to be treated with > diathermy without risk of injury. > > > RECOMMENDATIONS > > Shortwave or microwave diathermy SHOULD NOT BE USED on patients who have > ANY 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. > > If you are a physician who implants or monitors patients with leads or > implanted systems with leads: > > - Explain to the patient what diathermy is, and stress that they should > NOT receive shortwave or microwave diathermy therapy. > > If you are a health care professional who uses diathermy (shortwave or > microwave) in your practice: > > - Be sure to ask the patient about possible implants before deciding to > administer shortwave or microwave diathermy therapy. 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. 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. > > - Do not administer shortwave or microwave diathermy therapy to a > patient who has had an implant in the past unless you are absolutely > certain that the implant and all leads in their > entirety have been removed. Note that leads are often left implanted > after the implant is removed. > > > Reporting adverse events to FDA > > The Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other > user facilities to report deaths and serious injuries associated with > the use of medical devices. This means > that if a patient death or serious injury can possibly be attributable > to a diathermy device, or attributable to interactions of diathermy > devices with any implanted device, you should > follow the procedures established by your facility for mandatory > reporting. > > If you have experienced problems with diathermy devices, or adverse > events involving interactions of diathermy devices with any implanted > device, you can report this directly to the > manufacturer. Alternatively, you can report directly to MedWatch, the > FDA?s voluntary reporting program. You may submit reports to MedWatch > four ways: online to > http://www.accessdata.fda.gov/scripts/medwatch/; by telephone at > 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food > and Drug Administration, HF-2, 5600 > Fishers Lane, Rockville, MD 20857. > > > Getting more information > > If you have questions regarding this letter, please contact n > Kroen, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard > Drive, Rockville, land, 20850, by fax at > 301-594-2968, or by e-mail at phann@.... Additionally, a voice > mail message may be left at 301-594-0650 and your call will be returned > as soon as possible. > > All of the FDA medical device postmarket safety notifications can be > found on the World Wide Web at http://www.fda.gov/cdrh/safety.html. > Postmarket safety notifications can also be > obtained through e-mail on the day they are released by subscribing to > our list server. You may subscribe at > http://list.nih.gov/archives/dev-alert.html.ÿ > > > Sincerely yours, > > > W. al, Jr., MD, MPH > Director > Center for Devices and Radiological Health > Food and Drug Administration > > ---------- > > Toxic Discovery > Phone: (573) 445-0861 > Toll Free - 1-800-462-9106 > Fax: (573) 445-4700 > www.toxicdiscovery.com > " Informed Consent Begins With Informed Individuals " > _____________ > > -- > " Whatever a person thinketh in his heart so is he. " > Quote Link to comment Share on other sites More sharing options...
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