Diathermy Interactions with Implanted Leads and Implanted Systems with Leads .


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Unfavorable Events . Communications of diathermy treatment in patients with Deep Brain Stimulators Two patients treated with shortwave diathermy One pt. treated after oral surgery One pt. treated at thoracolumbar district Both patients went into a trance like state and in this manner passed on. . What is Deep Brain Stimulation?.
Transcripts
Slide 1

Diathermy Interactions with Implanted Leads and Implanted Systems with Leads Marian Kroen Office of Surveillance and Biometrics Issues Management Staff May 29, 2003

Slide 2

Adverse Events Interactions of diathermy treatment in patients with Deep Brain Stimulators Two patients treated with shortwave diathermy One pt. treated after oral surgery One pt. treated at thoracolumbar area Both patients went into a state of unconsciousness and in this manner kicked the bucket

Slide 3

What is Deep Brain Stimulation?

Slide 4

What is Diathermy? Diathermy can be considered as an electro-attractive warming cushion. While a warming cushion just warms the skin, this warms inside the body. Diathermy signifies \'profound warmth\', yet can be utilized as a part of both warming and non-warming modes. Utilized for alleviation of torment, sprains, strains, bursitis, muscle fits.

Slide 5

Diathermy

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Who Uses This? Diathermy is utilized by: physical advisors word related specialists sports coaches others… ..

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Three Kinds of Diathermy Shortwave (radio-recurrence) 13 to 27.12 MHz Newer models utilize 27.12 MHz Microwave Ultrasound

Slide 8

Medtronic Testing Medtronic performed in vitro testing to survey the impact of diathermy on DBS frameworks and gave the outcomes to FDA Results: Temperature ascent of 55º C at DBS lead terminal amid 15 minute diathermy presentation (max. diathermy settings) Temperature ascent of 27º at heartbeat rate of 8 and adequacy of 10 (setting for unfriendly occasion)

Slide 9

What Information Do We Need? ?

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What is the Scope of The Problem? Master council decided requirement for all the more testing to decide extent of connection issue Are all inserts influenced? Are all metal inserts influenced? Does the state of metal inserts matter? Is the issue just with dynamic inserts?

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OST Tested Active Implants Temperature ascend at the lead cathode is high. Temperature rise happens regardless of whether a pacemaker is associated. Cardiovascular lead and pacemaker framework demonstrated the most elevated temperature ascent of 48.8 degrees C Spinal Cord Stimulator framework and lead had second most astounding temperature ascent of 27.6 degrees C. The temperature ascend with leads was most elevated where a shallowly embedded lead was mimicked.

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OST Tested Non-Active Implants Minimal warming (1 to 3.6 degrees C) for: 4 inch long screw Fracture Plate Fracture plate screws Titanium bar Stainless Steel pole

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Conclusions Diathermy Interactions with hazardously high temperatures restricted to: Implantable frameworks with metallic (conductive) leads embedded metallic leads themselves

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Theory Implanted lead acts like a radio wire to get vitality. Power is scattered in the tissue where there is no protection (anodes). The present thickness, and along these lines the temperature, at the lead terminals can be high, because of the little surface range of the cathodes.

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Can All Types of Diathermy Cause this Interaction? Both Shortwave and Microwave diathermy deliver an electro-attractive field which can cooperate with embedded leads. Ultrasound diathermy would have an alternate method of collaboration with inserts (mechanical instead of electro-attractive).

Slide 16

Taking Action Alerts Recalls Education Labeling

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FDA Actions Labeling on Metallic Leads and Lead Systems Labeling on Diathermy Equipment FDA issued a Public Health Notification Journal Articles Patient Safety News

Slide 18

Hmm, Why No Injuries from Pacers? ?

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Why are There No Reported Injuries for Interactions of Diathermy with Cardiac Pacemakers and Leads? Testing indicates high pacing lead anode temperatures Pacemakers and leads have long history. Two reports of harm to the pacemaker (yet not to the heart) with diathermy utilize.

Slide 20

Possible Reasons for Lack of Pacing/Diathermy Injuries Warnings satisfactory? Blood stream in heart diverts warm Distance, diathermy to heart Damage, yet no one set up 2 + 2 together Brain has no agony receptors, heart does

Slide 21

Thoughts? ?

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