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No More Ect?


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9 replies to this topic

#1 medi

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Posted 20 April 2009 - 07:04 AM

Anyone heard about the FDA having stepped in and banned ECT machines?
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<p>Dx Axis 1: BD II. Had been diagnosed with MDD. Am sometimes also diagnosed with PTSD.Has undergone ECT in 2008.Current Meds: Lithium 600 mg, Synthroid 75 mcg, Inderal 40 mgs, Ativan 2 mg or more, as needed, Zolpidem.Have had experience with: Tricyclics (useless back then), Paxil, Celexa & Lexapro ( the three caused jitteriness&/or mixed states), Wellbutrin (also jitteriness, more severe), MAOI-B (Emsam patch)(hypomania, fun, but no way I could sit at my desk and think), Neurontin (innocuous), Depakote (too much weight gain, hair loss, sleepiness, lack of energy, and no noticeable benefit), Topamax (I'll only cite the suicidality obsession as of 75 mgs....), Lamictal (no benefit), Zyprexa (heart palpitations and shortness of breath at only 2.5 mgs), Abilify 2 mgs (serious GI pain), Calcium Channel Blockers (weak --- verrrry).



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#2 dymphna

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Posted 20 April 2009 - 09:30 AM

Anyone heard about the FDA having stepped in and banned ECT machines?


Well, as of April 1, 2008, the FDA still had them listed.

There are two American manufacturers of ECT devices: Somatics and MECTA.

If the FDA were planning on banning it, I really don't think they would be approving stuff like this:

Feb. 19, 2009
The U.S. Food and Drug Administration today approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD).

The U.S. Food and Drug Administration today approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD).

The Reclaim system uses a small electrical generator known as a pulse generator to create electrical stimulation that blocks abnormal nerve signals in the brain. This small battery-powered device is implanted near the abdomen or the collar bone and connected to four electrodes implanted in the brain through an insulated electric wire known as the lead. Two device systems may be implanted to stimulate both sides of the brain or one device may be implanted with two lead outputs.

[...]

Patients who require electroconvulsive shock therapy should not be implanted with the Reclaim device. Other patients who should not use the device include persons who will undergo magnetic resonance imaging (MRI) or deep tissue heat treatment known as diathermy.


What has happened recently (April 9, 2009) is that the FDA is requiring that manufacturers of Class III medical devices (which includes ECT machines) to "submit to FDA a summary of, and citation to, any known, or otherwise available, safety or efficacy information, including that information which has not been submitted under section 519 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360i)." You can see the entire list here.

As an aside, what would really frighten me would be this one:

Radiation-Emitting Product Code

Product Device, Electroconvulsive Therapy
Regulation Description Electroconvulsive therapy device.
Product Description Neurology Microwave Medical Products
Product Code GXC
Radiation Type Microwave EMF
Regulation Number 882.5940


Microwave? Like popcorn?


Dymphna
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#3 martasi2

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Posted 20 April 2009 - 10:15 AM

As an aside, what would really frighten me would be this one:

Radiation-Emitting Product Code

Product Device, Electroconvulsive Therapy
Regulation Description Electroconvulsive therapy device.
Product Description Neurology Microwave Medical Products
Product Code GXC
Radiation Type Microwave EMF
Regulation Number 882.5940


Microwave? Like popcorn?

Dymphna


We're talking about radiation as a function of electrical waves, not radioactive rays or radiation from nuclear devices, in case anyone reads this and panics. EMF stands for Electromagnetic Field, and I assume that Microwave EMF means the size and shape (fairly small) of the electrical wave contained in the ECT machine itself. Here's a link to a World Health Organization site about EMF if anyone's interested:

http://www.who.int/peh-emf/en/

and Dymphna, quit scaring people.

Edited by martasi2, 20 April 2009 - 10:16 AM.

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#4 martasi2

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Posted 20 April 2009 - 10:35 AM

Anyone heard about the FDA having stepped in and banned ECT machines?


This is a rhetorical question, right . . .
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#5 Nutter 6

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Posted 20 April 2009 - 10:58 AM

Anyone heard about the FDA having stepped in and banned ECT machines?


This is a rhetorical question, right . . .


Nope. If you put medi and dymphna's points together--because the FDA is going to require greater regulation, ECT may become less available (e.g., this blog explains it: http://psychcentral....-the-dinosaur/). Time will tell.

And no, no crunchy kernels of neural goodness, it's just the wavelengths that the brain operates on are small--wouldn't do much good if they used a long wavelength, like, say, FM radio, you know? This is a real source of weirdo stuff, btw--people talking about "kindling" the brain with ECT, because they are mixing up (intentionally or unintentionally) the idea of neural kindling and the kind you put in a fireplace. sheesh!
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#6 dymphna

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Posted 20 April 2009 - 12:25 PM

We're talking about radiation as a function of electrical waves, not radioactive rays or radiation from nuclear devices, in case anyone reads this and panics. EMF stands for Electromagnetic Field, and I assume that Microwave EMF means the size and shape (fairly small) of the electrical wave contained in the ECT machine itself. Here's a link to a World Health Organization site about EMF if anyone's interested:

http://www.who.int/peh-emf/en/

and Dymphna, quit scaring people.



I know... but you have to admit it - what would most people think upon seeing "Neurology Microwave Medical Products" on the side of the machine?

{sheesh - some things in life really shouldn't be so literal...}


d
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Yes, my name really is Dymphna.

 

I'm not a doctor, nurse, pharmacist, or therapist.

I can find you an answer and I won't blow smoke up your ass.

 

St. Dymphna is the Patron for brain maladies.

 

I'm the Enforcer.

 

eqnmrt.jpg

 


#7 martasi2

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Posted 20 April 2009 - 01:57 PM

I know... but you have to admit it - what would most people think upon seeing "Neurology Microwave Medical Products" on the side of the machine?

{sheesh - some things in life really shouldn't be so literal...}


d


Most people preparing for ECT don't check out the machinery. And doctors don't encourage it either. They don't want us cluttering our already cluttered mind w/details.

Nutter6 - tried your link, but it doesn't go where it's supposed to. Do you have another link? Thanks
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#8 martasi2

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Posted 20 April 2009 - 02:05 PM

Here's a Wall Street Journal (April 2009) article about ECT and FDA approval. I think this is similar to your article, nutter 6.


"Medical Devices Face New Scrutiny From FDA:
http://online.wsj.co...7438601763.html
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#9 medi

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Posted 21 April 2009 - 05:28 AM

Here's a Wall Street Journal (April 2009) article about ECT and FDA approval. I think this is similar to your article, nutter 6.


"Medical Devices Face New Scrutiny From FDA:
http://online.wsj.co...7438601763.html


  • 0
<p>Dx Axis 1: BD II. Had been diagnosed with MDD. Am sometimes also diagnosed with PTSD.Has undergone ECT in 2008.Current Meds: Lithium 600 mg, Synthroid 75 mcg, Inderal 40 mgs, Ativan 2 mg or more, as needed, Zolpidem.Have had experience with: Tricyclics (useless back then), Paxil, Celexa & Lexapro ( the three caused jitteriness&/or mixed states), Wellbutrin (also jitteriness, more severe), MAOI-B (Emsam patch)(hypomania, fun, but no way I could sit at my desk and think), Neurontin (innocuous), Depakote (too much weight gain, hair loss, sleepiness, lack of energy, and no noticeable benefit), Topamax (I'll only cite the suicidality obsession as of 75 mgs....), Lamictal (no benefit), Zyprexa (heart palpitations and shortness of breath at only 2.5 mgs), Abilify 2 mgs (serious GI pain), Calcium Channel Blockers (weak --- verrrry).

#10 medi

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Posted 21 April 2009 - 05:29 AM

I know... but you have to admit it - what would most people think upon seeing "Neurology Microwave Medical Products" on the side of the machine?

{sheesh - some things in life really shouldn't be so literal...}


d


Most people preparing for ECT don't check out the machinery. And doctors don't encourage it either. They don't want us cluttering our already cluttered mind w/details.

Nutter6 - tried your link, but it doesn't go where it's supposed to. Do you have another link? Thanks

Never realized the machines were really "old."
  • 0
<p>Dx Axis 1: BD II. Had been diagnosed with MDD. Am sometimes also diagnosed with PTSD.Has undergone ECT in 2008.Current Meds: Lithium 600 mg, Synthroid 75 mcg, Inderal 40 mgs, Ativan 2 mg or more, as needed, Zolpidem.Have had experience with: Tricyclics (useless back then), Paxil, Celexa & Lexapro ( the three caused jitteriness&/or mixed states), Wellbutrin (also jitteriness, more severe), MAOI-B (Emsam patch)(hypomania, fun, but no way I could sit at my desk and think), Neurontin (innocuous), Depakote (too much weight gain, hair loss, sleepiness, lack of energy, and no noticeable benefit), Topamax (I'll only cite the suicidality obsession as of 75 mgs....), Lamictal (no benefit), Zyprexa (heart palpitations and shortness of breath at only 2.5 mgs), Abilify 2 mgs (serious GI pain), Calcium Channel Blockers (weak --- verrrry).


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