Anyone heard about the FDA having stepped in and banned ECT machines?
No More Ect?
Started by
medi
, Apr 20 2009 07:04 AM
9 replies to this topic
#1
medi
-
- Members
-
- 360 posts
Amateur Psychopharmacologist
- Diagnoses:BP II, PTSD, Hypothyroidism, Migraine.
- Current Meds:Li 600, Synthroid 100, Amitriptylene 150 mgs, Zyprexa 2.5 mgs, Topamax 30 mgs.
- Location:Lebanon - the country
Posted 20 April 2009 - 07:04 AM
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, Klonopin 2 mg, Zyprexa 2.5 mgs, Remeron 30 mgs.
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 (chronic headache for a month), Zyprexa (heart palpitations and shortness of breath at only 2.5 mgs), Abilify 2 mgs (serious GI pain), Calcium Channel Blockers (weak --- verrrry), Beta Blockers (may have exacerbated depression).
Has undergone ECT in 2008.
Current Meds: Lithium 600 mg, Synthroid 75 mcg, Klonopin 2 mg, Zyprexa 2.5 mgs, Remeron 30 mgs.
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 (chronic headache for a month), Zyprexa (heart palpitations and shortness of breath at only 2.5 mgs), Abilify 2 mgs (serious GI pain), Calcium Channel Blockers (weak --- verrrry), Beta Blockers (may have exacerbated depression).
#2
dymphna
-
- Citizen Medical Expert
-
- 3,911 posts
Ready for the MCAT
- Diagnoses:Epilepsy, Endocrine Hell, Associated Mood Crap
- Current Meds:LTG 400, TPA 400, Klonopin 1.5, Vit D 1000 i.u.
- Location:A Mac Computer
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
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.
#3
martasi2
-
- Citizen Medical Expert
-
- 1,798 posts
Would-be Neurologist
- Diagnoses:BP, GAD, OCD, asthma, migraine
- Current Meds:keppra, ambien, dulera
- Location:U.S.
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.
"I don't spend more than five minutes a month in the past. The past really is a
foreign country, and they do things differently there." (Raymond Carver)
foreign country, and they do things differently there." (Raymond Carver)
#4
martasi2
-
- Citizen Medical Expert
-
- 1,798 posts
Would-be Neurologist
- Diagnoses:BP, GAD, OCD, asthma, migraine
- Current Meds:keppra, ambien, dulera
- Location:U.S.
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 . . .
"I don't spend more than five minutes a month in the past. The past really is a
foreign country, and they do things differently there." (Raymond Carver)
foreign country, and they do things differently there." (Raymond Carver)
#5
Nutter 6
-
- Members
-
- 483 posts
Amateur Psychopharmacologist
- Diagnoses:see sig
- Current Meds:see sig
- Location:In the Village
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!
Dx: OCD, GAD, PD, ADHD, Pain due to jaw injury hyperirritable trigeminal, facial, and spinal accessory nerves following jaw injury (Two Three Four Five months now, and counting...)
Psycho Rx: Cymbalta, 90; Vyvanse, 30; Klonopin, PRN, up to 1.5 x 3;
everchanging Pain RX: Neurontin, 400; Acetaminophen 650 x 3 (sometimes with codeine); Voltaren, PRN; Physio, Upper and lower jaws splinted, Lots and lots of ice...some nutters wear tin foil hats; I like ice hats...
---
'But I don’t want to go among mad people,' Alice remarked.
'Oh, you can’t help that,' said the Cat. 'We’re all mad here. I’m mad. You’re mad.'
'How do you know I’m mad?' said Alice.
'You must be,” said the Cat. 'or you wouldn’t have come here.'
Psycho Rx: Cymbalta, 90; Vyvanse, 30; Klonopin, PRN, up to 1.5 x 3;
everchanging Pain RX: Neurontin, 400; Acetaminophen 650 x 3 (sometimes with codeine); Voltaren, PRN; Physio, Upper and lower jaws splinted, Lots and lots of ice...some nutters wear tin foil hats; I like ice hats...
---
'But I don’t want to go among mad people,' Alice remarked.
'Oh, you can’t help that,' said the Cat. 'We’re all mad here. I’m mad. You’re mad.'
'How do you know I’m mad?' said Alice.
'You must be,” said the Cat. 'or you wouldn’t have come here.'
#6
dymphna
-
- Citizen Medical Expert
-
- 3,911 posts
Ready for the MCAT
- Diagnoses:Epilepsy, Endocrine Hell, Associated Mood Crap
- Current Meds:LTG 400, TPA 400, Klonopin 1.5, Vit D 1000 i.u.
- Location:A Mac Computer
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
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.
#7
martasi2
-
- Citizen Medical Expert
-
- 1,798 posts
Would-be Neurologist
- Diagnoses:BP, GAD, OCD, asthma, migraine
- Current Meds:keppra, ambien, dulera
- Location:U.S.
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
"I don't spend more than five minutes a month in the past. The past really is a
foreign country, and they do things differently there." (Raymond Carver)
foreign country, and they do things differently there." (Raymond Carver)
#8
martasi2
-
- Citizen Medical Expert
-
- 1,798 posts
Would-be Neurologist
- Diagnoses:BP, GAD, OCD, asthma, migraine
- Current Meds:keppra, ambien, dulera
- Location:U.S.
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
"Medical Devices Face New Scrutiny From FDA:
http://online.wsj.co...7438601763.html
"I don't spend more than five minutes a month in the past. The past really is a
foreign country, and they do things differently there." (Raymond Carver)
foreign country, and they do things differently there." (Raymond Carver)
#9
medi
-
- Members
-
- 360 posts
Amateur Psychopharmacologist
- Diagnoses:BP II, PTSD, Hypothyroidism, Migraine.
- Current Meds:Li 600, Synthroid 100, Amitriptylene 150 mgs, Zyprexa 2.5 mgs, Topamax 30 mgs.
- Location:Lebanon - the country
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
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, Klonopin 2 mg, Zyprexa 2.5 mgs, Remeron 30 mgs.
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 (chronic headache for a month), Zyprexa (heart palpitations and shortness of breath at only 2.5 mgs), Abilify 2 mgs (serious GI pain), Calcium Channel Blockers (weak --- verrrry), Beta Blockers (may have exacerbated depression).
Has undergone ECT in 2008.
Current Meds: Lithium 600 mg, Synthroid 75 mcg, Klonopin 2 mg, Zyprexa 2.5 mgs, Remeron 30 mgs.
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 (chronic headache for a month), Zyprexa (heart palpitations and shortness of breath at only 2.5 mgs), Abilify 2 mgs (serious GI pain), Calcium Channel Blockers (weak --- verrrry), Beta Blockers (may have exacerbated depression).
#10
medi
-
- Members
-
- 360 posts
Amateur Psychopharmacologist
- Diagnoses:BP II, PTSD, Hypothyroidism, Migraine.
- Current Meds:Li 600, Synthroid 100, Amitriptylene 150 mgs, Zyprexa 2.5 mgs, Topamax 30 mgs.
- Location:Lebanon - the country
Posted 21 April 2009 - 05:29 AM
Never realized the machines were really "old."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
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, Klonopin 2 mg, Zyprexa 2.5 mgs, Remeron 30 mgs.
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 (chronic headache for a month), Zyprexa (heart palpitations and shortness of breath at only 2.5 mgs), Abilify 2 mgs (serious GI pain), Calcium Channel Blockers (weak --- verrrry), Beta Blockers (may have exacerbated depression).
Has undergone ECT in 2008.
Current Meds: Lithium 600 mg, Synthroid 75 mcg, Klonopin 2 mg, Zyprexa 2.5 mgs, Remeron 30 mgs.
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 (chronic headache for a month), Zyprexa (heart palpitations and shortness of breath at only 2.5 mgs), Abilify 2 mgs (serious GI pain), Calcium Channel Blockers (weak --- verrrry), Beta Blockers (may have exacerbated depression).
0 user(s) are reading this topic
0 members, 0 guests, 0 anonymous users
