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Should the FDA Consider ECT Machines Less Dangerous?

July 28, 2011 Natasha Tracy

In January the FDA had a meeting about whether electroconvulsive therapy (ECT) machines should be moved from the most dangerous category of medical devices (Class 3) to the less dangerous Class 2.

And the freak outs began.

I saw people screaming about how wrong it was and writing petitions and wanting to go to the FDA meeting to voice their opinion. I mostly ignored this issue because, well, I didn't care. I have so many important issues on my plate there just wasn't room for one more.

That is until I can across an article in Psychiatric Times by Charles H. Kellner, MD. Kellner explains why the move from Class 3 to Class 2 is important and its possible effect on patients.

What if you didn't have access to ECT anymore?

ECT Machines and Class 3

The classes for devices were created in 1976 so devices could be categorized by risk. Each class has its own requirements for what has to be done to attain approval in its class.

It was recognized ECT machines should be in the most dangerous class of devices, but they were grandfathered in. This means they did not have to conduct additional tests on the machines due to their current use and supporting body of literature.

Additionally, future ECT machines also didn't have to have new safety and efficacy literature. Instead, ECT machine regulation "requires a showing of substantial equivalence to a legally marketed device," which is usually reserved for "intermediate and low risk devices."

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In other words, they were grandfathered into Class 3 but never had to play by the Class 3 rules.

ECT Machines are Dangerous

At first glance it seemed to me like they should be in the most dangerous class of devices. What's more dangerous than electrocuting your brain?

But the problem isn't with the "danger" aspect; it's with the regulatory aspect.

ECT Machines Should be Reclassified or Require Premarket Approval

In 2009, it was recommended the FDA reclassify grandfathered devices into Class 1 or 2, or require the standard class 3 requirements. This is when the FDA started considering moving the ECT machines into Class 2.

Here's why.

Class 3 Requirements

In order for a medical device to be approved in Class 3 it must, "affirmatively demonstrate a reasonable assurance of safety and effectiveness." And this means sham (placebo)-controlled clinical trials on the device before approval.

And as we discussed before, we cannot conduct sham-controlled clinical trials of ECT due to ethical issues.

The other option is a "paper" approval in which previous studies are used to certify a device.

Based on everything we know about ECT, can ECT gain Class 3 paper approval?

The FDA is uncertain, mostly because of political pressures. Mostly because of the stigma associated with the treatment. Mostly because of groups that haven't put down their petitions long enough to understand the issues and read the actual, clinical information on ECT. (It's freely available in a quaint 154-page document. Yes, I've snuggled with its pages.) Mostly because of people who fly by anecdotes and don't medically know what they're talking about.

Next time I'll discuss the clinical evidence the FDA is reviewing around the safety and efficacy of ECT as determined by over 1000 clinical trials and what this decision means for patients.

You can find Natasha Tracy on Facebook or GooglePlus or @Natasha_Tracy on Twitter.

APA Reference
Tracy, N. (2011, July 28). Should the FDA Consider ECT Machines Less Dangerous?, HealthyPlace. Retrieved on 2022, August 17 from https://www.healthyplace.com/blogs/breakingbipolar/2011/07/should-the-fda-consider-ect-machines-less-dangerous



Author: Natasha Tracy

Natasha Tracy is a renowned speaker, award-winning advocate, and author of Lost Marbles: Insights into My Life with Depression & Bipolar. She's also the host of the podcast Snap Out of It! The Mental Illness in the Workplace Podcast.

Find Natasha Tracy on her blog, Bipolar BurbleTwitter, InstagramFacebook, and YouTube.

r
July, 27 2015 at 11:12 am

Natasha
Memory loss can DEFINATELY be a result of brain injury and zapping your brain with volts of electricity can indeed injure a human brain as can some of the bipolar medications over time. Ask anyone who has ever had a bad experience.
Yes, I agree as a last resource ECT has helped many people but the good effects often don't last for very long
Suicide was decriminalized in Canada in 1972 although assisted suicide is still on the books
I wonder if someone with bipolar disorder would ever be considered of sound mind (let's say while in remission) to sign a do not recessitate order. Do you think it would be honoured somewhere down the road if they became ill again and chose to commit suicide?
Or what if they got cancer?
Not that I am promoting suicide I'm just trying to make a point, the difference between having a mental illness versus a physical illness. Shouldn't people have a choice?

r
July, 26 2015 at 5:17 pm

Like any medical procedure there are always risks involved. The results are not always so black and white. There is a lot of grey also...
I've never heard of a conscious adult undergoing a medical procedure against their will for any life threatening physical illness but with those suffering from a mental illness things are alway different. You automatically lose your rights if you are involuntarily committed. Even someone dying of cancer gets to choose whether or not they will accept a risky radical treatment, such as chemotherapy or radiation
It hardly seems fair since either way it is ultimately he patient that has to live with the outcome...
Doctors are not God although sometimes they pretend to be and many people often treat them as such. In a manner of speaking, some people are simply atheists or agnostics. No one should have the right to FORCE their brand of 'religion" (or medical procedure) on any body!!!

Sarah
April, 5 2013 at 12:18 am

Hi Diedre,
Public hospitals here in Australia are okay. You don't get much attention from the nursing staff though. Try to go to the outlying areas instead of the inner city, but it depends on where you live.
I'm sorry about your experiences. People will stop at nothing to keep you alive, when all you want to do is die. What can I say to you? Hold whatever is dearest to you close to your heart, and pray. There is one gift that cannot be taken from you.

Pat
April, 4 2013 at 1:04 pm

I had 7 ECT treatments, and I lost about 1 1/2 years of memories. It's 5 years later, and I haven't got them back. I think that memory problems are trivialized by pro-ECT folks. It's common. The ECT also failed to help.

Deirdre Oliver
March, 30 2013 at 3:02 pm

I am Australian. In April 2000 - January 2002, following a bad drug reaction I was given 66 ECT treatments, on many occasions without my permission. I was a voluntary patient during this time but was threatened with being sent to a public facility if I refused. That terrified me. It wasn't until 6 months after the last treatment that I discovered that I had huge `holes' in my retrograde memory. These `holes', (like wiping a wet rag across a blackboard) remain today. I do not remember my children's growing up, sports achievements, graduations etc. A professional sculptor, I have almost no memory of my technical expertise, and still don't recognise some of my work. I am also an author but can only manage to write short stories. The organisational skills required to write a book are beyond me now, so there are 2 novels, a full length play, a half written TV sit com, (previously optioned by a production company), and more, now never to be finished. Two years ago I enrolled in a university course and had to drop out halfway through because I couldn't manage work that I would have sailed through before ECT.
On top of all this the constant bullying, the sense of being raped that I felt through what I can remember from that time has delivered me a huge post traumatic stress syndrome where I have flashbacks, rages, nightmares plaguing me to this day.
As for rescuing people from suicide as is claimed willy nilly, I attempted suicide at least four times during the treatment, and another four times since. As for physical damage, I have been told by a neurologist that my brain is ten years older than I am. There is excessive shrinkage in the prefrontal cortex and the ventricles are enlarged, indication of loss of brain tissue. I had two neuropsychological batteries of tests both indicating that some areas of my cognitive functioning were not operating as they would be expected given results for other areas tested. I.E. one was responding as superior, but the next was only operating as average. The psychologists were confused and couldn't work it out. When I told them about the ECT they were hesitant saying that they'd heard that ECT was quite safe and did not effect cognitive functions.
Please, please work hard on your FDA. Don't let the greedy, cynical psychiatrists okay ECT.
So far from saving my life, ECT has ruined it.
PS. Maybe in Canada it is not a money machine, but it is here in Australia.

Catherine
January, 24 2013 at 1:38 pm

maintenance ECT is the only thing that keeps me alive and has done for 13 years.

Kathy C
August, 6 2011 at 12:11 pm

Hi Cheryl and Natasha. I have a daughter who has struggles with psychosis since early childhood. She has been on clozaril since the age of 9, clozaril is reserved for the most treatment resistant cases. We have tried augmenting with many different classes of meds, the ketogenic diet, there is not a treatment that we have not tried. The past four years her psychosis became quite severe once again and we again tried all medications available. The voices and visual hallucinations do not leave her alone and all that she wants is to be rid of them. Her development has been delayed due to the severity of her hallucinations and its impact on development since she is not able to take in information like others due to her severe and chronic psychosis. We recently began Ect, she has had 20 treatments and we are seeing slow and steady improvement. She has had some of the clearest days that she has had in years. She has no memory loss or ill effects. It was not easy getting the ECT clinic to accept her since she is only 18 years old, so they are not out to make money, they are not out to perform barbaric procedures on people. I suppose that most people who resort to ECT are in a pretty desperate position and trying to regain some normalcy to their lives. I do not think that it is fair for anyone to judge until they have walked in the shoes of a severely mentally ill individual. As I have said my daughter has not had any ill effects from the ECT whatsover, the ECT is meant to help normalize her brain chemicals not to lobotomize her. I was very hesitant and scared since it sounded so drastic, but sometimes the brain needs to be reset and meds do not always work.

Natasha Tracy
July, 30 2011 at 6:41 am

Hi Cheryl,
To the best of my knowledge there is no indication of brain damage in humans. Memory loss is _not_ brain damage.
It is _not_ the case that most people have ECT against their will. The vast majority of people undergo ECT under the strictest protocols of informed consent. Post-ECT 80% of patients say that ECT helped them.
ECT is not lucrative. Particularly here, in Canada, money has nothing to do with it.
ECT has a success rate of approximately 80% in the treatment of depression - often depression that responds to nothing else. This is not a minor thing.
I direct you to look at the FDA notes from January where they analyze over 1000 studies on ECT: http://1.usa.gov/mQyADg
(Page 24 lists the cognitive adverse events summary.)
- Natasha

Cheryl
July, 30 2011 at 12:49 am

All medical trials with animals have shown brain damage.
Sackheim 2007 found brain damage in humans.Memory loss = brain damage.
People are forced to have ECT against their will. This is wrong. ECT should be banned - period.
The reason ECT is still around is because they make big bucks out of it and it shuts patients up by stunning their brains! Electrical lobotomy.
www.breggin.com
www.mindfreedom.org
www.electricshocktherapy.info

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