OpenBCI for medical research in neurointensive care (EEG)

broesbybroesby
in General Discussion
Hi all,..

I am brand new to this place, almost new to the concept of BCI and somewhat new to EEG in general.
I am a medical doctor. I practice as a senior consultant in anesthesia, specifically in neuroanesthesia and intensive care in Odense, Denmark.

I have for some time now been interested in the use of continuous EEG monitoring in intensive care of neurointensive patients. My hospital of course have neurophysiologists but they are more focused on short term "full frame" EEG monitoring.

There are commercially available EEG modules for continuous EEG monitoring, but they are either very expensive or limited in scope / accesibility of the data.

My hope is that OpenBCI will be my saviour. I am quite tech savvy although not an engineer or programmer of course. I do however have some experience "programming" in the Unity3D Game environment.

My main question for starters is this:

IS OpenBCI licensed as medical-grade equipment whereby it can be used freely in a hospital setting? This is the first and imperative step for me since otherwise I cannot do any research with the module at all.

In case it is I have loads of other questions and I hope to find others who have similar interests or at the very least someone who can point me in the right direction on some of the more technical issues ;-)

Thx in advance,

Jesper Broesby, Denmark


Comments

  • wjcroftwjcroft Mount Shasta, CA
    edited September 2015
    Jesper, hi.

    CE Certification for medical devices cost estimates are in the tens of thousands of dollars. So OpenBCI has not pursued this. Also the nature of the OpenBCI board, being not enclosed would be a disqualifying factor. OpenBCI IS being used by researchers worldwide, but would likely not qualify in an intensive care medical application. Some examples of costs,

    https://www.google.com/search?q=iec+60601-1+certfication

    https://en.wikipedia.org/wiki/IEC_60601

    https://www.quora.com/What-is-the-average-cost-to-get-FCC-and-CE-certification-for-a-very-simple-electronic-gadget
    [but NOT a medical device]

    http://www.medicalelectronicsdesign.com/blog/medblog/how-scary-iec-60601-1
    [WAY scary, as in $40,000 and up.]

    [Example of test equipment used by certification labs. And some definitions.]

    ----

    Anesthesia applications typically use something called the BIS, Bispectral Index,

    https://en.wikipedia.org/wiki/Bispectral_index

    I believe some of the calculations used are public knowledge, they are looking at activity in the gamma and infralow (below .5 hz) frequency bands. So it would probably be possible to emulate a BIS calculation, but certainly would not want to be doing this in a critical care environment.

    Do you have access to a raw EEG stream from a medically approved device? Then you could pursue some calculations on your own medically certified computer to which it is connected.

    William

  • broesbybroesby
    Hi William,..

    Thx a lot for your answers.

    I'm afraid I thought as much - only wanted to verify it ;-)

    I already have access to the BIS monitor and we use it on a regular basis. Also I have an old 2-channel EEG monitor from Phillips. The problem is that both of them are proprietary formats and I cannot easily get access to the raw EEG stream to be able to use it for other visulalisations or calculations apart from what is already in the modules :-/

    I was hoping to be able to use one of the cheaper BCI solutions out there, partly also because they typically have the possibility to be used with open source software like OpenVibe, which would "free" me from the the proprietary company bonds on the data ...

    Damn ;-) But tha a lot.
  • wjcroftwjcroft Mount Shasta, CA
    Try asking Philips if they would share the raw format with you. Worth a try. Especially as it would promote more sales into medical research environments. Tell them that "open source" and open access is the norm these days, with all manufacturers.

    Those manufacturers that are a bit more shy, will instead provide a "DLL" module that has function calls that return the data. But access to raw data should be universal.

  • JakeStewJakeStew
    edited September 2015
    > CE Certification for medical devices cost estimates are in the tens of thousands of dollars. So OpenBCI has not pursued this.

    A FDA 510k might be as cheap as $2,000.  Might be something to look into.  The problem might be having to get a new one for every version though.  I don't know how much you can change without requiring a new one.

    Maybe we could do a kickstarter to raise the funds for it?  Sure would help out a lot of people in this situation.
    If you've ever seen one of those "Awake during surgery" shows is sure does scare the shite out of you!
  • wjcroftwjcroft Mount Shasta, CA
    edited September 2015
    By registering a medical device with the FDA, you then subject yourself to their restrictions on the sale of medical devices to only licensed practitioners. This is the unfortunate situation that U.S. manufacturers of neurofeedback equipment who chose 510K are in.

    http://www.brainmaster.com/kb/entry/559/

    The equipment is approved for Prescription Use, which means that is can be sold “to or on the order of a licensed practitioner.”

    In other words, 510K manufacturers of such equipment can ONLY sell to you, if you show them your state license. For example, licensed psychologist or M.D., etc.

    The entire field of BCI has escaped this onerous requirement by NOT registering with the FDA. CE Certification has no such sales restrictions.


    William


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