Author Topic: How to solve the “TI ADS1299 EEG demo kit is not save for humans” problem?  (Read 3508 times)

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Online Saskia

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Working in pharma I can tell that we do spend at least a decade to develop a substance into a medication and do the proper non clinical and clinical safety tests before we get the approval to bring the medication to the market.

At our company there is an army of safety experts, pathologists, toxicologists, etc (far more than 1000 employees) involved just to get approval to prepare the submission for requesting approval to start a clinical study. We have our QA department and extremely regular audits by the EMA, FDA, etc. In these audits we have to explain all of those measures we take to ensure drug safety. Including our SOPs, processes to deal with adverse events, incident management, etc. up to sourcing of components and validation of test equipment. If e.g. a scale does not meet validation criteria, it will get thrown out.

Non-compliance with the rules would get us shut down. Obviously our management is liable for ensuring compliance with the rules, and non-compliance will get employees fired on the spot. No one here wants to catch the blame for any patient mishap.

Medical devices that pose a risk to the patient will undergo similarly rigorous inspections and regulatory approvals.

Can you prove, that

- you have the proper certification and training to be conducting this kind of experiments ?
- you have the proper guidelines to be able to do a validation of the device that you are trying to build ?
- that the manufacturer of your evaluation board certified it for use in this kind of experiments ?
- that you have a setup which does not negate the board manufacturer's certification and specifications for use in medical experiments ?
- did you validate your setup according to good laboratory practice and good clinical practice PRIOR to any experiment taking place ?
- is this validation documented according to good documentation practice ?
- that your lab is actually fit for this kind of experiments ? A validation for labs is also required, see above ....
- that your lab equipment is certified and validated ?
- did you validate the software you are using to take those measurements ? if not, study Computer System Validation & Compliance first.

These are just a few superficial remarks scratching on the surface of this topic.

If the manufacturer does explicitly exclude his evaluation board for use in medical experiments, you should not even think about using it in such manner.



 
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Offline Tarloth

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In the paper, a Rasperri PI is used to aquire data from the TI EEG board and then stored on a SD card on the Rasperri PI. and then further analyzed by a MATLAB based GUI. i did not find any hints in the paper that the Rasperri PI was used for safety reasons. But does the Rasperri PI not solve the problem to prevent current to run from a PC to the TI EEG board to the EEG headseat?

No, RPI not improve the device or turn it "safer", probably turn it more riskie. I did read superficially the paper and scientist didn't test in humans, only it's a proof of concept, they didn't affirm that this configuration it's SAFE, only affirm that it's possible to meassure the signals.

You need to learn basic concepts, first at all signal isolation.

I suppouse that you are not thinking to start a crowd founding campain with another dangerous product,  isn't it?
 

Offline Peter Gamma

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It seems like the authors of the papers did not adress the topic safety at all. I saw that safety recommendations for instance for OpenBCI EEG are to use a Wifi setup. The Rasperri PI has wifi transmission, therefore the risk of unwanted current from a PC to the EEG headset could be solved by a Wifi bridge from the PC to the Rasperri PI.
« Last Edit: September 25, 2020, 02:32:27 am by Peter Gamma »
 

Offline Peter Gamma

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In the paper, a Rasperri PI is used to aquire data from the TI EEG board and then stored on a SD card on the Rasperri PI. and then further analyzed by a MATLAB based GUI. i did not find any hints in the paper that the Rasperri PI was used for safety reasons. But does the Rasperri PI not solve the problem to prevent current to run from a PC to the TI EEG board to the EEG headseat?

I suppouse that you are not thinking to start a crowd founding campain with another dangerous product,  isn't it?

No, since finding a croud for a research project is hopeless.
 

Offline Peter Gamma

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I saw someone else is looking for a crowd for his HackEEG (by Starcat, LLC)

8-32 channel TI ADS1299 Arduino shield for EEG, EMG, and EKG bio-signals acquisition

https://www.crowdsupply.com/starcat/hackeeg

but is this device safe for humans?
 

Offline aristarchus

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I saw someone else is looking for a crowd for his HackEEG (by Starcat, LLC)

8-32 channel TI ADS1299 Arduino shield for EEG, EMG, and EKG bio-signals acquisition

https://www.crowdsupply.com/starcat/hackeeg

but is this device safe for humans?


Their disclaimer on the page you specify tell it all..

"Important Warning

Although HackEEG has some of the features of a medical device, it does NOT have any certifications (FDA, CE, IEC, etc.) and is NOT officially approved for medical or diagnostic use. It is your responsibility to ensure your safety when using the device. Furthermore, you should never power the device from a non-isolated power source."


Don't you read the page that you, yourself, show to us?

 

Offline DrG

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Don't you read the page that you, yourself, show to us?

It does not appear so to me. He also does not appear to answer questions. There is also very little evidence that any of the considerable advice that has been given has had any real effect. It is a *very* important topic and yet he seems to be stuck on "is it safe", unwilling to pursue any study of even the fundamentals - as has been noted.

It is possible that he was the dentist in Marathon man. Now, I don't know that for a fact, I am just saying it is possible :)


- Invest in science - it pays big dividends. -
 
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Offline Peter Gamma

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I've read the pages and saw that the HackEEG can be connected to a Raspberry Pi 4 sending Lab Streaming Layer data over WiFi, which is a similar setup as was used for the TI EEG board in the papers. There is nothing to answer or not to answer anymore.
 

Online Saskia

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well, if he tries this on humans, report it to the authorities and watch in awe when they throw the book at him.

 

Offline aristarchus

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This guy is just a shill.
Never really discussed nor listened what others said and finally indirectly advertised a crowdfunding campaign trying to convince us that its just fine to use it.
Clever way indeed!

Suppose that some moderator if not ban him, then at least move this thread to Crowd Funded Projects......
 


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