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regulation of medical devices to diagnose stress in subjects in the UK

Discussion in 'Projects' started by RolandRB, May 31, 2011.

  1. RolandRB Member

    Those are not safety stickers.
  2. RightOn Member

    well it was about placing warning stickers, which can be a sort of safety sticker?
    here is what I found with a quick look
    In fact, the FDA imposed a requirement that all emeters bear this warning sticker:

    "By itself, this meter does nothing. It is solely for the guide of Ministers of the church in confessionals and pastoral counselling. The Electrometer is not medically or scientifically useful for the diagnosis, treatment or prevention of any disease. It is not medically or scientifically capable of improving the health or bodily function of anyone, and is for religious use by students and Ministers of the Church of Scientology only."
  3. RolandRB Member

    If the HMRA thing gets nowhere and they say it is not a medical instrument then if this thing is being used on people in stress tests in Europe then it should have a CE mark on it and if not maybe we can stop it from being used on the public. Then they can't do stress tests anymore.

    http://en.wikipedia.org/wiki/CE_mark
  4. DeathHamster Member

    Medical (or hobby) equipment that have electrodes in contact with the skin usually have pretty strict regulations for isolated grounds, etc. CoS probably dodges a lot of them by using batteries in e-meters, but if anyone ever cheats and uses a wall wart to power their e-meter, that's a tonne of regulatory bricks ready to land on them.

    Hobby electronics magazines used to have kits for alpha-wave monitors, EMGs, etc, but I have the feeling that the red tape and regulations made it too much bother.
  5. Anonymous Member

    I believe at least the MKVII comes with rechargeable batteries...and a wall wart to recharge them. Problem?
  6. DeathHamster Member

    So long as it's operated on battery power, with no wall wart during usage, they're dodging quite a few bullets.
  7. RolandRB Member

    Sometimes it is plugged into the wall socket during use. It has a step-down transformer I think that plugs into the wall.

    It is probably covered by the same sort of regulations as alpha-wave machines.

    See this:
    http://homepages.cae.wisc.edu/~bme200/eeg_biofeedback_fall05/reports/BME200-eegfinal.pdf

    "All aspects of the device need to be in compliance with AAMI and FDA standards and regulations for related devices."

    http://lmgtfy.com/?q=FDA biofeedback devices
  8. DeathHamster Member

    Then they are probably royally screwed. Even hobby alpha-wave machines require require all sorts of medical-grade power isolation, which I'm sure that e-meters don't have.
  9. moarxenu Member

    I just realized: Scientology is the only religion in which salvation depends on the availability of electricity. No batteries; no e-meter. No e-meter; no eternal salvation.
    • Like Like x 7
  10. RolandRB Member

    I am still wondering about "touch assists" performed on severly injured or traumatied patients. Can any Tom, Dick or Harry treat a severely injured person any way they see fit?

    http://www.gmc-uk.org/about/legislation/medical_act.asp

    If you were a member of a sect that practised thrashing the Devil out of people using birch twigs then would these people be allowed access to accident victims at scenes of disaster to provide assistance?

    For the UK this is looking more and more like a "letter to your MP" question and somebody needs to do this. I can not as I am living and working in Germany at the moment.
  11. RolandRB Member

    Then whom do we bring this matter to the attention of?
  12. Go Solar Maximum! Fry the fucking power grids naow! :D
  13. RolandRB Member

    Does anyone know the potential difference across the two electrodes (aka "soup cans")? This might be important.
    And to anyone who wants it I am prepared to give a sworn statement to the effect that I have received an electic shock from an e-meter.
  14. Scatman Member

    No, emeters do not have medical grade power isolation as part of their circuitry, nor does scientology supply power isolation accessories.
  15. DeathHamster Member

    Here's the CoverYourAss file for an open EEG project. Considering that they don't sell kits or actual hardware, it's pretty extensive (but I doubt that a lawyer drafted it).
    http://openeeg.sourceforge.net/doc/WARNING.html
    http://openeeg.sourceforge.net/doc/WARNING.txt
    The next step would be to locate the actual regulations in each country. (In the USA, CoS will, of course, keep playing the Religion trump card against the FDA on the quack angle. Medically dangerous might be a new line of attack.)

    Photos of CoS body-routers operating e-meters connected to wall-warts might be useful. (Real photos, not staged.)

    I'm surprised that CoS doesn't soak their members for expensive gold-plated cans. For conductivity and corrosion-resistance, gold would be one of the best materials and they could charge a premium price for it. Perhaps it works too well and the e-meter doesn't work "right"? (Similar to how they have to use particular meters that have a "bouncy" action.)
  16. RolandRB Member

    They can play the religious trump card and say it is for religious purposes but as soon as they use those devices on the public outside of religious usage (in this case for a "stress test") then the e-meter will fall under those regulations. Regulations not only for medical instruments but a safety certificate will be needed as well.

    For stress tests done outside the Org they will be running on battery power.

    To reemphasize and to put it another way, when they use it on each other in the religious practices and used as part of a religious ceremony then they can do what they like. But as soon as they use one on a member of a public where it is not part of a relgious ceremony then these regulations will apply. Sombody needs to make this point to the FDA and send them those two video clips where the e-meter is being used for stress tests. I am still waiting for the HMRA in the UK to get back to me on this one.

    I just sent in a complaint to the HSE in the UK. That is the Health and Safety Executive. I am not sure they are the right people to complain to but I should find out soon.
  17. RolandRB Member

    Here is a status report on "stress tests", "touch assists" and the regulations surrounding use of the e-meter on the public in the UK:

    GMC: diagnosis of stress (refused because anyone can do this)
    GMC: touch assists on injured persons (still waiting - GMC probably has no jurisdiction over this)
    HMRA: unregulated medical device (still no response)
    HSE: unregulated electrical device used on the public (sent today - maybe not the right body)

    I can only do the UK and I am not able to write in to my MP as I live and work in Germany. Somebody else will need to do other countries and I feel this is well worth doing. I don't know how far it will get but it is an important avenue to explore.
    • Like Like x 1
  18. RolandRB Member

    With the e-meter there is a matter of the hygiene of the electrodes (cans) that people hold. At the stress test table these cans are not sterilised between uses. There is sure to be germs on them as people's hands will sweat holding them. There could be e.coli and MRSA on the cans. The cans are not easy to sterilise because they are tin-plated steel and there will be cavities in the surface where germs can hide and wiping with sterilised solution will not kill all the germs. It is worth reporting them to the local hygiene people, whoever they are.
  19. RightOn Member

    do you think people would listen about this tho?
    Take for instance carnivals/fairs/video game halls that all have games that people touch. They never sanitize the games in which people play. Throwing balls, hoops/rings on milk bottles, water guns that shoot, playing video games and so on. I would think that that the emeter would be in the same boat as a carnival game when it comes to sanitizing? People are suppose to sanitze gym equipment and tanning beds too, but many don't.
    Not trying to be a Debbie Downer here, I just think people need to stick to the more disturbing finds of the emeter, like fake diagnosis and no warning lables? Instead of sounding like germaphobes?
  20. RolandRB Member

    I'll try anything.
  21. RightOn Member

    good enough. I hear yah
    just thought people should focus on something more important that would appear more credible to the listener
  22. RolandRB Member

    Tie them up in as much red tape as possible.
  23. RightOn Member

    I understand, but sometimes if someone comes off as an alarmist, the more important issues may not get read and may fall to the wayside.
    I say stick to the issues that are the most damaging. And I don't think sanitzing the cans would be red tape.
    my 2 cents
  24. RolandRB Member

    I have never heard of unsanitized electrodes being used on a person.
  25. RightOn Member

    me neither
  26. RolandRB Member

    It is full and concentrated skin contact and not sanitizing them would be like sharing the same towel so I think it is worth pushing.
  27. RightOn Member

    go for it Ro!
  28. RolandRB Member

    HSE is not the right body as I suspected. They got back to me. It has to be reported to the local authority. I will try to get more details on who to report it to exactly.
    -------------------
    Dear Mr Rashleigh

    Unfortunately, I do not have the contacts for those who may deal with this in the local authorities. However health and safety concerns are mainly dealt with the Environmental Health department.
  29. Anonymous Member

    I am not in the UK nor familiar with UK laws; however, it seems illogical that electrical or other safety standards could be ignored on the basis of religious use...are you sure this is the case?
  30. RolandRB Member

    Yes, mainly because of the US. It is an "essential religious instrument" or somesuch.
  31. RolandRB Member

    Torpedo launched blind
    ----------------------
    Use of e-meters by churches of Scientology

    From: Roland Rashleigh-Berry (rolandberry@hotmail.com)
    Sent: 13 June 2011 16:48:04
    To: healthandsafety@cityoflondon.gov.uk

    Dear Sirs,

    I want to bring to your attention the use of e-meters by churches of Scientology on their own members, job applicants and members of the public. To explain, the "e-meter" is something like an electrical resistance meter that measures electrical body resistance and detects changes to electrical body resistance due to sweating reactions. A Wiki search will reveal more detail. This e-meter is used extensively on church members during their religious services either applied by one person to another or applied to oneself (at higher levels of church membership). It is also used for reaction tests on job applicants for their church staff to detect possible dishonesty and is also used on ordinary members of the public in their "free stress tests" that are held up and down the country.

    My concern about the use of this e-meter is that is has no safety certificate to say it can be safely used on the public and no CE marking that I am aware of. As such, I am concerned that its use on its own membership for many hundreds of hours or its use on job applicants or its use on the public during "free stress tests" could lead to harm or injury. From what I understand it is regarded as a religious instrument and as such can circumvent safety regulations, but when used on the public in a non-religious setting such as "free stress tests" or used to check on the honesty of job applicants then I imagine these e-meters would have to be certified for this purpose to ensure they are safe for public use.

    You have a church of Scientology in your borough at 146 Queen Victoria Street where they are using these e-meters and no doubt supplying them to church members for use in their "free stress tests" in various locations and I would be grateful if you could look into this matter to ensure that all relevant laws and regulations concerning the usage of this type of equipment are being complied with.

    Yours faithfully,
    Roland Rashleigh-Berry
  32. Anonymous Member

    ^^^ Well done. Those e-meters on the street are ridiculous. Yesterday in New York, I noticed a lady that had her entire leg in cast, and she walking on crutches sitting down for this free "stress test". The woman was clearly distressed, possibly couldn't work because of her medical condition and was feeling miserable. I bet she thought that the free stress test was going to help her. It's disgusting that the CoS take advantage of people like her to sell their courses.
    • Like Like x 1
  33. Im glad you spotted this out. We must inform people with serious medical problems that Scientology will not cure you. I feel sorry for that woman using scientology as a last resort.
  34. RolandRB Member

    No joy on the GMC front either for stress tests or touch assists.
    -------------------------------------------------------------


    Dear Mr Rashleigh-Berry
    Thank you for your reply email of 9 June 2011.

    The General Medical Council's remit covers the area of clinical practise in allopathic medicine. All doctors who are granted registration must have an acceptable primary medical qualification which has been awarded by an institution listed on the Avicenna Directory, is otherwise acceptable to the GMC and is currently acceptable to the GMC.

    The procedure you have mentioned is not covered under this remit and therefore we are unable to help you.
  35. RolandRB Member

    ^^^^^^
    All we've got to go on is the as-yet-no-reply to the issue of the e-meter not having the relevant safety sticker (CE marking in Europe). I have taken this up with Edinburgh and City of London as safety issue and HMRA have still not gotten back to me. I guess the clams could get that sticker if they made the effort but I consider it my duty to make them make the effort. I like to "Keep Scientology Working".
    • Like Like x 1
  36. DeathHamster Member

  37. RolandRB Member

    Still no response nor even an acknowledgement from the HMRA.

    This is what I sent them today.
    ---------------------------------------------------------------
    Scientology e-meters used on the public



    Dear Sirs,

    I am writing to ask if the Church of Scientology are allowed to use their device known as the e-meter on their own members and members of the public. This is an electrical device that measures body and skin resistance. In the US there is an existing Federal court order that forbids the use of the e-meter in all circumstances except for bona fide religious counseling. In the UK, not only is it used for this purpose but also to offer "free stress tests" to the public held at fairs up and down the country. This device has no approval in the UK that I am aware of and nor does it carry a CE marking so I am wondering if this is breaking a law.

    You can find out more about the e-meter doing a Wiki search.

    You can find a copy of the court order concerning the e-meter here:
    http://www.cs.cmu.edu/~dst/E-Meter/meter-warning.pdf

    You can see an example of its use on a member of the public taking part in a "free stress test" here:
    http://www.youtube.com/watch?v=zDMRCaM_hvo

    Yours faithfully,
    Roland Rashleigh-Berry
  38. RolandRB Member

    I am not getting any response from HMRA on this and I can only conclude it is willful avoidance so I have passed it on to the press.
  39. RolandRB Member

    I am getting nowhere with this because nobody is doing anything. I have not even gotten an acknowledgement out of them. Can somebody in the UK take up this matter with them and PM me? The jist of it is in the email I sent them.

    http://www.mhra.gov.uk/Contactus/index.htm
    ------------------------------------------------
    Dear Sirs,

    I am writing to ask if the Church of Scientology are allowed to use their device known as the e-meter on their own members and members of the public. This is an electrical device that measures body and skin resistance. In the US there is an existing Federal court order that forbids the use of the e-meter in all circumstances except for bona fide religious counseling. In the UK, not only is it used for this purpose but also to offer "free stress tests" to the public held at fairs up and down the country. This device has no approval in the UK that I am aware of and nor does it carry a CE marking so I am wondering if this is breaking a law.

    You can find out more about the e-meter doing a Wiki search.

    You can find a copy of the court order concerning the e-meter here:
    http://www.cs.cmu.edu/~dst/E-Meter/meter-warning.pdf

    You can see an example of its use on a member of the public taking part in a "free stress test" here:
    http://www.youtube.com/watch?v=zDMRCaM_hvo

    Yours faithfully,
    Roland Rashleigh-Berry
  40. RolandRB Member

    28 June 2011 Our Ref: E/2011/0563

    Dear Mr Rashleigh-Berry,

    Thank you for your email enquiry of 1 June regarding stress tests.

    If a product has a medical purpose, i.e. it is specifically intended to provide or assist with the diagnosis, monitoring, prevention or treatment of a medical condition, it is likely to be a Medical Device under the Medical Devices Directive (MDD) 93/42/EEC. A Medical Device is defined in Article 1 clause 2(a) of the MDD. This will not only depend on the device itself, but also on the claims made for its intended use in the accompanying documentation.

    As we have no information regarding the ‘e-meter’ and what claims are made for it by its manufacturer, we are unable to advice whether this is a Medical Device and whether it is approved for the use you refer to.

    I can also inform you that stress is not in itself considered to be a medical condition, but severe stress may of course lead to other clinical conditions. As the MHRA does not regulate services or medical procedures, we are also unable to comment on the ‘stress tests’ that you refer to in your letter.

    I hope this has been of some assistance to answer your question.
    -------------------------------------------------------------------------------------------------------
    Dear Sir,

    thanks for this information. I found a link to this medical directive MDD 93/42/EEC and I see the following on the following page:

    http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML

    2. For the purposes of this Directive, the following definitions shall apply:
    (a) 'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
    - diagnosis, prevention, monitoring, treatment or alleviation of disease,
    - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
    - investigation, replacement or modification of the anatomy or of a physiological process,
    - control of conception,
    and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

    These devices are manufactured by the Church of Scientology and their use is controlled by them according to their own internal policies. They are used for multiple purposes within the Church but since this instrument is distributed internally then there is no usage claims accompanying the device since they are not enticing the public to purchase these instruments. The only way to know what is "intended by the manufacturer" is to judge by the way it is put to use by the official representatives of the Church. If we have evidence that the Church is using it for the diagnosis of disease then I think we can conclude that it was manufactured for the purpose of "diagnosis of disease" (albeit other purposes as well).

    I refer you to the following video clip where you can see an example of its use on a member of the public taking part in a "free stress test". The person administering this test would be a Church member of staff:
    http://www.youtube.com/watch?v=zDMRCaM_hvo

    "Stress" is not a medical condition but other things are. At certain times into this video clip we hear the following:
    6:26 we hear a diagnosis concerning a stomach problem
    7:05 we hear direct confirmation that the e-meter can diagnose a stomach problem
    8:12 again the same
    9:20 we hear about the ability to cure bipolar disorder

    Since this instrument is being used on the public to make these diagnoses of disease then it would seem to me that the public would benefit if this instrument were registered as a medical device and subject to those regulations that safeguard and protect the interests of those it is used on.

    Roland Rashleigh-Berry

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