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

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

  1. RolandRB Member

    Looks like that leaves us with just the lack of a CE Marking in the EU.

    To sum up where we are regarding stress tests and the use of e-meters on the public:

    The MHRA are not interested in the e-meter as they do not regard it as a medical device.
    The GMC are not interested in "stress tests" as they do not regard it as practising medicine.
    It has been reported as false advertising to the OFT but I do not think it is one of their priorities.

    But we DO have the missing CE marking to go on (if it needs one).

    Writing in to your local OFT where you see stress tests might help move it to a higher priority.

    I have taken up this issue about the missing CE marking with the CoL and also pointed out that when they use it it is sometimes plugged into the power supply during use to replenish the batteries and that without a CE marking it could be dangerous. I gave them the above link. We'll see how it goes.

    It is possible that the e-meter does not need a CE marking in which case all that is left is sending complaints in to the OFT for misleading advertising and doing the usual demonstrating where they are holding stress tests.

    Edit: I've found the relevant legislation and they do not need a CE marking for the e-meter as a "measuring device" nor as "low voltage electrical equipment". I am looking at the packaging of a USB webcam and that has a CE marking on it. USB ports have a 5V supply so it should not need one but maybe it has one because it can be used as a toy by under 14 year olds.

    Looks like we just have the OFT to send letters to and the rest has to be done by picketing the stress test tables.
  2. Herro Member

    lmao @ this thread.
  3. Ann O'Nymous Member

    Thanks for your useful contribution.
  4. Herro Member

    Funny comming from you, master of "So Interesting."

    Aren't you always calling me a hypocrite?
  5. Herro. Member

    Ann, you have a beautiful soul.
  6. Ann O'Nymous Member

  7. Herro. Member

    I love you, Ann.
  8. Anonymous Member

    There's allways Mr. Pickles.
  9. RolandRB Member

    That's strictly to do with the business of rates (property tax) relief and nothing to do with the e-meter being a medical device.
  10. Anonymous Member

    i'll just leave there here:

  11. RolandRB Member

  12. RolandRB Member

    Further to the above:

    Dear Sir,

    further to my previous email to you I have been able to get further information on how the e-meter is used to diagnose physical illness. The attached document entitled "The Sequence for Handling a Physical Condition" is not literature distributed with the e-meter nor used to advertise its capabilities but is rather a single document in what is known as the "NOTs Series" which is from the confidential higher levels of Scientology. This "sequence for handling a physical condition" is done using the e-meter but this will not be clear from reading the document. All these higher levels are done using the e-meter as a tool and I can provide proof of that if required.

    I am sure that when you read the attached document it will seem very strange to you but I am happy to explain and answer any questions you may have.

    You may wish to receive this document directly from the Church to ensure its authenticity but I am very familiar with this document and can vouch for its authenticity, albeit an electronic copy rather than a paper issue.

    Although the material you read will seem bizarre and you will want to dismiss it out of hand, there is still the matter of the existing wording of the MDD 93/42/EEC which makes it inescapable that this device was manufactured with the intention for it to be used for medical diagnoses as one of its purposes. As such, I feel it should be covered by existing legislation.

    Roland Rashleigh-Berry
  13. RolandRB Member

    I got a response to my above email
    Good Morning,

    I have referred your emails to our Compliance Unit.
  14. RolandRB Member

    More about what action the MHRA Compliance Unit will take:

    I'm not sure what will become of this and we might never get the details but I'd call that a win. I'll cut and smoke a cigar (I already did that yesterday evening because I had a good feeling about this), have a couple of beers this evening and have an evil inward chuckle about all this.

    I wonder if this will up my ranking on RFW.

    Sorry to disappoint you, Herro. You had better report this matter to your handlers without delay.
    • Like Like x 1
  15. RolandRB Member

    This was an earlier email I sent that I did not post here yet

    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:

    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:

    "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
  16. RolandRB Member

    If the "Free Stress Test" tables vanish from the UK about the end of July and don't come back for the rest of 2011 then you will know who was behind it.
    • Like Like x 1
  17. Random guy Member

    If you manage to get this one through, you will piss them off considerably!
  18. Anonymous Member
  19. RolandRB Member

    It might be worth a few more column inches on RFW. :)
  20. Anonymous Member

    For some reason this thread gives me happy-pants.
    Good on ya Roland, there may be a few other angles to tackle this with yet, I am thinking footage/recordings of what is
    actually claimed by the 'expert auditors' themselves.
    Some input from ex's would be great here, especially 1st-hand accounts of how to fleece people/make peeps feel bad, and promise to
    cure or diagnose anything.
  21. RolandRB Member

    I don't know how far this will go but for an internal MHRA expert on medical devices to refer it to their Compliance Unit sounds like a major thing.

    A week ago I thought this was as good as dead. Now I think otherwise. Something big might come of this. On the other hand, maybe nothing will come of it.

    If it DOES get knocked out of the UK then since the MHRA is a European Agency, the decision can be used to knock it out of the other EU countries as well.

    It has the potential of not only stopping its use in "Free Stress Tests" but stopping its use altogether, including for audíting, unless there can be safeguards put in place so that it can never be used for a medical diagnosis.

    I am thinking, though, that at the very least this will cause the "Church" sufficient problems to have made it worth all my efforts.
  22. RolandRB Member

    At some stage I am guessing the MHRA will be talking to the FDA about the e-meter and it may stir things up at the US end as a result so we might see some major action worldwide if we get lucky.

    Just imagine what would happen if they took the e-meters away from these junkies. They'd be climbing up the wall with their BTs telling them to jump off tall buildings.
  23. RolandRB Member

    Now if we have some affidavits that the e-meter was used to diagnose a physical problem that later turned into incurable cancer then that would be just wonderful.
  24. Herro Member

    I don't think my handler is going to be upset about you getting more form letter responses. Enjoy that cigar.
  25. Ann O'Nymous Member

    Motivational employee of the month.
  26. RolandRB Member

    I am wondering how this will pan out now it is in the hands of the MHRA Compliance Unit. The following is pure speculation:

    Once it can be confirmed by the MHRA Press Office that there is some sort of investigation going on, The Guardian will publish a story about it quoting from NOTs 34, "Sequence for Handling a Physical Condition" and the clams will go apeshit and get Carter-Fuck to sue them.

    With the profile raised by the Guardian then the MHRA will feel obliged to do something noticeable. The safest and cheapest thing to do will be to demand of the manufacturer that they withdraw the product until such time that it has a CE marking. So the Church will have to recall each and every e-meter in Europe and ship it back to the US pending receiving registration for the device which they will not get in Europe in any case.

    The Church will claim that they are being prevented from practising their religion by this action and of course the Yanks will support them and pressure the UK government to accept the e-meters back again on the promise that they do not ever use it for diagnosis of health problems.

    So with the e-meters being back again the Free Stress Tests will stop for a few months and the meter monkeys will carry on using NOTs 34 to cure themselves of cancer with it and then when things quieten down the Free Stress Tests tables will be out again and they will be advising the public on how the e-meter can cure them and we will be back to the way it was. But I think this will take a year.

    In the meantime the Anons will have worked out how to film them and go to them with a false ID and film them giving out advice on medical problems they say they have and then somebody can send this to the MHRA pointing out the exact time in the video clip these things were said and then we can start at the beginning again.
  27. RolandRB Member

    NOTs 34 is so secret that if it ever got published here in full then this forum would be closed down for good in a matter of hours and it could spell the end of Project Chanology and the end of all Anon protests of the Church worldwide. Fortunately, there are none so bold nor foolhardy enough to do this.

    Edit: I hope I am not giving Herro any ideas.
  28. RolandRB Member

    I am thinking of writing another e-mail to the MHRA regarding this little snippet about NOTs 34 but I can't think of the right wording as yet. The wording of these e-mails is all important and makes the difference between it being glossed over or acted upon.
  29. RolandRB Member

    This is what I was looking for that says the NOTs are done with an e-meter including the most important NOTs 34. It is in NOTs 4:


    One of the reasons NED for OTs is an audited action, and not Solo, is because two cans give a greater depth of read than a Solo can. On a Solo can you get to a point where all of the more available charge has been removed and the needle doesn't read and just F/Ns, however on two cans you can get reads on BTs and clusters that didn't read on a Solo can. This is because you are now dealing with BTs and clusters in states below unconsciousness and stuck down the track.
  30. RolandRB Member


    Herro Herro, I think you need to report me to your handlers for Copyright infringement.
  31. RolandRB Member

    Dear Sir,

    I had not provided proof that NOTs 34, "Sequence for Handling a Physical Condition", is done using an e-meter but I have found the reference that proves it now. It is in NOTs 4 that follows (there are more than 50 issues that describe the actions in NOTs, "New Era Dianetics for Operation Thetans", so this issue comes early in the sequence). The "two cans" referred to in the extract from this document are the tin cans connected to the e-meter that you see in the video that the person on the Free Stress Test is holding:


    One of the reasons NED for OTs is an audited action, and not Solo, is because two cans give a greater depth of read than a Solo can. On a Solo can you get to a point where all of the more available charge has been removed and the needle doesn't read and just F/Ns, however on two cans you can get reads on BTs and clusters that didn't read on a Solo can. This is because you are now dealing with BTs and clusters in states below unconsciousness and stuck down the track.

    The e-meter is a religious ecclesiastical instrument, essential to the practice of the Scientology religion, and as such, can not be withdrawn from use due to religious freedom considerations, but I feel that if this instrument is being used to diagnose physical illness both within and outside the Church then it should be constructed to a sufficiently high standard to ensure that any diagnosis made with it of any physical illness is accurate and beneficial to the person it is used on. The consequences of the inappropriate use of this instrument for such a purpose could otherwise be fatal as we will see from an example. Here is an extract from an affidavit (a statement with legal standing made under penalty or perjury) made by a former very senior member of the Church called Jesse Prince:

    "b) Ted Cormier, a personal friend of mine. He had Parkinson's disease. He was ordered to leave Gilman Hot Springs and go directly to Flag for NOTS 34, auditing to cure his cancer. When this failed, Ray Mithoff sent him orders in his Pre-Clear folder for him to "end cycle." He died."

    I am available to answer any questions your department may have concerning this matter.

    Roland Rashleigh-Berry
    • Like Like x 1
  32. RolandRB Member

    I feel good about the above. I think it will hit its mark. Another cigar is in order!
  33. RolandRB Member

    I just informed the City of London Health and Safety people about the MHRA Compliance Unit thing so hopefully the meter monkeys at QVS there will have their drug taken away.
  34. RolandRB Member

    If anything is going to happen about this then I am expecting a recall of the e-meters to be requested either today (Tuesday 5th July 2011) or tomorrow. It will be hard to find out what is going on though. If Free Stress Tests stop any time soon then that will be it - the e-meter recall. Then they will miss out on a million quid a year plus at their headquarters in East Grinstaead, St. Hill. Unless they get their e-meters back they will have to close the place and the Big Ideal Org at 146 QVS will be dead in the water so they will have to close that as well.

    They get about 1000 quid a day from each person doing audited actions on an e-meter and there are about 5 people on average as a minimum getting services at St. Hill at any time, 7 hours a day 7 days a week at 140 quid an hour. Take that away and they will not be able to pay their property tax or the utilities bills.
  35. RolandRB Member

    If the Free Stress Tests stop then it would be a good time to go into an Org and look around for any e-meters or een ask about whether they still do Free Stress Tests.
  36. RolandRB Member

    It is interesting to compare the e-meter with the above. I am sure the above is not a medical device. The e-meter only gets into trouble when they claim it can explain the cause of a physical disease. If they can stop doing that on their Free Stress Tests they can probably carry on doing it. But then there is the small matter of NOTs 34 which they are not going to remove from their "scriptures".

    Though maybe they could get "done" for this:
  37. Herro Member

    Lol. Keep up the good work Roland, you're clearly making such an impact.
  38. RolandRB Member

    The matter has been referred to the MHRA Compliance Unit and now all we can do is wait. We don't know if anything has happened or will happen. What would be useful is for people to look out for the e-meter at the Free Stress Tests in the UK. If they have gone then something has already happened. If they are there then suddenly gone then something just happened. If they are still there then something might be about to happen.

    All we can do is wait but I would urge Anons to report on Free Stress Tests taking place in the UK. But I get the impression that Anons are very thin on the ground.
  39. EvanHaywood Member

    In the United States, FDA is a regulating firm, responsible for manufacturing, repackaging, relabeling or importing medical devices. Medical device manufacturers need to register their product, facilities and follow general control needs defined by FDA. The devices are classified in three categories according to the risk they create to consumers.

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