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

To info@ema.europa.eu
From: Roland Rashleigh-Berry (rolandberry@hotmail.com)
Sent: 31 May 2011 08:37:18
To: info@ema.europa.eu

Dear Sirs,

I am wondering whether it is your agency that deals with the approval of medical instruments that diagnose disease. I am thinking specifically about the use of the Scientology e-meter that is used to diagnose stress in passers by outside their churches and whether this practice and their instrument to diagnose stress needs to comply with regulations covered by your department.

Yours faithfully,
Roland Rashleigh-Berry

FW: Question about medical instruments RFI-2011 No 05-312‏
To 'rolandberry@hotmail.com'
From: EMA Info (EMAInfo@ema.europa.eu)
Sent: 31 May 2011 09:57:45
To: 'rolandberry@hotmail.com' (rolandberry@hotmail.com)


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Q: regulation of medical devices to diagnose stress in subjects

From: Roland Rashleigh-Berry (rolandberry@hotmail.com)
Sent: 31 May 2011 10:25:37
To: info@mhra.gsi.gov.uk

Dear Sirs,

the Church of Scientology in the UK frequently set up tables outside their churches and offer "stress tests" to passers by using a device they call an e-meter which is used to diagnose this condition. Could you tell me if this instrument has to be approved by your agency and if so, whether it has received approval for the use to which it is being put.

Yours faithfully,
Roland Rashleigh-Berry

Roland this is good stuff here, i liek how you think...

If these fishing expeditions lead anywhere, any chance you could start a new thread to properly focus on these fine efforts since it has nothing to do with sparrow's FDA complaint nor the catholic.org article?

OK, but most likely it will amount to nothing so will leave them where they are for now.

BTW, it IS to do with Sparrow's FDA complaint in that it is for the European end.

You want to e-mail devices.compliance@mhra.gsi.gov.uk instead of info.

From a quick review it looks like the e-Meter is probably a class IIb device, which means you need to have your design and manufacturing processes conform to an appropriate ISO standard and have this audited regularly by a recognized company.

Anyone know if the e-Meter has a CE mark on it?

"RULE 10 covers active diagnostic devices. They are in Class IIa if they supply energy (other than
for illumination) absorbed by the body or if they monitor physiological processes or if they image in
vivo distribution of radiopharmaceuticals. They may be in Class IIb if they are used for similar
monitoring but intended specifically for critical situations. Radiological equipment will also
generally be in Class IIb."

I am impressed, Roland. Very nice work.

It needs to move to its own thread now.

I guess a situation room is appropriate.

bump for watching new split thread - thks mods

Looks like a medical diagnosis using a medical instrument to me!



Actually, if it can tell whether your stomach problems is not due to illness but rather due to your reactive mind then maybe doctors should be using this instrument.

GO ROLAND!

The Scientology e-meter and "stress tests"‏

From: Roland Rashleigh-Berry (rolandberry@hotmail.com)
Sent: 31 May 2011 21:21:06
To: devices.compliance@mhra.gsi.gov.uk

Dear Sirs,

I have a question about the Church of Scientology device know as the "e-meter" that is used on passers by of their churches for their advertised "stress tests" that they commonly have set up on tables outside their premises. These devices are used to diagnose whether participants are suffering from the medical condition known as "stress". The participant holds two metal cans attached by wires to this e-meter which passes a very small electrical current through the bodies of people and measures their electrical resistance and well as amplifying sudden changes of electrical resistance that occur in response to verbal questions posed to the participants.

I am wondering whether these devices in the way they are used are compliant with all applicable regulations covered by your agency and if not, when they will either be made to be so or universally withdrawn for this purpose across the European Union.

Yours faithfully,
Roland Rashleigh-Berry

---------------------------

Now follows the autoresponse. Note that evidence may be required for them to do anything otherwise they may conclude it is a "non-complaint". <ha ha ha>

---------------------------

Thank you for notifying us of a suspected non-complaint Medical Device under the Medical Devices Directives 2002 (As Amended).

The information you have provided will now be risk assessed to determine whether an investigation is warranted. However, allegations of non-compliance with the Directives can only be investigated if they are supported by evidence.

As you will appreciate, the Agency is bound by Article 20 of the Medical Devices Directives, which requires that details of any investigation and it's outcome should remain confidential between the Agency and the Manufacturer. Nevertheless, you may rest assured that any enquiry will be pursued with all due vigour.

Thank you once again for bringing this matter to our attention.
-------------------------------------------------
I have a good photo linking the advertised "stress test" with subjects being hooked up to the e-meter in this form:

http://upload.wikimedia.org/wikipedia/commons/3/3d/Stresstest.jpg

(came from here http://en.wikipedia.org/wiki/File:Stresstest.jpg )

And I have a perfect video of the whole patter of the use of the electrical device known as the "e-meter" to make a medical diagnosis of the medical condition known as "stress" in this form:



I am working on the European Front but I want to let my 'merkin cousins know that what you see above is enough to get it stopped in the US.

It would be nice to have matching evidence taken in Europe but I am happy for now. And when I say "happy" it means I cut and smoked a cigar.
------------------------------------------------

Dear Sirs,

Further to my email of yesterday, I read in your automatic response that you require evidence before an investigation can be started therefore I submit the following as proof. You can see the e-meter being used to diagnose stress in a person. This was done in America but since this Church is controlled from America then the same patter and same techniques will be in operation in Europe.

http://www.youtube.com/watch?v=ntpQHIzP6ZA

Yours faithfully,

Roland Rashleigh-Berry
------------------------------------------------
Dear Roland,

Thank you for your enquiry of 31 May which is now receiving attention.

Straightforward requests can expect a reply within a few days. Those requiring a more detailed response or contribution from a specialist are likely to take longer. In any event we endeavour to provide a response to all enquiries as quickly as possible, within the Agency's target response time of 20 working days from the date of receipt your enquiry.

Kind regards
European Regulatory Affairs
Medicines and Healthcare products Regulatory Agency
--------------------------------------------------------------------
Sent to the General Medical Council in the UK:


Dear Sirs,

I am wondering whether members of the Church of Scientology in the UK who do "stress testing" on the public outside their churches require a medical licence to carry out such activities because "stress" is, I believe, a medical condition and they appear to be diagnosing this medical condition.

I will give you a link to a video recorded during this activity. This was recorded in the US but the same will be done in the UK.

http://www.youtube.com/watch?v=ntpQHIzP6ZA

If they require a licence to do this then please advise on what should be done next to ensure this practise complies with regulations.

Yours faithfiully,
Roland Rashleigh-Berry

Another one sent to the GMC in the UK
---------------------------------------

Dear Sirs,

further to my e-mail of yesterday, I have another example of the Church of Scientology practicing stress testing and making a medical diagnosis. In this example they give advice on the cause of stomach problems and a remedy to bipolar disorder.

http://www.youtube.com/watch?v=zDMRCaM_hvo

Again, this is from the US but since the Church is controlled from there the same patter will be used in the UK. This seems very much like medical practice or mental health practice to me plus using a medical instrument to aid in the diagnosis.

Your faithfully,
Roland Rashleigh-Berry

Note that the GMC is UK specific. The e-meter as a medical device regulated by the MHRA is Europe-wide.. I am attacking the e-meter as a medical device across Europe but I am also attacking the whole practise of stress-testing and making medical diagnoses with it on the medical licencing front and I can only do that for the UK. I think it needs to be attacked on both fronts. So people in other European countries will have to take this up with their own regulators for the practice of medicine.

So the war is on two fronts:

1) European-wide effort to get the MHRA to ban the use of the e-meter as part of any medical diagnosis for stress or any other medical condition across Europe and so remove e-meters from "stress testing".

2) UK wide to stop church of Scientology staff giving medical advice unless they are licensed by the GMC (which they never will be) and so knock out the whole stress test and its patter used to introduce people to Scientology.

--------and for the future--------

3) If 2) works and the stress tests stop then maybe focus on the touch assists the VMs are giving injured or traumatised people at disasters. Say that "touch assists" is a medical procedure that involved applying finger pressure to the body parts of injured persons (perhaps directly to broken limbs themselves) and so, as medical practicioners, they should be licensed by the GMC (which they never will be). Then no more VMs in the UK.

Imagine that in the UK. No stress test tables. No VMs turning up at disasters or introducing themselves to the public.

How will they get the raw meat through the door then?

Edit: Now I think about it maybe it is better to get 3) to drive 2) hence my later post.

Roland, you continue to deliver.
View attachment 340x_custom_1267994345305_a20few20good20men20-20to

&quot;touch assists&quot; given to injured people by Volunteer Ministers of the Church of Scientology‏


To gmc@gmc-uk.org

Dear Sirs,

I would like to bring to your attention the particular issue of the &quot;touch assists&quot; given to injured people at scenes of disaster by the &quot;Volunteer Ministers&quot; (VMs) of the Church of Scientology in the UK. What these &quot;touch assists&quot; consist of is best explained by their own literature that you can access in the link below.

http://www.scientologyhandbook.org/SH6_4.HTM

Volunteer Ministers are known to turn up at disasters in the UK to offer their own form of assistance. For their &quot;touch assists&quot; this involves the repeat application of finger pressure and could be performed on seriously injured people at the scene of a disaster. This repeat finger pressure might even be applied to broken limbs, perhaps even limbs with compound fractures. If the people performing these medical procedures are not trained to a high standard and possess basic medical knowledge, at least up to First Aid standards, then I feel there is an attendant risk of causing further injury through these actions. As such, I feel they should be licensed as medical care workers in performing these procedures and I believe they are not.

I hope there is something your agency can do to ensure regulations are adhered to for the sake of the safety of the UK public.

Yours faithfully,
Roland Rashleigh-Berry

oh hai! happened up this while digging thru old leaks from puddle for other stuffs, and thought Roland might find a use for it ITT

Emeter - Mark Super VII Owner's Manual (1990)

Torpedoes launched and running.

(I've also given the press a heads up)

Good work, Roland.

Q. Wondering if there exists some kind of medical umbrella under which stress diagnosis is regulated/enforced across the EU.

There is nothing across the EU like that. Only drugs and medical devices. Practice of medicine is country-dependent on applicable laws.

I hope it is possible to get things moving in other European countries aboiut this. There will be some sort of governing body for medics in each country. It will be the same body as bans people from practicing if they have done something very wrong or if they are unfit to practice.

I think this is a much better angle to use than pointing out to emergency services that the VMs are just a nuisance and hoping the emergency services chase them away. I use the angle that VMs are medical practicioners and so should be licensed and I ask the appropriate agency to consider licencing them.

If ambulance workers are covered by some sort of regulations or laws then I am guessing that VMs should be covered by the same regulations or laws. Is there an ambulance worker here who can enlighten us?

If we could force VMs to get a certificate (or whatever) in First Aid then that would be enough to stop them poking injured people with their fingers.

Somebody please find out what regulations ambulance workers are covered by. If you know one then please ask them and report back. They might work for St. John's ambulance, for example.

This is useful
http://en.wikipedia.org/wiki/St_Joh...alifications_in_First_Aid_and_Allied_Subjects

I imagine the VM leader would have to hold a qualification to allow them to supervise the others.

This issue of VMs poking injured people with their fingers during their "touch assists" could be a good issue to bring up with your member of parliament in the UK. You could express your concern about it further injuring people. But if you do write to your MP in the UK remember these points:

1) Write to YOUR MP for YOUR ward on PAPER giving your name and address as you will receive a written response.
2) Write it in your own words - no form letters.

You can find out who your MP (for the UK) is here:
http://findyourmp.parliament.uk/

I think this is needed for the UK. I can't do it because I don't live there.

Thinking over this with VMs compared to ambulance staff then ambulance staff hold First Aid qualifications and their job is to look after patients until they can receive medical help whereas the VMs are not doing this but rather treating the patients, some of whom will be severely injured, so it seems to me that they should hold qualifications to allow them to do this and would require qualifications in an approved branch of medicine and hold a certificate to practice issued by the GMC.

Nice.

Even though they are highly trained, and certified as such, the EMTs on the ambulances in the US are still under the supervision, via radio, of a doctor at the hospital or trauma center. They don't administer anything without the doctors "OK". So you may be on to something with the VMs administering medical treatment with their "touch assists" that is not monitored or controlled by an MD.

BigBeard

That's good info - thanks. Yes, I think I am onto something. Reported to the GMC (who have not even acknowledged my email) so now given to the press.

If somebody in the UK could write in to their MP about it then this would greatly help. I can not do it from where I am.

If in another country then please report as well through your government representative.

Just think if we could ban the use of the "touch assist" or any other form of counselling the patients one country at a time then wouldn't that be worth a celebration? Report to the relevant authority and if no response follow up with the press. Done country by country then Big Wins(tm) could be ours. I've started with the UK and I hope people from other countries will do the same.

The "stress test" thing might get nowhere because psychologists are not obliged to register and there is no control over them in the UK.

http://www.psychotherapy.org.uk/article1182.html

The "touch assists" by VMs is still running.

As for the "stress test" then we might have to use the Office of Fair Trading to counter them.

http://www.oft.gov.uk/about-the-oft/legal-powers/legal/misleading-advertisements/what-is-it

EMA wrote back to say it was not their affair and that I should write to the HMRA which is true and which I have already done. HMRA are looking into it.

YES! YES! OH YES! (so satisfying!)
keep on them Roland!
The squeaky wheel gets the greese

They are just torpedoes launched and running. None of them might hit the target. For stress tests we might have to use the Office of Fair Trading in the UK if that fails but then that would have to be done locally. So for now we just see if we get lucky and get a result. Save your cheering for when you hear the KABOOOM !!!

gentle prodding and positive reinforcement never hurt anyone
well..... unless you are talking about COS love bombing! lol

good job Roland... altho your new avatar is way too nice & friendly looking.

needs moar of cantankerous smirk or atleast a smart ass leer to suit you.

I was trying to do one. Will try again when in the right mood.

Edit: Is that any better? It's more of an "I'm getting up to as much trouble as I possibly can and enjoying it" look.

A reply from the GMC
-------------------------------

Dear Mr Berry

Thank you for your email of 2 June 2011 regarding a license to practise.

'Stress-testing' is not necessarily a medical procedure, therefore a person conducting this test does not have to be a medical doctor nor a registered medical practitioner.

-------------------------------

This means the use of the e-meter for this purpose will probably not matter so both these torpedoes missed their target.

There is one more torpedo left. That to use the "misleading advertising" torpedo and use it locally where they set up their "stress test" tables. Write in to the fair trading office and complain and say you were misled by their advertising.

I've been banging on about this for years but very little has come of it.
Here are the Consumer Protection from Unfair Trading Regulations of 2007 which scientology breaches or can be shown to breach, they fall under Schedule 1 regulation 3 (5)(d):
3. Claiming that a code of conduct has an endorsement from a public or other body which it does not have.

6. Making an invitation to purchase products at a specified price and then—

(a) refusing to show the advertised item to consumers,

(b) refusing to take orders for it or deliver it within a reasonable time, or

(c) demonstrating a defective sample of it,

with the intention of promoting a different product (bait and switch).


7. Falsely stating that a product will only be available for a very limited time, or that it will only be available on particular terms for a very limited time, in order to elicit an immediate decision and deprive consumers of sufficient opportunity or time to make an informed choice.

12. Making a materially inaccurate claim concerning the nature and extent of the risk to the personal security of the consumer or his family if the consumer does not purchase the product.

And my personal favorite, which covers every scientology claim:
17. Falsely claiming that a product is able to cure illnesses, dysfunction or malformations.

Some areas where the cult tends to operate:
20. Describing a product as ‘gratis’, ‘free’, ‘without charge’ or similar if the consumer has to pay anything other than the unavoidable cost of responding to the commercial practice and collecting or paying for delivery of the item.

24. Creating the impression that the consumer cannot leave the premises until a contract is formed.
26. Making persistent and unwanted solicitations by telephone, fax, e-mail or other remote media except in circumstances and to the extent justified to enforce a contractual obligation.
Judging from the usual Hodkin Address, their home office for Trading Standards is West Sussex. So that's the one to contact if possible, attempts to go to any other authority would just be directed there anyway.

Well done Roland. Though unfortunately I'm not too hopeful. There are plenty other quacks on the streets of Europe, saying they can cure illness with crystals, or pendants or reiki or dead llama fetuses [ok, that one I've seen in Bolivia].

This is a good point, the difference is that scientology is a registered business and therefor is identifiable and can be held responsible and accountable. They're quacks with a registered address.

You're making a very good point there. In addition, there is already a precedent against Scientology and e-mter, so that's good. Europeans and other countries really hold the FDA in high regard and might follow the suit.

maybe Roland can send them a copy of the FDA regulation that was made for e-meters?

There is always just plain safety of electrical equipment. I guess that even a ohm meter you buy at your local hardware shop has a safety approved sticker on it. I don't know if the e-meter has one.

Can somebody dig around about safety stickers and such like. Does a torch (flashlight) need one, for example? If they do then surely the e-meter needs one if tested on the public.

They ruled that there was supposed to be stickers on the emeters
Somewhere on WWP there is the actual regulation that was made