The principle of equivalence, Einstein and Tecartherapy

The principle of equivalence, Einstein and Tecartherapy

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The principle of equivalence, Einstein and Tecartherapy

Catch the wave!

Not a day goes by that someone wants to “ride the wave of success” of Tecartherapy.

Always wondered how people could get up one morning with the idea of “inventing” a new tool for making Tecartherapy, thinking about making money and … succeeding: a few steps and few efforts are enough to reach the intent.

Everyone knows this story: “Tecartherapy” device selling phenomenon exploded like a bomb.

The resulting market is flourishing “pulling” for years and that the success wave is long moreover several competitors displayed.

Stories of unfair competition and trade war no longer counted.

It still mystery how “the box with some wires” has to be registered as an electro-medical and marketed as a device used in physiotherapy.

I am sure; there has always been extreme curiosity to understand how the various tools that sold as “Tecartherapy” work.

I have tried many over the years, not all, but almost. No one even comes close to the functionality, in the strict sense of the term, of the original Indiba SA tool.

Every time I get my hands on an instrument other than the “original” one, the questions that arise are several.

Gianluca is a friend of mine, and we know each other for a lifetime, Some of the mischief he and I, and he was a professional athlete, I duffer. Today he has a company that creates electrical circuits, assembles semi-finished electronic devices for third parties and in his out searching work he came across the construction of electromedical devices.

The year was 2010 and one day Gianluca presented me with a magazine:

Nuova elettronica” a monthly magazine for laboratory nerds that dedicated a whole special issue to the Diatermiain that month.

Inside we read how to build a device for Tecartherapy, and there are all the electronic diagrams whit case indications.

Gianluca proposes me to build an “innovative diathermic device for “Tecartherapy” using those patterns.

The strategy was more or less this:

Combining his skills and his means with my experience, then we would have relied on the supervision of his company’s electronic engineer:

“No more bets!”

Unfortunately, to the point “my experience” and Gianluca’s strategy was watery, and so the whole plan concocted shipwrecked: we did not have the resources to set up scientific research work, and we were not even able to test the effective functioning of metabolism of the biological tissues of the human body.

Thinking today about what I learned on that occasion, it makes me smile because the enthusiasm behind our intent has given way to common sense and the ability to make choices according to a basic idea based on the ability to distinguish the good things from bad ones and the will to choose the first ones.

Today I smile because in light of the facts it seems that my choice of then is not a common thing and I look amazed at the many, many Tecar therapy devices that can found on the market.

I remember that it was 2012 when opening a magazine in the physiotherapy sector, to each article followed an advertising page of a diathermic device for Tecartherapy.

Common sense, professional ethics, morals, and lived experience tell me it is NOT possible that all the “Tecartherapy” devices I have touched, tested and tested on myself can be on the market.

 

I ask you a couple of questions to understand:

  • Has it ever happened to you to use a “Tecar” device that fails to keep the output power stable and burns immediately, always and in any case, leaving you as the only option to run the electrode on the skin as quickly as possible?
  • Have you ever used a “Tecar” device that does not signal the malfunction of a return electrode transmission cable?

Here is the question that must ask, though:

  • How was the medical CE obtained and the ministry of health registered, which then allows us to certify that an electromedical conforms with the sale?

In 2010, I sought the answer by searching for precise information describing the exact procedures.

I read the European law that we all have to refer to in Italy and my friend Gianluca, and I realized that we would never be able to get a medical CE for our Tecartherapy device but today I know we were probably wrong …

STAY TUNED!

Not long ago, it was Sunday evening; I was lying comfortably on the sofa zapping as every average Italian does. Moreover, I made a mistake: The Error!

I have been telling myself for years that I cannot “ruin my liver” by watching the “Report” broadcast, but then from time to time, I fall back into a frenzy to take a peek, a single service, a few minutes and … Bam! That evening I watched the whole episode.

The title of the service broadcast was “affairs of the heart” by journalist Giulio Valesini.

The service culminates with the inquiry of the Dutch journalist Jet Schouten interviewed by Giulio Valesini that looks like a joke, but alas it is the description of a private negotiation that shows how it can be certified as a Medical Device a retina of oranges bought at the supermarket.

If you want to have a look at what I am describing to you:

httpss://www.rai.it/programmi/report/inchieste/Affari-di-cuore-3357cd39-d57f-4625-a9cb-a7e463be341e.html

I figured out how and realized that medical EC is an easy goal to achieve: all too easy!

With Gianluca at the time, we informed that a few simple steps are needed:

The manufacturer presents the “technical file” of the new device for Tecartherapy to the accrediting body.

The Accrediting Body (which is a private company) called the Notified Body takes charge of the application for certification and accompanies the company requesting the EC “medical device”.

The technical file must contain:

1. Document with design diagrams

2. Risk analysis document

3. Document reference technical standards applied

4. Document of test reports

5. Document analysis of clinical evaluation

6. Labelling project document

7. Instructions for use document

The Notified Body follows the client in the submission procedure and expects the technical times for the electromedical device for Tecartherapy, in our case, to credited.

What we did not know at the time was that we would produce the one required by the technical file in point “5. Document analysis of clinical evaluation “was and remains today child’s play: bad boys!

It works like this:

better bet and invest some money (in a short time) on the Notified Body instead of spending money, time and energy to produce scientific evidence that validates the effect of your innovative device.

Now if you are wondering how this is possible, sit down, take a breath and do not start thinking that I am a conspiracy theorist.

I am describing facts that happen and documented.

I have to pull on “The System” and its laws, in particular, the one that regulates the sector called MedTech in Europe.

I quickly summarize what you find in the Report service.

The medical devices in Europe approved for sale with a system designed to be fast and easy “to overcome”. In the US, it seems that the procedure is much more severe and there are no conflicts of interest with private entrepreneurship that instead in the EU is present and organized to be well “infiltrated”.

The highlights are:

  • The company that attends the Medical Device accreditation exam at the EU MedTech commission is not obliged to make the scientific documentation public.
  • For the presentation of scientific data, the company presenting a medical EC request may use the principle of equivalence.
  • Controllers charge for not checking (see the net of oranges)

I want to clarify how the principle of equivalence works because I have seen and see every day its application by the whole physiotherapy world, from the doctor to the operator, passing by the seller of medical devices.

You can do it too, and it works like this: working on the technical file.

    • A. Photographs of the device are attached

    • B. Existing clinical data of the already approved device copied or new ones are “invented.”

    • C. A technical/scientific report is written and attached, made up of data taken from studies done with the already existing and approved.

    • D. DECLARES that the new device under examination IS EQUIVALENT.

If you have not understood correctly, the law accepts statements that sound like this:

“Since your device also works my work because I called it as yours.”

When the sun rises, the rooster sings, and the ancient Mayan population believed that it was the rooster that made the sunrise: but this is another story!

Today the law makes it possible to appeal to the principle of equivalence, and the controllers do the rest.

There is no hope for the moment that things improve. The law is 20 years old and reviews in 2020:

    • There will not be a verification step by direct public inspection.
    • The Notifying Bodies will be reconfirmed and always be private companies certified by the EU.

I remind you that Heinstein said that the difference is visible only from a reference system that is not in solidarity with the masses in motion.

If it is still the equivalence that dictates the effectiveness parameters of a Medical Device, the sensation always is that of Heinstein’s elevator into which he rushes without noticing the mass difference, (even though I am small and you are significant) but eventually crashing both to the ground because we live within a gravitational field.

If you want to deepen and verify the info you have read:

Here are links to the documentation of the EU Law in the Medtech area.

httpsss://eur-lex.europa.eu/legal-content/IT/TXT/PDF/?uri=CELEX:31993L0042&from=IT

httpsss://eur-lex.europa.eu/legal-content/IT/TXT/PDF/?uri=CELEX:32017R0745&from=IT

httpsss://www.aosp.bo.it/files/dlgs_46_del_1997_modificato_dal_dlgs_37_del_2010.pdf

httpsss://www.dichiarazionediconformita.eu/dispositivi-medici/novita-per-i-dispositivi-medici

For any advice write to me: vincelancini@gmail.com.

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Vincenzo Lancini

PI: 02947020166