Temple street hospital using unauthorised devices

br8

https://www.boards.ie/discussion/comment/121181615#Comment_121181615

It's not about EU approval or CE marks. The springs used in the Dutch study did not have any EU approval.

BUT, THEY WERE MEDICAL GRADE!! The dutch did it properly and got them made. They didn't buy low grade steel springs from springs'r's for €4.99 a pop

It's surgery 101, you cannot put non medical grade items in a human body.

https://www.boards.ie/discussion/comment/121181615#Comment_121181615

just to make the point that it wasn’t just the EU but no where in the world has approved this treatment. At best the FDA has noted it has potential.

children should not be the subject of experimental surgeries that are hardly more than theories at this stage. There’s a study on the matter and as far as I can tell it’s never had anything beyond that (ie medical trials etc).

If an adult wants to commit to an experimental procedure for the betterment of medical science and potentially their own lives, god bless

Mrs OBumble

https://www.boards.ie/discussion/comment/121181855#Comment_121181855

On that basis, no new techniques for treating children could ever be progressed.

Sheep breeder

https://www.boards.ie/discussion/comment/121180322#Comment_121180322

you should take up writing fantasy novels and forget about facts, what have you got to play in this game, maybe playing as a defender like Harry Maguire.

Sheep breeder

https://www.boards.ie/discussion/comment/121180519#Comment_121180519

Fact parents are not told exactly what parts go into their children bodies, they are lucky that the procedure is explained and roughly how long it will take and the surgeon only knows when the operation starts what he is going to encounter, the surgeon and team are under pressure with the backlog caused by the lack of poor attention being paid to the backlog by the HSE and the government and Simon the weasel has a lotto answer for.

Sheep breeder

https://www.boards.ie/discussion/comment/121180539#Comment_121180539

What proof have you got that parents agree to these unapproved procedures. Looking forward to the evidence that you provide here.

Rubberchikken

It's shameful and a.stain.on this country's medical service but is anyone here truly surprised?

The only shock I have at this stage is.qhy it took so long to come out.

The findings will be dragged out. The questions asked and answered(some not all) will be so slow.in coming we will have.moved into the next scandal.

This surgeon (and I use the term loosely) should.be named shamed and fired.

But we know that won't happen.

Will we find out in time that his credentials are in question like other doctors in the HSE system in the past.?

Caquas

https://www.boards.ie/discussion/comment/121181814#Comment_121181814

So you would agree with this procedure if a “MEDICAL GRADE!!” spring was used, even if it was not approved by the EU?

Who decides what is a “MEDICAL GRADE!!” spring if it is not EU approved?

And we are back to my original question- why did the surgeon use these unapproved (not MEDICAL GRADE!!) springs?

https://www.boards.ie/discussion/comment/121182216#Comment_121182216

As I said, correct me if I’m wrong.

But if these procedures were carried out without the consent of the parents of these suffering children, what about all those idiot journalists who harped on about “unapproved springs” while failimg to mention an incredible failure of medical ethics.

Tow

https://www.boards.ie/discussion/comment/121181855#Comment_121181855

All medical procedures start out as experimental. This is how we progress.

Tow

https://www.boards.ie/discussion/comment/121182262#Comment_121182262

What is EU approved? You mean with a CE mark? You do know that CE Marks are self certified. The joke is that CE stands for China Export!

Doc07

https://www.boards.ie/discussion/comment/121182371#Comment_121182371

partially correct. Self certified for some of the lowest risk class of devices . Absolutely NOT self certified for higher risk devices or anything that is implanted

ohnonotgmail

https://www.boards.ie/discussion/comment/121182262#Comment_121182262

If you are making claims then you need to provide proof. What is the source for what you are posting?

https://www.boards.ie/discussion/comment/121182341#Comment_121182341

I simply wouldn’t give this chap the satisfaction of what he has done be made comparable to actual clinical trials and safe acceptable practices in testing experimental procedures.

I dare say there’s very few cases where children were more or less secretly implanted with devices or objects which were medically unsuitable for implant to say the least.

a study was done which suggested it may have some benefit but there’s nothing in the study that I’m aware of which recommends the procedure should be carried out.

Of course all experiments have risks, I’m nearly positive where possible due to those risks kids would not be first on the list to test on but regardless when these things happen everyone is on the same page about all involved. In this case it appears no one but the surgeon knew the full details and there was clearly not enough follow up care.

I mean in a real clinical trial if several patients present with problems after the procedure/medication they generally stop to take a look at what’s happening rather than just carry on as he did…

RetroEncabulator

https://www.boards.ie/discussion/comment/121182570#Comment_121182570

This outlines some of the current Irish and EU processes:

https://www.hpra.ie/homepage/medical-devices/regulatory-information

MDR: (Medical Devices Regulation [EU regulation]) https://www.hpra.ie/homepage/medical-devices/regulatory-information/medical-devices-regulation

Hellrazer

@[Deleted User] a study was done which suggested it may have some benefit but there’s nothing in the study that I’m aware of which recommends the procedure should be carried out.

Heres the full Dutch study.

dutch study.pdf

Well worth a read especially the part quoted below.

The springs were made specifically for the dutch study in medical grade Titanium to the highest standard. The springs used in the Irish kids werent. I know its a joke about them being bought in woodies or B&Q but they may as well have been for all the use they were.

While the Dutch concept looks very promising its still in early stages. The system in use currently employs titanium rods fixed to the spine and in some cases these need to be removed and longer ones put in. The dutch method is trying to remove the need for further surgeries.

Now as a parent whos child got the spinal operation - had a surgeon explained it was experimental I dont think we would have consented. Its hard to say now that its been done and hindsight is a great thing.

The issue here is that this surgeon from what my gut is telling me is that they went rogue and implanted non medical grade implants into kids. Maybe or maybe not the parents consented to the surgery but at the end of the day the materials used werent of a satisfactory use for implantation into a body and thats the most serious issue here. Not about whether the parents consented or the springs were EU approved but the fact that the surgeon took it on himself to carry out unauthorized experiments on kids.

The key component of the experimental device (SDS) consists of a custom-made helical coil spring that was designed after extensive literature reviews to determine force safety limits and spinal growth [[6],19, 20, 21, 22, 23]. We chose a maximum spring force of 75 N, which is much lower than the distraction force of a single MCGR rod (around 200 N), and forces applied in TGR lengthenings (which may easily exceed 500 N) [[15],[19],[23]]. The medical grade titanium (Ti-6Al-4V) spring was manufactured by Lesjöfors AB (Karlstad, Sweden) to fit around a 4.5 mm rod, with an uncompressed length of 72.0 mm, compressed length of 38.0 mm, spring constant of 2.15 N/mm and maximum compressed force of 75 N [[36]]. Since Lesjöfors AB does not have a quality management system for producing medical devices, the ISO 13485 certified department of Medical Technology and Clinical Physics of the the UMC Utrecht acted as the manufacturer of the spring, took lead in the design and manufacturing process and created an Investigational Medical Device Dossier, including quality control, risk analysis and postmarket surveillance and vigilance.

Caquas

https://www.boards.ie/discussion/comment/121182760#Comment_121182760

I am not making claims, as I said very clearly in my post I was offering a hypothesis and inviting corrections.

That’s how science works.

Caquas

https://www.boards.ie/discussion/comment/121183188#Comment_121183188

That’s very helpful.

I hope your child is feeling better.

I note the conclusion that

However, as in all growth-friendly implants, complications and reoperations could not be prevented, which emphasizes the need for further improvement.

I assume that was explained to the parents. If not, why have the media and politicians ignored the central issue in this scandal?

And we are still left with the most basic question- why? Or more precisely now, why did Temple Street Hospital not procure these highly specialised springs from their original manufacturers, as described in this paper?

If the answer is saving money, what did the HSE do with the other €22,000,000 it spends each year? (That’s a trick number, just millions. The HSE spends a thousand times more that that annually, I just dropped a few zeros). Oh, and that is just the HSE’s “budget”, an imaginary number announced each year in the Budget. The HSE actually spent a couple of billion on top of that last year and will go on spending more than any Government will allocate to it.

But back to those cheapo springs and the unanswered question- why?

ohnonotgmail

https://www.boards.ie/discussion/comment/121183692#Comment_121183692

so you're just making stuff up. thought so

Caquas

https://www.boards.ie/discussion/comment/121183821#Comment_121183821

That’s what they said to Socrates!😁

Now prove me wrong!

Sheep breeder

https://www.boards.ie/discussion/comment/121183821#Comment_121183821

Well said that is it a nutshell, just trying to make a case that the surgeon got consent from parents to try play god and massage his ego.

ohnonotgmail

https://www.boards.ie/discussion/comment/121183846#Comment_121183846

The only people who say "prove me wrong" are bullshitters.

Caquas

https://www.boards.ie/discussion/comment/121184203#Comment_121184203

A Class-A Bullshitter like Einstein is often quoted as saying "prove me wrong"

"No amount of experimentation can ever prove me right; a single experiment can prove me wrong”?

Whether or not he used these words, it encapsulates a truth about the scientific method, and rational discourse in general. And it is very apt when we are discussing an experimental medical procedure.

But you should get busy shutting down all the other discussions on Boards were people make speculative statements, conjectures or hypotheses which have not yet been proven to your satisfaction.

I suggest you start over on the Tubridy thread. Lots of details came to light which would never have been revealed if nothing could be said which was not already proven e.g. those barter accounts.

ohnonotgmail

https://www.boards.ie/discussion/comment/121184779#Comment_121184779

you're not Einstein.

Caquas

https://www.boards.ie/discussion/comment/121184984#Comment_121184984

None of us are, but happily Einstein wasn’t claiming a personal privilege. He believed in the rational process of discovery by hypothesis and refutation, AKA science.

I expressly invited everyone here to correct me if my thesis was wrong.

There is another method that you might prefer. Let’s call it legal inquiry. Everyone involved has a vested interest in the outcome. Everyone tries to block any evidence that might disadvantage them. Any assertion is challenged, not just to disprove it but to undermine it in any way e.g. by personal attack. And if an assertion is in any way “defamatory”, all hell breaks loose. How has that method of fact-finding worked for us in the myriad Tribunals and Inquiries? Yet that is what our politicians want in this case.

Here’s something that will blow your mind. I would be perfectly happy to have my thesis disproven. I would be even happier if someone could explain why the surgeons in Temple Street used these springs.

I would be horrified and scandalised if the surgeons had operated without the consent of the parents. Part of the scandal would be the failure of the media and politicians to reveal an outrageous breach of medical ethics. If you know something about this that we don’t, I would ask you please to say it now.

But I won’t have you shut down discussion when you don’t have anything to offer.

a safe bet Einstein had better things to do than argue on boards about whether he was right or wrong.

TheChizler

I've seen conflicting reports, simultaneously saying possibly dozen(s?) of patients were affected, but only 3 springs were actually used by this surgeon. Anybody got a clearer understanding?

RetroEncabulator

https://www.boards.ie/discussion/comment/121185199#Comment_121185199

It used to take ages to argue by sending postcards and telegrams tbh.

However, there's a massive problem with this whole incident. It's not something very light hearted.

CE approval or no CE approval, anything implantable has to be biocompatible. A LOT is involved in that and it's not something you can gloss over. It's regulated for, but it's hardly a surprise that it's essential that anything like that fully compatible with being implemented. It's not just a mechanical or sterilisation issue - it's about the materials used, types of metal, purity of metals, coatings, all sorts of stuff and how they interact with your body and immune system. There's a whole branch of biomedical engineering dedicated to this kind of thing. It's an incredibly complicated area that crosses between medicine, engineering and materials science.

I still can't get my head around how this could possibly have happened.I mean, there are extensive regulations in place, but it just seems bizarre that someone working in that field would in anyway just gloss over that and use some generic device that's not specifically designed for this purpose.

All any of us can go on at the moment is what's in the public domain. I think it's very important that the details are made public. There's a huge element of trust in healthcare involved in this.

I mean, this is like boarding a plane and discovering the engines had been repaired using washing machine components.

It just is not the kind of thing you should have to think about in a developed medical system in a developed country in the EU. I'm not staying that to in anyway denigrate developing world countries, I'm just saying it in the sense that we have serious resources, systems, regulations, supposedly excellent training and so on. There aren't really any contextual issues that explain this away.

I would like to see this forensically analysed, step by step, just like an air crash investigation. We need to know what happened and how to ensure it cannot ever possibly happen in any context again. I know people will dismiss the notions of 'lessons will be learned' but they really have to be. The system's clearly not working.

https://www.boards.ie/discussion/comment/121185522#Comment_121185522

No it’s honestly not. What I want to see happen above all else is that the surgeon is not the only one who is severely sanctioned here. Heads should roll for this.

Flinty997

https://www.boards.ie/discussion/comment/121185259#Comment_121185259

I got the impression only very few were used. Then removed.

I also got the impression that separately to this, there's a higher rate (than normal) of infections in patients (without springs). But also this surgery has a high infection rate normally.

No idea what's the normal rate of infection or fatality for these surgeries. No idea if there's any other underlying issues or complexity. It's all very vague.

Flinty997

From experience and in my opinion it's very likely these surgeries were discussed at length with all parties before going ahead. It would have been a large team of people for the surgeries and supporting it.

If you were to sanction all those people it's likely you'd obliterate a wide range of surgeries and treatments for a decade or more. I think it would be wise not to rush in with pitchforks and torches.