Temple street hospital using unauthorised devices

Caquas · 02-10-2023 05:36PM

https://www.boards.ie/discussion/comment/121185697#Comment_121185697

“Let the jury consider their verdict,” the King said, for about the twentieth time that day.

“No, no!” said the Queen. “Sentence first—verdict afterwards.”

“Stuff and nonsense!” said Alice loudly

Caquas · 05-10-2023 01:33PM

Is this whole controversy based on a huge misunderstanding?

It seems that the use of unauthorised devices is not just acceptable, it is commonplace and consistent with international best practice,

That’s what Senator Tom Clonan told the Seanad yesterday, based on information he has received from surgeons in many different disciplines, including paediatric surgeons. His speech is worth reading because he has direct experience- his son underwent surgery in Temple Street.

Perhaps the real issue is around the process in Temple Street for managing the use of “custom or in-house” devices

https://www.oireachtas.ie/en/debates/debate/seanad/2023-10-04/13/

How does this square with the view of the chief executive of Children’s Health Ireland who is reportedly tellingly the Oireachtas Health Committee today that the use of unapproved springs in Temple Street was “an unprecedented occurrence” and “truly shocking”?

https://www.irishtimes.com/health/2023/09/28/use-of-unapproved-springs-at-temple-street-truly-shocking-chi-head-to-tell-oireachtas/

crusd · 05-10-2023 01:54PM

https://www.boards.ie/discussion/comment/121197324#Comment_121197324

There is an attempt to obscure the issue. The use of unapproved devices is allowed in the case of trials where the risks are accepted, where there are no alternatives and to not act would cause more harm. However biocompatability of components is a basic requirement. e.g Don't use stainless steel springs that are not certified as suitable for medical use.

Caquas · 05-10-2023 02:07PM

It would be very unfair to accuse Senator Clonan of trying to obscure the issue. I think he is entirely sincere in his efforts to clarify the medical issues when the media have been trying to present a simplified narrative.

If it is normal practice to use uncertified devices, why can’t stainless steel springs be used if a surgeon deems them appropriate?

Flinty997 · 05-10-2023 02:26PM

Obscure for what reason?

Sheep breeder · 05-10-2023 03:42PM

https://www.boards.ie/discussion/comment/121197552#Comment_121197552

In the link you provided above you need to go down and read what the minister stated that no unproved fit for purpose product of the correct grade can be used in these operations. Why are you trying to make this out as a misunderstanding and are you a Leo fan boy trying to deflect from the seriousness of these medical procedures. Take it from somebody who’s child has had four operations ( two emergency at nighttime) in the last 12 months and the families involved in this are not telling lies about children being sick after medical procedures.

Flinty997 · 05-10-2023 03:45PM

https://www.boards.ie/discussion/comment/121198076#Comment_121198076

What's the normal post operative infection rate of the surgeries in question?

Caquas · 05-10-2023 04:19PM

https://www.boards.ie/discussion/comment/121198076#Comment_121198076

I don’t appreciate your nonsensical ad hominem attack. A sure sign of a bully.

I simply drew attention to Senator Clonan’s statement which I believe is sincere and which he says is based on information from many medical experts. Are they wrong?

Sheep breeder · 05-10-2023 04:24PM

https://www.boards.ie/discussion/comment/121198252#Comment_121198252

Just go and read what the minister said in his statement, you quoted one part go and read the rest. The enquiry is going ahead simple and all hospitals are involved as well as temple street as the minister stated in his speech yesterday.

Flinty997 · 05-10-2023 05:23PM

https://www.boards.ie/discussion/comment/121198252#Comment_121198252

We assume. Not quite the same issue. One is using a material approved for medical use. If not the specific surgery. The other is not approved(or suitable) for any surgery.

Though what Leo has to do with it, or why someone is surprised to find sick people in a hospital I can't explain. I can't see where the minister did either.

Caquas · 05-10-2023 06:35PM

https://www.boards.ie/discussion/comment/121198268#Comment_121198268

The Minister did not answer Senator Clonan's statement so obviously you don't have an answer either.

But take your own advice and read the entire Seanad debate at the link I shared. You must agree that the Minister's silence was particularly eloquent after numerous interventions by other Senators highlighting Senator Clonan's contribution, and after the acting Ceann Comhairle specifically mentioned Senator Clonan when he invited the Minister to respond to the debate. All the Minister did was name-check Senator Clonan in a remark about it being too late for some patients to get the care they need. Was that what passes for an answer in your mind?

I fear that an official answer to Senator Clonan will only come from the Statutory Inquiry i.e. years from now and far too late for many other children currently awaiting spinal surgery.

Flinty997 · 05-10-2023 07:05PM

I wouldn't expect him to do anything other than acknowledge everything. He'd be crazy ahead of an enquiry..

Caquas · 05-10-2023 08:05PM

https://www.boards.ie/discussion/comment/121198885#Comment_121198885

The Minister didn’t even acknowledge Senator Clonan’s points. Still less did he offer to look into them.

The prospect of a Statutory Inquiry does not suspend the Minister’s powers. I hope this isn’t a case of kicking the can not just down the road but into the long grass.

Flinty997 · 05-10-2023 08:33PM

https://www.boards.ie/discussion/comment/121199088#Comment_121199088

Not specifically. Just the contributions generally He's hardly ready to state as fact something that may or may not be normal practice in Ireland.

05-10-2023 11:27PM

The issue would seem to not be the device is bespoke / made in-house, rather about the biocompatibility of the springs used.

We don't yet have enough information in the public domain to really get our heads around exactly what happened. That's why this is going to need the forensic enquiry approach to find all the facts before anyone can really draw conclusions.

My concern is that in the interests of public confidence in the medical system, this needs to be a very transparent process.

Hellrazer · 05-10-2023 11:59PM

https://www.boards.ie/discussion/comment/121198093#Comment_121198093

It depends on what the spinal fusion is being carried out for - "normal" scoliosis ie adolescent scoliosis its around 1-3% for spina bifida its 8-22% and for cerebal palsy its 6-8%

Flinty997 · 06-10-2023 12:30AM

https://www.boards.ie/discussion/comment/121199699#Comment_121199699

Where are you getting that from? When I look, and admittedly I hardly can follow the medical terms. I see rates of 6%-40%. Of curse I could be looking at the wrong thing. Its very hard reading.

Hellrazer · 06-10-2023 09:00AM

https://www.boards.ie/discussion/comment/121199741#Comment_121199741

It wont allow me to post the URL but quoted from the site below - Its a US study PMC3282867 - National Library of Medicine.

Myelomeningocele is spina bifida btw.

Infection rates and causative factors

The rate of infection in surgery for adolescent idiopathic scoliosis (AIS) has ranged from 0.9% to 3%. The rate of infection in spinal surgery for deformity related to myelomeningocele has been reported to be from 8% to 24%. The rate of infection in spinal surgery for deformity related to cerebral palsy has been reported to be from 6.1% to 8.7%. Infection after spinal fusion for scoliosis related to a muscular dystrophy is generally less frequent. Despite a large number of cases and studies, the literature did not provide documentation of several factors that may be related to the occurrence of wound infection. The rate of wound infection after spine surgery is dependent on many factors, including the complexity of the procedure, health status of the patient, and potentially the experience and technique of the operating surgeon.

Flinty997 · 06-10-2023 10:29AM

I got...

The incidence of surgical site infection (SSI) after spinal deformity surgery for adolescent idiopathic scoliosis ranges from 0.5–6.7%. The risk of infection following spinal fusion in patients with neuromuscular scoliosis is greater, with reported rates of 6.1–15.2% for cerebral palsy and 8–41.7% for myelodysplasia.

Also these patients often have multiple issues, which rise infection rates, and increase likelihood of further surgeries. Its hard to quantify that, iwth out knowing the details.

Three children had an unauthorised device implanted during

12 out of 16 patients (75%) developed a wound infection requiring additional surgery

Non-infective metal work complications were identified in 7 out of 16 (44%) of the patients.

Removal of metal work was required in 9 out of 16 patients (56%).

261 children are now waiting for spinal surgery across CHI sites.

The number of spinal surgeries carried out at Temple Street in 2022 increased to 124, up from 93 in 2017.

From what I've read it's not unusual common for these type of patients to get post surgery infections, or have to implants removed. But 75% is unusually high, and also they mostly aren't related to unauthorized device patients.

Obviously the priority in all these is the patients, the children. Getting them the best outcomes.

Hellrazer · 06-10-2023 11:27AM

Theres a lot more to post op infection rates than a study can really achieve - it could be down to an individual doctor or nurse not disinfecting properly, using different disinfection products etc.

It could be down to something as simple to an out of date bandage or broken package.

I know at the time of our daughters surgery we were advised of about a 5% infection chance post op.

75% is nuts as a post op infection figure - theres something else seriously going wrong and I suspect its not all about the unauthorised implants either.

Flinty997 · 06-10-2023 12:29PM

Seemed to a lot of techniques and treatments to reduce post op surgical infections. Seems a very complex area in itself. I suspect there's more to this than just the surgeon(s) involved. Which is why people are saying nothing and going to wait for enquiry, to look at the wider issues. I'm guessing the surgeons won't just work in this area, they will do other types of surgeries across different hospitals, and the figures do not align as you'd expect. It seems (open to correction) to be just be (mostly?) this location. At this point speculation isn't that helpful. We'll have to wait for an enquiry.

Itssoeasy · 08-04-2025 08:59PM

HIQA have released a 170 odd page report and it a disgrace. The CDU department didn’t follow their own guidelines on sterilisation. Also it says that a rep from another company brought those screws to the CDU department, which I can’t understand.

plodder · 08-04-2025 10:02PM

Seems like the springs were regular "industrial" non CE marked steel that would be prone to corrosion and not even medical grade stainless steel as the surgeon had initially claimed. The experimental surgery in the Netherlands that the surgeon was replicating, had used Titanium.

Sheep breeder · 08-04-2025 10:42PM

https://www.boards.ie/discussion/comment/123339412#Comment_123339412

The guys from the Netherlands had no contact with the surgeon as stated in the report, the surgeon now should be struck off for what he done to those children, the head guy that resigned should have went day one, our daughter has been through 4 spine operations in 3 years and have seen the CHI system in full operation, the major problem is the admin side and the waste is unreal and staff not interested in helping families.

expectationlost · 08-04-2025 11:27PM

heres the report https://www.hiqa.ie/hiqa-news-updates/hiqa-makes-19-recommendations-improve-governance-and-oversight-implantable

expectationlost · 08-04-2025 11:27PM

Where are all the surgeon A fans today?

Flinty997 · 09-04-2025 12:57AM

https://www.boards.ie/discussion/comment/123339617#Comment_123339617

Good luck expecting people to read and analyze a 170 report in the seconds between you posted the link, then looked for a response. How is that reasonable.

I've just scanned it and it seems like systemic failures at every turn. None of it makes sense. Not to be crude, but its like a F1 driver swapped his F1 engine for a Micra engine while the whole team watched and bought the engine for him. Just bypassed a litany of checks and procedures and no one said boo. Maybe I'm not reading or understanding it properly., maybe I missed a lot in scanning through it.

None of it makes sense.

expectationlost · 09-04-2025 01:22AM

https://www.boards.ie/discussion/comment/123339695#Comment_123339695

the report has been available since this morning

Flinty997 · 09-04-2025 01:41AM

https://www.boards.ie/discussion/comment/123339709#Comment_123339709

Then why didn't you post the link this morning…

People are busy. They'll get to it when they get to it.

Hellrazer · 09-04-2025 12:28PM

It's typical of this country. The surgeon is suspended on full pay if I'm not mistaken.He should be charged with assault and struck off.

Temple street hospital using unauthorised devices

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