Temple street hospital using unauthorised devices

Caquas

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

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

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

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

Obscure for what reason?

Sheep breeder

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

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

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

Caquas

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

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

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

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

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

Caquas

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

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.

RetroEncabulator

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

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

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

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

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

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

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.