LAST UPDATE | 18 Sep 2023

THE HSE HAS commissioned an external review into elements of paediatric care at Children’s Health Ireland (CHI) at Temple Street after one child died and others suffered serious post-surgery complications following spinal surgery there. 

The review is focusing on the clinical care provided by an individual consultant at CHI. The consultant is no longer conducting surgeries and a referral has been made about them to the Irish Medical Council. 

The review arises from very serious concerns identified by CHI since last year in relation to poor surgical outcomes in spinal surgery at Temple Street. 

Among the concerns were the use of a certain spinal surgical technique and a significant number of negative post-surgery outcomes, which led to serious complications and in one case the death of a child. 

It has also recently been revealed that unauthorised devices were implanted in three patients during spinal surgery procedures. The use of these devices was first reported last week by online news outlet The Ditch.

The review

Late last year, senior management in CHI were made aware of patient safety concerns in relation to the treatment of a small number of patients with Spina Bifida who had spinal surgery at CHI at Temple Street.

The concerns related to poor clinical outcomes following complex spinal surgery, including a high number of post-surgery infections and complications. There were also two serious surgical incidents that happened in July and September of last year.

An internal and external review were commissioned and have taken place, which looked into the care provided by one consultant to 17 children who had complex spinal surgery in CHI at Temple Street. An additional external review has now also been commissioned.

Since then, one of these children has died, and a number of others have suffered significant post-operative complications. Including the number of patients affected by use of unauthorised implantable devices, the total number of affected patients is 19.

In a statement, the HSE said:

“These patients and their families already face enormous challenges due to their condition, and CHI deeply regrets the failings in the care provided to them.

CHI is engaged with these families on an ongoing basis and will continue to provide support needed.

“CHI has recently met with each of these families to explain the review process to them and, if appropriate to outline to them any issues that were identified relating to the care their child received.

“Each of these patients have now been assigned to a new clinical team in CHI and if they have not already met their new consultant, will be meeting the consultants who will be taking over their care later this week to review and plan their future treatment.

CHI acknowledges the anxiety that this news may cause to our patients and their families. However, we would like to reassure our patients and their families that everybody known to have been affected has been contacted.

An external review will now be carried out by a UK expert, Mr Selvadurai Nayagam, Consultant in Orthopaedics and Trauma, and Head of the Limb Reconstruction Unit at the Royal Liverpool University and Royal Liverpool Children’s Hospitals.

‘Serious complications’

Úna Keightley, co-lead of the Spina Bifida & Hydrocephalus Paediatric Advocacy Group, said there are numerous issues still to be dealt with that the report has not adequately addressed.

In particular, she said that a comprehensive list of the recommendations arising from the reviews that have taken place should have been made available (the report published today summarises the recommendations rather than printing them in full).

Additionally, parents of the children affected should have been engaged with during the course of the reviews to date, she said.

“The next external review must give parents the opportunity to give their account,” Keightley said, speaking to The Journal.

She questioned why complications from procedures in Crumlin hospital have not been included in the review, calling for the terms of reference to be expanded to include all of Ireland’s children’s hospitals, and condemned the use of non-medical grade devices in some surgeries. 

“The non-medical grade devices – how did they get through the procurement and sterilisation and pre-theatre checklist when they had no CE mark?” Keightley said. “How did that end up on a theatre floor? Nobody is answering that. It is a major error.”

Commenting today on RTÉ’s News at One, HSE Chief Operations Officer Damien McCallion said that the initial review carried out identified a number of significant issues in post-surgery patients.

“These were areas like wound complications after surgery, or metalwork had to be removed which is part of this complex surgery and higher level infections,” he said.

“Tragically one of those children passed and [is] deceased, and there has been a lot of contact with that family.

“That’s subject to investigation, and forms part of this review. Secondly, there was a child who had very serious complications.

Then there were three children who had an unauthorised device, non-certified for use in the procedure, and then a variety of complications, which are the 19 children that are impacted here.

McCallion said that all of these cases form part of the review, and have been followed up on. In relation to the unauthorised devices, he said two patients have subsequently had them removed.

“I suppose in simple terms, these are parts that are used as part of the surgery. And they’re basically metalwork parts that are used. And unfortunately in this instance, it appears that three children had authorised parts used as part of their surgery,” he said.

They’ve all been contacted, two have subsequently had them removed as part of their normal process and CHI and working with the other family, in relation to what’s needed and what needs to be done with their child.

 Chief clinical officer at the HSE Dr Colm Henry said in a statement that the review will “examine the reports already completed and complete a risk assessment of the relevant areas of orthopaedic surgery in CHI at Temple Street as soon as practicable and before the end of 2023″.

“This will determine the specific timelines and milestones for the review process. The review may also make findings and recommendations that apply across all CHI hospitals and to the new children’s hospital and will be published,” he said.

Dr Allan Goldman, Chief Medical Officer of CHI said in a statement that CHI “deeply regrets the impact that the issues identified have had on patients and their families”.

“We welcome the HSE’s external review. We will use the findings, in conjunction with the findings and actions from CHI’s reviews of the Spinal Surgery service at CHI at Temple Street, to inform our ongoing improvement programme.

“CHI staff are committed and motivated to provide safe, effective, patient-centred and efficient care to spina bifida patients to improve clinical outcomes.

We care deeply about the quality of that care. The families involved and the safety of patients remain our priority. We are in the process of putting in place measures to ensure the treatment of our patients is not disrupted or delayed as a result of this review.