CHI Clinical Director Dr Ike Okafor has said he is confident the body will be able to retain trust from the public following today's publication of a review into the use of unapproved implantable springs in spinal surgery at Temple Street Children’s Hospital.
Dr Okafor said that procedures highlighted in today’s review were down to "an isolated group of clinicians", adding that "this will not happen again".
The independent statutory review found that devices were implanted into three children and that "children were not protected from the risk of harm".
The review said the use of these devices for scoliosis patients was wrong and there was no evidence of ethical approval at the hospital for their use by one surgeon, detailed as Surgeon A.
The 200-page review has been published by the health watchdog, the Health Information & Quality Authority.
CHI Chairperson Dr Jim Browne resigned from his role and offered his apologies to those who "have been failed by the care they received, following the release of the HIQA report today".
Speaking on RTÉ’s Six One News, Dr Okafor stressed that CHI has over 4,000 staff who are "really hard working and dedicated and skillful professionals. Every year we deliver care to over 250,000 children."
"What we're dealing with is a very isolated group of clinicians and I know that the harm that has been done to these three children is immense, and I'm here just to convince the public and the parents of our children that this will not happen again."
"What I can say is that the process is much more robust and such an occurrence would not happen now"
Dr Okafor said that more robust processes were now in place to ensure such an incident would not be repeated.
"If you look at the HIQA report, it clearly outlines the failings in the governance structures. Either they were not robust enough, or where they existed, they weren't used by the clinicians involved," he said.
He added: "What we want to make sure is that there's a balance and that children are kept safe. Parents and children are well informed and we're able to measure good outcomes. There is a process in place.
"What I can say is that the process is much more robust and such an occurrence would not happen now," he said.
Dr Okafor said that CHI were offering support to all three affected families, with some getting treatment in Ireland and some getting treatment abroad.
Surgeon A described the use of the springs to HIQA as "bespoke and experimental" and the watchdog found there was a lack of detailed discussions with parents in line with consent practice.
It found no written approval from any senior manager in Children's Health Ireland for the use of the springs.
The springs were not ordered, tracked or recorded on the hospital business management system and were bought from abroad.
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HIQA found the springs were made of a material called non-alloyed spring steel, which was different to the initial description of the springs provided by Surgeon A during interview with HIQA.
"This is important because non-alloyed steel is not used for surgical implantation," the report states. It is known to corrode in the presence of moisture.
The report said that Surgeon A and Surgeon B met to discuss the use of springs among themselves.
Read the full report here
Separately, they claim they met the then-Chief Executive of CHI in February 2020 to seek approval for the use of the springs.
The former Chief Executive disputes that this meeting occurred.
HIQA found there was no written approval from any manager in CHI to approve the use of the springs.
The review also found that there were opportunities for CHI to be more proactive in the ongoing care and support of affected children and their families.
Theatre staff present during the surgical procedures did not receive any training or information in advance of the procedures using the springs.
The report said Surgeon A had attended an expert international orthopaedic conference on scoliosis in The Netherlands in 2018 where a team from The Netherlands presented initial findings of a new implantable spring system for the treatment of scoliosis.
It found there was an attempt by Surgeon A to replicate this experimental surgical technique that was still under investigation at a hospital in another country.
The review said this "formed part of a well-intentioned but ill-considered effort to provide an alternative approach to surgical treatment, involving a single operation, for a number of children with life-limiting conditions" at Temple Street who had otherwise been facing multiple operations, each with its associated risks.
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Surgeon A told the review that the use of new and experimental procedures in children's surgery is not uncommon considering the increased complexity inherently associated with surgical procedures of this nature.
Surgeon A also stated that it was their view that this was neither "innovation nor research", and that "it was a bespoke solution for a small group of patients using an existing technique at the experimental stage of development."
Surgeon A told HIQA that while they did not engage with the Ethics and Research Committee, they would have engaged with this committee, had they been directed to do so by the CHI CEO in February 2020.
Surgeon A remains on leave from Temple Street.
The review also points to inadequate oversight by CHI and there was no committee in place to approve and oversee the use of such devices.
The review found that there were no overarching CHI standardised governance structures in place for the use of medical devices.
It also found a lack of formal documented procedures to be followed within CHI for the introduction and use of a non-CE marked medical device.
In Ireland, the use of surgical implants in patients is governed by the European Union and Irish law.
The HIQA review found the orthopaedic service at Temple Street had been affected by long-standing issues with communications and team dynamics, as well as challenges in providing timely access to paediatric spinal surgical services for many years, with long waiting lists for children.
The report makes 19 recommendations, including a review of organisation-wide corporate and clinical governance at CHI.
The review by HIQA was set up in November 2023 at the request of the then minister for health.
It covered the period between 2020 and 2022.
In September 2023, it emerged publicly that non-EU approved (non-CE marked) metal springs had been surgically implanted into a number of children who underwent spinal surgery at Children's Health Ireland in Temple Street.
This led to concern among the families of the children affected and the wider public.
'Wrong and unacceptable'
In a statement, the HSE said it accepts the report in full, adding that recommendations will be "immediately followed through to implementation and we will also be seeking oversight of how CHI approaches the recommendations specific to them".
HSE Chief Executive Bernard Gloster said that what happened was "wrong and unacceptable".
"Given the role of the HSE in funding CHI, I want to offer a sincere and unequivocal apology to the children and families affected by these issues," he said.
"I will be requesting an early meeting with the Board and Executive of CHI to set out our clear expectations in all matters of governance and oversight."
'Deep disquiet'
Minister for Health Jennifer Carroll MacNeill said the report makes it clear that where parents had put their trust in clinicians to treat their children, this trust was breached.
In a statement, she apologised to the three young children and their families and said the children were not protected from the risk of harm, "as they should have been".
"What happened was wrong, should not have happened and should not have been allowed to happen," she said.
The minister said she met both the CHI's Chief Executive Lucy Nugent and Chairperson Dr Browne yesterday, and said she "made very clear to them my deep disquiet at what happened".
She added: "I note that both CHI and the HSE have accepted the recommendations of this review in their entirety and have already begun to implement them. I also note that they have apologised in full to the patients and families for the failings outlined in this report."
