“Young people with scoliosis are suffering severe physical and psychological effects as a result of the delays they experience.”
Those were the words of Ombudsman for Children Niall Muldoon following the publication of a 2017 report which criticised “unacceptable” delays in providing spinal surgery to these children.
At the time, 119 children with scoliosis were on the waiting list for more than six months, with 46 on the list for more than a year.
It was in that same year then minister for health Simon Harris pledged that no child would wait longer than four months for orthopaedic surgery.
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This target has not been met, though the number of children waiting longer than this benchmark has reduced considerably over the past 12 months.
It was clear eight years ago that there were difficulties in the paediatric orthopaedic services. Families and advocacy groups highlighted again and again the issues children faced as their conditions worsened while on waiting lists.
In the following years, further controversy emerged – one of which was the implantation of unapproved springs in three children requiring spinal surgery.
On Tuesday, the Health Information and Quality Authority (Hiqa) published its report into the issue, describing the use of the unlicensed devices as “wrong” and finding that the processes in the hospital “did not protect children from harm”.
Connor Green, the surgeon at the centre of the controversy, went on voluntary leave in September 2023 and was referred to the Irish Medical Council.
Mr Green, who was not named in the report but referred to as Surgeon A, was contacted for comment about the findings.
According to Hiqa’s report, the use of springs was first considered as a possible treatment option for a small cohort of children in November 2018.
Mr Green attended an “expert international orthopaedic conference” on early onset scoliosis that year, during which a team of researchers from the Netherlands presented initial findings of a new implantable “spring-distraction system” for the treatment of scoliosis.
Medical-grade titanium springs, manufactured by the Dutch university, were used in the study.
According to Hiqa, there was an intention to replicate this new technique in Temple Street but in a modified way. However, at this point, outcomes for the scientific study had yet to be published in a peer-reviewed scientific journal.
The Dutch research team told Hiqa they were not contacted by Mr Green at any time to discuss their research.
The proposed surgical solution was presented at a Childrens Health Ireland (CHI) meeting at Temple Street “in or around August 2019”.
It was described by Mr Green as a bespoke solution for a small group of patients and would use a standard implantable rod system that was already in routine use in Temple Street hospital and would be adapted with the spring.
According to the report, the children were suffering from “progressive respiratory failure”, which was expected to limit their lifespan. The conventional surgical treatment would require multiple procedures – and, given the complexity of their conditions, this presented a “significant treatment challenge”, the report said.
“There were likely well-intentioned efforts to seek to provide a new approach to surgical treatment for a number of children with life-limiting conditions at CHI at Temple Street,” Hiqa concluded.
But the meeting created as many questions as answers for Hiqa, as there was no formal agenda nor minutes available, meaning the watchdog was unable to confirm who attended or the precise details of what was discussed.
Following the conference, Mr Green identified a company as a potential supplier of the springs.
He told the watchdog he understood the firm, which is not named in the report, to be that which provided springs used in the clinical study in Utrecht and he contacted them through its website.
The company was an industrial machinery supplier and not a recognised manufacturer of medical-grade products for the healthcare industry.
There was also no evidence suggesting the company professed to fulfil such a role in the supply of these springs, the report said, though Mr Green’s email subject line to the company stated he was enquiring about “medical springs”.
The springs were ordered outside of typical procurement rules, meaning they were not ordered, tracked or recorded on the business management system in the correct way. A clinical engineer who was engaged with Mr Green on obtaining the springs said he did not know they were for implantation.
In February 2020, Mr Green said he and another surgeon met the then chief executive of CHI, Eilish Hardiman, to discuss spinal springs. The then chief executive has denied any such conversation took place.
That year, the first unapproved spring was implanted in a child, with a further two children receiving the implanted springs between then and 2022.
This occurred without formal approval from any senior clinical leader within CHI, the report said, nor was there any ethical approval.
It also, according to Hiqa, occurred without informed consent from the parents of the three children, though Mr Green maintains he told the family about the “experimental and off-label” nature of the procedures.
Hiqa later discovered the springs were made of “non-alloyed spring steel”, which is not used in implantation because it is known to corrode when it comes in contact with moisture.
Liz McMahon and David Ryan, the parents of Luke Ryan, one of the children who received a spring implant, said they “could never have contemplated that an experimental non-medical grade spring would without our knowledge or consent be placed in our child in an Irish hospital”.
While this was occurring, there were other issues in Temple Street’s orthopaedic department. Late in 2022, patient safety concerns were raised about a small number of children with spina bifida who had surgery in the hospital.
These concerns related to poor outcomes from complex spinal surgery, with a high incidence of post-operative complications and infections. Two particularly serious surgical incidents occurred in July and September of that year.
A significant contributory factor to the concerns in the orthopaedic department, according to Hiqa, was a consequence of cultural and communication issues in the unit, as well as a lack of oversight more broadly in CHI.
Sean Egan, director of healthcare regulation at Hiqa, said the agency concluded there was an absence of “an open, inter-collegiate atmosphere”, as well as difficulties in relationships between team members which he said was a significant contributing factor in the issues that have arisen.
Adding to this, there were a number of staff and organisational changes at CHI after it took over governance of paediatric healthcare in 2019.
Due to the manner in which this was done, there was a loss of oversight in certain areas and a breakdown in some reporting relationships, particularly in relation to the medical devices committee, Hiqa said.
This was most obvious by the fact that Dr Jim Browne, then chairman of the board of CHI, told Hiqa that before November 2022, the board had no sense the issues in orthopaedic surgery “were as serious as they were later identified to be”.
Dr Browne resigned from his role as chairman hours after the Hiqa report was released, issuing an apology to the children and families affected.
The issues were made public in 2023, after which Hiqa was directed to complete its review. Other reviews remain ongoing.
On Tuesday, the Minister for Health, the head of the HSE and the chief executive of CHI all issued apologies to affected families and committed to implementing the recommendations in the report.
Some of these governance changes have already begun, but it would appear this is, as advocates have said, “the beginning, not the end” of the work that needs to be done.
