Temple Street scandal: how non-medical springs were implanted in children with scoliosis
A CHI principal clinical engineering technician was copied in the emails but does not seem to have questioned how the springs would be used. Picture: Sasko Lazarov
In November 2018 an Irish spinal surgeon travelled to Portugal for a conference featuring some of the world’s top scoliosis researchers.
What he heard there ultimately led to a metal spring disintegrating inside Luke Ryan, now 8, and similar surgery on two other children.
This series of unlikely events included a box of ordinary springs bought by CHI at Temple Street hospital.
Each spring cost for £4.58 and a number ended up in operating theatres.
How did this happen?
That conference took place in a time of intense focus on scoliosis.
In 2017 surgical waiting lists held 312 children.
The ombudsman published a report on “consistent breaches” of children’s right to health.
Under-pressure health minister Simon Harris committed to a four-month waiting time for surgery to parents’ delight — but scepticism.
More money was made available and numbers began to come down, but slowly.
So Professor Connor Green was no doubt open to a new treatment option he heard discussed in Lisbon by a research team from the University Medical Center Utrecht in Holland.
He was one of the few surgeons in Ireland working with children with scoliosis and other complex conditions.
For some children, he was their only hope and parents trusted him completely.
The Dutch team talked about research with a new spring distraction system.
It involved placing medical-grade titanium springs around conventional growing rods.
These are implanted into vertebrae in the spine.
The compressed helical coil spring applies a continuous distraction force which should modify spine growth and correct scoliosis.
The coiled spring lengthens as the patient grows.
The idea is this could reduce the number of procedures needed later to lengthen the rods.
Prof Green did not contact the Dutch team but the seed was planted.
By early autumn 2019, at a specially-convened multidisciplinary team (MDT) meeting in Temple Street hospital, he was ready to discuss this option with colleagues.
They talked about this and an older option for treating early-onset scoliosis.
They opted for stainless steel rather than titanium.
When Hiqa began investigating in 2023, he described it as “a bespoke solution for a small group of patients” and as “experimental”.
An MDT is usually one team with all professions, but this service had one for surgical staff and one for nursing and health and social care professionals.
So “potential missed opportunities” to question the springs.
Referring to Prof Green as ‘Surgeon A’, Hiqa said the springs were part of “likely well-intentioned efforts” to help children.
Emails show him in contact with a manufacturer discussing a company product catalogue number, invoicing, and payment options in December 2019 and January 2020.
That number linked to compression springs made from ‘unalloyed spring steel’.
This rusts in water unlike medical grade metals.
A CHI principal clinical engineering technician was copied in the emails but does not seem to have questioned how the springs would be used.
The stores office was not involved, and the springs were “not ordered, tracked or recorded on the business management system”.
Documents indicate Hiqa said: “One box of 10 springs was paid for by CHI at Temple Street on January 8, 2020 at a cost of £4.58 sterling per spring”.
This was delivered by courier on February 7 to Temple Street, addressed to the orthopaedic department.
The stores department signed the proof of delivery docket.
That month, Prof Green and another surgeon said they met with then CEO Eilish Hardiman to discuss the springs at Temple St.
She told Hiqa this meeting did not happen.
She said she met Prof Green at another CHI site and did not discuss the springs.
It is also unclear whether a letter written by Prof Green and addressed to Ms Hardiman discussing the springs was delivered or received.
Ms Hardiman later told the Oireachtas health committee: “No approval was granted and none would be granted for a non-medical-grade device to be implanted."
Then the springs came to the Temple Street central decontamination unit in July.
They did not have a CE mark — again a gap which should have set off alarm bells.
The springs were to be used with the standard rod systems.
Someone from the company which makes the rods brought the springs to this unit.
It is not known who authorised this.
There was “significant deviation” from what Hiqa described as “good” decontamination checks.
The unit emailed Prof Green asking for manufacturer’s sterilisation instructions.
He emailed the company who said these are standard springs and “not something designed to be covered by any specific medical requirements”.
The company said in another email “they are prone to rust”.
Hiqa noted: “These emails should have raised concerns with Surgeon A."
Ultimately five springs were implanted in three children during 2020 to 2022.
Of the 10 springs, two were disposed of as unsuitable during surgery, one was disposed of in early 2023 — before the scandal emerged — and one is with CHI management, but one is lost.
In operating theatres staff run through a check-list first, much like airline pilots before take-off.
Nurses said they were not given information about equipment additional to the rods and Hiqa said it is “unclear” why nurse or clinicians did not query this.
Theatre staff said the springs were not raised during this process, but the lead surgeon said he did so.
These were “key control failures”, Hiqa found.
Luke’s parents in Mornington, Meath, were appalled this week.
Liz McMahon and David Ryan said: “Tragically, it is now abundantly clear as a child Luke was failed by the paediatric services at CHI.
Reading the report left them sure: “Luke was used for unauthorised experimentation."
He was aged two years and nine months then and they said it was done “without our knowledge or consent”.
They explained: “Not surprisingly, that spring device then disintegrated inside Luke resulting in the necessity for further surgical intervention.”
They were “appalled by this failure of proper governance at CHI”.
Their solicitor, Raymond Bradley, said removing the spring was complex and “didn’t go as smoothly as it could have”.
The family had to go before the High Court in 2023 to get his medical records before the spring was later removed.
Luke has spinal muscular atrophy (SMA) and scoliosis.
His parents successfully campaigned recently to have SMA included in newborn heel-prick tests.
They are still fighting now, calling on health minister Jennifer Carroll MacNeill to step in, saying: “We hope Luke’s unnecessary suffering will improve the lot of all children.”
Hiqa said none of the parents gave informed consent due to the limited information they were given. They found found children were not protected from risk of harm.
Solicitor for the other families affected, Ciaran Tansey, said the report was “horrible for our clients and their families to digest”.
He spoke of how “shocking” they found it CHI permitted “risk-taking at this level”.
These concerns are widely shared according to advocate Amanda Coughlan-Santry who said: “We have families who are scared to put a toe across the threshold of CHI now.”
Co-founder of the spina bifida hydrocephalus paediatric advocacy group, she added this is not the first report to raise concerns.
Many children in this group were under Prof Green, and she said some remain without a consultant over 18 months since he went on leave.
The group emailed Ms Carroll MacNeill on March 18 asking for a meeting.
They have not received a response.
Another group, Orthokids, this week called for Prof Green to be reinstated.
Founder Diane Hodnet’s child has waited two years for surgery with him.
She said: “The Hiqa report rejects the CHI leadership’s efforts to shift blame onto a single surgeon.”
The minister faces the prospect of the new children’s hospital opening next year — hopefully — with a cloud hanging over it.
Questions are being raised too about staff morale with Hiqa finding an “absence of a culture which supported questioning” in services examined.
Hiqa director of healthcare Seán Egan, talked about “pretty weak” managerial structures at CHI broadly.
Hiqa found “unclear lines of reporting, accountability and oversight across the organisation”.
He warned moving three hospitals to the new hospital “is definitely a factor here in terms of the difficulties CHI have had with this".
CHI board chairman Dr Jim Browne has stepped down with the minister resisting calls for more resignations.
CEO Lucy Nugent apologised to children and pledged to implement all recommendations.
She accepted corporate and clinical governance arrangements were “inadequate” and said changes are under way.
CHI clinical director Ike Okafor also apologised.
He said more than 250,000 children are treated across their hospitals annually, and their staff are “some of the best in the world”.
On Friday CHI said 123 spinal surgeries were done between January and March, but also around 50 new patients are listed every month.
Other reviews — including a hip dysplasia audit — continue, so can CHI get parents back on side before the big move?
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