The chairman of the board of Children’s Health Ireland Dr Jim Browne has resigned following the publication of a report into the use of unauthorised springs in children requiring spinal surgery at a Dublin paediatric hospital.
The use of such springs as surgical implants in operations at a Dublin paediatric hospital was “wrong”, while failures in controls meant “children were not protected from the risk of harm”, the State’s health services watchdog has found.
In a report on Tuesday, the Health Information and Quality Authority (Hiqa) found that as part of paediatric spinal surgery procedures at Temple Street Hospital, which is run by the Children’s Health Ireland (CHI) group, metal springs – not marked as “CE” compliant under EU health and safety rules – were implanted in three children with the intention to treat scoliosis of their spines.
Dr Browne issued a statement before lunchtime on Tuesday announcing his resignation, having served since 2013 as chair of the Children’s Hospital Group Board, and more recently as chair of the CHI board since its establishment in 2019 to manage paediatric services within the HSE.
“Following discussions over recent weeks with the Department for Health, I now wish to step down and provide for an orderly transition to a new Chair to allow for renewed enthusiasm and passion to guide this great organisation,” he said.
“I wish to convey my sincere apologies to the children, young people and families that have been failed by the care they received, following the release of the Hiqa report today.”
Hiqa found the use of the springs was an attempt to replicate an experimental surgical technique that was still under investigation at a hospital abroad, but in a modified way.
“Hiqa found that ethical approval was not sought from any ethical research committee in CHI for the introduction of this new technique.”
Hiqa said it could not identify evidence of any senior manager at CHI providing written approval on the clinical use of the springs.
“Furthermore, Hiqa found that there was a lack of information provided to families on the new or experimental nature of the intended surgery, and therefore the request for consent from families by CHI to carry out the surgeries was not in line with the HSE’s National Consent Policy 2013, which was in operation in CHI.”
“The use of the springs in this manner should not have happened.”
The health watchdog said the use of the springs “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”.
Hiqa said the controls in place within CHI for the management of the end-to-end processes did not provide the necessary adequate safeguards at each stage, including those required for the procurement, introduction, decontamination and use of the springs in surgeries.
Hiqa said the absence of questioning and verification was accompanied by a failure to adhere to policy and process in some instances with numerous missed opportunities to identify and prevent the use of the springs in the surgery of three children spanning the period from 2020 to 2022.
“Overall Hiqa found that due to failures in the design and delivery and oversight of end-to-end processes and controls within the spinal service at CHI, children were not protected from the risk of harm.”
Hiqa maintained governance structures and management arrangements at the CHI group, which also runs the paediatric services at Crumlin and Tallaght hospitals, were “overly complex”.
It said these “did not enable effective management and oversight of the orthopaedic service at CHI at Temple Street”.
“Following the establishment of CHI as a legal entity in 2019, changes to organisational structures led to unclear lines of reporting, accountability and oversight across the organisation which could not ensure the safe introduction and use of new surgical implants and implantable medical devices.”
“As a consequence, a number of key approval processes, policies or safety checks were not properly applied in treating these children, resulting in the springs being used inappropriately.”
The Hiqa report, which was ordered 18 months ago by former Minister for Health Stephen Donnelly, also found that the orthopaedic service in CHI at Temple Street “had been affected by long-standing issues with communications and team dynamics”.
It said in 2019, senior management at Temple Street had “recognised that there were behavioural and cultural issues within the orthopaedic department and sought external input over the following two years as a management intervention to address the challenges within the service”.
Hiqa said that since July 2021 managers had been reporting to the CHI board on issues in the orthopaedic service at CHI at Temple Street, including the management intervention.
“In Hiqa’s view, the cultural issues on the orthopaedic surgical team were a significant factor in the introduction of the springs, as they impacted on important and relevant questions not being raised at various steps, in the absence of a formal process also not being followed.”
Hiqa said: “Had a formal multidisciplinary structure been in place, it might have mitigated the surgical safety issues and risks of using a non-CE marked medical devices in orthopaedics at Temple Street.”
“These challenges included problems with team working, poor processes for communication and documenting of associated actions, lack of a formal multidisciplinary structure or a single multidisciplinary team, or a standardised process to enable effective interaction between the two multidisciplinary teams.”
The report said there was also an apparent absence of a culture which supported questioning.
In a statement, Lucy Nugent, chief executive of Children’s Health Ireland, apologised to the families affected, describing what happened as “unacceptable”.
“We are deeply sorry that these children, young people and families did not get the care they deserved,” she said.
Ms Nugent said the hospital group “sincerely regrets and apologises” for the risks posed to the three patients who had the non-CE mark springs implanted.
“We do not underestimate the impact that this has had and is having on the families affected, and the distress that it has caused to all patients and families in the spinal service.”
Ms Nugent said the recommendations would be implemented through a quality improvement plan, “alongside the many changes that are already underway”
“Issues of poor performance and noncompliance with policies are being addressed with the staff involved, in line with relevant hospital policies. I want to assure families of my commitment to ensuring that something like this never happens again in our organisation,” she added.
Bernard Gloster, chief executive of the HSE said what happened here 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.
“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.”
Minister for Health Jennifer Carroll MacNeill said the Hiqa report highlights how families’ “trust was breached” in this scenario.
“These children were not protected from the risk of harm, as they should have been,” she said.
Ms Carroll MacNeill said she met both the chief executive and the chairperson of Children’s Health Ireland on Monday.
“I made very clear to them my deep disquiet at what happened here and my clear expectations in terms of reform and change to ensure it does not happen again,” she added.
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