The use of unauthorised metal springs, implanted into a number of children during spinal surgeries was wrong, HIQA has said following the publication of a damning review.
A report published today by the Health Information and Quality Authority (HIQA) said that non-CE-marked springs were implanted into a number of children who underwent spinal surgeries at Temple Street Children’s Hospital. The surgeries were carried out by a surgeon at Children’s Health Ireland.
CE marking indicates that a product has been assessed and is deemed to meet EU safety requirements – but in September 2023, it emerged for the first time publicly that non-CE-marked metal springs had been used in surgeries at Temple Street.
The review published on Tuesday was the result of HIQA’s examination of the circumstances that had given rise to concerns, after a request for the Minister for Health in October 2023.
In the wake of the scathing report, the chairman of the board of Children’s Health Ireland (CHI) has resigned.
Dr Jim Browne apologised to the “children, young people and families that have been failed by the care they received, following the release of the Hiqa report.”.
Dr Browne has served as chair of the board since it was established in 2019.
‘BESPOKE AND EXPERIMENTAL’
A surgeon told a HIQA review team that the use of non-medical grade springs in child spine surgeries was “bespoke and experimental,” according to the report from the health watchdog. No written approval from Children’s Health Ireland (CHI) was found in relation to what the report said was a “novel, surgical procedure.
Paediatric spinal surgery services are provided at two Children’s Hospital Ireland sites: CHI at Temple Street and CHI at Crumlin. The experiences of children and families who used the orthopaedic spinal surgery service in CHI at Temple Street were taken into account for the review.
The review covered the period from November 2018, when the use of the springs was first considered as a possible treatment option for a small cohort of children attending CHI at Temple Street, to July 2023, when it was confirmed internally by CHI that the springs implanted into a number of children during spinal surgery, between 2020 and 2022, were not CE marked.
The report notes that two serious incidents were reported within the service in 2022 which led to both internal and external reviews focusing on clinical outcomes for patients.
HIQA said 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.”
The report said that while the safe introduction and use of medical devices and surgical implants requires specific governance arrangements across a number of departments and functions within a hospital, relevant structures and processes were “not in place” for all those functions.
The statutory body pointed to a “lack of formal documented procedures to be followed” within CHI for the introduction and use of a non-CE marked medical device in any of the specific circumstances where a non-CE marked medical device could be used under the regulatory frameworks in place. HIQA also found that there were no formal multidisciplinary processes for assessing and approving implantable medical devices at CHI at Temple Street
It also said it found that there was no standardised set of policies and procedures for theatres across the CHI at Temple Street and CHI at Crumlin sites up to November 2023.
The review team said that between 2020 and 2022, non-CE marked springs were implanted into three children who had undergone spinal surgical operations at CHI at Temple Street. The report is of the opinion that the use of the springs was 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 CHI at Temple Street who had otherwise been facing multiple operations, each with its associated risks.
The report said there was a lack of information provided to families on the new or experimental nature of the intended surgery, and for that reason, the request for consent from families was not in line with the HSE’s National Consent Policy.
HIQA, through the review, said it found that the use of the non CE-marked springs as surgical implants was “wrong.”
Controls in place within CHI did not provide the necessary adequate safeguards during the process, including those required for the procurement, introduction, decontamination and use of the springs in operations.
It detailed how the surgeon who carried out the surgical procedures using the springs, who is referred to as Surgeon A, attended an expert international orthopaedic conference on early onset scoliosis in 2018 where a team of researchers from The Netherlands presented the initial findings of a new implantable ‘spring-distraction system’ for the treatment of scoliosis. Medical-grade titanium springs, manufactured by the university, were used in that study. However, the research team from The Netherlands told HIQA that they were not contacted by Surgeon A at any time to discuss their research.
HIQA found there was a “lack of formal documented procedures” to be followed within CHI for the introduction and use of a non-CE marked medical device in any of the specific circumstances where a non-CE marked medical device could be used under the regulatory frameworks in place.
The review pointed out that a research ethics oversight process was in place at CHI in Temple Street at the time when the springs were being considered for use. However, the body said it found “no evidence” of any engagement with the formal ethical approval mechanisms and processes to support an approach using the springs.
HIQA further said there was no evidence that the introduction and use of the springs in spinal surgery at CHI at Temple street had been backed up by a clinical investigation, clinical study, or trial.
There were also no formal structures or processes in place to support the surgical multidisciplinary team at CHI at Temple Street, the review said – pointing to a “number of underlying challenges.” The report says that had a formal multidisciplinary structure been in place, it may have mitigated the surgical safety issues and risks of using a non-CE marked medical devices in orthopaedics at CHI at Temple Street.
Specifically, HIQA said there were 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.
It also referenced an “apparent absence of a culture which supported questioning” – saying that all of these factors contributed to failures in the clinical governance of surgical safety in orthopaedics.
“Had a fully functioning and effective multidisciplinary meeting process been in place, there may have been opportunities for more considered discussion and shared understanding amongst the multidisciplinary team that the implanting of the springs was not a usual practice,” the report noted.
Taoiseach Micheál Martin pushed back against suggestions made in the Dáil today that the Government was partly to blame for the “litany” of failures on the use of non-medical grade springs in the surgeries.
“Let’s call a spade a spade here, we can be political about these things, but there are fundamental issues here that happened, that should not have happened, and there has to be individual responsibility,” Mr Martin said.
“There has to be accountability in that respect, there has to be management accountability in terms of CHI and the board and so on, in terms of why the governance procedures were not followed and why they were essentially bypassed.
“The idea that you would use springs outside of (the) entire protection framework is beyond belief, and responsibility there, in my view, lies with the individual in the first instance.
“It’s as plain as night follows day, you do not use unauthorised devices on any child, that is at the heart of it.”
Health Minister Jennifer Carroll MacNeill said that the findings of the report were “indefensible.”