A surgeon told a review team that the use of non-medical grade springs in child spine surgeries was “bespoke and experimental”, according to a report by the health watchdog that determined their use was “wrong”. The Health Information and Quality Authority (HIQA) has published 19 recommendations after investigating the implantation of springs in three children during surgeries to treat scoliosis of their spines between 2020 and 2023. The surgeries were carried out by a surgeon at Children’s Health Ireland (CHI) at Temple Street hospital. It found that the springs were made of a material called non-alloyed spring steel, which it said was different to the initial description of the springs provided by the surgeon during interview to HIQA. Non-alloyed spring steel is not used for surgical implantation and is is known to corrode in the presence of moisture. There is very limited information available on its use or the risks of its use for implantation. The springs were also not CE marked (Conformite Europeene), which indicates that they had been deemed to meet EU health and safety requirements. HIQA said the surgeon had initially described the product ordered as being made of medical grade stainless steel, a material sometimes used for surgical implants. It found that use of the springs in these surgeries was an attempt to replicate an experimental surgical technique that was still under investigation. The surgeon had attended an international conference on scoliosis in 2018, where a team from The Netherlands presented findings on an implantable “spring-distraction system” using medical-grade titanium springs. That team told HIQA they were not contacted by the surgeon at any time to discuss the research. The HIQA reviewers are of the opinion that 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 CHI at Temple Street, who had otherwise been facing multiple operations – each with its associated risks. The inspectors found through this review that the use of the non CE-marked springs as surgical implants was “wrong”. It found that ethical approval was not sought from any ethical research committee in CHI for the introduction of this new technique. HIQA could not identify any evidence to demonstrate any written approval from any senior manager in CHI on the clinical use of the springs. It also said 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 was not in line with the HSE’s National Consent Policy. HIQA said: “The use of the springs in this manner should not have happened.” Controls in place within CHI did not provide the necessary adequate safeguards at each stage of the process, including those required for the procurement, introduction, decontamination and use of the springs in surgeries. As a result, children were not protected from the risk of harm. HIQA found that the orthopaedic service in CHI at Temple Street had been affected by “long-standing issues with communications and team dynamics” since 2019. It believes this was a “significant factor” in the introduction of the springs as it impacted on important and relevant questions not being raised at various steps in the absence of a formal process also not being followed. 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. HIQA’s director of healthcare regulation Sean Egan said: “It is essential that key lessons are learned from this review at both CHI, and in other health services nationally, particularly with respect to the governance of clinical innovation and practice.” 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. In Ireland, the use of surgical implants in patients is governed by the EU and Irish legislation. 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 circumstances allowed for under regulatory frameworks. CHI had no committee in place to approve and oversee the introduction of high risk “class III medical devices” like the implanted springs. The report comes as hundreds of children remain on waiting lists for spinal surgery.