Martin Daly warns over non-medical springs and DDH inconsistencies

Minister, I'm grateful for the opportunity to make the statement on Children's Health Ireland and to reflect on the recent deeply troubling revelations, both in relation to the insertion of non-medical grade springs into the spines of children undergoing complex spinal surgery and the emergence of a divergence in clinical decision-making for the threshold for pelvic osteotomies for developmental dysplasia of the hip in children between separate sites in the CHI hospital group, Crumlin, Temple Street, and also the National Orthopaedic Hospital, Kappa. These are distinct issues, but they raise the most serious questions about clinical governance and patient safety in the CHI group of hospitals. As both a TD and a practising GP, I must begin by expressing my profound concern at the finding of the recent HICWA report in relation to the use of non-medical grade springs in three children's complex spinal surgeries. The unauthorised use of non-approved implants in complex spinal surgeries, absent of ethical approval and appropriate clinical governments, is truly alarming. It is very difficult to comprehend how such a practice was allowed to occur. HICWA's report, and I quote, There were no overarching CHI-wide standardised governance structures and supporting policies and procedures in place for the introduction and use of medical devices. This is an astounding fact. In additional, HICWA found that whilst corporate and clinical governance procedures were in place in the CHI group, they were over-complex and difficult to understand for management and staff, both at site-specific hospitals and the overall CHI group. With the changes from 2019 onwards, there was a loss of experienced management staff at Tempest Street, resulting in a breakdown of communication and governance pathways. Whilst there were a number of controls in place, these did not provide adequate safeguards at each stage of the end-to-end process for the introduction and use of the springs. This occurred across a number of stages in the process, including approvals processes, multidisciplinary teams, procurement, decontamination and use in theatre. HICWA identified cultural differences in the orthopaedic department, which mitigated against peer review and multidisciplinary decision-making for proposed surgeries. In effect, HICWA is saying the surgeons in the unit weren't getting along and there was very little communication or peer review as a result. This is simply unacceptable. Team working in the interest of the patient should be a primary ethical and contractual obligation. These are systematic failures that allow individual failure in judgement to flourish. In summary, there was a failure in regulatory and ethical procedures, clinical governance, medical device approval and sourcing and procurement of medical devices, decontamination and traceability and consent. Consent is critical to this issue. Any procedure, most especially an experimental procedure, must be explained fully to the parents or guardians. The fundamental principle of informed consent must not be fudged or circumvented, most especially in complex high-risk surgery. The sense of failure, hurt, anger and helplessness on the part of parents is compounded by the lack of full disclosure of surgical intervention and its attendant risks. HICWA did also find that the management of the issues once disclosed could have been better. We need to remember at all times the health service exists for patients and their families and that they are the centre of the service, not the organisation. Self-preservation of the organisation over the individual, and we have seen this in many examples through other organisations, compounds the insult and never serves us well. I welcome that CHI has accepted fully the HICWA report, is committed to implementing its recommendations with a quality improvement plan, is working with the Minister for Health Health Proactively, improving all aspects of the delivery of orthopaedic and spinal care at Temple Street and CHI. I also welcome the comprehensive patient safety review and the assurance process into the paediatric orthopaedic surgery services under the independent expert, Mr Nugayam. That review is in two parts with the review of the work of Surgeon A and a comprehensive review of the governance of the paediatric outpatient service at CHI. I also welcome the unqualified regret and apologies from CHI, the HSC and the Minister. It is the least we can do. Next I want to address a very serious matter concerning the developmental dysplasia of the HIP or DDH and the ongoing clinical audit examining surgical practices at Children's Health Ireland and the National Orthopaedic Hospital in Capa. The issue was brought to light through a protected disclosure in September 2023 and it centres on concerns that different thresholds for corrective surgery were being applied across sites. In practical terms this means that a child presenting with the same clinical condition might have been offered surgery in one hospital but not in the other. Or surgery being promoted in one hospital and not being recommended in another might be a better way to put it. That kind of inconsistency raises real questions about the standards of care, clinical decision making and ultimately patient safety. As a doctor and as a public representative I find any suggestion that children may have undergone unnecessary or inappropriate procedures deeply unsettling. This is a matter that strikes the heart of trust in our health system and we owe to families to deal with it transparently and responsibly. The Department of Health was formally notified in May 2024. A clinical audit was commissioned to examine the matter led by Mr Simon Thomas, an experienced international paediatric orthopaedic surgeon based in Bristol Royal Hospital for Children. That audit has reviewed a random anonymised sample of children between age one to seven who underwent pelvic osteotomy procedures for DDH between 2021 and 2023. While it's a relief that no patient safety incidents have been reported to date, that does not diminish the seriousness of what is being examined. At its core this audit is about whether the clinical thresholds for surgery adhere to international standards and whether there was consistency across our national paediatric orthopaedic service. The audit is now at its final stages. Feedback on the draft report has been received and it is currently under review. Once that report is complete, CHI and CAPA have committed to publishing its findings. That is as it should be. Families deserve clarity, accountability and full transparency. In the meantime, steps have been taken to ensure that no child is offered surgery without a unified cross-site decision-making process. I welcome that. Multidisciplinary decision-making, systemic safety netting, that is what is so important about that process so that there is a combined professional approach to decision-making. It is a necessary safeguard that would have served both the children who had springs inserted into their spines and perhaps unnecessary surgeries carried out on their hips would have helped. An action plan is also being developed to address any additional patient groups not covered by the original audit sample and that is also to be welcomed. Clinical follow-up will be offered where appropriate and clear communications issued to families as the situation evolves. We are learning. I have heard concerns that not enough has been done or that progress has been too slow and I understand those frustrations but I also believe it is essential that this process is thorough, clinically sound and focused on facts. Only when the audit is complete can we truly understand what has happened, why it has happened and what needs to be done next. If unnecessary surgeries are found to be carried out then we need to know why it happened and for what reason. Was it poor clinical judgment or were there other reasons involved? Accountability at a professional and corporate level will have to be sought. We owe that to the children affected and to the parents who put their trust in our health service. Whilst it is absolutely crucial we discover poor practices and learn lessons we must also acknowledge the progress that has been achieved. Significant additional funding for spinal surgeries for scoliosis and spina bifida, public health initiatives including national immunisation programmes and neonatal support and early developmental interventions and the extension of the GP service eligibility have led to measurable improvements in child outcomes. These gains are a credit to frontline professionals and to sustained government commitment. The new National Children's Hospital is emblematic of the government's commitment to children's medicine and well-being in Ireland, but ultimately the success of CHI will be judged not by its buildings but by the quality of care delivered within those buildings. We must continue to work to ensure that every child in Ireland receives safe, timely and compassionate treatment. Go raibh maaka.