Martin Daly (Roscommon-Galway, Fianna Fail) | Oireachtas source

I am grateful for the opportunity to make a statement on Children's Health Ireland, CHI, and to reflect on the recent deeply troubling revelations about 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, comprising Crumlin, Temple Street and the National Orthopaedic Hospital Cappagh. These are distinct issues, but they raise the most serious questions about clinical governance and patient safety in the CHI group of hospitals.

As a Deputy and practising GP, I must begin by expressing my profound concern at the findings of the recent HIQA report on 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 governance, is truly alarming. It is very difficult to comprehend how such a practice was allowed to occur. HIQA's report states that there were no overarching CHI-wide standardised governance structures and supporting policies and procedures in place for the introduction and use of medical devices. That is an astounding fact.

In addition, HIQA found that while corporate and clinical governance procedures were in place in the CHI group, they were overly complex and difficult to understand for management and staff at site-specific hospitals and within the overall CHI group. With the changes from 2019 onwards, there was a loss of experienced management and staff at Temple Street, resulting in a breakdown in communication and governance pathways. While 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.

HIQA identified cultural differences in the orthopaedic department that mitigated against peer review and multidisciplinary decision-making for proposed surgeries. In effect, HIQA said the surgeons in the unit were not getting along and there was very little communication or peer review as a result. This is simply unacceptable. Teamwork in the interests of the patient should be a primary ethical and contractual obligation. These are systematic failures that allow individual failures in judgment to flourish.

In summary, there was a failure in regulatory and ethical procedures, clinical governance, medical device approval, the sourcing and procurement of medical devices, decontamination, 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.

HIQA also found that the management of the issues, once disclosed, could have been better. We need to remember at all times that the health service exists for patients and their families and they, not the organisation, are the centre of the service. Self-preservation of the organisation over the individual, something we have seen in many organisations, compounds the insult and never serves us well.

I welcome that CHI has accepted fully the HIQA report, is committed to implementing its recommendations with a quality improvement plan, is working with the Minister for Health proactively and is improving all aspects of the delivery of orthopaedic and spinal care at Temple Street and CHI more widely. I also welcome the comprehensive patient safety review and the assurance process into the paediatric orthopaedic surgery services under the independent expert, Mr. Nayagam. That review is in two parts, with a 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 HSE and the Minister. It is the least we can do.

I want to address a very serious matter concerning developmental dysplasia of the hip, DDH, and the ongoing clinical audit examining surgical practices at CHI and the National Orthopaedic Hospital Cappagh. The issue was brought to light through a protected disclosure in September 23, 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 another. Surgery may have been promoted in one hospital but not recommended in another. This kind of inconsistency raises questions about the standards of care, clinical decision-making and, ultimately, patient safety.

As a doctor and public representative, I find any suggestion that children may have undergone unnecessary or inappropriate procedures deeply unsettling. This is a matter that strikes at the heart of trust in our health system. We owe it to families to deal with this 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 one and seven years of age who underwent pelvic osteotomy procedures for DDH between 2021 and 2023. While it is 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 adhered to international standards and whether there was consistency across our natural national paediatric orthopaedic service.

The audit is now in its final stages. Feedback on the draft report has been received and is currently under review. Once that report has been completed, CHI and Cappagh 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, and I welcome that. Multidisciplinary decision-making and systemic safety netting are important in that process so that there is a combined professional approach to decision-making. It is a necessary safeguard that would have helped the children who had springs inserted into their spines and perhaps unnecessary surgeries carried out on their hips.

An action plan is also being developed to address any additional patient groups not covered by the original audit sample, which 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 progress has been too slow, and I understand those frustrations. It is essential that this process be 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 have been carried out, then we need to know why that happened and for what reason. Was it poor clinical judgment or were there other reasons?

Accountability at a professional and corporate level will have to be sought. We owe that to the children affected and the parents who put their trust in our health service. While it is crucial that 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, neonatal supports and early developmental interventions, and the extension of GP service eligibility have led to measurable improvements in child outcomes. These gains are a credit to front line professionals and to sustained Government commitment.

The new national children's hospital is emblematic of the Government's commitment to children's medicine and wellbeing 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.

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