Cormac Devlin (Dún Laoghaire, Fianna Fail) | Oireachtas source

I welcome the opportunity to address the profoundly disturbing findings of the HIQA report published on 8 April 2025 into Children's Health Ireland, CHI. The revelation of governance and clinical failures at CHI, particularly at Temple Street hospital, is beyond comprehension and demands our urgent attention.

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We have learned that extremely vulnerable children were subjected to unapproved and dangerous surgical practices. It is our duty, on behalf of those children and their families, to ensure accountability for what has happened and to highlight the reforms needed to prevent any such travesty from ever occurring again.

The HIQA investigation lays bare a chain of failures in CHI’s governance, clinical practice and medical device oversight. In a small number of complex surgery cases involving three children between 2020 and 2022 a surgeon implanted metal springs that were not medically approved. These springs were not CE-marked as required by EU safety regulations and were made of a material known to corrode inside the human body. This was, as HIQA unequivocally stated, wrong and should never have happened. Shockingly, no ethical approval was sought from any research ethics committee for this novel, experimental technique, nor was there any sign-off from senior management for using these implants on children. Families were not properly informed that this was an experimental or new procedure and the request for parental consent failed to disclose the true nature of the surgery. This amounted to an unethical trial on children, which is a breach of trust and of medical ethics of the highest order.

HIQA’s review identified systemic failures at every stage of CHI’s processes that allowed this catastrophe to unfold. Controls that should have safeguarded children were glaringly absent or ignored. There were numerous missed opportunities to catch and prevent the use of these springs. The HIQA report damningly concluded "children were not protected from the risk of harm". The report shines a light on deeper governance issues within CHI where there appears to be a deeply dysfunctional culture. HIQA found CHI’s management structures to be overly complex and unclear. The board of CHI was evidently not aware of what was happening on the ground in Temple Street until it was far too late. Furthermore, there were long-standing issues with communication, team dynamics and a lack of a formal multidisciplinary team structure. The environment did not encourage open discussion or questioning and this enabled one surgeon’s ill-considered idea to bypass all institutional safeguards.

Tragically, our healthcare system is not alone in facing such failures. In the UK, Great Ormond Street Hospital was recently found to have allowed an orthopaedic surgeon to carry out "inappropriate and unnecessary" operations that left children in chronic pain. These findings are shockingly parallel. Both cases show a rogue element of clinical practice persisting unchecked and families not being fully informed or heard. In response to its own scandals, the UK strengthened governance frameworks, empowered regulators like the Care Quality Commission and introduced a patient safety commissioner. Ireland must adopt similarly robust reforms.

I fully endorse HIQA’s nine recommendations for CHI and nine for the wider health service. These include overhauling CHI’s governance structures, establishing a clinical innovation approval process, tightening medical device procurement oversight, embedding a culture of safety and ethical practice and ensuring transparency and regular public reporting. The culture of paternalist secrecy in the medical sector also needs to be overturned. Patients and parents must be given access to their information. Frustratingly this is not the first time I have raised this issue in the House and I hope the Minister will work to deal with this culture. At the national level, the HSE must ensure all hospitals have effective oversight of surgical innovations. Consideration should be given to establishing an independent patient safety commissioner as the UK has done. The Minister must also ensure HIQA and the HPRA are properly empowered to intervene earlier.

Let us remember the human cost behind this report and all this scandal. Children who were already facing serious health challenges were put in danger. Parents have had their trust shattered. Irish children deserve the highest standard of care. We must rebuild trust in CHI and across our health service through honesty, accountability and excellence in governance.

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