Children's Health Ireland acknowledges the publication of HIQA report
Children’s Health Ireland (CHI) acknowledges the publication of Health Information and Quality Authority (HIQA) report: Independent review of governance at Children's Health Ireland in the use of implantable medical devices, including the use of non-CE marked springs in spinal surgery at CHI at Temple Street.
April 8, 2025
- Review on governance of implantable medical devices at CHI, including use of non-CE marked springs in surgery at CHI at Temple Street
- Please see: Spinal service improvements | Children's Health Ireland
- Please see: Frequently Asked Questions: HIQA Review
Children’s Health Ireland (CHI) acknowledges the publication of the Health Information and Quality Authority (HIQA) Independent review of governance at Children's Health Ireland in the use of implantable medical devices, including the use of non-CE marked springs in spinal surgery at CHI at Temple Street.
HIQA conducted this review under section 8(1)(c) of the Health Act 2007, following a request by the Minister for Health on 4th October 2023. This review was primarily commissioned to investigate patient safety concerns relating to non-CE-marked devices (springs) used in three spinal surgery procedures in CHI at Temple Street.
The HIQA review found that the use of the non-CE-marked springs as surgical implants was wrong.
Lucy Nugent, Chief Executive of Children's Health Ireland, apologises to the families affected:
“Children's Health Ireland is an organisation that exists with a singular focus to deliver safe, quality care to children and young people. We are deeply sorry that these children, young people and families did not get the care they deserved. This is unacceptable.
“Children’s Health Ireland sincerely regrets and apologises for the risks that were posed to three patients through the use of non-CE-marked spring implants in their spinal surgeries. We do not underestimate the impact that this has had and is having on the families affected, and the distress that it has caused to all patients and families in the spinal service.”
The HIQA review found that while corporate and clinical governance arrangements were in place in Children's Health Ireland, there were unclear lines of reporting and accountability to ensure the safe introduction and use of new surgical implants and implantable medical devices. It also found that supporting policies and procedures were either not in place, not fit for purpose or were not followed. However, HIQA acknowledged the work done by Children's Health Ireland in the interim to date, to implement measures for the ongoing care for children and families affected by this review.
Despite Children's Health Ireland’s corporate and clinical governance arrangements in place at the time (acknowledged as insufficient) HIQA’s report highlighted that there was no evidence to demonstrate that there was any written approval from any senior manager for these devices, nor was any ethical approval sought. The report also documents that staff in theatre were unaware that a new spring was being used, alongside conventional spinal surgery implements.
Most concerningly, HIQA found that there was a lack of information provided to families on the new or experimental nature of the intended surgery.
Following the publication of HIQA’s report today, Lucy Nugent, Chief Executive of Children's Health Ireland, said:
“The findings and recommendations from HIQA will be implemented, through a Quality Improvement Plan, alongside the many changes that are already underway within Children's Health Ireland’s services. Children's Health Ireland is committed to ensuring robust governance and compliance processes and to providing safe, high-quality, and child-centred healthcare services.
“Issues of poor performance and non-compliance with policies are being addressed with the staff involved, in line with relevant hospital policies. I want to assure families of my commitment to ensuring that something like this never happens again in our organisation.”
HIQA outlined nine recommendations for Children’s Health Ireland, relating to:
- A review of organisation-wide corporate and clinical governance arrangements.
- A review of the span of responsibilities of Clinical Directors.
- A review of the role of Clinical Specialty Leads.
- A review of the governance arrangements for multidisciplinary team working in the orthopaedic service.
- A plan to address issues relating to culture and interpersonal challenges.
- Embedding of Children's Health Ireland’s existing Medical Device Management System.
- Ensuring effective ongoing communication with children and families as to any implications for their care, particularly when things go wrong.
- An audit and assessment of Children's Health Ireland’s compliance with the HSE National Consent Policy.
- The development of a Quality Improvement Plan for the implementation of these recommendations.
Children's Health Ireland entirely accepts HIQA’s findings and recommendations, five of which are completed with the remainder partially completed as part of the Quality Improvement Plan.
Throughout 2023, 2024 and 2025, Children's Health Ireland has initiated additional patient safety measures, which also directly address recommendations from the previous External Quality Review and Programme Assessment (“Boston Review”), carried out by international experts. Details of these improvements can be found here.
For families:
Contact details for patients of the spinal service who need support following this report publication can be found on
Spinal Surgery Helpline:
- Phone: 01 409 6117
- Open Monday to Friday, 9am to 5pm