Frequently Asked Questions: HIQA Review

Where is the HIQA report published?

The review is available on HIQA’s website here:

Review on governance of implantable medical devices at CHI, including use of non-CE marked springs in surgery at CHI at Temple Street

Why was this HIQA report commissioned? 

On 4th October 2023, the Minister for Health announced that HIQA would investigate the implantation of unlicensed springs in three children undergoing spinal surgery at Temple Street.

When did these three surgeries happen?

Non-CE-marked implants were used in three separate spinal surgeries in 2020 and 2022.

How did the issue come to light?

The incidents were brought to light through Parliamentary Questions in July 2023, and subsequent investigations.

When did the board of Children's Health Ireland learn about the surgeries?

In July 2023. The HIQA report confirms that regular Board meetings were taking place in line with the functions of the board, and documentation to show formal reporting structures of the CEO and Executive Management Team to the CHI board, providing updates on a regular basis.

What did the HIQA report find?

HIQA found that the use of the non-CE-marked springs as surgical implants was wrong.

HIQA could not identify any evidence to demonstrate that there was any written approval from any senior manager in Children's Health Ireland for these devices.

It 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.

HIQA acknowledged the work done by Children's Health Ireland to date to implement measures for the ongoing care for children and families affected by this review.

For further information, pages 17 and 18 of the report provides an “overall conclusion”.

What are the current health outcomes of the affected patients?

Children's Health Ireland will not provide clinical details of individual patients.

Children’s Health Ireland deeply 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 on the families affected, and the distress that it has caused all to all patients and families in the spinal service.

What is Children's Health Ireland response to the report?

For an organisation that exists with a singular focus to deliver safe, quality car.e to those we serve, these findings are unacceptable. We are deeply sorry that these children, young people and families did not get the care they deserved.

What recommendations did HIQA make for CHI?

HIQA has made nine recommendations for Children’s Health Ireland, relating to:

1. A review of organisation-wide corporate and clinical governance arrangements.
2. A review of the span of responsibilities of Clinical Directors.
3. A review of the role of Clinical Specialty Leads.
4. A review of the governance arrangements for multidisciplinary team working in the orthopaedic service.
5. A plan to address issues relating to culture and interpersonal challenges.
6. Embedding of CHI’s existing Medical Device Management System.
7. Ensuring effective ongoing communication with children and families as to any implications for their care, particularly when things go wrong.
8. An audit and assessment of CHI’s compliance with the HSE National Consent Policy.
9. The development of a Quality Improvement Plan for the implementation of these recommendations.

What actions will be taken by Children's Health Ireland?

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.

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.

How will Children's Health Ireland ensure transparency in addressing the report’s recommendations?

The Quality Improvement Plan (QIP) is in development and will be published on the Children's Health Ireland website within three months. Children's Health Ireland is committed to providing updates on the QIP quarterly.

What improvements to the spinal service have been made since the surgical implant issue came to light in 2023?

Throughout 2023, 2024 and 2025, Children's Health Ireland initiated additional patient safety and governance measures.

Details of those measures are outlined in detail here: Spinal service improvements

When will remaining reports/reviews into CHI’s Orthopaedic Services be complete?

Review of Paediatric Orthopaedic Surgery Service at CHI and Dublin Hospitals (Nayagam Review): This report is a HSE commissioned report, and we are awaiting the results of it.

Development Dysplasia of the Hip (DDH) Audit: Children’s Health Ireland (CHI) and the National Orthopaedic Hospital Cappagh (NOHC) confirmed in July 2024 that it would undertake a joint clinical audit to look at a random and anonymised sample of DDH surgeries performed during the 2021-2023 period, after a concern was reported that the threshold criteria being used for surgical intervention in relation to DDH may have been different across CHI and NOHC.

The audit is being conducted by a UK paediatric orthopaedic consultant with specialist expertise in this area.  The audit is in draft form and is not final, and so we cannot yet comment on it.  However, we will ensure our patients, and their families are kept informed as we move through this process. CHI and NOHC will share the findings of this clinical audit, once completed.

CHI and NOHC is committed to improving access to quality care across our services and regularly undertakes quality assurance checks in line with HSE standards.