The Health Information and Quality Authority (HIQA) has published the report on its independent statutory review into governance and oversight of the use of surgical implants and implantable medical devices in Children’s Health Ireland (CHI), including at CHI Temple Street.

Commenting on the publication of the report, HIQA’s Director of Healthcare Regulation, Sean Egan, said: “This review was initiated as a result of significant public concerns about paediatric spinal surgery procedures undertaken at CHI at Temple Street Hospital, Dublin, where non-CE marked metal springs were implanted in three children with the intention to treat scoliosis of their spines. The experience of these children and their families is at the core of this review and we would like to thank those families who engaged with us and provided valuable insights into their experiences of the service.”

HIQA found that use of the springs in these surgeries was an attempt to replicate an experimental surgical technique that was still under investigation at a hospital in another country, but in a modified way. HIQA found that ethical approval was not sought from any ethical research committee in CHI for the introduction of this new technique. HIQA could not identify any evidence to demonstrate any written approval from any senior manager in CHI on the clinical use of the springs. Furthermore, HIQA found that there was a lack of information provided to families on the new or experimental nature of the intended surgery, and therefore the request for consent from families by CHI to carry out the surgeries was not in line with the HSE’s National Consent Policy 2013, which was in operation in CHI. The use of the springs in this manner should not have happened.

HIQA identified that the controls in place within CHI for the management of the end-to-end processes did not provide the necessary adequate safeguards at each stage of the process, including those required for the procurement, introduction, decontamination and use of the springs in surgeries. As a result, children were not protected from the risk of harm. 

HIQA identified that the overall governance structures and management arrangements at CHI were overly complex, and did not enable effective management and oversight of the orthopaedic service at CHI at Temple Street. Following the establishment of CHI as a legal entity in 2019, changes to organisational structures led to unclear lines of reporting, accountability and oversight across the organisation which could not ensure the safe introduction and use of new surgical implants and implantable medical devices. As a consequence, a number of key approval processes, policies or safety checks were not properly applied in treating these children, resulting in the springs being used inappropriately.

HIQA’s Director of Healthcare Regulation, Sean Egan, continued: “It is essential that key lessons are learned from this review at both CHI, and in other health services nationally, particularly with respect to the governance of clinical innovation and practice.”

Based on the findings of this review, HIQA has made nine recommendations specifically for implementation by CHI, nine recommendations for implementation nationally by HSE-provided and funded health services, and one recommendation for HSE-provided and funded health services and private hospitals.

The full report can be found at the link at the top of the page.

Ends.

Further information:
Marty Whelan, Head of Communications & Stakeholder Engagement
085 805 5202, mwhelan@hiqa.ie

Notes to Editor:

• In November 2023, HIQA commenced this review under section 8(1)(c) of the Health Act 2007, as amended, following a request by the Minister for Health on 4 October 2023. Terms of Reference for the review were developed and published on www.hiqa.ie. In accordance with its remit, HIQA assessed compliance against eight of the National Standards for Safer Better Healthcare relevant to the terms of reference for this review.
• This review covers the period from November 2018, when the use of the springs was first considered as a possible treatment option for a small cohort of children attending CHI at Temple Street, to July 2023, when it was confirmed internally by CHI that the springs implanted into a number of children during spinal surgery, between 2020 and 2022, were not CE marked.
• Many products (including medical devices) require CE marking (Conformité Européene) before they can be sold in the EU. CE marking indicates that a product has been assessed and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. The requirements will depend on the product type and its intended purpose.
• HIQA found the springs implanted in children were made of a material called non-alloyed spring steel. Non-alloyed spring steel is not used for surgical implantation.
• HIQA found that the orthopaedic service in CHI at Temple Street had been affected by long-standing issues with communications and team dynamics since 2019, which HIQA believes was a significant factor in the introduction of the springs, as it impacted on important and relevant questions not being raised at various steps, in the absence of a formal process also not being followed.
• The HSE’s National Consent Policy 2013 sets out that a cornerstone of securing consent is ensuring the availability of all relevant information to the patient to enable them to be fully informed prior to giving consent.