The publication of the Health Information and Quality Authority (HIQA) review into spinal surgeries at Children’s Health Ireland (CHI) at Temple Street represents an important moment in Irish healthcare accountability. While the underlying issues first came to public attention in 2023—and relate to surgeries carried out between 2020 and 2022—the findings continue to shape how patients, families and legal practitioners understand medical device governance, patient safety, and potential avenues for legal recourse.
For those affected, the report is not simply a retrospective account. It provides clarity on what went wrong, highlights systemic failures, and sets out lessons for the future. It also underscores the circumstances in which legal advice may be appropriate.
What Happened: A Brief Overview
The HIQA review examined the use of non-CE marked springs during paediatric spinal surgeries at CHI at Temple Street. These springs were implanted into three children as part of procedures intended to treat scoliosis.
Under EU law, most medical devices must carry a CE mark, which confirms they meet required safety and regulatory standards. The review found that the springs used did not meet these requirements and were not approved under any recognised pathway for non-CE marked devices (such as clinical investigation or compassionate use).
HIQA ultimately determined that the use of these devices “was wrong” and that multiple opportunities to prevent their use were missed.
Key Findings: A Breakdown of Systemic Failures
The report identifies a number of significant failings across governance, communication, and clinical oversight.
1. Lack of Governance and Oversight
HIQA found that Children’s Health Ireland did not have a consistent, organisation-wide system for approving and overseeing medical devices. In particular:
There were no standardised procedures for introducing new or experimental devices
There was no central approval mechanism for high-risk implantable medical devices
Governance structures were described as complex and unclear, leading to gaps in accountability
These deficiencies meant that safeguards designed to protect patients were not functioning effectively.
2. Absence of Regulatory and Ethical Approval
Where a non-CE marked device is used, strict regulatory and ethical processes must be followed. These include engagement with:
The Health Products Regulatory Authority (HPRA)
A formal clinical investigation process
A research ethics committee
HIQA found no evidence that any of these steps were taken before the springs were used in surgery.
3. Failures in Multidisciplinary Review
Modern clinical practice relies on multidisciplinary teams to assess risks and ensure appropriate decision-making. However, the report highlights:
A lack of formal structures for multidisciplinary review
Poor communication between teams
An absence of meaningful challenge or questioning
This environment contributed to decisions being made without the benefit of wider clinical input.
4. Procurement and Device Safety Concerns
The springs themselves raised serious safety issues:
They were sourced from a supplier not specialising in medical devices
They were made from non-alloyed spring steel, a material not typically used for implantation and prone to corrosion
There were no safety or technical checks carried out before use
This represented a fundamental breakdown in procurement and quality assurance processes.
5. Informed Consent Issues
Perhaps most concerningly, HIQA found that the consent process did not meet required standards:
Parents were not provided with sufficient written information about the procedure
The experimental nature of the device use was not clearly documented
There was no evidence of fully informed consent in line with national policy
As a result, the consent obtained for these surgeries was deemed inadequate.
What This Means for Affected Families
While each situation is unique, the findings highlight certain circumstances in which families may wish to seek legal advice.
These include cases where:
There is written confirmation that a non-approved or non-CE marked device was used
There is evidence that the device has failed, or requires corrective surgery
There are concerns that appropriate information was not provided before consent was given
The HIQA report confirms that failures occurred across multiple stages of care—from decision-making and procurement to communication with families. In some cases, these failures may give rise to valid concerns about patient safety and accountability.
Wider Implications for Patient Safety
Beyond individual cases, the review has significant implications for the healthcare system as a whole.
HIQA identified national lessons in areas such as:
Medical device regulation and approval
Clinical governance and accountability
The importance of organisational culture and open communication
Traceability and monitoring of implants
Importantly, the report emphasises that clear governance structures and a culture of questioning are essential to safe patient care.
Looking Ahead: Why This Still Matters
Although the events in question are not new, the impact of the findings continues to unfold. The case has heightened awareness of:
The importance of strict regulatory compliance
The risks associated with experimental or innovative treatments
The role of transparency and communication in building patient trust
For patients and families, it reinforces the importance of asking questions, seeking clarity, and understanding their rights when it comes to medical treatment.
Supporting Patients Through Complex Situations
At Gibson & Associates, we recognise that situations like this can be deeply concerning for families. Our role is to provide clear, practical guidance where questions arise around medical care, treatment decisions, or patient safety.
If you have been affected by similar issues—or have concerns about treatment received—it may be helpful to seek advice to better understand your position and the options available to you.
