Concerns over experimental implants used in children’s spinal surgery at Temple Street

A report by the Health Information and Quality Authority (HIQA) has raised serious concerns about the use of non-CE marked metal springs in paediatric spinal surgeries at Children’s Health Ireland (CHI), particularly at the Temple Street Hospital.

The review, which was conducted independently by HIQA, focused on the governance and oversight of surgical implants and implantable medical devices used within the hospital.

The review was initiated following significant public concern after it emerged that three children had undergone spinal surgery involving these unapproved implants, intended to treat scoliosis.

The springs, which were used in an attempt to replicate an experimental technique from an overseas hospital, were not approved for use and had not been subject to necessary ethical oversight.

Sean Egan, Director of Healthcare Regulation at HIQA, commented on the findings, stating that the families of the children involved played a vital role in shedding light on the issue.

“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,” Egan said.

The review revealed that the use of the springs was part of an attempt to modify an experimental technique still under investigation elsewhere.

However, no ethical approval was sought from any committee within CHI, and no written consent from senior management was found to support the use of this experimental procedure.

Moreover, the families were not fully informed of the experimental nature of the surgery, meaning the request for consent did not comply with the HSE’s National Consent Policy 2013.

HIQA’s investigation also uncovered systemic failures in the hospital’s management practices.

Controls meant to safeguard patients, particularly regarding the procurement, introduction, and use of medical devices, were found to be inadequate.

The review pointed to deficiencies in governance structures at CHI, noting that changes made to organisational structures in 2019 had created confusion over reporting lines and accountability.

As a result, necessary safety checks and approval processes were bypassed, leaving children exposed to unnecessary risks.

Egan stressed the importance of learning from this case, not just within CHI, but across Ireland’s healthcare services.

“It is essential that key lessons are learned from this review, particularly with respect to the governance of clinical innovation and practice,” he stated.

In response to the findings, HIQA has outlined a series of recommendations.

Nine of these are directed specifically at CHI, while others are intended to be implemented across HSE-provided and funded health services, as well as private hospitals.

These recommendations aim to address the lapses in governance, consent procedures, and safety practices uncovered during the review.

This report highlights the need for more robust oversight and transparency in the use of medical devices in Irish hospitals, ensuring that patient safety remains the top priority in all medical procedures.