A review into the use of unauthorised springs in children at Temple Street hospital will make interim findings by the end of this year, according to the State’s health watchdog.
On Friday, the Health Information and Quality Authority (Hiqa) published its terms of reference for the independent statutory review ordered by Minister for Health Stephen Donnelly after it emerged that non CE-certified springs were implanted in three children at the hospital.
Hiqa’s review is into the governance and oversight of the use of surgical implants and implantable medical devices in Children’s Health Ireland (CHI), including the CHI site at Temple Street.
The review will be conducted in two phases; the first looking at Temple Street and the second involving a wider examination of CHI.
“It is essential that children and their families, as well as the wider public, can be assured that surgical services are safe, and that appropriate governance structures are in place,” said Sean Egan, Hiqa’s director of healthcare regulation.
“This review aims to determine the end-to-end processes around any use of non-CE spring implants during spinal surgery in CHI at Temple Street. It will also assess the controls, oversight processes and governance arrangements in place within all CHI hospitals and services for the use of such implants and medical devices, including internal governance processes in meeting regulatory requirements.
“Furthermore, we will report on any potential opportunities for wider system learnings and system-wide improvements.”
Hiqa says it intends to conclude the first phase of the review, dealing with Temple Street, “as quickly as possible in the interest of providing answers to the Minister no later than the end of 2023″.
The second phase will examine “controls and oversight processes and governance within CHI on the use of surgical implants/implantable medical devices, including processes around regulatory requirements and notifications”.
In assessing the quality and safety of services, Hiqa says it will assess the extent to which the governance arrangements support a child-centred approach to care and the provision of safe and effective care, in relation to the use of surgical devices in children.
A consultant at Temple Street hospital has been referred to the Medical Council after two serious incidents in children undergoing spinal surgery, including the death of a child. An internal review found high complication rates, including repeated returns for surgery and high infection rates.
It later emerged that unauthorised springs were implanted in three children, two of which have been removed.
A separate review into these issues, ordered by the HSE, is ongoing.
