The chief executive of Children’s Health Ireland (CHI) says she has no recollection of discussing with Temple Street hospital consultants their planned use of unauthorised springs in spinal operations.
Eilish Hardiman says she has no notes of any such discussion and it would not be normal for her to get into such a level of detail.
A consultant at the hospital has been referred to the Medical Council after two serious incidents in children undergoing spinal surgery, including the death of a child. It has also emerged that unauthorised springs were implanted in three children, two of which have been removed.
Ms Hardiman said the implantation of non-medical grade devices “should not happen”, and cannot be approved by CHI or the medical devices regulator, the Health Products Regulatory Authority. Their use is the subject of an investigation by CHI, she added.
Ms Hardiman was asked repeatedly about a February 2020 letter addressed to her by the consultant, which referred to the consultant’s intention to deploy experimental techniques on some children.
She told Fianna Fáil’s John Lahart that she only became aware of the 2020 letter last August. An internal office check could find to record of it having been received.
Asked whether she had attended a meeting with clinicians referred to in the letter at which the use of experimental springs was discussed, she said she did attend a meeting but it was about the separate issue of Magec rods. These approved devices are the subject of a field safety notice.
She declined to answer a number of TDs’ questions about the use of the springs in spinal operations at Temple Street.
Sinn Féin health spokesman David Cullinane repeatedly asked Ms Hardiman whether she had discussed with clinicians in 2020 the use of “high-risk” metal rods in operations.
Ms Hardiman said issues relating to the use of non-medical devices were the subject of an investigation and she was therefore precluded from answering the question.
Asked whether CHI had procured the spring, she again said she was unable to disclose this information as it formed part of the ongoing investigation.
“We have evidence of it being invoiced but that doesn’t mean it was procured.”
Asked whether consultants at Temple Street were placed under “huge pressure” to meet targets for cutting the waiting list for spinal surgeries, she replied: “We don’t pressurise our clinicians into spaces where they’re not comfortable”.
Paula Kelly, clinical director and paediatric orthopaedic consultant, said the implantation of the unauthorised spring devices was “not appropriate in any situation in the surgical world”.
Under Royal College of Surgeons in Ireland guidelines, it is up to the surgeon to ensure that any new device complies with EU standards and is certified by the competent body, she said.
“We cannot stand over any surgeon that implants non-approved devices,” Ms Kelly said.
Senator Tom Clonan said his son received spinal surgery at Temple St. He was nearly 18 by the time he was operated on when it should have happened at age 12. By then, the curvature of his spine was so pronounced that he had only 20 per cent lung function.
“That’s preventable, foreseeable and wrong,” Senator Clonan said. Ireland was out of step with the rest of Europe for long waits for spinal surgery.
Senator Clonan described the external review ordered into Temple St as “a rhetorical device to avoid questions” and the springs under investigation as “a symptom of a completely dysfunctional system” presided over by Ms Hardiman.