The HSE Chief Executive has said that springs used in complex spinal surgery on young children at Temple Street Children's Hospital were not medical devices or approved to a basic European CE standard.
Speaking on RTÉ’s This Week programme, Bernard Gloster said that nobody appears to have sought assistance from the Health Products Regulatory Authority (HPRA).
Mr Gloster said the springs were bought from a UK company that specialises in the manufacture of springs.
He said that ten springs were bought and three were used. Two have been removed from children, but one has not.
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Mr Gloster said that innovation is important in healthcare, but that in this case "they should not have been used or procured in this manner".
He said that it is of serious concern to him that "nobody put their hand up" if they knew of plans to use these devices.
Mr Gloster said he does not know who ordered the springs, but they were "invoiced to someone in Temple Street".
"I cannot be clear about who was or wasn't involved in any part of the process without looking at the end-to-end process," he said, adding that everyone had a right to fair procedure.
Mr Gloster said that he has spoken with the CEO of Children's Health Ireland and he understands she was not involved in authorising the procurement of the springs.
However, he said it would be impossible to believe that just one person was involved in the entire transaction.
In a statement, the HPRA said that it understood that the compression springs involved were not intended to be sold or supplied as medical devices.
It added that the springs would need certification from the EU in order to be supplied to the Irish market for such use, and that particular devices such as implants must also be assessed by another EU body before they can be legally supplied.
It said it does not have a direct role in governance until a device is made available for sale in Ireland and is classed a being for medical use, but it does not regulate or assess devices that are not marked as such.
It added that it holds a role in approving devices to be used in clinical studies, and in those cases a risk assessment is carried out. The National Research Ethics Committee, which operates outside the HPRA, is also involved in granting approval during such processes.
In this case the HPRA said that no application was made to them regarding the use of compression springs at CHI.
New external review will not be paused
Two reviews examined the care provided by one consultant to 17 children who had complex spinal surgery at Temple Street Children's Hospital.
Of the 17 children, one child has since died and a number of other children suffered significant post-operative complications.
The surgeon involved has stepped back from performing operations and another external review will be led by a UK expert.
Mr Gloster said he is open to hearing anything that the families of the children involved have to say about the terms of reference for the proposed external review.
Mr Gloster said the inclusion of these families "could have been better" and the HSE takes responsibility for this, but insisted that the review will not be paused.
Mr Gloster added that he intends to engage with parents in the coming days and seek their views on the terms and listen to their concerns.
The Health Minister has offered to meet the groups via video link on Friday. But they have requested a meeting with the Taoiseach.
Asked if the Taoiseach would meet advocacy groups for patients effected by spinal surgeries at Temple Street, a spokesperson said: "Minister Donnelly will meet the groups and continue to provide updates to the Taoiseach and his Government colleagues."
Likely delays to surgery in 'short-term'
Mr Gloster acknowledged that there will be delays for children waiting for surgery "in the short term", but said he did not believe there would be a major effect in the long term.
The HSE chief told the programme that consideration would be given to sending children abroad for treatment, but that "this is not always the easiest option" for children with complex medical needs.
Separately, Mr Gloster was also asked about overspending at the HSE and acknowledged an overrun at the end of July of around €700m.
He said that health inflation has been significant, while demand on the system has been "way beyond what was projected".
Mr Gloster said the HSE is going to need substantial assistance before the end of this year and into next year, but he could not yet say how much would be needed.
He said that the executive will be seeking more money in the upcoming Budget.
