Uncertified springs used in spinal surgeries at Temple Street Children's Hospital were not ordered from a "retail establishment", the Clinical Director of Children's Health Ireland (CHI) has said.
An investigation is in place to look at the process around how the springs were procured and how they were used and a separate investigation into the use of the springs has been commissioned by the Health Service Executive.
It comes after revelations into aspects of orthopaedic surgery at Temple Street relating to poor surgical outcomes in spinal surgery and the use of unauthorised implantable devices.
Speaking on RTÉ’s News at One, Dr Ike Okafor apologised to those affected.
He said: "On behalf of CHI and on behalf of myself, that we are really, really sorry and we want to apologise to all the families and children who have been affected and that we are doing our best to ensure that things get better."
Dr Okafor said he did not know what the uncertified springs did to the affected patients.
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He said: "There is a lot of false information circulating in social media around these springs.
"We are investigating this, and there is an external group that is going to look at this, and we have to wait until they submit their findings."
Dr Okafor said CHI was aware of these springs being used and said "again it is going to be part of the investigation".
He said the investigation is separate from the review that is taking place.
Dr Okafor said the review will be a "wider scope" that will investigate children who have had surgeries at the hospital in the orthopaedics section.
He added the focus of reviews is still on the clinical care provided by one individual surgeon.
Dr Okafor said that the review team will speak with families and added that a small and isolated group of children are affected and other families should not be concerned.
He added that these type of surgeries are often "very challenging" and when an infection occurs post-surgery, patients may need another procedure to have their wounds "washed out".
Dr Okafor said: "Children are still getting surgeries. We suspended the most complex type of surgery in this group of patients in November last year. The other surgeries are still ongoing at our sister site in Crumlin.
He said last year CHI completed 500 spinal surgeries and added: "We have 13,000 children who get surgery in CHI every year, so again, this is a small number of really, really complicated cases."
Speaking later to RTÉ's Drivetime, CEO of Spina Bifida Hydrocephalus Ireland Gerry Maguire said Dr Okafor's comments answered few questions.
He said: "We have identified that there are uncertified, unlicensed pieces of metal purchased by the hospital.
"Who purchased them within the hospital I want to know?"
However, he also welcomed the apology from Dr Okafor but described it as a "sound bite".
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Elsewhere, head of the HSE Bernard Gloster said it has still to be determined how Temple Street did not detect the use of unauthorised medical implants.
Speaking in Kilkenny, he said it has to be seen how the end-to-end processes within the hospital did not detect that particular problem.
He said it was a problem that came on top of the incidents that they were already reviewing, from the two reports that people are now familiar with.
Mr Gloster said that the new investigation had to be allowed explain how that happened.
He said the external review they have now commissioned will look at all these issues.
However, he said CHI followed good practice in relation to the two incidents "of serious concern" identified in July and September.
Mr Gloster said they initiated audits which in turn led to an external review.
He said that given the scale of public confidence issues arising from the reports, he welcomed the decision by the CHI to publish both reports unredacted yesterday.
Responding to criticism from the families involved that they were not included in the scope or terms of reference of the review by Boston Children's Hospital, Mr Gloster said they were asked to look at clinical outcomes first.
However, he assured families that they will be consulted as part of the new review.
He also said that he would be open to meeting the families and advocacy groups to ensure the "proper inclusion of their views".
Mr Gloster rejected any suggestion that the consultant at the centre of the reviews "was thrown under the bus".
He also confirmed that CHI as the employer, has made a referral to the Irish Medical Council, that there are other matters to be investigated, but people are, he said, "entitled to fair procedures and those fair procedures will apply".
He also apologised to the children and families involved.
While the reviews identified 19 children, he said that if the external review identifies other cases, they will be included.
Mr Gloster added he hoped to meet the external reviewer, with the Minister for Health and his Chief Clinical Officer on Monday.
