An investigation into the use of uncertified springs in spinal surgeries at Temple Street Children's Hospital will examine if senior management was aware of their use, how many people knew, and when.
The clinical director of Children's Health Ireland (CHI) confirmed yesterday that a number of clinicians and others within CHI were aware that the uncertified implants were being used.
Dr Ike Okafor said an external group has been tasked to examine how and when the springs were procured and the full extent of who knew.
Earlier this week, the HSE commissioned Selvadurai Nayagam to review surgeries carried out by a consultant at Temple Street after an internal and external review found irishexaminer.com/news/arid-41230501.html'>serious issues at the hospital.
The consultant at the centre of the controversy ceased doing complex spinal surgery on children with spina bifida in November 2022.
Health Minister Stephen Donnelly said he is "deeply concerned" that a number of people within CHI knew that unauthorised devices were being used.
Speaking in New York, Mr Donnelly said: “It is clear that other people knew that non-medical devices were being used.
"I'm very concerned about this. I introduced the Patient Safety Act recently to make sure that we have mandatory open disclosure in our country."
He could not say how many people knew about the devices at the time they were being used, but this will be examined. He confirmed that he was first made aware of issues at the hospital last year, when surgeries were stopped after "red flags" were raised.
Mr Donnelly said Mr Nayagam will have "full authority to go as wide as he wants and as deep as he wants".
"It is absolutely essential that when people know about this, people involved in the process, people who might be supporting the process, that first and foremost they immediately raise a flag," he said.
"They must feel safe doing that, they must feel supported doing that, and indeed the Patient Safety Act mandates mandatory disclosure to patients.”
He said he is “deeply concerned” that it appears people in CHI did not feel safe and protected in raising a red flag.
The head of the HSE Bernard Gloster said the external review of the surgeries could take 12 months. He will meet the reviewer, Liverpool-based consultant Mr Nayagam, "on Monday week".
Speaking at the Nursing Homes Ireland Conference, he said it was possible that other issues would emerge but that "fair and objective" assessment was needed.
Regarding the use of unauthorised implants in three children, he said: “We do have to see how the end-to-end processes actually did not detect that particular problem. We really have to allow that investigation to actually happen.”
In relation to senior management’s potential knowledge of this process, he told the
: “CHI have to be allowed, to be fair, to do their own investigation of how that happened.“I reserve the right to see what the outcome of that is, and then if we need to take other steps, to either inquire into that further or consider that further, of course we will do that.”
Asked if the HSE had thrown the Temple Street consultant “under the bus”, Mr Gloster said: “I would reject that. CHI as the employer has made a referral to the Medical Council; there are other matters to be investigated. People are entitled to fair procedures."
Meanwhile, the family of Dollceanna Carter from Co Meath, who died after undergoing a number of operations for spina bifida and scoliosis, plans to set up a foundation in her memory.
"We did not know a lot of things about scoliosis. We want to use our experience to help other families too," Michael Carter told the
.Dollceanna was one of 19 children included in the reviews, and her death was described by the HSE as a "serious surgical incident". It is currently the subject of a serious incident investigation review.
Dollceanna's sister Santana died of spina bifida when she was just 11 months old.