The Minister for Health has acknowledged that there should have been a "deeper" consultation with families on the draft terms of reference for the review into Children's Health Ireland.
Taoiseach Leo Varadkar and Minister Stephen Donnelly will meet patient advocacy groups later this week to discuss the crisis engulfing Temple Street Children's Hospital over its use of unlicensed surgical implants.
Mr Varadkar said that he was keen to hear what the groups had to say and that their concerns "would be taken on board".
Minister Donnelly acknowledged to the Dáil "the intense distress and anxiety" caused to patients and their families.
Making his first comments in the Oireachtas since the crisis erupted, Minister Donnelly offered his "deepest condolences to the parents and the family of Dollceanna Carter" for the "incredible loss suffered".
The draft terms had been shown to the families just before publication, shortly after the external review had been ordered by the HSE at the start of last week.
"I think with the benefit of hindsight, there should have been a deeper consultation with the families, with the groups on the [draft] terms", Minister Donnelly said this evening.
"The intention was that Mr [Selvadurai] Nayagam [the Liverpool-based expert] would meet with them, and he has full discretion within the current terms to adjust them according to what he hears directly from the families," the minster told the Dáil.
He added: "He has full discretion to do whatever he wants, he can go as wide as he wants, he can go as deep as he wants. He will have my full support."
"Yes, he's looking at the use of non-medical equipment. He will be going much wider, not just on Temple Street, but across Children's Health Ireland, right across pediatric orthopedics," Minister Donnelly said.
"Families have legitimate questions about waiting times and governance, and I am absolutely determined that these questions will be fully answered for them," he insisted.
No confidence
But Sinn Féin's health spokesperson David Cullinane responded that the "families and their advocates do not have confidence" in the external review.
"The HSE and Children's Health Ireland (CHI) need to be many steps removed from this review process," he said.
The only way forward is for the minister "to sit down with the families and their advocates and work out a terms of reference which will be acceptable to them. There is no other way, there's no shortcuts," Mr Cullinane said.
Deputy Paul Murphy, Solidarity-PBP, put on the record of the Dáil that three types of sub-standard springs had been used as implants in the 19 children whose cases have been examined.
"One caused severe damage to a child's pelvis and ribcage requiring multiple operations.
"One broke a few ribs, and one is still in a patient having broken, and may have corroded as a result of not being made of titanium as the appropriate metal," he noted.
Minister Donnelly said that he had first heard about the implants on 4 August.
'Scapegoating'
"In relation to the use of implants", Mr Cullinane said, "I don't believe that this is about one individual. There may be culpability in relation to a single individual, but I believe that there are wider issues here in relation to clinical governance".
"There are fundamental questions that need to be answered by Children's Health Ireland", he said, noting that may others on the Opposition benches had raised the same concern.
Children's Health Ireland are due to appear before the Oireachtas Health Committee on Thursday.
Labour's Health spokesperson Duncan Smith agreed.
He said this "scandal" was about a "governance process that would allow it to happen" and insisted that at the heart of the review "must be the families".
"It is a scandal, it's a national scandal," Róisín Shortall, Social Democrats TD, declared.
This is "a much wider isssue than one individual consultant", she said, and noted concern that we are seeing "scapegoating" of an individual.
She welcomed the Taoiseach meeting advocacy groups, and also emphasised that they must have an input into the review's terms of reference.
'Too tardy a manner'
In his opening statement, Minister Donnelly said that he had been notified of two serious patient safety incidents at Temple Street Hospital in November 2022.
Mr Cullinane cited a CHI report which said that the incidents had occurred months earlier, in July and September, and asked if this was accurate.
"I'll check the exact timing," the minister replied.
Mr Donnelly later said that he was "arguably informed in too tardy a manner on the July one" by CHI.
"When did he inform the Taoiseach?" Mr Cullinane asked.
"I'll check exactly when it was", the minister replied, adding that he had spoken to the Taoiseach in depth about this last week, and that "there was previous communication in August and potentially before that".
A review into procedures at Crumlin Children's Hospital will be published on Thursday, the minister added.
