Update and clarification on 29 September
On 29 September, the Health Products Regulatory Authority contacted The Journal to update information it had given to us earlier this month.
In a statement, it provided extra detail not previously known in relation to its contact with CHI about the potential use of products not intended as medical devices. The watchdog said:
“One report was made through the HPRA vigilance system by CHI relating to the potential use of product not intended as a medical device and identified by the reported as a spring in early August 2023.
“While the normal medical device vigilance system would not apply due to the nature of the product, the HPRA has been liaising with CHI to ascertain further details in relation to the procedure(s) involved, the setting of use and the nature of any resultant adverse outcomes.”
The Health Products Regulatory Authority (HPRA) was not notified by Children’s Health Ireland (CHI) that springs were being used in surgeries on children at CHI Temple Street.
Two investigations are underway into paediatric orthopaedic surgery amid a crisis at one of the country’s main children’s hospitals, with one of the inquiries examining the use of “unauthorised implantable devices” in a small number of cases.
The HPRA said the use of products not intended to be sold or supplied as medical devices fell beyond its remit.
Dr Ike Okafor, clinical director of CHI, confirmed on Thursday that the unauthorised devices implanted in three children were springs. Speaking on RTÉ Radio’s News at One, he said that two of the springs had been removed and one was still in place.
Okafor also said “there were people in CHI who knew that these springs were being used” in surgery in children, adding that the investigation into the matter would examine this.
The HPRA told The Journal that it was aware of reports regarding the clinical use of non-medical grade products at Temple Street not intended to be sold or supplied as medical devices.
It said it had not received or approved any related applications for such use of non-medical grade equipment for clinical use in surgery.
On occasion, the HPRA can approve the use of unauthorised medical devices which do not carry a “CE mark” signifying EU regulatory approval. This type of derogation can be granted if a non-CE marked medical product is in development or part of a clinical trial.
The HPRA can grant such a derogation if a clinician can make a case, usually on compassionate grounds – and with the support of the relevant device manufacturer – that the device is essential for urgent patient care and there is no suitable CE-marked alternative.
“The HPRA approval of such compassionate use is on the understanding that appropriate clinical governance structures are being notified of the proposed procedure involving the device. It is also on the understanding that appropriate information on the device is made available to the patient or caregiver as part of the clinician’s consent process,” it said.
Asked whether it had granted this type of approval for any use of springs in surgery at Temple Street, the HPRA said it had not.
The regulator said it will “assist the HSE in any relevant review if regulatory input is required”. It added that has “not received vigilance reports in relation to these cases” at Temple Street.
In a statement, CHI said it “has commissioned a team external to CHI to investigate this very serious matter”.
‘Loss of trust’
In a statement on Friday, two advocacy organisations working with families of children waiting for or receiving spinal surgery at CHI expressed “a complete loss of faith and trust in both the HSE and CHI”.
The Spina Bifida & Hydrocephalus Paediatric Advocacy Group and The Scoliosis Advocacy Network have asked the Taoiseach to meet with them to give them assurances about care for their children and about the upcoming review of the service.
They said they would boycott the review unless its terms of reference were extended in consultation with families.
On Monday, the HSE announced it had commissioned an external review into paediatric orthopaedic care after one child died and others suffered serious complications following spinal surgery at Temple Street. A second review is examining the use of unauthorised devices.
The first review – which follows internal and external reviews commissioned by CHI itself – has a “primary focus” on one consultant, who has been referred to the Medical Council, but is also expected to examine resourcing of the service and the impact of delayed access to surgery, as well as governance at the hospital.
Taoiseach’s solidarity
The Taoiseach pledged on Friday that the government would “get to the bottom” of the problems at Temple Street.
Leo Varadkar expressed “sympathy and solidarity” with the children and families affected, adding: “We’ll do all we can find out all the facts as quickly as we can, and then take whatever actions are necessary to stabilise the service and then also to improve it.”
He acknowledged that there were two issues: the long delays in accessing surgery, and a separate issue in relation to the quality of some surgery carried out at Temple Street.
Patient advocates have sharply criticised the lack of focus on the impacts of delayed access to care on children in the HSE’s promised review of paediatric orthopaedic services. The HSE has emphasised that its review will particularly focus on one consultant, who has been reported to the Medical Council.
Asked if compensation to those affected by what happened at Temple Street could run into millions of euro, the Taoiseach said, “that may well be the case”, but the number one concern now was to ensure families “get the answers they need”.
“Since I was in medical school, we’ve had problems with spinal surgery services for children in Ireland. I don’t know how many ministers now have tried to fix it – six, seven, maybe eight. I don’t know how much money was poured into the service and while it has improved somewhat, it’s well short of where it needs to be,” he said.
Tough questions
Sinn Féin has said Minister for Health Stephen Donnelly will face tough questions next week not only on accountability and transparency in relation to the Temple Street crisis, but also on what the state will do now to help children waiting for spinal surgery.
The minister, who travelled to the US this week, is expected to take questions in the Dáil on the crisis on Tuesday, while Children’s Health Ireland – of which Temple Street forms part – will come before the Oireachtas health committee.
David Cullinane, Sinn Féin health spokesman said on Friday that he has spoken with families of children with spinal problem in the wake of the crisis emerging, adding that “the problem, as they see it, is the length of time children are waiting”.
“The longer the child has to wait for treatment, the more potential complications will potentially emerged then, as a consequence of those surgeries,” he said.
“The three issues for me are supports for the families and the children, full transparency and then figuring out what we do now, including treatment abroad,” Cullinane said.
Minister Donnelly said last night that he was “very concerned” that other clinicians and people at Temple Street Hospital knew about non-medical devices being used but did not follow the mandatory open disclosure policy within the HSE.
“It is absolutely essential that when people know about [things like] this… that first and foremost they raise a flag, and they must feel safe and supported doing that.
“That would appear to have not happened in this case and I am deeply concerned about that,” he said.
Dr Okafor has said while the most complex type of spinal surgery has been suspended, other surgeries are ongoing at Crumlin.
He said CHI was increasing its surgical capacity with a fifth theatre opening next week and was opening additional beds, and it had a new spinal surgeon starting. He added that CHI was looking at “all options” within CHI and within the private sector.
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