The external review of spinal surgeries at Temple Street children’s hospital may not be completed for at least a year, according to Health Service Executive chief executive Bernard Gloster.
The review, to be conducted by a UK expert, will have the scope to address wider issues such as the delivery of services and governance, he promised, and could be expanded to examine wider groups of patients.
The HSE this week commissioned Selvadurai Nayagam to review surgeries carried out by a Temple Street consultant after two initial reviews identified “serious spinal surgical incidents” in the service, it said on Monday. One child died and others suffered serious post-operative complications.
Asked if the HSE had chosen to throw the Temple Street consultant “under the bus” in preference to examining systemic issues, Mr Gloster replied: “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”.
Asked how three patients received implants containing non-certified springs, Mr Gloster said “we do have to see how the end-to-end processes within the hospital did not detect that particular problem”.
“It’s a problem that came on top of the incidents that they were already reviewing, from the two reports that people are now familiar with this week. We have to allow the investigation tell us how that actually happened.”
Children’s Health Ireland has to be allowed to do its own investigation of how this happened, he said. Mr Gloster said he reserved the right to take “other steps” once the outcome of this investigation emerges.
Speaking in Kilkenny at the Nursing Homes Ireland conference, he promised the external review commissioned this week will look at all the issues that have arisen within orthopaedic services for children. “The mark of any good healthcare system is not one that says it has no faults but (one that) has the ability to detect faults, mitigate them quickly and correct them.”
The children affected by high complications following procedures in Temple Street are owed a “very, very sincere apology,” he acknowledged. “There is no doubt that on top of already serious, complex lives caused by their health condition ... to have this on top of that, to cope with this is a dreadful, dreadful outcome for them.”
He said he has been assured by CHI that all affected families have been contacted and that adequate supports are being provided for them. “If there’s more we need to do, of course we will do that.”
The newly commissioned independent review will “comprehend” the view of many people, including families, he promised, adding that he was “very open” to meeting advocacy groups and families on the issue.
Children whose spinal surgery has been delayed may have their operations outsourced if this helps to reduce waiting times and the required treatment can be provided, he said. However, travelling distances for complex surgery can be “exceptionally complex”.
Asked when the external review will be completed, Mr Gloster warned it “could certainly go well out over the next 12 months” but the “priority dimension” will be well under way by the end of this year.
Minister for Health Stephen Donnelly has said that it is “clear” other people knew about the scandal, after clinicians raised concerns about spinal surgeries at Temple Street children’s hospital last year.
“It is clear that other people knew that non-medical devices were being used,” he told reporters in New York on Thursday.
“It is absolutely essential that when people know about this – people involved in or supporting the process – that first and foremost they immediately raise a red flag. That would appear not to have happened at CHI, and I am deeply concerned about that, and that is one of the issues that will be looked at by the external reviewer.”
Meanwhile, the clinical director for Children’s Health Ireland has said there is a separate investigation into the use of surgical springs in spinal surgeries in children.
Dr Ike Okafor was speaking on RTÉ Radio’s News at One following the publication of further reviews by Children’s Health Ireland into spinal surgery cases at Temple Street hospital.
The number of cases in which there were problems were a small cohort of “really, really complicated cases,” he said.
“Last year we did over 500 spinal surgeries, that’s probably the average of what we do each year. So you’re looking at over the period that was reviewed, we’ve probably done about 2,000 spinal surgeries and we’re looking at a small cohort of children. We have 13,000 children who get surgery in CHI every year.”
Dr Okafor said the next review will include families who had not been involved in previous reviews. He also pointed out there was false information circulating on social media about the spring medical devices implanted in some children.
“There is currently an investigation in place to look at the process around how they were procured and how they were used.”
The devices had not been purchased from a company being named on social media, he said.
When asked when CHI was made aware of the use of the surgical springs in the small cohort of children, Dr Okafor said: “The information came to us at the end of June, early July. And that’s how we became aware that there were none authorised. There were people in CHI who knew that they were being used when they were being used. There were clinicians who knew that they were being used.”
This would be a separate investigation to the external review ordered by the HSE this week, he said.
The investigation process would examine if CE marks were recorded when surgical devices were implanted in children, he explained.
Minister for Health Stephen Donnelly will address the Dáil next week on spinal surgeries at Temple Street Children’s Hospital.
Sinn Féin’s health spokesman David Cullinane told the Dáil on Thursday that he found it “incredible” that Mr Donnelly “left the country knowing this scandal was going to break and, it seems, did not inform either the Taoiseach or Tánaiste about the seriousness of these issues”.
“We have demanded statements in the House on that very important issue, which we need to have as quickly as possible,” he said. “We should have had them today”.
In response, Minister of State Hildegarde Naughton said the health minister would come before the Dáil next Tuesday in relation to the issue.
Speaking in New York on Wednesday, where he was attending the United Nations general assembly, Mr Donnelly said his department was informed in August that there were issues in relation to unauthorised medical devices being used as part of spinal surgeries in Temple Street Hospital.
He said he wants a “detailed explanation” of what happened in the hospital.
Taoiseach Leo Varadkar has said he has more questions about spinal surgery at Temple Street Hospital.
Speaking in Miami, Florida, he said that he had been first informed “a few weeks ago” that there might be an issue in relation to the hospital.
“But the detail of it, in terms of the possible use of inappropriate devices and so on, that was really only in the last couple of days.”.
Mr Varadkar said he had read the two initial reports published by health authorities on the issue on Wednesday and that he had spoken to the Minister for Health Stephen Donnelly on the issue on Wednesday night.
“I am reassured that all the necessary external reviews are underway. But I do have some more questions.”
He said he would be speaking with the clinical director of the HSE in the next couple of days.
“Because obviously coming from the point of view of a doctor as well as Taoiseach, there are some questions that I want to ask and I want to understand a bit better.”
“But I am reassured that open disclosure is happening, that families affected are being communicated with individually and that there are external reviews underway.”
“And while I am very concerned about this, I really think it is important that we get all the facts before we come to any conclusions.”
He said he was not sure that anyone knew the full facts about the issue and that is why external reviews had been commissioned and that a Medical Council process was underway.
He said in other health controversies such as regarding Cervical Check, some people had jumped to conclusions too quickly.
Mr Varadkar said that it was not the case the people could bring their own devices into hospitals where they worked.
“That is not allowed. But I am not actually sure that is actually what happened. And that is why I think it is really important that we get to the facts before we have too many opinions on it.”
Meanwhile, the Joint Committee on Health said it is urgently seeking a meeting with Children’s Health Ireland to discuss issues relating to the spinal surgeries.
Committee Cathaoirleach Deputy Seán Crowe said: “Myself and members of the committee are deeply concerned at the revelations regarding spinal surgeries on a number of children at Temple Street and we feel it is important that these matters are examined in detail at a meeting in public session with Children’s Health Ireland at the earliest opportunity. We are working to arrange that the meeting will take place next week.”