- The use of unapproved springs in complex spinal surgery carried out at Crumlin children’s hospital was unprecedented and “shocking”, Children’s Health Ireland will tell the Oireachtas Committee on Health from 1.30pm today.
- The statement comes after a review last week found high levels of post-operative complications and infection in children undergoing spinal surgery at Temple Street children’s hospital, including two serious incidents and the death of one patient.
- Spinal surgery at Temple Street children’s hospital is currently subject to an external review after earlier investigations found a high rate of complications in the work of one surgeon.
- Children’s Health Ireland, which provides and manages hospital care for children across Ireland, will also say the group is “deeply sorry” that the children and their families did not get the care they deserved and will apologise “unreservedly for the harm that they endured”.
- Senator Dr Tom Clonan has given emotional testimony to the committee recounting how his son spent six years waiting to get an operation in Temple Street.
Committee chair Seán Crowe has concluded the meeting. He admits that it has been “heated” at times but he is conscious of families looking in from home at what is going on.
He asked CHI to provide information to the committee on the broader cohort of families who are waiting for surgery. He wants to know what waiting times for spinal surgery are at present.
Senator Tom Clonan, who is a long-time advocate for disabled children, is furious. His son had spinal surgery in Temple Street in 2018 at the age of 18 when he should have had it when he was 12. That’s Ireland for you, he believes.
He tells the committee that what was happening in Temple Street was “foreseeable and reoccurring” and yet nothing was done about it.
Had it been an oncology or cardiac department performing that way, CHI would have called for help. The reason they didn’t is that the children involved are disabled children and don’t have the same value in Irish society.
Committee chair Sean Crowe has repeatedly interrupted Senator Clonan to tell him to allow the witnesses to answer the question.
Ms Hardiman said access to care is a big issue, but the situation will improve once the new Children’s Hospital is opened in 18 months time. There will be 22 theatres in the new hospital in comparison with 12 together in Crumlin and Temple Street.
Senator Martin Conway asks if the springs involved were from an approved supplier. “No,” said Ms Hardiman.
“How can you say there aren’t similar devices?” he asks.
“We have raised awareness around this. It is a very unusual event and it has caused us shock. There are quality control mechanisms in place,” Ms Hardiman responds.
Senator Conway says there was quality control mechanisms in place when the springs were used.
“Yes,” she admits.
CHI clinical director Paula Kelly said the use of the springs is “indefensible” and that email correspondence has gone around to all theatre users that this wouldn’t happen again.
Senator Conway said he is not assured that such unauthorized devices were not used elsewhere in the hospital system.
Paul Murphy asks if there surgeons were pressurised to begin spinal surgery again in March this year after they were suspended in November following the Boston Review. Dr Ike Okafor said spinal surgeries in the hospital never stopped and therefore could not be restarted.
Dr Goldman said they have sent a “very strong message” out to clinicians that the use of unauthorised medical devices such as the springs that were used on spinal patients should never happen again. There are new theatre governance committee which meets monthly and goes through the standards and metrics for operating theatres. “We need to try and get data on patient outcomes,” she said.
The committee is now taking a 10 minute break.
Green Party TD: Neasa Hourigan says she does not know much about the medical profession, but she knows a lot about procurement: “Who is in charge of procurement? Why is a device like this walked into a theatre like this?”
CHI chief medical officer Dr Goldman said the questions she is asking are the questions they have been asking themselves. “We are as perplexed as you about all of this. This is such an unusual thing to happen.”
Ms Hardiman says she didn’t receive a letter, dated February 21st, 2020 seeking her guidance about using spinal surgical procedure involving springs. She only became aware of it last month.
Ms Hardiman is being pressed by Social Democrats TD Róisín Shortall as to a letter that was sent to her back in 2020 asking for advice by surgeons for guidance on the use of these techniques”.
She said she has no recollection of having had a discussion with surgeons about the use of non-medical springs.
She said she has “no evidence of having received a letter” which was raised in the Dáil yesterday by Sinn Féin leader Mary Lou McDonald.
She only discussed the possibility of using “magic rods” - another experimental procedure with consultants at the hospital.
CHI chief executive Dr Allan Goldman said they head treated 257 spinal patients over 20 years. Of those 45 per cent of the patients came back for unplanned surgery and 25 per cent of patients were subject to metal work failure.
David Cullinane asks if there was “huge pressure” on consultants to do more of these types of surgeries? Ms Hardiman says they do not put that sort of pressure on surgeons. Mr Cullinane said there should be reporting back to CHI about the review. Were the springs procured through CHI? “I can’t disclose that,” said Ms Hardiman. There is evidence that an invoice was sent, she adds. Mr Cullinane says it make no sense that the CHI could not have known if the consultant involved ordered the springs.
Eilish Hardiman said she is going to look at every aspect of how non-medical springs were used in the case of three patients.
Sinn Féin health spokesman David Cullinane said the revelations about Temple Street is “a dark day for children health services. He counted nine apologies. “I can guarantee there will be more apologies coming into the days and weeks ahead,” he said.
Mr Cullinane said another apology is needed for not publishing the original two reports in full into spinal surgery at the hospital.
“Reports need to be published in full, all reports,” she said.
Ms Hardiman said they decided to publish the two reports in one report, but they were not trying to hide anything.
Children’s Health Ireland chief executive Eilísh Hardiman has apologized to the children and their families who were the subject of a clinical review of surgeries carried out at Temple Street Hospital.
Ms Hardiman told the Oireachtas Committee on Health that they were “deeply sorry” and “apologise unreservedly” to the families involved.
In her opening statement, she described the use of non-medical grade devices implanted in three children as a “shocking litany of events”.
It is “unheard of”, she suggested, that any clinicial wound use a non-medical grade device. “It is simply not done.
“No approval was granted and none would be granted for a non-medical grade devise to be implanted.
“Things happened at CHI in Temple Street that should not have happened. Decisions were made, certain procedures were carried out, children were subjected to higher than-expected unplanned return trips to theatre and, alarmingly unapproved, non-medical grade devices were implanted in three children.
“Without in any way seeking to qualify the apologies that we have given, it should be said that complex spinal surgery in Spina Bifida children, unfortunately, has high complication rates. However, in these cases the level of infection was above what would have been expected and is unacceptable.”
She added that since the end of 2022, Children’s Health Ireland (CHI) and the National Orthopaedic Hospital Cappagh (NOHC) had completed 509 spinal procedures.
This was a 47 per cent increase in activity compared with 2021, which equated to 162 more children who have had their spinal surgery.
There has also been a 57 per cent increase in children added to our spinal surgery waiting list. We are doing all we can to reduce waiting times and will continue to do so.
Welcome to our live coverage of the appearance of executives from Children’s Health Ireland before the Oireachtas Committee on Health today to answer questions about spinal surgery procedures carried out in Temple Street Hospital.
An independent investigation found 19 children with spina bifida suffered serious complications after they were operated on in the hospital. One child was readmitted to the operating theatre 33 times after her initial operation.
It also emerged in the course of those outside investigations that coiled springs, which were commercial rather than medical devices, were used in three patients with spina bifida.
Spinal surgery procedures at Temple Street hospital will now be reviewed by a UK-based surgeon Dr Selvadurai Nayagam.
“The primary focus of this external review will be the clinical care provided by an individual consultant based at CHI at Temple Street, who is currently not conducting surgeries, and in respect of whom a referral has been made to the Medical Council,” the HSE said in a statement on Monday.
The families of those involved have not yet committed to cooperating with the investigation as they believe it will focus on just one individual surgeon and not the culture in the hospital.
Committee chairman Sean Crowe told RTÉ's Morning Ireland on Thursday that members will be seeking answers as to what had happened to children who had undergone operations in the hospital.