LAST UPDATE | 28 Sep 2023
THE CHIEF EXECUTIVE of Children’s Health Ireland (CHI) has “stepped back” from the serious incident review into the use of non-medical grade ‘springs’ in children’s spinal surgeries, after she learned “last month” of a letter purportedly sent to her in 2020 flagging concerns about the practice.
She said that the CHI deputy CEO has now taken over work in relation to the review, as the letter that was allegedly sent to her is now under investigation.
The deputy CEO did not attend today’s Oireachtas Health Committee meeting, and her absence was questioned by TDs.
Eilish Hardiman was grilled by TDs at the committee on what she knew and when in relation to the use of the devices on children.
On being repeatedly asked if she “ever” discussed the use of these devices in children’s surgeries with clinicians, Hardiman repeatedly said she “couldn’t recall” any such conversation.
John Lahart TD presented her with a letter, which he said was sent to her via email in February 2020 by two consultants, who flagged a discussion about the use of “off-label” devices.
He said that the letter is a record of a meeting with Hardiman, in which the consultants had suggested the use of spring assisted distraction devices as opposed to “magic rods” in children’s surgeries.
“They claim that they told the families that these were off label devices. And that as CEO, they needed to make you aware of the request [to use them],” Lahart added.
Hardiman said that she did not see the letter on the use of experimental measures in February 2020, and that her office has since checked her email inbox, and has not found any record of the email.
She reiterated that she first learned of the letter last month.
Bernard Durkan TD asked the CHI representatives at the meeting to reflect on the fact that the issues in spinal surgery at Temple Street has “cost a child their life’.
He asked them how it is the case that a surgeon could proceed with an experimental procedure without anyone else knowing or approving.
Clinical Director Paula Kelly said that clinical guidelines for surgeons are clear that the use of non-medical grade devices is not allowed in surgery, and that CHI “cannot stand over” any surgeon who implants them.
CEO Hardiman said that although the use of the devices is an employer control issue, it is also one of “professional accountability” for the surgeon.
There was little clarity given on how the springs made it into the operating theatre in Temple Street in the first place.
Hardiman said it didn’t come from an approved supplier to the hospital, or through the mainstream “procurement process”.
Neasa Hourigan TD asked the CHI representatives if the committee is to believe that a surgeon went into an operating theatre with a spring device “in their pocket” and then implanted it in a child.
“I just don’t understand how it happened,” she added.
Indefensible
Maybe you could explain to me how a device, walked into a theatre that isn't packaged, and CE marked,- I don't understand -@neasa_neasa
— CM Haughey Solicitors (@CMHaughey) September 28, 2023
'I've worked on building sites and you couldn't put a non, up to grade window into a building because somebody would stop you'#TempleStreet pic.twitter.com/tzpAMR4338
Hourigan was told that a “rigorous investigation” would discover how the devices came to be used.
Dr Allan Goldman said: “This has shocked us, it is indefensible, we can only put our hands up, and say it will not happen again.”
Senator Martin Conway replied: “But you cannot sit here and tell me that there weren’t other non medical grade devices used on children.”
“All we can say is it’s terrible,” Dr Goldman said, adding that CHI is not aware of any other incidents of non-medical grade devices being used in surgery on children.
Hardiman told the health committee that CHI staff are “distraught” over the death of a child that was included in a review into spinal surgeries carried out at Temple Street on children with spina bifida.
In her opening statement Eilish Hardiman stated that the use of unapproved non-medical grade devices (meaning springs) in children’s surgeries is “truly shocking” and “unprecedented” .
“It is simply not done,” Hardiman said, adding “no approval was granted, and none would be”.
She added that while innovative approaches to care are sometimes considered on one-off compassionate grounds, it is “unheard of” for unapproved devices to be used.
Hardiamn said that the implementation of these devices into three children is the subject of a serious incident investigation, which will examine processes within the hospital, including the procurement and custody of these devices, and why “at no stage, did anyone say stop”.
Hardiman explained that over the course of last summer, a higher rate of kyphectomy procedures were carried out on children in CHI Temple Street by its multi-disciplinary team, thanks to a funding boost from the Government aimed to cut down waiting times.
Kyphectomy procedures are highly complex surgeries carried out on children with spina bifida, that involve the insertion of medical rods into the patient’s spine to correct curvature.
These operations, Hardiman said, are “high risk, with high postoperative complication rates”.
Concerns were first raised about the outcomes of patients undergoing these surgeries last summer by a member of the team responsible for the children’s care, following two serious incidents.
They were noticing children having to return to the operating theatre more than usual, and a seemingly higher rate of postoperative infections.
A review into these surgeries was commenced last November following two serious incidents. At this point, Hardiman stated, the clinician who had been carrying them out paused the practice – a decision that CHI supported.
Two reviews have now been published by CHI that involved the participation of 19 families and their children, who underwent these surgeries. They do not deal with the issue of unauthorised devices being implanted into children, or how these devices were procured.
A new investigation into the matter is now being conducted by an external expert who was commissioned by the HSE.
Advocacy groups working with the families have called for further consultation with them and an expansion of the terms of this fresh investigation. They have also said that it should not be taking place under the governance of the HSE.
Hardiman stated that the clinician who carried out the surgeries under investigation is now subject to Irish Medical Council and human resources processes.
She also assured TDs that the children who underwent these surgeries have now been clinically reviewed, and have a dedicated care pathway that is being followed.
Hardiman apologised for “poor communications” on the part of CHI over the course of the last week.
She said that, at large, CHI continues to deliver “excellent care to children and young people everyday” while dealing with “outdated and inadequate infrastructure”.
On the current waiting times for children’s spinal surgery she said that last year CHI and the national orthopedic hospital cappagh had completed 509 procedures, representing a 47% increase compared to the previous year, meaning that 162 more children had spinal surgery.
“There has also been a 57% 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,” she adds.
This week in the Dáil, Sinn Féin leader Mary Lou McDonald said that she had seen a letter that “seems to confirm” that CHI was carrying out meetings on complications in children’s spinal surgeries back in 2020.
She stated that the letter shows that the techniques that were used by a clinician who is under investigation now were questioned three years ago, and that “the head of Children’s Health Ireland was involved in these matters and was even asked by surgeons for guidance on the use of these techniques”.
Varadkar, in reply to McDonald, said he has also read the letter, and that “it does put a new complexion on this”.
“I don’t know if it is genuine. I don’t know if it was ever actually sent, I don’t know if it was received, I don’t know if it was acknowledged and I don’t think you know these things either,” he added.
CHI has since put out a statement that said it has no record of receiving the letter that is purported to have been sent to its CEO on the use of non-medical grade devices in children’s surgeries.
Hardiman was joined at the meeting by Chief Medical Officer Dr Allan Goldman, Clinical Director and Paediatric Orthopaedic Consultant Paula Kelly, and Dr Ike Okafor, Clinical Director and Consultant in Paediatric Emergency Medicine.
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