Children’s Health Ireland (CHI) management was made aware in 2020 that experimental surgical techniques would be used on children at Temple Street hospital, internal correspondence suggests.
Parents of children undergoing the surgeries were also made aware of the use of the techniques, including the deployment of springs that were not commercially available, according to the letter raised in the Dáil by Sinn Féin leader Mary Lou McDonald.
Speaking during Leaders’ Questions, Ms McDonald said a letter had come into her possession, which suggested that CHI chief executive Eilish Hardiman was involved in discussions about the experimental surgical techniques as far back as 2020 and “was even asked by surgeons for guidance on the use of these techniques”.
Taoiseach Leo Varadkar acknowledged the letter shared with him by Ms McDonald on Wednesday morning does “put a new complexion” on experimental surgical techniques used in paediatric spinal surgeries.
Mr Varadkar told the Dáil that he did not know if the letter was genuine, but that it did indicate there “was a level of knowledge at management level about what was happening”.
Ms Hardiman said in a statement she has no record of receiving the letter. “The letter, and its origin, is the subject of an independent investigation. To be clear, no authority was granted and no authority would ever be granted for the implantation of a non-CE marked non-medical grade device in a patient.”
Spinal surgery at Temple Street is currently the subject of an external review after earlier investigations found a high rate of complications in the work of one surgeon. These include multiple unplanned returns to the operating theatre and high-levels of wound infection. Two serious incidents were recorded last year and one child died after requiring multiple procedures.
The letter referred to by Ms McDonald was written by the consultant at the centre of the current controversy to Ms Hardiman in February 2020. In it, the consultant discusses the treatment options for children aged under six months requiring scoliosis operations, who are not suitable for multiple courses of anaesthetic.
The solution presented to families was a “spring-assisted distraction device” which was not commercially available, the consultant says in the letter. “We have told families and told them these are an off label and experimental techniques using devices not designed for this purpose. However, a [sic] CEO we needed to make you aware of this to for any guidance we may need,” according to the letter, which was compiled using a dictaphone.
Ms McDonald said the letter raised “very serious questions for CHI and these questions require urgent answers”.
“Did these meetings happen? What guidance or advice, if any, was given to surgeons and clinicians by the head of CHI?”
The Sinn Féin leader said these facts needed to be established urgently as the information was fundamental to the drafting of terms of reference for an independent review into the matter.
“Certainly these issues add weight to the call from parents and advocacy groups that Children’s Health guardians can have no hand, act or part in drafting terms of reference and certainly cannot be the body to which any of these reviews report back,” Ms McDonald said.
“[The letter] does indicate that there was a level of knowledge at management level about what was happening, that a multidisciplinary team involving nurses, doctors, therapists was consulted and also it claims perhaps correctly or incorrectly, that the families and parents involved consented to what were essentially experimental procedures in a very difficult case, patients that weren’t fit for any other surgery,” Mr Varadkar replied.
“So that puts a very different complexion on what we’ve heard to date and very much at variance with the impression created by some of the stories that you and I would have read on the online media.
“It’s exactly why we shouldn’t jump to conclusions. We need to come at this from a sensible, level-headed, calm, considered approach and make sure that nobody jumps to conclusions until we know all the facts and, of course, the review therefore has to be thorough and has to be independent.”
Mr Varadkar said the terms of reference of the review would be compiled in consultation with families and advocacy groups and that the HSE would not be writing them, but would also be consulted as part of the process.
He said it might take “some time” to come up with the terms of reference but that they had to be done correctly. The Fine Gael leader also said he was determined “that we will get to the bottom of it”.
CHI officials are due to appear before the Oireachtas health committee on Thursday. Mr Varadkar and Minister for Health Stephen Donnelly are due to meet patient advocacy groups on the issue on Friday.