CHI says ‘no record' of CEO receiving letter about non-approved medical devices
Children’s Health Ireland (CHI) has said it has no record of receiving a letter that is purported to have been sent to its CEO about the use of non-medical grade devices in paediatric surgery.
It comes after the Dail was told that a letter “seems to confirm” that the head of Children’s Health Ireland was asked for advice on the controversial child spinal surgeries in 2020.
The development comes amid calls for the terms of reference of an external review into spinal surgeries to be expanded following input from affected families.
The Government has faced criticism from some patients’ advocacy groups on the terms of the HSE-commissioned review into children’s spinal surgeries.
Liverpool-based orthopaedics expert Selvadurai Nayagam has been appointed by the HSE to undertake a review that was triggered by concerns over the post-operative outcomes of several children with serious spinal conditions who had been operated on by a surgeon at Temple Street hospital in Dublin.
The use of a spring-type device in some surgeries at the CHI hospital is also being examined.
The details of the alleged letter emerged during Leaders’ Questions on Wednesday.
Sinn Fein leader Mary Lou McDonald said she had shared a letter she received with Taoiseach Leo Varadkar, which “seems to confirm” that meetings involving Children’s Health Ireland on the matters date back to 2020.
She said the letter suggests “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”.
Ms McDonald asked the Taoiseach if these meetings happened and what advice, if any, was given to surgeons from the head of CHI.
In his response, Mr Varadkar confirmed he had read the letter.
He said: “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.
“But it does indicate that there was a level of knowledge at management level about what was happening, that an MDT Multidisciplinary Team involving nurses, doctors, therapists was consulted.
“And it also claims – perhaps correctly or incorrectly – that the families and parents involved consented to what were essentially experimenting procedures in a very difficult case, patients that weren’t fit for any other surgery.
“So that puts a very different complexion on what we’ve heard to date and is very much at variance with some of the stories you and I would have read in some of the online media.”
However, he cautioned that he had appealed to all politicians and the media “not to come to any conclusions” about what had happened until the facts are established.
“We need to come at this with a levelheaded, calm, considered approach,” he added.
However, Children’s Health Ireland said its CEO, Eilish Hardiman, had no record of receiving such a letter.
In a statement, a spokeswoman said: “The CEO has no record of receiving the letter that is purported to have been sent to the CEO in relation to the potential use of non-medical grade devices in children’s surgery.
“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.”
In her contribution, Ms McDonald also said she met parents and patient groups on Tuesday.
She said: “They are very angry. They say that Children’s Health Ireland and the HSE have not been upfront with them and are seeking to dodge accountability for the scandal.”
She said the groups believe CHI or the HSE should not play any part in drafting the terms of reference for the external review, adding they would boycott the probe if the terms fall short of their needs.
Ms McDonald said the parents have experienced systemic failures in clinical governance and that issues in paediatric orthapaedics extend beyond one site and one clinician.
Mr Varadkar also said the review would be independent but added that CHI and the HSE would “have to be consulted at some level”.
He added: “It would be improper not to do so.”
Children’s Health Ireland has been contacted for comment.