Ireland
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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 spinal surgery.

It comes after the Dáil 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.

Speaking in the Dáil, Ms McDonald said she shared the letter with Taoiseach Leo Varadkar on Wednesday morning prior to Leader’s Questions.

Mr Varadkar said the letter “puts a new complexion” on the scandal but he did not know if the letter was genuine, whether it was sent or received or acknowledged.

However, he said the letter did indicate “that there was a level of knowledge at management level about what was happening.” He said the letter also indicated a team involving nurses, doctors and therapists was consulted.

“And it also claims, perhaps correctly or incorrectly, that the families or parents involved consented to what were essentially experimental procedures in very difficult cases, patients that weren't fit for any other surgery. So that puts a very different complexion on what we've heard to date,” Mr Varadkar told the Dáil.

The Taoiseach said the letter was “very much at variance” with the “impression created by some of the stories” he read online.

“That'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 until they know all the facts.” 

Ms McDonald said the letter she was referring to raised “fundamental questions of fact that need to be answered urgently and directly by Children’s Health Ireland”. 

Ms McDonald called on the Taoiseach to “simply establish” the facts, whether a meeting or meetings did occur involving clinicians but also the head of CHI “in which these experimental surgical techniques were discussed, whether guidance was sought and whether or not it was given because I think not alone just the establishment of those basic facts, not conclusions but just basic at matters of fact, creates a very different complexion and framework for what the work of the review.” 

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."