The use of unapproved springs in complex spinal surgery carried out at Temple Street children’s hospital was an unprecedented occurrence and “truly shocking”, Children’s Health Ireland chief executive Eilísh Hardiman will tell the Oireachtas on Thursday.
A review of the unit last week found high levels of post-operative complications and infection in children undergoing spinal surgery, including two serious incidents and the death of one patient.
One consultant has been referred to the Medical Council, and the care of children on waiting lists is being transferred to Crumlin.
HSE chief executive Bernard Gloster has said he is “seriously concerned” nobody in Temple Street appeared to have objected to the use in medical procedures of springs that were not approved to a basic European CE standard.
The springs, used in three patients requiring spinal surgery, were described by Health Service Executive (HSE) officials as unauthorised, uncertified implantable devices. Two of the springs have since been removed.
“Members will, of course, be concerned about the unauthorised use in spinal surgeries of unapproved non-medical grade devices – or in other words, springs,” Ms Hardiman will tell the Oireachtas health committee.
“Quite frankly, this is an unprecedented occurrence and truly shocking. The facts around this matter are the subject of a serious incident investigation – commissioned by the board of CHI.
“This investigation will examine end-to-end processes within the hospital – including procurement and custody of these items. It will also look at who knew that non-medical grade devices were being used, how they were procured and why, at no stage, did someone say stop.
“While innovative approaches to care might be considered on one-off compassionate grounds, it is unheard of for any clinician to determine to use a non-approved non-medical grade device in a patient. It is simply not done.”
She will add that no approval was granted and “none would be granted for a non-medical grade device to be implanted”.
She 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”.
In addition, she will also apologise for “poor communication on our part across last week”, adding: “While we spoke and met with all 19 families whose children were the subject of the reviews, I am aware that more could have been done.”
She will add that the group is currently implementing the review recommendations, with 20 per cent already completed with the remainder all under way and scheduled to be completed by the end of this year.