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Springs used on children were not ordered through hospital procurement process, says CEO

The chief executive of Children’s Health Ireland has said unauthorised medical devices implanted in three children were not ordered through the hospital’s usual procurement process.

Eilish Hardiman answered questions on Thursday from members of the Oireachtas health committee around serious safety concerns with complex spinal surgery for children with spina bifida at Temple Street Children's Hospital, which is part of the CHI group. This included queries around unauthorised devices, now known to be springs, implanted in three children.

Ms Hardiman initially declined to answer in relation to procurement, saying this was subject to investigation.

However, she later said: “It didn’t come in through the procurement process, it didn’t come in through that route.” 

She said the surgeon involved was in a human resources and Irish Medical Council process. She also denied receiving an email asking for guidance around potential use of devices not designed for surgical purposes.

The email, raised in the Dáil by Sinn Féin leader Mary-Lou McDonald, suggested the surgeon had sought guidance from Ms Hardiman in 2020.

However, she said: “I have no recollection of being asked about non-medical grade, unapproved unauthorised devices.

“I have recollection of being in discussion around MAGEC rods, because I do know those quite well, that’s the only ones I am aware of. I wouldn’t get into that level of detail to be honest.” 

She said there was an investigation under way attempting to identify the source of the email, and she has stepped aside from this process. 

She added she did not have the authority to approve devices allegedly mentioned in the email, which was quoted from by many committee members.

The disputed email also refers to a consent process with families.

CHI clinical director Dr Ike Okafor said: “I believe that is a matter for the investigation." 

He said spina bifida surgeries on other body parts continued as only complex spinal surgery was paused. 

CHI chief medical officer Dr Allan Goldman said in relation to the springs: “This has shocked us, this is unacceptable. We can only put our hands up at this stage and say exactly that, then we need to understand what happened and we need to improve and make sure it never happens again.”

Pressed on whether he can definitively say this had not happened elsewhere, he said: “All we can say at this stage we are completely unaware of any other devices, nobody can say 100% on anything.” 

He defended an external review by Boston Children’s Hospital, published last week, saying they examined files for up to six weeks before visiting from a Sunday to Wednesday. He said the surgeon was “supportive of the external review". 

CHI said it would provide implementation updates on the 50 recommendations which cover many areas.

A report into the death of Dollceanna Carter, 10, is expected in October following an almost one-year process, Ms Hardiman confirmed.

“We have listened to the issues raised by the advocacy groups and also intend to improve our communications,” she said.

“While we have a road to travel, we will then focus on rebuilding trust and confidence amongst the children, young people and families who need services in CHI at Temple Street.”