knew about unlicensed springs earlier than claimed

Senior management at Children's Health Ireland at Temple Street (CHI) knew that unlicensed springs had been used in spinal surgery in May this year.

Sources at Temple Street have confirmed to The Ditch that management was aware about these non-medical springs in early summer – despite CHI’s claims to the contrary when being questioned by the Oireachtas health committee yesterday.

The use of the springs is believed to have caused significant harm to patients in at least two instances.

'To the best of our knowledge'

On 4 May, with an external review ongoing and certain surgery suspended at Temple Street, People Before Profit TD Paul Murphy put a parliamentary question to health minister Stephen Donnelly.

The question asked if “all implants used in spinal surgery for patients with spina bifida and spinal muscular atrophy across Temple Street and Crumlin hospitals are appropriately licensed”.

Hospital sources say that this question compelled Temple Street staff to formulate a response that referred to unlicensed springs but claimed that patients had been fully informed of the experimental nature of the implants. This claim has since been disputed by the parents of affected children.

The ultimate response to the question, from Temple Street directorate operations lead Sharon Ryan, on 25 May read, “Children’s Health Ireland can advise that to the best of our knowledge, it is standard practice that all implants, and specifically spinal implants, used in surgical have been, and continue to be, CE approved and licensed appropriately for this purpose.”

This claim about what staff in the hospital knew about unlicensed springs, as well as its use of the phrase “to the best of our knowledge”, wasn’t accurate, according to a Temple Street source.

Senior management at the hospital had asked the appropriate department to answer the question. The question was then put to clinicians as a group.

“The answer given included the information that springs which were not licensed had been used in surgery but that they had gone through a full consent process and that the patients and parents were aware of this,” said the source.

This answer was then changed.

“Somehow this answer changed to what was effectively a denial by the time it reached the Dáil. Even after this there was no proper investigation into what had been going on until further pressure was applied from the outside,” said the source.

CHI CEO Eilish Hardiman, being questioned by the Oireachtas health committee yesterday, said the hospital only became aware of the issue much later. She said "We first became of aware of this in July and it was deputy Paul Murphy's parliamentary questions that raised the matter for us," also saying, "Issues around the springs has been very latter into July/August".

CHI clinical director Ike Okafor meanwhile, when asked by Paul Murphy if there had been any reference to springs in correspondence to him in May, said, “No. No.”

CHI has been contacted for comment.