HSE CEO admits spinal surgery wait lists will increase without surgeon at centre of probe

Bernard Gloster also said it is his understanding that the group CEO Eilish Hardiman was not aware a technique involving the use of springs unauthorized for that purpose was being used in three of the 19 children whose care is under review. Picture Denis Minihane.

There are almost 300 children waiting for spinal surgery at Children's Health Ireland (CHI) and that number will go up, with a surgeon at the centre of a safety concerns controversy ceasing operations, the head of the HSE has admitted.

This follows widespread concern over revelations of serious safety concerns linked to complex spinal surgery for children with spina bifida in CHI at Temple Street.

Bernard Gloster also said it is his understanding that the group CEO Eilish Hardiman was not aware a technique involving the use of springs unauthorized for that purpose was being used in three of the 19 children whose care is under review.

An external review, announced by the HSE on Monday, will also include a review of the “end-to-end process” through which devices are ordered and assessed before being used in operations at the hospital.

Mr Gloster told RTÉ radio that while most spinal surgeries, except for one specialist type called Kyphectomy, continue safely at the hospital, some patients will be impacted by delays.

The orthopaedic surgeon in question ceased complex spinal surgery in CHI in November last year, ceased all spinal surgery in May 2023, and ceased all surgeries in July 2023.

Mr Gloster said: “There are about 284 children for spinal surgery on the waiting list, over 100 of those are beyond the target of four months (waiting time).” 

There is no doubt that the drop of one surgeon, in what is a very highly specialised area, will cause some impact on that in the short-term. I don’t think it will have a major effect on the long-term.

He agreed some children will have to wait longer, saying: “You do not have a position where a surgeon in a speciality stops operating for any time, and that doesn’t impact on waiting lists.” 

He reiterated treatment abroad is being considered, but only for children for whom this is appropriate.

As well as concerns around a higher-than-expected rate of follow-on surgery for some of the 19 children impacted, concern has been raised about the use of unauthorised springs in three children.

Asked if he knew where the devices came from, Mr Gloster said: “The information available to me this weekend, is firstly they are not medical devices, they are springs. They are not approved, or authorised in the sense that we would understand that to mean, being CE-certified which is a basic European standard.

“There doesn’t appear to have been any engagement with the Health Products Regulatory Authority for consultation or assistance, in understanding the possible implications.” 

What internal discussions were happening in CHI about them, that remains to be found.

Mr Gloster said they were ordered from the UK-based company, 10 were bought and three were used.

“The simple reality is they should not have been used or procured in this manner,” he said. 

“Regardless of the motivation, which might well be to innovate, and innovation is important. It is exceptionally important that any material being implanted into a person’s body has very sound governance around it.” 

He also said “a critical point” is: “If it was known by people who should have known that these were unauthorised, that these were well outside custom and practice, it is of serious concern to me as to why somebody didn’t put their hand up, before we heard about this in recent weeks through a completely external process.”

On Sunday night, CHI issued a statement in relation to the spring devices.

"The CEO of CHI did not provide any approval for the use of these springs, and in any event has no authority to grant approval.

A spokeswoman said Ms Hardiman had "no role whatsoever in the approval of the procurement and implantation of unauthorised non-CE marked implants".

This process does not require CEO approval, she said.

She added: "Nor would her approval be sufficient to allow an unauthorised non-approved spring to be procured and implanted."

Ms Hardiman regularly meets clinical staff she said, and "they may describe plans and proposed innovations".

Multi-disciplinary teams also have discussions and plan treatment pathways, the spokeswoman said.

"Nevertheless, they do not have the authority to approve an unauthorised non-CE marked, non-medically approved device for implantation," she said.

"Meetings of this nature would be of no significance or relevance to the approval process."