The news two years ago that unapproved springs were inserted into three children requiring spinal surgery at Temple Street Children’s Hospital was met with considerable concern among the public, Government and hospital management.
Connor Green, the surgeon at the centre of the controversy, took voluntary leave from Temple Street in 2023 and was referred to the Irish Medical Council.
A number of reviews were commissioned into the topic, the first of which was published on Tuesday.
The report, by the Health Information and Quality Authority (Hiqa), focused on governance and oversight at Children’s Health Ireland (CHI) and Temple Street Hospital.
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Mr Green has not replied to a request for comment about the contents of the report.
Here are five things we learned from the report:
Children not protected from risk of harm
According to Hiqa, the safe introduction and use of medical devices and surgical implants requires specific governance arrangements across a number of departments and functions within a hospital.
“Overall, Hiqa found that due to failures in the design and delivery and oversight of end-to-end processes and controls within the spinal service at CHI, children were not protected from the risk of harm.”
Clinical trial abroad
The Hiqa report revealed the inspiration for the use of non-authorised springs in the three children in Ireland was a clinical trial that took place in the Netherlands.
The intention was to replicate the study’s technique but in a modified way, Hiqa said.
The research team from the Netherlands told Hiqa they were not contacted by Mr Green, referred to as Surgeon A throughout the report, at any time to discuss their research.
Medical-grade titanium springs were used in this trial, which are different from the ones used in CHI Temple Street.
No written approval from any senior manager
Mr Green told Hiqa he did not discuss the proposed technique, or the intention to procure and utilise springs with his clinical director at CHI Temple Street.
“In addition, throughout the course of this review, Hiqa has not identified any written evidence demonstrating that there was formal approval from any senior clinical leader within CHI for the conduct of the procedures where springs had been implanted,” Hiqa said.
Consent
When speaking to Hiqa, Mr Green said he told the parents the procedure was “experimental and an off-label use”. He also said he explained the treatment process, alternatives, expectations and associated complications with patients and their families over many consultations.
However, Hiqa said there was a lack of written information provided to families about the new or experimental nature of the treatment, as well as a lack of written records to demonstrate these conversations took place.
As such, Hiqa said consent for these surgeries “was not fully informed” and was not in line with national policy.
Springs
The springs were bought from an unnamed firm, referred to as Company 1, which did not specialise in medical-grade equipment. There was no evidence to suggest the company professed to fulfilling such a role in the supply of the springs.
Though Hiqa acknowledged emails between Mr Green and the company had the subject line “medical springs”, the body said it found “no evidence” the surgeon informed the company the intended purpose of the springs was for surgical implantation.
The springs used in children at CHI were “non-alloyed spring steel”, which is not used for implantation because it is known to corrode in the presence of moisture, the report said.
