Paediatricians and health executives in Dublin were aware that a leading children’s hospital in the city was using “unauthorised, uncertified” medical implants in surgery, a top health official has said.
Ireland is facing a growing scandal over paediatric spinal surgery. An independent investigation found that 19 children with spina bifida suffered serious complications after they were operated on by one surgeon at Temple Street hospital. One child was readmitted to the operating theatre 33 times after her initial operation.
The consultant is now on leave and has been reported to the medical council, but a report by experts brought in from Boston children’s hospital has sparked wider concerns.
The country’s health minister, Stephen Donnelly, indicated he planned to widen an independent investigation into the sector, the Irish Times reported.
Initially the review focused on safety concerns about the work of a single doctor at Temple Street, but it is now expected to expand to cover all paediatric orthopaedics. Investigators will also look at long waiting lists and how the spinal surgery service was run.
In an interview with RTÉ radio, Ike Okafor, the clinical director of Children’s Health Ireland (CHI), which runs the Temple Street children’s hospital, apologised to families affected.
He also acknowledged that some failures were still being investigated. These include the use of implants that were not medically certified, and which went ahead with the knowledge of medical professionals.
“There were people in CHI who knew they were being used when they were being used, there were clinicians who knew that they were being used,” Okafor said.
Under normal procedures, doctors carrying out an operation would register the CE number – which certifies that a product has met EU health and safety requirements – at the time of surgery. It was not clear if this had happened, Okafor added.
The most complex types of surgery were suspended last year over safety concerns. Okafor said the hospital was looking into all options to resume this surgery, and other operations were continuing.
Ireland’s taoiseach said this week that he was increasingly concerned that there could be systemic failings in hospital governance, as details of the full extent of problems in the spinal surgery unit became clear.
“The more and more I read about it, the more concerned I am and the more bothered I am,” Leo Varadkar told reporters at the United Nations in New York.
“If you have a child awaiting surgery, you think if they get the surgery that is going to make them better, not worse. It seems that some of these surgeries were performed incorrectly and children suffered and were harmed as a result. That is unbelievably serious.”
“I don’t want to jump to conclusions because this will have to be investigated properly … but the kinds of things I’m hearing about and reading about if they’re true, extend well beyond malpractice.”