Colleagues of the consultant whose work at Temple Street children’s hospital has been linked to serious surgical incidents were aware they were using spring implants, it has emerged.
“There were people in CHI (Children’s Health Ireland) who knew that they were being used when they were being used. There were clinicians who knew that they were being used,” according to the hospital’s clinical director, Dr Ike Okafor.
The springs used in three patients were described by Health Service Executive (HSE) officials this week as unauthorised, uncertified implantable devices.
A lot of false information is circulating on social media about the spring-type medical devices implanted in some children requiring spinal surgery, Dr Okafor cautioned. Two have been removed and one is still in place.
“There is currently an investigation in place to look at the process around how they were procured and how they were used.”
The devices were ordered from a company, not a “retail establishment” that has been named on social media, he added.
Asked when CHI was made aware of the use of the springs in a small cohort of children, Dr Okafor said: “The information came to us at the end of June, early July. And that’s how we became aware that they were non-authorised.”
The investigation into their use will be separate to the wider external review ordered by the HSE this week, he told RTÉ's News at One, and will examine whether CE marks were recorded on the file as required when surgical devices are implanted in children.
Asked how three patients received implants containing non-certified springs, HSE chief executive Bernard Gloster said “We do have to see how the end-to-end processes within the hospital did not detect that particular problem.”
The external review of spinal surgeries at Temple Street children’s hospital may not be completed for at least a year, he told reporters.
The review, to be conducted by a UK expert, will have the scope to address wider issues such as the delivery of services and governance, he promised, and could be expanded to examine wider groups of patients.
The HSE this week commissioned Selvadurai Nayagam to review surgeries carried out by a Temple Street consultant after two initial reviews identified “serious spinal surgical incidents” in the service. One child died and others suffered serious post-operative complications.
Asked if the HSE had chosen to throw the Temple Street consultant “under the bus” in preference to examining systemic issues, Mr Gloster replied: “I would reject that. CHI as the employer has made a referral to the Medical Council; there are other matters to be investigated. People are entitled to fair procedures.
“It’s a problem that came on top of the incidents that they were already reviewing, from the two reports that people are now familiar with this week. We have to allow the investigation tell us how that actually happened.”
Children’s Health Ireland has to be allowed to do its own investigation into how this happened, he said. Mr Gloster said he reserved the right to take “other steps” once the outcome of this investigation emerged.
Speaking in Kilkenny at the Nursing Homes Ireland conference, he promised the external review commissioned this week would look at all the issues that had arisen within orthopaedic services for children.
The newly commissioned independent review would “comprehend” the view of many people, including families, he promised, adding that he was “very open” to meeting advocacy groups and families on the issue.
Asked when the external review would be completed, Mr Gloster warned it “could certainly go well out over the next 12 months” but the “priority dimension” would be well under way by the end of this year.
Dr Ikafor said the number of cases with problems arose from a small cohort of “really, really complicated cases”.
Minister for Health Stephen Donnelly will address the Dáil next week on the issue.
Sinn Féin’s health spokesman, David Cullinane, told the Dáil on Thursday that he found it “incredible” that Mr Donnelly “left the country knowing this scandal was going to break and, it seems, did not inform either the Taoiseach or Tánaiste about the seriousness of these issues”.
Speaking in New York on Wednesday, where he was attending the United Nations general assembly, Mr Donnelly said his department was informed in August that there were issues in relation to unauthorised medical devices being used as part of spinal surgeries in Temple Street.