HSE chief executive Bernard Gloster says he is “seriously concerned” that nobody in Temple Street hospital appeared to have objected to the use in medical procedures of springs that were not approved to a basic European CE standard.
The springs, used in three patients requiring spinal surgery, were described by Health Service Executive (HSE) officials this week as unauthorised, uncertified implantable devices. Two of the springs have since been removed and a third child is undergoing constant medical assessment, HSE officials said.
Speaking on RTÉ Radio 1′s This Week programme, Mr Gloster said it is “exceptionally important” that any medical device has, at the very least, the CE mark which is recognised across the European Union.
He added that it appeared nobody had contacted the Health Protection Regulatory Authority to ask if such devices were acceptable for use in surgical procedures in the hospital. He wondered why nobody “put their hands up” and raised the alarm before they were used.
“The simple reality is that these should not have been used or procured in this manner,” he said.
“Regardless of the motivation, it is exceptionally important that any material implanted in a person’s body has very sound governance around it.”
An independent investigation found 19 children with spina bifida suffered serious complications after they were operated on in the hospital. One child was readmitted to the operating theatre 33 times after her initial operation.
The HSE this week commissioned UK expert Dr Selvadurai Nayagam to investigate after two initial reviews identified “serious spinal surgical incidents” in the service. One child died and others suffered serious post-operative complications.
On Friday the Spina Bifida & Hydrocephalus Paediatric Advocacy Group and The Scoliosis Advocacy Network said they would withhold patient medical record consent and boycott the external review.
They say an earlier Boston review had included the medical records for children that were used without the permission of their parents. The two groups say this is unacceptable and they will report it to the Data Protection Commissioner.
They believe that it cannot be an independent review if the HSE and Children’s Health Ireland (CHI), which is responsible for paediatric care nationally, are involved in drawing up the terms of reference.
On Friday the patient advocacy bodies stated: “We will not allow them to be restricted by CHI and the HSE, the very bodies that have consistently failed our beautiful children and us as parents.”
Terms of reference
They also believe that the review may put the focus on one surgeon whereas they believe the problems may not just be about one individual.
Mr Gloster said the HSE could have done more to involve the 19 families of the children involved in earlier reviews.
“My intention is that we will engage with them in the coming days and seek to establish what views they have on the terms of reference and what may or may not be missing from those terms,” he said.
However, he added that he believed the terms of reference were “wide enough” and that Dr Nayagam will not be restricted in any way from making any inquiries he needs to make.
Neither would it be “fair or appropriate” to blame one individual. The surgeon involved has been referred to the Medical Council. “Any person involved is absolutely entitled to fair procedure and the principles of natural justice,” said Mr Gloster.
He would not allow any review to limit its exposure to one individual to protect the HSE or any organisation funded by the HSE, he said.
“I have no fears about the independence of this. There is a view that this review is limited to one clinician. This is not true. Any fair reading of the four terms of reference would show that.”