11-05-2025
CHI accused of using off-label treatment without parental consent
Advocacy groups have accused Children's Health Ireland of treating children with an off-label application of a medical device without the informed consent of their parents.
However, the hospital group has defended the insertion of gastrostomy buttons in the bladders of some children, saying it is a practice used around the world and has been found to be safe
Gastrostomy buttons are designed to be inserted into the stomachs of patients to deliver medicines or nutrition.
Amanda Coughlan Santry of the Spina Bifida and Hydrocephalus Paediatric Advocacy Group says the issue arose when some children went to the UK for treatment and doctors there discovered the buttons in their bladders.
She told RTÉ News the medics there wanted to know why it had been done in Ireland.
When parents contacted a manufacturer of the devices they were told gastrostomy buttons are not suitable or tested for use in the bladder, she added.
Some parents are concerned the practice may have put their children at increased risk from urinary tract infections.
Responding to concerns first reported in the Sunday Times, CHI issued a statement saying "the placement of a gastrostomy button in the bladder, also known as a vesicostomy button (VB), is a long-standing internationally recognised practice."
It says that a quick search found nine published studies from around the world, over an 18-year period, which covered the use of the buttons in the bladders of almost 190 patients.
It claims all the reports found the practice is a safe method of bladder drainage for patients where use of a catheter is not an option.
CHI says none of the studies supported the suggestion that the use of the buttons in the bladder could lead to an increased risk of infection.
The CHI statement also included a link to an NHS information page, for parents of children getting the treatment, on the use of the buttons in the bladder which says "it has been recognised that the same device can be used for a different purpose that is, it can be placed into the bladder, through a vesicostomy, and used to drain urine out of the bladder. When used in this latter way it is referred to as a 'button vesicostomy'."
However the page also says the use of the buttons can increase the risk of UTI.
"This can be more common than when an intermittent catheter is used and the UTI can be more difficult to treat," the NHS page has said.
The SBHPAG and the Scoliosis Advocacy Network met Minister for Health Jennifer Carroll McNeill to voice their concerns.
In follow up correspondence, she referred to the CHI arguments for using the devices and told the advocacy groups that "CHI have advised that all historical use of technically off-label use of devices are retrospectively going through Clinical Ethics and the Medical Device Management Committees as good practice."
She added that on the issue of communicating with patients and their parents "there is certainly room for improvement on this."
The SBHPAG told RTÉ News that it is aware of three children who had gastrostomy buttons inserted into their bladders during treatment at CHI.
However it added it represents a small cohort of families and it expects there could be other children affected by this.
CHI says it cannot access the data at the weekend to find out how many patients were treated in this way.
