There is “little research” into the off-label use of a medical device in the bladder of children with spina bifida but there are “no serious safety concerns”, according to the health services watchdog.
The Health Information and Quality Authority (Hiqa) on Thursday published a rapid health technology assessment of vesicostomy buttons – devices used to allow urine to drain out of the bladder – following a request from Minister for Health Jennifer Carroll MacNeill.
The assessment was requested after advocacy groups accused Children’s Health Ireland (CHI) of using the devices without informed consent from parents.
According to Hiqa, the buttons are a way of managing urine storage and bladder emptying problems in a very small number of children with certain complex health conditions, such as spina bifida.
READ MORE
This cohort of children is at an increased risk of urinary problems, including kidney damage, and may have limited options to manage these problems, the authority said.
Hiqa found there are two vesicostomy button devices currently in use, with both devices being used ‘off label’ – meaning for a purpose other than the one for which they were originally approved. This is commonplace in clinical practice.
The assessment found there was limited published research on vesicostomy buttons in children.
Fourteen studies were identified across several countries, including a total of 244 children – most of whom were around five years old when the device was inserted.
No serious safety concerns were identified in the literature over the last 30 years of vesicostomy button use in clinical practice, and, generally, positive outcomes were reported, the assessment said.
Dr Máirín Ryan, deputy chief executive of Hiqa, said compared with standard catheters for urine drainage, the buttons are “discreet” and can make everyday activities “more comfortable for children”.
“The assessment did note the occurrence of complications such as leakage, infections and skin reactions. However, it is hard to determine if these complications occur more often than with standard catheters,” she said.
“The current evidence base suggests that vesicostomy buttons may be a useful option for certain children, particularly when standard catheterisation is difficult, painful or not possible.”
