Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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57. To ask the Minister for Health the position regarding the use of a device (details supplied) in the treatment of children with scoliosis; the steps he has taken to satisfy himself that there are no health and safety risks to children with scoliosis being treated with the device; the steps he has taken to ensure that parents are informed regarding potential health and safety risks in the use of the device and to ensure informed consent guidelines are abided by in all such instances; and if he will make a statement on the matter. [50873/18]

Simon Harris (Wicklow, Fine Gael)
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The NuVasive MAGEC Spinal Bracing and Distraction System is a CE-marked medical device and, as such, it has been assessed by an EU-based notified body as complying with the safety and performance requirements of the EU medical device Directives. Certification requires that any clinical risks associated with a device are mitigated and reduced as far as possible, and that all risks cumulatively are weighed against the clinical benefits. It is important to note that the MAGEC system has also been assessed by the National Institute for Health and Care Excellence (NICE) in the UK as an effective surgical treatment option for scoliosis, where other treatments such as casting or bracing have failed or are not suitable.

Our Lady’s Children’s Hospital, Crumlin (OLCHC) has confirmed that these devices are only used in children with progressive scoliosis who are too young to undergo a full spinal fusion and who need a growing system to help straighten the spine but still allow growth. When a child receives their MAGEC Rods, they continue to attend a dedicated OLCHC outpatient clinic, which ensures monitoring and adjustments to the rods while the child continues to grow.

The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines and medical devices in Ireland. The Agency has confirmed that it has not received any reported safety incidents from the Irish market in relation to the MAGEC system. However, the HPRA is aware of concerns raised in relation to this device and is currently conducting a market surveillance review in relation to the product. The outcome of this market surveillance will be communicated when available.

The HPRA’s primary function with regard to the regulation of devices is in post-market surveillance. The HPRA does not maintain a register of devices implanted in people in Ireland. However, orthopaedic surgeons at OLCHC have advocated for the development of a national Spinal Register, and the Children’s Hospital Group has undertaken to progress such a Register and to ensure that it is adequately resourced. While this is happening, the hospital will continue to monitor patients and audit their ongoing care, documenting any problems that arise. OLCHC also has a dedicated telephone line in place for parents or guardians who have queries in relation to their child regarding scoliosis-related surgery.

Medical device legislation requires that information is made available with the device relating to its intended purpose, and that as far as practicable and appropriate, the information needed to use the device safely must be provided on the packaging or by a leaflet setting out use instructions and possible side-effects.

New EU Medical Device Regulation will be implemented over the coming years and will enhance and reinforce the existing regulatory system.