Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

200. To ask the Minister for Health if she will direct Children’s Health Ireland to carry out a retrospective communication campaign to formally notify all families of children and young people who have ever received MAGEC rod implants of a field safety notice (FSN) issued by a manufacturer in December 2021, including those patients whose rods have been removed or who have aged out of paediatric care (details supplied); if she will ensure that personalised correspondence are issued to disclose the clinical significance of this FSN, including the reduced recommended implantation duration and associated risks; that appropriate clinical follow-up and advice is offered to all affected individuals, in line with specific regulations and standards; and if she will make a statement on the matter. [24702/25]

Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

203. To ask the Minister for Health if Children’s Health Ireland obtained explicit, informed consent from each family prior to a clinical decision being made to leave MAGEC rods in place to fuse in situ; if this consent process included the provision of written information outlining the known increased risks of adverse events associated with prolonged implantation beyond two years as required (details supplied); and if she will make a statement on the matter. [24705/25]

Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

204. To ask the Minister for Health if the use of MAGEC rods left to fuse in situ beyond two years in patients under the care of Children’s Health Ireland (CHI), contrary to the manufacturer’s instructions for use, was treated as off-label use under EU Medical Devices Regulation (MDR) 2017/745; if CHI ensured that a documented clinical justification was made; if families received written information explaining the off-label use and associated risks; if specific informed consent was obtained in line with legal obligations under MDR and national policy; and if she will make a statement on the matter. [24706/25]

Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

205. To ask the Minister for Health if any cases involving the off-label use of MAGEC rods were reviewed by clinical governance structures, ethics committees, or hospital risk management teams within Children’s Health Ireland (CHI) (details supplied); if not, if she will now require CHI to carry out a retrospective audit of these cases to ensure regulatory and ethical compliance; and if she will make a statement on the matter. [24707/25]

Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

206. To ask the Minister for Health if Children’s Health Ireland (CHI) routinely monitors blood levels of titanium, cobalt, and chromium in patients with MAGEC rods left to fuse in situ, in light of CHI's own findings (details supplied); if she will publish CHI's clinical policy for the follow-up and monitoring of patients who have aged out of paediatric care with MAGEC rods still in place, including access to adult services for ongoing review and surveillance; and if she will make a statement on the matter. [24708/25]

Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

207. To ask the Minister for Health the number of vigilance reports or device-related incident notifications which have been submitted by Children’s Health Ireland (CHI) or the HSE to the Health Products Regulatory Authority in relation to MAGEC rods since the implementation of EU Medical Devices Regulation (MDR) 2017/745; if she will publish a breakdown of the nature of adverse events or faults reported, including mechanical failure, metallosis, or off-label use; and if she will make a statement on the matter. [24709/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

I propose to take Questions Nos. 200, 203, 204, 205, 206 and 207 together.

As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

201. To ask the Minister for Health if she will provide a detailed breakdown of the total number of children and young people in Ireland who have received MAGEC rod implants, in tabular form; the number that currently have MAGEC rods left to fuse in situ; and the number that have aged out of paediatric care with MAGEC rods still in place; and if she will make a statement on the matter. [24703/25]

Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

202. To ask the Minister for Health if she will publish the clinical rationale for the approach of leaving MAGEC rod implants in situ beyond the two-year implantation period recommended by the manufacturer in the December 2021 field safety notice (details supplied); and if she will make a statement on the matter. [24704/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

I propose to take Questions Nos. 201 and 202 together.

As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

208. To ask the Minister for Health the reason MAGEC rods remain unapproved for general use in Ireland and are only accessible under compassionate grounds; if she will publish the clinical and regulatory rationale for this continued restriction, including any safety concerns identified by the Health Products Regulatory Authority or other regulatory bodies; the steps being taken to assess the safety and efficacy of MAGEC rods for potential future approval; and if she will make a statement on the matter. [24710/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

As the PQ relates to regulatory aspects of medical devices, I have reached out to the Health Products Regulatory Authority who are the agency in Ireland with responsibility of regulating medical devices for the benefit of people. The Department of Health engages with the HPRA regularity on their remit.

Within the medical device regulatory framework, medical devices placed on the Irish or European market must conform to the requirements of the relevant European legislation. These require that medical devices perform safely while achieving the purpose intended by the medical device manufacturer. Certain medical devices, such as those implanted in patients, must be assessed by a conformity assessment body in Europe, known as a Notified Body (NB), before they can be legally placed on the market. Once the notified body has satisfactorily completed its assessment it issues a certificate to the manufacturer who can then label their device with a CE mark. Medical devices which are appropriately CE marked may be freely placed on the European market.

While the HPRA understands that the MAGEC spinal system is currently CE marked, it is on voluntary hold by the manufacturer in Ireland. By way of background, the HPRA has an ongoing market surveillance review in relation to this product and in April 2020 the manufacturer issued a field safety notice (FSN) informing customers that no MAGEC System rods of any model number shall be implanted in Ireland (or the United Kingdom) pending completion of the market surveillance review of the MAGEC system by the HPRA (and MHRA for UK).

The CE certificate for the device was suspended in March 2021 by the notified body due to safety concerns associated with a version of the device. When the CE certificate was reinstated, the manufacturer issued a new FSN issued (December 2021) outlining changes to the instructions for use and also informing that MAGEC devices would remain on-hold, in Ireland, until the HPRA has concluded the market surveillance review. The FSN also re-iterated that in the exceptionally rare case where the use of the device is deemed by the clinician to be essential, the HPRA would consider these on a case-by-case basis.

As part of the market surveillance review, the HPRA has sought a range of additional measures from the manufacturer including improved post-market monitoring. This includes strengthened post-market studies to be carried out in Ireland, which will allow closer monitoring of the safety and performance of the new MAGEC spinal system. The HPRA has also sought enhanced product information to be provided to patients and their parents. The manufacturer has agreed to these measures and the HPRA is awaiting confirmation of their implementation prior to conclusion of the review and full re-introduction of the device to the Irish market.

Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

209. To ask the Minister for Health if Children’s Health Ireland and associated paediatric spinal services record and report deaths of children and young people following scoliosis surgery using internationally recognised postoperative timeframes, including 30-day and 90-day mortality and in-hospital death; if she will publish all available data on postoperative mortality following scoliosis surgery in Ireland over the last ten years, including deaths occurring after discharge, to ensure comprehensive oversight of surgical outcomes and compliance with national and international safety reporting standards; if any of these deaths were reported through internal risk systems or to the Health Products Regulatory Authority under post-market surveillance obligations; and if she will make a statement on the matter. [24711/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.