Peadar Tóibín (Meath West, Aontú)
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824. To ask the Minister for Health whether vertebral body tethering (VBT) was included in HIQA’s review into the governance of implantable medical devices at Children’s Health Ireland (CHI), which examined the use of non-CE marked springs at Temple Street; if VBT was not included in that review, the reason for its exclusion, given that CHI has confirmed it has carried out VBT as an “emerging and experimental procedure” involving spinal implants on children; if she will now request HIQA to examine the procurement, regulatory status and oversight of the devices used for VBT at CHI; and if HIQA did not assess VBT as part of its completed review, if she will confirm who, if anyone, has examined its use, safety governance, or regulatory compliance; and if she will make a statement on the matter. [57187/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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In August 2023 patient safety concerns in the paediatric orthopaedic surgical services in Children’s Health Ireland at Temple Street were raised. One of these serious patient safety concerns related to the use of non-CE spring implants in surgeries in Temple Street Children’s Hospital. The Health Information and Quality Authority (HIQA) were requested to carry out a review of the end-to-end processes around the use of the non-CE spring implants during spinal surgery in Temple Street Children’s Hospital. HIQA were also asked to examine the controls and oversight processes and governance within CHI on the use of surgical implants / implantable medical devices, including processes around regulatory requirements and notifications. The final report, which was published on 8th April 2025, did not include any reference to Vertebral Body Tethering (VBT).

The management of all medical devices across CHI is done according to the Medical Device Management System. There is a single CHI-wide Medical Device Committee in place to oversee the implementation of the Medical Device System Policy. CHI has standardised policies and procedures in relation to procurement, medical device management, decontamination and theatre governance in line with best practice.

Peadar Tóibín (Meath West, Aontú)
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825. To ask the Minister for Health the hospital sites at which vertebral body tethering (VBT) procedures have been carried out, including Children’s Health Ireland (CHI) locations (Temple Street, Crumlin, Cappagh) and any external providers such as a clinic (details supplied) under the national outsourcing arrangements; the means by which follow-up, outcomes and complications relating to VBT have been recorded and monitored, given that hospital in-patient enquiry (HIPE) has no specific procedure code for VBT; the basis on which the HSE, CHI or the healthcare pricing office have been funding or coding VBT procedures in the absence of a designated HIPE code; and whether patient safety, audit and governance requirements can be met where a surgical technique is not identifiable in national activity, outcome or costing data; and if she will make a statement on the matter. [57188/25]

Peadar Tóibín (Meath West, Aontú)
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826. To ask the Minister for Health whether vertebral body tethering (VBT) was reviewed, approved or considered by the CHI Ethics Committee prior to being introduced as a surgical option for children; if not, the reason ethical approval was not sought for a new and experimental procedure; whether the devices used for VBT were brought before CHI’s Medical Devices Committee for assessment, approval or procurement review; to provide the dates and documentation of any such consideration; whether a separate or enhanced consent process was developed for VBT, given that CHI has described it as an “emerging and experimental procedure”; whether consent standards for new techniques differ from those used for established spinal fusion surgery; whether VBT was introduced or conducted under any research, pilot, innovation or clinical investigation pathway; if so, the governance, monitoring or ethical approvals that were in place; and if she will make a statement on the matter. [57189/25]

Peadar Tóibín (Meath West, Aontú)
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827. To ask the Minister for Health whether devices used for vertebral body tethering (VBT) at Children’s Health Ireland were added to the SAP procurement system and approved by the CHI Medical Devices Committee despite there being no HIPE procedure code for VBT; if so, that way in which use, cost and oversight of those implants have been recorded and monitored at national level; and if she will make a statement on the matter. [57190/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 825, 826 and 827 together.

I am committed to continue to drive progress in paediatric spinal services.

CHI advises that Vertebral Body Tethering (VBT) is a surgical technique designed for children and adolescents with idiopathic scoliosis who are still growing and for whom non-operative treatments such as bracing have not worked. VBT procedures have been carried out in CHI at Crumlin and Temple Street, and no VBT procedures have been outsourced to private facilities. There is also no separate funding stream for VBT procedures.

CHI advises that it adheres to the National Consent Policy and Medical Council Guidelines in relation to obtaining consent for a medical, surgical, or dental procedure, and that VBT has not been conducted as part of any research, pilot, innovation or clinical investigation pathway.

CHI advises that all implantable devices currently set up on the SAP System have been through the CHI Medical Device Committee, approved for use and CE Certifications obtained. Any non-CE marked devices have obtained derogations via the HPRA.

In relation to your specific queries that relate to operational matters, I have asked the HSE to respond to the deputy directly, as soon as possible.