Hospital Procedures

Tuesday, 21 October 2025

Questions (824)

Peadar Tóibín

Question:

824. Deputy Peadar Tóibín asked 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]

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Written answers

Minister for Health

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.