826. Deputy Peadar Tóibín asked 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]

Summary

826. Deputy Peadar Tóibín asked 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]

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