Ms Eil?sh Hardiman:

Deputy Durkan asked first about controls. Yes, there are well-established processes within hospitals to oversee what would be research or innovation. To be clear, however, none of those processes would have approved a non-medical-grade device. It would just never be approved for implantation. We have a research ethics committee if a research study has been done. We know that the particular treatment was first under a research study in the children's hospital in Utrecht, and that went through the full research ethics processes. The device that was used there was a medical-grade device and it went through all the proper processes as a proper piece of research. As regards those controls, I want to give assurance that for anybody doing research or innovation, we have processes for that. We also have processes around medical devices. The issue here, which will be part of this investigation, is why this happened despite those being in place. We are as anxious as everybody else to understand that and we will fully engage with the external team. I want to give assurance that the team has a competency around the full end-to-end element of these medical devices, so it is competent as regards spinal surgery. It is also competent in quality and safety issues in acute hospitals. There are competencies on the team as regards medical devices and authority to use medical devices, as well as in respect of decontamination. The HSE has nominated an external team to undertake this investigation, and we will co-operate fully with that.