Stephen Donnelly (Wicklow, Fianna Fail) | Oireachtas source

I thank the Deputy. What I can tell him is this: the springs that were used were not authorised for medical use, which is very serious. We do not know - the review is now establishing this - how that happened in terms of procurement and getting into theatre. There are protocols for checks on everything that is used in theatre. Exactly how all of that happened is being established right now, but we know that these were not authorised. Furthermore, we know there are processes in place through the Health Products Regulatory Authority, HPRA, which authorises the health devices, to be able to identify materials that can be authorised for medical use. This is obviously subject to a battery of tests and regulations.

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