Carol Nolan (Laois-Offaly, Independent) | Oireachtas source

This issue is about as serious as it gets. It represents a fundamental failure of professional care for spina bifida patients. It has been an absolute nightmare for the children involved and their parents. One can only imagine what they are all going through. It is a betrayal of trust on a scale that is hard to imagine or, indeed, quantify. Of the 16 case files reviewed, 13 patients, or 81.2%, required further unplanned surgery. One of these patients, who had multiple procedures, unfortunately passed away. My thoughts and prayers are with the Carter family at this very difficult time following the loss of their daughter. How on earth could a situation like this, whereby unlicensed devices made with non-medical parts were implanted into highly vulnerable patients with complex needs, arise? What level of serious failure had to occur for this to happen? Where were the safeguards and where were the processes that should have put a halt to this sooner when initial concerns were raised by staff?

I understand that the surgeon at the centre of the external review at Children's Health Ireland at Temple Street has been referred to the Medical Council and is not carrying out surgeries while investigations are under way. That is the very least that should happen. Quite frankly, to read that the overall infection rate for these cases was 73.4% and that nine of the 16 cases, or 56%, had mechanical complications, is like reading a report from a Third World clinic. This is a tragedy that must never happen again and it is absolutely shameful that it has occurred.

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