Marian Harkin (Sligo-Leitrim, Independent) | Oireachtas source

Like many of my colleagues, I also want to offer my sincere sympathy to the family of Dollceanna Carter and express my deep concern to the families of those children who find themselves in the middle of this medical crisis. Our role here today, of course, is to ensure that lessons are learned and that action is taken to fully implement those learnings.

I listened to the Minister, Deputy Donnelly's contribution earlier, and welcome his reassurance that the terms of reference have been deliberately written to be as all-encompassing as needs be. The Minister said that the independent consultant can expand the terms of reference to be as wide and deep as he wants, and that parents will have a real and meaningful impact on determining the terms of reference. I genuinely hope this is true because it is, at the very least, what parents and patients can expect after the series of unacceptable mistakes that have been made. I am using the word "mistake" for now because as of now, that is the only word I can use. We need to get to the bottom of this and, as I said earlier, not just learn lessons but make sure we implement all of the learnings at all levels of responsibility.

I cannot imagine the agony of parents reading this CHI report. I will mention one statistic that many others have also mentioned, which is the 81.2% of patients who required further unexpected surgery. The word "unexpected" hit me in the stomach. I cannot imagine how parents and patients felt.

The report from the Boston Children's Hospital, at 27 pages, contains a long list of recommendations. If I were to try to summarise them, it comes down to a serious lack of good governance and teamwork, emanating from the top, an inexcusable absence of fairly basic checklists pre- and post-operation and many other issues to which I will return during the question-and-answer session. As Deputy Connolly said, and this is important, none of these reports were published proactively and it took Deputy Paul Murphy and others to ensure they were.

Like others, I was totally shocked to see that non-CE marked and unregulated medical devices were used. In my time in the European Parliament, I was closely involved with the most recent update of the medical devices directive. I remember at the time unregulated devices being introduced into the healthcare system in France and a number of other countries. The motive at that time was corruption. I am not saying there was anything like that in this case, nor am I making any comparisons. However, I was absolutely shocked that such a thing could happen in a hospital in Ireland despite the new regulations we put in place, which I thought were comprehensive. Despite the checklists around procurement, despite all the checks in the supply chain under the auspices of the Health Products Regulatory Authority, HPRA, which acts as Ireland's notified body, and despite internal checks within the hospital, unregulated devices were used. How did this happen? I will come back to the issue later.

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