Tom Clonan (Independent) | Oireachtas source

Cuirim fáilte roimh an Aire go dtí an Teach. I spoke at the meeting of the Joint Committee on Health last week and asked questions of the chief medical officer, CMO, and the CEO of CHI. I am a parent of an adult son who had surgery in Temple Street hospital. Like so many children on that list, he had his surgery way too late. He was on that waiting list for years. This is the situation for hundreds and hundreds of other children and young adults as we speak. I am not a member of that committee. I was not aware that committee was taking place only that I met some families there and went down. Notwithstanding what I said, I have had some time to reflect on the responses given by the CMO and the CEO. In the past week, it has been brought to my attention by all sorts of paediatric surgeons in many different disciplines that the use of non-standard devices in procedures on children is commonplace, not just in Ireland but throughout the world. For example, in the case of an eight-month-old baby who needs a stent put in his or her heart, the medical device manufacturers do not make stents for children of that age. In such instances, it is common practice for a surgeon to take an adult stent and, in consultation with the hospital management and the quality management system, QMS, to alter or modify that device to fit the small child. This is commonplace and is considered best practice throughout the world. It saves hundreds of thousands of young lives every year. We can take that practice from cardiology and make the same observations in respect of urology and every other surgical discipline. This is not an unusual or strange occurrence. It is consistent with international best practice.

Prior to 2019, this practice was dealt with by the medical devices directive. In 2019, the medical devices regulations were introduced by the EU. In hospitals such as Temple Street, Crumlin and others governed by CHI, there would have been a lot of discussion and consideration of the new medical devices recommendations. For anybody to suggest there had never been a conversation about what were called custom or in-house devices is simply not credible. Article 5 of the directive, in paragraphs (c), (d) and (e), sets out clearly the position in respect of responsibility for the use of such a device. Paragraph (c) states that the health institution must "[justify] in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market". It is very clear that it is the responsibility of the institution's CEO to set out the documentation and quality assurance process for any device that is used in surgery on a child.

I have several questions I would have liked to ask last week had I had time to reflect on all the issues. What process is in place in CHI for the use of in-house devices, previously known under the medical devices directive as custom devices and which are commonplace around the world, in terms of design, manufacture and safety testing? Is there a QMS in place, as there ought to be as set out by the medical devices directive and, subsequently, the medical devices regulations and as implemented by the Health Products Regulatory Authority, HPRA? Can CHI produce evidence of such a QMS and the documentation relating to that process? What was the process in 2020 when the update happened and hospitals all around Europe were talking about it? The CEO seems to be blithely unaware of it, saying she did not get that letter or any letter. Where is the documentation on the process that was updated in 2020? If CHI denies any knowledge of the use of in-house or custom-made devices, it is simply not credible. It would place CHI completely and utterly out of step with best practice around the world. It is completely and utterly not credible.

I am also concerned by the mention of the biocompatibility of the spring that was contained within a device. It appears CHI is conflating the biomedical compatibility of an element of a device with the use of a device in the first place. If the CEO says no custom or in-house devices are allowed, then that is compromising patients and setting us as outliers in the international community. One would hope that a surgeon, if it is a cardiac issue, would use all the methods at his or her disposal to intervene and save a child. Article 5 of the EU directive is publicly available. I downloaded it. It is common knowledge among the surgical community. I have been contacted by so many surgeons who have highlighted the absolutely glaring inconsistencies between practice and what was presented at the health committee last week. We need accountability, but we do not have time to wait. As long as we wait and surgeries are suspended, children like my son are impacted. A woman at the committee meeting last week spoke of how her daughter's condition is now inoperable.

I urge the Minister to bring these people in and put these questions to them. I will happily give him a copy of my notes and everything I have. If they cannot answer satisfactorily, then it is very clear what they should do in terms of accountability and from an ethical and moral perspective. I do not want an apology from the CMO as we got last week. I want an end to having children in this country being outliers, stuck on waiting lists for so long that they miss a developmental window. That does not happen anywhere else in the EU, in Britain or elsewhere. It does not even happen in Trump's America. The people in charge have presided over this situation. What action have they taken to address it? We got no answers last week at the health committee. I am happy to give the Minister my notes and I urge him to seek answers from the CMO and the CEO. I ask any political correspondents or media people watching this debate to raise the issue. The clock is ticking for all these children and young adults. For some of them, their lives will be irrevocably limited and altered because of a delay in surgery. We do not have time to delay.