Stephen Donnelly (Wicklow, Fianna Fail) | Oireachtas source

I thank the Acting Chair for his kind words and colleagues for raising the issue and their contributions. I have listened very carefully to what has been said.

I want to start by again acknowledging the extraordinary distress, anger, fear and frustration that all of this is causing. There are 20 families directly involved. There are 20 boys, girls and young men and women, one of whom has passed away, affected by this. All of their families, and many other boys, girls and young men and women and their families, are waiting for care. As Senator Clonan said, there are those for whom it is now too late to get the care they need. My focus, like that of all of us, remains on the people who are directly affected by this, namely the 20 families we know about, and all of those who are in need of and continue to use the services.

I know there is a lot of anxiety, upset and anger. Families are right to be angry because a lot of these children have been failed by the State. We have not got it right yet. We have not fixed this yet. Many of those who are using Temple Street services for spinal surgery are asking very legitimate questions about what has happened regarding the 20 families involved. They are asking questions about clinical care, medical devices, whistleblowing, safety protocols and many other issues, many of which have been referenced. People are asking broader questions about paediatric orthopaedics in CHI. They are asking very legitimate questions about governance and patient safety, communications and engagement.

During statements in the Dáil last week, I outlined the background to how we got here. I will not reiterate that. I am sure colleagues are clearly up to speed on what has happened. I want to focus today on what has happened since then. As colleagues have asked about what will happen, I will focus on that.

I and the chief executive of the Department of Health met Mr. Selvadurai Nayagam, the external reviewer, in the Department on Monday evening. It was a very good, constructive and positive meeting. I am very grateful to him for agreeing to lead this work. He is a paediatric orthopaedic specialist and will bring in spinal paediatric specialties as required, along with other specialties as required. He has been provided with a completely independent secretariat to support him. It is not a case of Department or HSE staff moving in to support the work, as sometimes happens. Rather, it is an independent group. He has also been provided with an independent legal firm to get advice directly on any and all issues he wishes to address, including ensuring we have a report which can be published. In the Oireachtas, we are all acutely aware of some of the problems we can have with publishing reports. I and the chief executive have asked Mr. Nayagam to try to make sure we can publish the report. I do not want a report sitting on my desk that cannot be published.

The need for an independent external review is clear. We all accept it. The independent review at Temple Street and across CHI will cover Temple Street, Crumlin, Cappagh and Blackrock, where relevant – some of Blackrock's facilities were used for some less complex work. Mr. Nayagam has been told directly by me that he can go as wide and deep as he wants to and that I want no stone left unturned. We want nobody's blushes spared. We do not want political language, not that I believe he would entertain such a thing anyway. We are not looking for polite responses and recommendations. We want the pure unvarnished truth, bad and good, because a lot of good things are happening, which is not the focus of this debate today.

Mr. Nayagam made the point to me that the first cohort he wants to hear from is the 20 families involved, as well as advocacy groups. I have said to him directly that he has full scope to adjust the draft terms of reference and objectives in any way he wants, based on what he hears directly from the families affected and advocacy groups. Some advocacy groups have met him and have publicly stated that they found it to be useful and that they will engage in the review.

I held individual meetings with some advocacy groups last week. The Taoiseach and I met several of the groups last Friday in Government Buildings. Engagement is ongoing regarding their involvement in the external review. Mr. Nayagam has listened to the groups he has met, and is going to listen very carefully to the groups and families who want to meet him. I fully respect that there are groups who, at this point, are not meeting him.

This moment must be a watershed moment in terms of addressing the issues in our paediatric orthopaedic services, which everyone knows have been tolerated for too long in our country. As colleagues are aware, an additional patient safety concern concerning the use of non-CE springs was reported to me by CHI in late July and then in early August. This is very concerning. While no findings have been made at this time of surgeries with a higher than expected level of return, it is absolutely clear that non-medical-grade equipment cannot end up inside the human body. As has been stated, of course innovation means devices not intended for a specific purpose can, are and must be considered, such is the nature of innovation. Within that, it is taken as a given and there are numerous protocols in place such that whatever devices are used in whatever way is agreed, they are medical grade devices. We do not put non-medical-grade devices inside the human body. That has happened here and it is very serious.

Therefore, today I wrote to the chief executive of HIQA to request it to conduct an independent statutory review of the use of the non-CE spring implants during those three spinal surgeries in Temple Street. I also asked HIQA to review the controls and oversight processes and governance across CHI on the use of surgical implants - not just these springs - and implantable medical devices, including the processes around regulatory requirements and notifications.

The need for wider assurance was raised directly with the Taoiseach and me by patient advocates at our meeting last Friday. The second part of the HIQA review is in direct response to the concerns they raised with us. We are following up on several other concerns and issues raised by the advocacy groups involving both hospital and community-based services for patients. It is important to note that we focus, understandably, on the hospital care and surgeries. As was raised with me by the groups, there is pre-hospital care, in-hospital care, post-operative care and then just ongoing care, such as the provision of medical devices, housing adaptations, access to primary care teams, physiotherapy and multidisciplinary primary care. All of that is being looked at, not just the hospital work.

Paediatric spinal services, including spina bifida and scoliosis, were prioritised by me and by Government in both the 2022 and 2023 waiting list action plans. A total of €19 million of public money, both current and capital investment, was committed specifically to tackling these waiting lists. It was specifically for that purpose. Since then, that investment has led to a substantial increase in the number of surgeries happening. Last year, there were about one third more surgeries than in 2019, which is encouraging. For every three surgeries in 2019, there were four surgeries in 2022. That is encouraging. To date, 151 additional healthcare professionals have been hired as part of this push to increase capacity. Extra beds have been opened and additional capacity has been put in place.

However, it is not enough. In spite of this important increase in the number of surgeries being performed, the waiting lists are not falling. Ultimately, that must happen. Right now, additional capacity from that €19 million is being added. In the coming days, a fifth theatre in Temple Street will open. This was one of the core elements of the €19 million. In the coming weeks, a second MRI in Crumlin hospital will open. This is very important. I went to Crumlin hospital very shortly after being appointed as Minister. One of the things they said to me was that there are many children waiting sometimes years for an MRI under general anaesthetic. The second MRI machine is being put in place explicitly to address the waiting list for children waiting for MRIs, including those waiting for MRIs under general anaesthetic. There are 24 beds across Temple Street and Crumlin hospitals as well as additional ICU beds not funded out of the €19 million. Many of the 24 acute beds, as part of the €19 million, are in place and the rest are coming online in the coming weeks. This additional capacity will make a difference. It means more theatre time and more access to beds, ICU, MRIs and diagnostics. The clear intention with the extra capacity is that the number of surgeries increases.

Everything we have done and will do in response to waiting times is to serve the patients. This additional capacity we will bring online in the next few weeks, including in the next few days, in and of itself is not enough either. There is a draft plan for changes to how spinal services are managed. I am interrogating that plan in detail. I am talking to experts in paediatric orthopaedics and paediatric spinal services. We are evolving that plan. I think there are more things that need to be done, including consolidation of surgeries, dedicated beds, post-operative teams, dedicated theatre teams, central management of waiting lists, changes to governance, changes to clinical governance and more. All of this additional capacity and the changes, some of which have been made and more that we will make, have one simple goal: to make sure the children who need these services get access to them when they need them in a way they can be confident they are absolutely world-class services in respect of patient safety and patient care.

I have no doubt that through the review Mr. Nayagam is conducting, he will be able to come back with additional recommendations. The families involved and the advocacy groups have valuable input. The front-line clinicians, surgeons, theatre staff, ward staff, anaesthetists, health and social care professionals - the people delivering these services - need to be listened to carefully. Between them, the families, the advocacy groups, Mr. Nayagam's work and whatever expertise we need to pull in, we will design a service that befits our Republic. We have never done it. This is not a party political issue but obviously it is a political issue. None of us will rest until these services are fit for the children and the Republic we live in.

I thank colleagues again for the opportunity to listen to their input and update the Seanad on what happened in the past week and where we are going.