I want to start by acknowledging the intense distress and anxiety this whole episode is causing to the patients themselves involved in these reviews. These are girls and boys, young women and men, and, of course, their parents and families. These young people and families already have so much to deal with as regards their underlying medical conditions, and I am acutely aware, as I know all of us in this House are, of the very significant added stress and worry this situation has brought for them.

I also offer my deepest condolences to the parents and family of Dollceanna Carter, the ten-year-old girl who, sadly, passed away last year. Nobody who has seen the photographs of Dollceanna which have been published in recent days and have heard her family speak about her can be in any doubt as to the incredible loss suffered by all those who loved this beautiful child.

While my immediate focus is on those patients directly involved and affected, I acknowledge there are many other children and young people, and their families, who are anxious and upset by what they have heard. Many of those availing of care and services in Temple Street hospital or who are awaiting those services will be concerned by what has happened and by what they have heard. They have legitimate questions about waiting times and governance, and I am absolutely determined these questions will be fully answered for them.

When it comes to the waiting times, I know and we all know why the families involved and those advocating for them are so frustrated. Their children, their boys and girls, have in far too many cases waited or are still waiting far too long, sometimes years, for surgery they should have had rapid access to. They know and we know the health consequences for the children of not getting access to these services when they need them. I understand, as we all do, why parents are angry. They have every right to be angry.

Today I will set out the timeline and facts that have emerged; details of the communications and engagement there has been with the patients and families involved; an overview of the main reviews that have taken place or are under way; and why I believe we need a new external independent review by Dr. Nayagam. I will address an issue which has caused great concern, which is the use of non-CE-marked or unauthorised spring implants in three of the surgeries. It is important to stress that some of the matters that colleagues and the wider public have legitimate questions about have yet to be fully clarified, reviewed and investigated. This is part of the reason for the commissioning of the independent external review by an international expert. It is also important that I do not pre-empt, or prejudice, some of those findings or facts until those processes and procedures have been completed in a fair, objective and transparent manner.

I will discuss now the timeline of what occurred. In November 2022, my Department was notified that two serious patient safety incidents had occurred in Temple Street hospital. As per existing protocols, these incidents are notified to my Department, which, in turn, alerts me and provides assurances that reviews and open disclosure are under way. We receive 20 to 30 of these alerts in any given year. These reviews of serious incidents give important answers and clarity for patients and families about what has happened. They often identify ways in which the health service can learn and thereby continue to improve patient safety right across the board.

At the same time last November, my Department was advised that an internal clinical review of outcomes of complex spinal surgery for spina bifida patients at Temple Street was initiated. This happened after concerns were raised by the spina bifida multidisciplinary team. This is the team jointly looking after these children which comprises paediatricians, nurses, physiotherapists and an occupational therapist. This team raised concerns about surgical outcomes. Furthermore, we were also advised that an external review was also being commissioned by Children’s Health Ireland, CHI, the voluntary group that governs Temple Street hospital. This was done given the technical and highly complex and specialist nature of this service.

The external or Boston review was completed in July of this year. After considering the findings, the HSE’s chief clinical officer made an assessment that an additional, wider and externally led review was needed. I fully supported that view and will shortly speak more with colleagues about the review, which is being led by an international clinical expert.

By late July 2023, CHI was advancing plans for further communication and open disclosure meetings with the families involved in the Boston review to discuss the findings with them. These open disclosure meetings and clinical discussions about the ongoing care of these patients were conducted through August and September.

As colleagues are aware, an additional patient safety concern was reported by CHI in early August, concerning the use of non-CE spring implants in three surgeries. A specific complex procedure, known as kyphectomy, was paused by the surgeon in November 2022 and patient safety protective measures were put in place by CHI in line with the consultant contract. This includes measures such as working under additional supervisions and restricting certain clinical duties. The surgeon involved in all the incidents, following concerns raised to date, has now stopped all clinical practice and has been referred to the Medical Council.

I will now talk about engagement with families involved in the incidents and reviews. When things go wrong in healthcare, patients have a right to be told what happened. It is absolutely crucial that there is openness, truth and honesty in communication between healthcare professionals and patients and families. Children’s Health Ireland has advised that there has been ongoing communication, and open disclosure to all of the 19 impacted patients and families involved in the serious incidents and the reviews to date. This includes those affected by the use of non-CE implants - the springs.

Children’s Health Ireland has advised that the patients and families involved in the external, Boston, review were informed of their inclusion in the external review last November. In addition, advocacy groups were updated about the external, Boston, review at the time and a statement published on CHI’s website on 1 December 2022.

Communication and open disclosure on the Boston review findings began on 10 August 2023, with initial calls to patients and families, and meetings were held from late August to mid-September. Further clinical meetings were held last Saturday, 23 September, and discussions are ongoing about the future care needs of these patients. CHI has advised that all of these patients, as well as other patients who were waiting for surgery with this surgeon, have had their care transferred to other clinicians.

I have offered to meet patients and families directly impacted and look forward to meeting advocacy groups this week. The patients and families involved in the Boston review were recently provided with the draft terms of reference for the new process led by Mr. Nayagam and will be offered the opportunity to meet with him and to provide their views and feedback to him in terms of what they want to see covered in this review.

Regarding the new review, as I said earlier, I supported the view of the HSE’s chief clinical officer to commission a new review to be led by an international expert. I am grateful to Mr. Nayagam, whom I will meet next Monday, for agreeing to lead this review. The need for this further review, which is intended to go as deep and as wide as is necessary, is threefold. First, the internal CHI clinical review and the Boston review looked at the clinical outcomes of a specific group of patients with spina bifida. This was because concerns about their outcomes were raised by the spina bifida multidisciplinary team in Temple Street, and there was particular concern around a specific surgical procedure, kyphectomy. Both the internal and the external reviews found that the rates of complications were higher than internationally expected. Therefore, there is more to learn about why that was the case and whether a wider group of patients may have been impacted by the factors affecting these outcomes.

Second, while these reviews have useful findings and recommendations, they did not examine some of the wider aspects relevant to surgical practice at Temple Street which the chief clinical officer and I want to see examined. The reviews also raised further questions about aspects of culture and governance which require a deeper examination. Third, the issue of the non-CE springs was not part of the internal or external, Boston, reviews.

The terms of reference for Mr. Nayagam’s review as drafted are intended to be further defined by him as he engages fully in the work. This includes via his interactions with patients and families affected. The review was scoped with four broad objectives. The first and most urgent objective is to look at the practice of the surgeon concerned and determine if any wider review is required in order to provide a risk assessment and assurance on core patient safety issues.

The other objectives of Mr. Nayagam’s review relate to wider issues including culture and governance within the paediatric orthopaedic service, and to review the current and future delivery of this service and make any recommendations he sees fit. I have specifically directed that the review incorporates a service-level examination of paediatric spinal services across the Children’s Health Ireland hospitals. Last year, €19 million was allocated specifically for paediatric spinal services and paediatric orthopaedic services, as colleagues will be aware. Important things are happening as a result of that money, including a fifth theatre opening this week in Temple Street. Shortly a new MRI machine will become operational in Crumlin hospital. There have been significant additional beds and significant additional workforce.

Because of that investment, the level of activity - the number of spinal surgeries - has gone way up, which is very important. However, in spite of the amount of activity significantly increasing - compared not just with the years of the Covid pandemic, but with prior years - the waiting list has not reduced. I have not yet had an answer from CHI that I am satisfied with as to why if the number of spinal surgeries has significantly increased, as it has, the other part of this has not happened, which was a reduction in waiting lists as signed up to by CHI. I want an external independent view as to why that has not happened. I believe we are all absolutely at one in this House in agreeing that that four-month list, unless clinically indicated, must be met for every boy, girl, young man and young woman.

Regarding the review, patients, families, advocates and staff will be consulted and offered opportunities to engage with Mr. Nayagam as he undertakes this work. There is full scope for him to extend the terms of reference for his review as it progresses.

I will now address the issue of the non-CE springs. One of the most concerning aspects of this has been the information that has emerged more recently about the use of non-CE spring implants in three patients. This issue was reported by CHI in early August, while the surgeries where these springs were used, according to the information currently available, happened in 2020 and 2022. An external investigation is under way into the use of these springs, as well as a clinical review of the three patients, two of whom have since had the springs removed. This investigation needs to establish all the facts, in the end-to-end process, about how these springs came to be procured and ultimately used in surgeries.

The HPRA issued clear statements last week about the regulatory processes for medical devices that are in place to protect patients and about the processes available for the exceptional circumstances where a non-CE device is being considered. The HPRA has confirmed that it has not had any applications to that exceptional process for approval for the use of non-medical-grade products, which are sold or supplied not intended for medical use, for clinical use in surgery. This is a very serious matter and while there is some information circulating, we must await the outcome of the investigation before we can draw conclusions. We need the full facts established. I have asked for this investigation to be completed as quickly as possible.

I look forward to meeting with patients' families and advocates in the coming days. The first of the meetings I have scheduled will take place tomorrow morning. I was keen to hold this meeting before meeting with Mr. Nayagam, whom I will meet along with the chief clinical officer on Monday.

We are putting significant investment into the children’s paediatric orthopaedic service, including in spinal services. However, while the number of procedures being carried out has increased significantly, we have not seen that turn into what we must see it turn into, which is a reduction in waiting times to meet that four-month target.

When things go wrong, patients must have a number of things. They need what has gone wrong to be acknowledged. They need to know the truth and they need assurances that any mistakes that were made will not be repeated. I am determined that we will get to the full truth and details of what happened here. That is why Mr. Nayagam has been asked to carry out this comprehensive additional review.

This is an extremely difficult scandal to come to terms with. My thoughts are with the children affected by this tragedy and their families. I hope the Minister will ensure those children and their families will get every support they need, including health supports, emotional supports and other supports as well. This is one of the most tragic scandals I have come across in my time as spokesperson on health. At the heart of this scandal are 19 children and their families who have been traumatised, harmed and wronged. Sadly, in one case, a child has passed away. That family will not be whole again and many other families will carry with them for many years to come the harm and trauma of what happened to their kids.

I have two young boys and we all worry about the health of our children. Any harmful impact to any of our children is obviously really traumatic. I hope every person in this House empathises and fully understands the scale of the trauma and hurt those families will be feeling. I can only imagine what that pain is and their experience in recent times.

These families are at the centre of this scandal but they must also be placed at the centre of the State's response. The children and their families must be put first. That has to be the Minister's main priority as Minister for Health. That may not be easy for them but it is only right we give them their place and it would be wrong to exclude them. As families have told me, however difficult this might be, it would be worse for them to be excluded, yet that is what many of them feel. They feel the Minister has excluded them. He certainly excluded patient advocates and the parents of children who are languishing on waiting lists from the drafting of the terms of reference of the independent review he talked about. That was a fundamental mistake on his part and I believe he should apologise for it.

The families and their advocates do not have confidence in the HSE's external review. The HSE and Children's Health Ireland need to be many steps removed from this review process, yet families were excluded from devising the terms of reference. It is essential, first of all, that the Minister accepts that fact. I welcome some of those families and representatives of advocate groups to the Public Gallery today. They have been campaigning for years about the growing crisis in paediatric orthopaedic services. As we know, this has come to a head in recent weeks with the suspension of surgical procedures in Temple Street and Cappagh.

This crisis goes far beyond just the surgical procedures in question. The failure of the State to properly care for and meet the needs of these children includes pre-care and aftercare, follow-up care, and extremely long waiting lists which allow conditions to get worse and further complications to arise. I do not use the word "failure" lightly but the Minister has to accept the State has failed those children and their families. The acceptance of failure of an unfit system should be the Minister's and our starting point. The exclusion of patient advocates from the drafting of the terms of reference of the independent review is a sad indication that this fundamental failure has not been accepted.

I am deeply disappointed by the Minister's response and the response of the Taoiseach. I welcome that he now says he will meet advocate groups and parents. I acknowledge that the Taoiseach confirmed in the Chamber earlier today he will meet families and advocate groups as well. That should have happened much earlier. I think, in the Minister's heart, he knows that.

The Minister said in his opening statement today that the first he and his Department became aware of this was in November 2022, if I am reading the statement right. He travelled to the US. Did he know this scandal was going to break before he travelled? Did he make any effort to ensure the wider group of families and patient advocacy organisations were kept in the loop and informed as the situation developed? Did he meet any of the families who were directly affected? Has he heard their experience and listened to them? It would seem the answer to that question is "No" when it is considered that the Minister has certainly not met the advocate groups. As I said, he did not ensure they were involved in the drafting of the terms of reference.

There is a way forward, which is for the Minister to sit down with the families and their advocates, and work out terms of reference which would be acceptable to them. There is no other way. There is no shortcut. The Minister has to meet them and they have to be assured so they can have the comfort and knowledge that this review is truly independent. That is the only way, in my view, we can restore confidence in Children's Health Ireland and the services it offers. That cannot be done without a serious review of the totality of failings, from pre-care to aftercare and everything in between.

The Minister said earlier that while he accepts additional capacity has been put in the system, the waiting lists have not decreased. Is that not what the Minister said? Yet in August this year, a few short weeks ago, he tweeted about a reduction in wait times in Temple Street. He boasted about it and said that wait times have reduced by 51%. Which is it? Was the Minister wrong in August when he tweeted or is he wrong today? I think he needs to be clear with people about where we are in all these situations.

A number of reports have still not been published in full. What we have is a summary of the internal and external reviews which were carried out. I know the advocate groups I met over recent days and again today were part of the Boston review. The summary does not contain any of the issues they raised. The Minister needs to publish the Boston review in full. We are sitting here today having statements with the Minister. We still do not have those full reports.

We do. They are published.

The Boston review as well?

Yes. They were published last week.

The report into Crumlin, in my view, has still not been published. There are other reports which have not been published which need to be published. For us to have confidence in understanding all of the problems, we need to see all the reports and the information behind it, as do the advocate groups. We cannot have anything other than full transparency. We cannot have anything other than full support for the families.

On the use of the implants and the springs that were unauthorised, it is for a small number of children but it is a very serious issue. There are processes in place in hospitals to ensure these things do not happen. The Minister outlined some of those processes, including the regulations. Fundamental questions need to be answered by Children's Health Ireland. I really do not believe this is about one individual. There may be culpability regarding a single individual, but I believe there are wider issues regarding clinical governance. In fact, looking at the reviews which have been published and the recommendations they made, it will be seen that all the issues they raise have been raised by advocate groups and parents of children for years.

How many times in this Chamber have we had debates on paediatric orthopaedic services? When the Minister, Deputy Harris, made the commitment in 2017 that no child would have to wait longer than four months, that rings hollow to those families today who are traumatised by what they are hearing. Many other families are wondering about their children as well. We have a duty of care to ensure we provide the very best services to them. While we have to get to the bottom of what happened at Temple Street and look at issues that may pertain to Crumlin, for which we are waiting until the report is published, with a review that has to be as wide-ranging as possible, we also have to have an eye to those children who are on waiting lists. There are more than 260 of them. There is a fear, because of suspension of services, that children will have to wait longer.

I will finish with this, because I think it is important. We have had a number of reports from the Office of the Ombudsman for Children regarding a number of children who have received treatment or delayed access to treatment. The most recent one was a child called Ivy. I met her dad over the weekend. He talked about the child waiting for five years and having to deal with that every single day, going on that journey with that child. He knew there would be real difficulties because of the length of time the child was waiting.

I put it to the Minister that it is not just about the surgeries but the aftercare. That child has received no physiotherapy since that procedure. She has been waiting for two years for hip surgery.

She has no idea when she will receive the hip surgery and the family are asking me to find out. There is no joined-up plan for continuity of care. In my view, these children have been abandoned, badly let down and badly failed. What the ombudsman said in his most recent report is that there was a litany of failures. The Government has to take responsibility for that. Once and for all, we have to stop the talking on this issue and put in place a plan to ensure each and every child with spina bifida and scoliosis gets the treatment he or she needs.

There is a long history of abysmal waiting lists and agonising waiting times for children with spina bifida and scoliosis. For years, this has been a recurring issue that government after government has failed to address, time after time. In 2017, the then Minister for Health, Deputy Simon Harris, set a target for a maximum wait time of four months for surgery but this has never been met. As of June this year, 287 children are on a waiting list for spinal surgery, 120 of whom have been waiting more than a year. During this time, the Government ceased a treatment abroad option which helped more than 30 children get access to care.

This information alone is, in itself, shocking. However, we recently found out, primarily through the reporting of The Ditch, that allegations have arisen that in a number of spina bifida-related surgeries carried out at Temple Street Children’s Hospital, unlicensed implants made with non-medical parts were implanted in children. It is alleged that springs which were not meant for surgical use were purchased and subsequently used on at least three young patients. In two cases, these springs had to be removed after causing significant harm to the patients.

Patient safety concerns about the number of repeat operations required on young spina bifida patients and associated rates of reinfection were raised from July 2022 onwards. This eventually resulted in certain surgeries being suspended at Temple Street in November 2022 and in Children’s Health Ireland, CHI, commissioning an internal and an external review. The HSE was advised by CHI that a number of reviews relating to patient safety concerns within the CHI paediatric orthopaedic surgery service were being undertaken and, in August this year, the report was provided to the HSE. Advocates and families report that they have, however, still not seen the full external report, which has been published only in abbreviated form.

In July this year, the HSE took the decision to commission an independent, overarching external review by an international clinical expert. However, advocates and families have reported that they are excluded from devising the terms of reference of this review. They use the analogy of the review being like a bus journey where the HSE is in the driving seat, dictating the destination, while they are told to sit at the back and stay silent. The hands-off approach taken by the Minister has made the situation for these families worse by failing to include them. This has led to the families and their advocates stating that they do not have confidence in the HSE’s review. It is simply a disgrace that children and their families have not been put first throughout this scandal. They are at the centre of this and they should be central to the Government and the HSE’s response. Their voices must be heard and their input must be taken on board. I am glad the Minister and the head of the review are meeting with the families. As I said, their input has to be taken on board and it cannot be just a box-ticking exercise.

All of the reviews must be published in full to provide full clarity and transparency for families. The terms of reference for the independent review must address all of the concerns of the families and advocacy groups, including the years-long failure to address agonising waiting lists. The current review cannot simply focus on the actions of one doctor. There needs to be an investigation regarding clinical governance, not only at Temple Street but across all hospitals under CHI that have been carrying out these procedures.

It is highly concerning that a consultant managed to purchase and use these devices in the first place. It is equally concerning that CHI and the HSE kept this under wraps. The length of time it took to disclose these events to families and children under the care of this consultant is completely unacceptable. The review must be widened so we can get to the bottom of what happened, how it was allowed to happen and what must be done to ensure it does not happen again. There are still many outstanding issues and questions that must be addressed. Why were families not immediately involved as soon as the Minister became aware of the allegations in order to ensure engagement and transparency? Why were they not made aware of exactly what was happening? Why were they not included in drafting the terms of reference of the current review? If they are to be included now, it has to mean they are fully included. The first external review has not been shared or published and this should be done immediately, although the Minister may have clarified that it has been. All reviews need to be published. When did CHI learn of these experimental surgeries? When did staff first raise concerns? Processes need to be put in place around the procurement of devices. We need to ensure arrangements are in place to ensure proper clinical governance. I do not know how this fell through the gaps for so long and how unauthorised devices were used in operations. When the first adverse incident occurred in July 2022, why did it take until November 2022 to commission an investigation? While this review is proceeding, it is imperative that the Government acts to ensure the children waiting for surgery are not forced to wait even longer.

In a sector that is beset by perpetual crisis and all-too-regular scandal, this particular scandal stands somewhat apart, or, if it does not stand apart, it stands with a select few scandals as one of the worst in the history of the State. One of the perpetual crises that we have throughout our health service is waiting lists across every aspect of the service, be it emergency medicine, mental health services, social care in the community or surgery. It is here we have focused so much of our political energies in the past couple of years in terms of scoliosis, spina bifida and spinal surgeries in order to get this waiting list down, to get these children through those theatre doors, where we hoped and expected they would get the excellence in clinical delivery they deserved. Why this scandal hits so hard and so deep is because it was not about the waiting lists or about the crisis that we understand and see across our entire health service. It is because it happened in the theatre, where we all expect and put our trust that the delivery of clinical excellence is going to happen.

All of our thoughts have been with these patients - these children - and their families and advocacy groups in the past eight days in particular, as this has burst onto the national political airwaves. I know the Minister was away last week but it is very disappointing that it is eight days after this news broke that we are now having this discussion. There is nothing in the Minister's statement that could not have been delivered to us and to families at some point last week, on Wednesday or Thursday, and we could have had the departure point from then rather than from now. However, we are where we are. The families and the advocacy groups feel they are being ignored, not being listened to and not being contacted, and if they make contact with the hotline, they are not getting a return call. This is unacceptable.

When it comes to the further external review and the terms of reference, the Minister mentioned in his statement that the further review is intended to go “as deep and as wide as is necessary”. He said, “The terms of reference for Mr. Nayagam’s review as drafted are intended to be further defined by him as he properly gets into his work”. To what extent could these terms of reference be further defined and expanded upon following the Minister and the Taoiseach’s meetings with the families’ representative bodies later this week? It would be good to know, when the groups meet the Taoiseach and the Minister, that their hopes of being able to inform these terms of reference will be listened to and that there will be actually a chance that this could happen.

I will have seven and a half minutes for questions later, which I welcome, but I want to put some questions to the Minister now. With regard to the fact that spinal surgeries are continuing, what is the status of kyphectomy in terms of those surgeries happening at the moment?

Mr. Nayagam's review is on the wider issues of culture and governance. That is like asking how long is a piece of a string. How will that be defined? When we think of the use of non-CE-related devices, we are going back to 2020. Regarding the sourcing of these devices, how many people in CHI at Temple Street signed off on that? How many departments and how many sections? Is there anything that the Minister has found out in the last eight days on which he and his Department have been able to action in advance, without needing recourse to the further review? They seem to be quite procedural and administrative areas but they are no less concerning, given the number of people who would have had some kind of sight of what was happening. These are the kinds of questions to which we need answers from the Minister this evening as we go through this debate.

I cannot over-emphasise enough just how forgotten, left behind, let down and angry these families feel. It is almost, if not without peer, one of the worst scandals that has ever hit our health service. We all need to be more conscious that waiting lists are one thing, but if you get to the end of that list and if you get through that door, if you are not getting the excellence and competency of care that is required, then our health service is unfortunately in a much greater crisis than we believed it to be. I look forward to questions and answers later.

I am sharing time with Deputy Durkan. I want to begin by acknowledging the anxiety that many young patients and their families will be feeling this week, particularly the young patients who are directly involved in these reviews and incidents, as well as their parents and their families.

Openness, transparency and learning for patients and families must be at the heart of our health service. These families must continue to be our priority as we move forward with a response to what has happened. I also want to take this opportunity to offer my deepest condolences to the parents and family of Dollceanna Carter on the loss of their beautiful daughter and sister. There are many other families, parents and children attending CHI at Temple Street for appointments and procedures this week, or who are waiting to hear about an appointment. It is vitally important that their concerns and questions are addressed in a comprehensive response that is now under way.

I also recognise the frustration of families of patients who are waiting for surgery for spina bifida and scoliosis in particular, and the impact this wait continues to have on their daily lives. This Government has invested and will continue to invest significant funding to help clinicians reduce the amount of time children are waiting for important hospital appointments and procedures. Scoliosis and spina bifida have been identified as a priority in both the 2022 and 2023 waiting list action plans, with significant investment provided to increase capacity and staffing. Last year, there was a commitment of some €19 million of current and capital funding to tackle these waiting lists by improving the patient’s journey and creating additional capacity.

I welcome the request by the Minister, Deputy Stephen Donnelly, that the HSE explores all options to increase capacity for this vital service, including outsourcing care both at home and abroad. The Department of Health continues to work with the HSE and CHI to drive progress on the waiting list action plan. I would like to assure children and their families that the Department of Health and the HSE remain committed to reducing the amount of time children are waiting for hospital appointments and procedures. I welcome the offer by the Minister, Deputy Stephen Donnelly, to meet with families who are directly impacted, as well as with the advocacy groups who work so hard on behalf of children with spina bifida and scoliosis and their families. I welcome that meetings will be happening this week.

Listening to the voices and experiences of families and patients, as well as to those who advocate and care for them, is a vital part of how we learn and improve the quality of safety of our health services. I welcome the fact that the voices and views of these families and advocacy groups will be heard by Mr. Nayagam, the international expert who will be carrying out this important review. It is important that these young patients and their families continue to be the priority and be at the heart of this process. As the Minister has outlined, there are a number of investigations and processes under way to establish facts and find answers to the many questions we all have. I concur that it is important that the findings from these various processes are not prejudged and that they are allowed to be conducted and completed in a fair and objective manner. These reports and their findings will be important to enable Mr. Nayagam to progress with his review. They will assist him in identifying the necessary learnings and improvements to be made in the service for the future and to ensure that the experiences of patients and their families can be continuously improved.

These events have highlighted even further the need for openness and transparency and the need to ensure that the patient's voice is at the heart of everything we do in the health sector in Ireland. Our priority now is to ensure that the patient safety concerns that have come to light are comprehensively addressed, that patients and families receive the assurances they deserve and that they are receiving high-quality, patient-centred care.

When things go wrong in our health services, it is vital that we have the systems in place to respond to them, to find answers for patients, their families and staff about what happened and why and, most importantly, to identify the ways we can learn for the wider health services. This is essential for us to continue to improve the safety and quality of all our services.

It is sad that we find ourselves at this juncture again, particularly because there have been a number of tragedies in the health service over recent years. There was the cervical screening campaign. There were issues where results were misread or improperly read. There were a number of other peculiar procedures that took place in this country, where women were subjected to some very crude procedures. Thankfully, they no longer happen, but they did happen at that time.

This situation is particularly tragic because it affects children. It affects children who, in the first instance, knew they were different. They were suffering in silence. They knew they were different from their colleagues, who were able-bodied. They presumed and were led to believe that help was at hand and that it would soon come. This issue was raised at the Oireachtas Joint Committee on Health by virtually every member, where we had a number of discussions and briefings on it. Strangely, however, in the last 12 months, very little information came our way. No information came our way at all, despite the fact that the issue was raised on numerous occasions by different Members of the House, including the Cathaoirleach of the committee and others. I myself raised it on numerous occasions because no information was coming our way. I have sympathy for the Minister and the Ministers of State for the situation in which they find themselves. We could not get information that should have been readily available. It appears that the Minister did not get the information that should have been readily available at a much earlier stage.

There is also the issue of the procedures that took place, how they were approved, why they were approved and who approved them. For instance, how did non-EU-approved instruments come to be used in the course of the surgery? I cannot understand how that could happen, because there have been situations in the past where not only were the EU criteria observed in full, but in the degree to which the Irish authorities scrutinised them they had been exceeded. I do not think that was a bad thing. It did not help in many of the cases where patients were concerned, and it involved costs.

In this situation, the first thing one must remember is the tragic consequences for the parents who were bereaved. After all, they hoped, too, to see an end to their suffering and to their children’s suffering. It is a natural consequence after such a long time, and after being on such a long waiting list, with so little information in the public arena, that their bereavement has been accentuated by the lack of any kind of consultation, explanation or dialogue with the parents, families and advocate groups.

In this situation, everybody knows they know best themselves, but they did not know best.

There should have been ongoing consultation with the advocacy groups. It still needs to be ongoing, not only in respect of this situation, but in respect of many other situations that might come to light.

This is a sorry time. We are visiting again an area that involves everyone in the country, as public health is a vital issue. The system failed the patients, their families and the professions. The system did not work, but it needs to, particularly where there are vulnerable people like children. These children know that there is something different about the way in which they go about their lives. They are not too sure about the cause of that, and they are certainly not too sure about why resolving it takes so long. How is this area handled in other jurisdictions? To what extent have we or the authorities checked other jurisdictions, to what extent are the outcomes there monitored and to what extent have they been put into operation in Ireland where they should be?

There are many children still awaiting procedures for spina bifida and scoliosis. That is particularly sad for people and their families who have been affected by these afflictions for so long. At a time when progress was in sight, we suddenly suffered a downer once again and the whole thing fell into disrepute.

I understand the frustration of the Minister and Minister of State. The lack of information was such that not only did they not get information, but neither did the health committee, which is supposed to be responsible to the House for issues of that nature and to be able to influence in a meaningful and positive way what should take place and when. I pay tribute to my colleagues on the committee, of whom there are four in the Chamber at the moment. It was not for want of their asking. The request was made several times, and the issues were pointed out several times. There is not much sense in having an Oireachtas committee, whose members are allegedly elected to do a job, unless there is a recognition by those involved in a situation that they must deliver and respond. Otherwise, we are at nothing.

We should not have to have this debate. It should not need to happen again, and I hope it does not. In deference to the parents and children who have been affected, I hope that we can point to what comes from this debate and the ongoing review and say that we have put an end to indecision and to the use of devices that are not allowed in the EU. I cannot understand how that last happened in the first place. I hope that this debate sets the precedent for the end of such situations.

Next is Deputy Patricia Ryan, who is sharing time with Deputy Martin Kenny.

The report on failures to ensure the safety of already-vulnerable children at Temple Street hospital makes for shocking reading. It is no surprise that the HSE commissioned an independent external review. What is even more shocking is that the families and advocates of children affected by these failures were excluded from having any input into the review's terms of reference and have not even seen them. How are the parents of such vulnerable children going to have any trust or confidence in a review conducted by the very people who allowed the issuing of unauthorised devices to take place? How can any family have faith in a process into which they and their children’s advocates were not allowed any input?

How was this allowed to happen? When did the Minister know? More seriously, how did the HSE and CHI keep it quiet for so long? My heart breaks for the children affected and their families, whose trust has been broken and who have been failed yet again by their exclusion from the review process, adding to the suffering of these children and of those languishing on long waiting lists for spinal surgery, including for scoliosis. The four-month target set by the previous Fine Gael Minister for Health, Deputy Harris, is a dim and distant memory now. There cannot be a hands-off approach. The Minister has to act now and ensure that children waiting on urgent spinal surgeries are not forgotten because of this scandal. I call on the Government to recommence the treatment abroad scheme urgently for those children who are able to travel in order to help address the large backlog in surgeries owing to this scandal. The Minister stated that he did not know why there was such a large backlog. He was surprised.

I call on the Government to publish this report and the review of spinal surgeries at Crumlin hospital so as to give families the clarity they and their children deserve. I call on the Minister to ensure that no stone is left unturned in the interests of full transparency and accountability and to ensure that this scandal is never repeated.

In what world is it okay that this situation could come to light in July 2022 only for the report to be commissioned four months later in November? Families all over the country are in a dismal situation now, having waited and waited to get appointments, to be seen and to have operations. For a very long time, people have been approaching every Deputy and Senator about significant problems with access. Dealing with conditions like spina bifida and scoliosis is terrifying for any family because they know what they will be facing, given that many others have already had such negative experiences for so long.

Deputy Durkan stated that he hoped this situation would be resolved, but we need more than hope. We need action. That is the problem now. Good work is done in every part of the public sector, and no one denies that that includes the HSE, but when there is a difficulty, it seems that there is a rush to cover it up, not to resolve it and ensure it does not happen again. That is the case in many areas of the public sector, and seems to be the case in the HSE. We need to be able to find a way of ensuring that does not happen any more so that people can have confidence in what the future holds for them.

Too many people have been in this situation for too long. It is not just about today’s families who are burdened with this situation and have had to wait for years to have their loved ones looked after. Every week, there are new families looking for a resolution to this situation. They see the suffering and terrible predicament of so many others. They need to be able to see that the future will be better than the present.

While I appreciate Deputy Durkan’s remark that he hopes this situation changes, we need action to do that. Such action can only come from the Minister. He is responsible. He needs to ensure that no other family is put in a position where they cannot trust that their child will be looked after properly. That has already happened to too many.

At the outset, I extend my condolences to the family of Dollceanna Carter. I offer my sympathies to all of the families impacted by this saga. It is a national scandal and a major issue that needs to be addressed. We need a timely response to it. It cannot just be another example of setting up a review and kicking it down the road, but my fear is that that is what will happen.

The Minister and the Minister of State spoke about the importance of having an appropriate response when things go wrong and of ensuring that that response is honest, open and transparent. There should be full disclosure and a candid response, but I am concerned that we have not got that. The first I heard of this situation was Monday morning last week when the article in The Ditch was brought to my attention. At around lunchtime, we got further information from the HSE. If it had not been for the article in The Ditch, when would we have heard about all of this?

I also have a concern about the response to that and how this was announced publicly last Monday. It was very much announced on the basis that there was a single issue and it was all about an individual consultant. That is how the HSE press statement was framed and how a spokesperson for the HSE framed it - that this whole thing was about an individual consultant.

We were also told that the two reviews that had been completed - internal and external - would be published that day. It turned out that they were not published that day. In fact, a HSE report on the two reviews was published that day. Essentially, that filtered the reviews. When I and others called for those reviews to be published, we were told they could not be published because of confidentiality and due to the fact that people who participated in them had been assured of confidentiality. Of course, that was not the case. Further to political pressure being applied throughout Monday and Tuesday, finally, on Wednesday, the two reviews were published. I have big concerns about the handling of this issue at official level, how it came to be announced and the framing of it.

When we did eventually get to see the two reviews - I do not know who carried out the internal review but it was basically a statistical review. The external review did not refer to any individual consultant, which is notable. It made 50 recommendations. It did not outline problems that were identified but one could read between the lines from the 50 recommendations about where the problems were within Temple Street. Pretty basic things were identified that needed to be addressed, such as the need for a clinical specialty lead for orthopaedics and that the operating theatre governance committee needed to be put in place. Why was that not there already? Another was the need to develop a quality improvement team to strengthen a quality improvement programme and to establish a culture of high reliability that demonstrates consistent excellence. One would have expected these things to exist already. Another was the need for evidence-based clinical guidelines and checklists. All of these things relate to the operation and management of Temple Street but there is no talk about any of this in the official response to this issue. Clearly, it was a much wider issue than one individual consultant. That is why concerns are being expressed that there is an element of scapegoating going on. When will the Minister tell us what Temple Street is doing in relation to those pretty severe implied criticisms and clear recommendations about the functioning of that hospital? Has Temple Street management taken on those? Will it respond to them?

There have already been three reviews, none of which was published. Now, there are another two, so there are five reviews. This latest fifth review may potentially take up to a year to complete. When will we know the facts of this and when will action be taken? In the meantime, the reaction of parents and advocacy groups is very understandable. They do not know where they stand. They are in a limbo at the moment. They do not know if all of the surgeries have been stopped in Temple Street, if things are safe or not or if CHI has the ICU beds to carry out surgeries elsewhere if they are stopped in Temple Street. There is a need for an interim plan. It is important that we find out what happened in the past and that there is a thorough review but what is going to happen now? Parents were expecting their children to have their surgeries today, next week or next month. What is happening to those? The Minister needs to produce an interim strategy or an interim plan in relation to that. It is not just those children who had spinal surgery. There were other surgeries carried out by the surgeon in question. What about the concerns of those families? When will they be addressed? There are adult patients of that surgeon as well who do not know where they stand. I welcome that the Taoiseach has now agreed to meet the advocacy groups but it is absolutely critical that they have a clear input into the terms of reference now. They know what happened in the past. They are now in a situation in which trust has broken down. The most important thing the Minister has to do is to restore that trust.

Last week's revelation detailing the severe complications faced by 19 children at Temple Street Hospital is nothing short of a nightmare for families. Revelations like this challenge the very fabric of trust on which our healthcare system is built. I was reassured to hear Bernard Gloster, the CEO of the HSE, confirm that planned spinal surgeries are not being postponed, but we must acknowledge the grim reality. Families continue to endure unacceptably long waits for critical surgeries and the trust these families have in the medical system has been shaken. Every aspect of the situation needs to be examined, from the unauthorised use of springs in spinal surgeries to the broader governance and operational matters across the health service. It is important that we acknowledge the recent strides that have been made. There has been a 47% increase in scoliosis procedures and 509 spinal surgeries were conducted last year and this year's count is already at 290. There was also the inauguration of the fifth theatre at Temple Street. The reality is that trust in the system has now been shaken and we need to rebuild it. Having information and facts is how we do that. The unwavering efforts of the whistleblower and advocacy groups like Scoliosis Advocacy Network and the Spina Bifida and Hydrocephalus Paediatric Advocacy group show why it is important for everyone to pay attention and speak up in the pursuit of information and facts. I am pleased the Taoiseach is meeting them because their persistent calls for transparency highlight the importance of outside voices in maintaining accountability within our institutions.

To Mr. Nayagam, who is leading the review, it is vital to widen the investigation and directly involve affected families and advocacy groups. I was pleased to hear this morning that is his intention. We must hear from the families at the heart of this. We must listen to their concerns and once we have the facts, the Government must respond. I urge the Minister to push for the broadening of the scope of the investigation. Let us ensure that every aspect, decision point and flaw that led to this failure is laid bare. Only then can we rebuild trust with these families and parents and children who are still waiting on surgeries.

I appreciate being given time to contribute on this very important yet disturbing situation at Temple Street. At the outset, I offer my condolences to the family and parents of Dollceanna Carter and all those affected. This issue is causing great anxiety for many patients and families who have used the services of Temple Street. It has caused significant public disquiet and has the potential to undermine the great work done by the entire community at Children's Health Ireland. I welcome the comprehensive patient safety review overseen by Dr. Colm Henry, the chief clinical officer, into elements of the paediatric orthopaedics surgery service. I also welcome the independent external review being carried out by Mr. Nayagam from the Royal Liverpool Children's Hospital. The allegations emerging from Temple Street are extremely serious and very distressing for families and the wider public. The initial handling of the situation was poor, with only the partial reports being published. Given the gravity of the situation, the full facts must be established, which is what the external review will do.

It is critical that the views of parents and families are taken into account in the terms of reference during these reviews. The reports must be published as quickly as possible. It is also important that families are supported. I welcome the open disclosure process for the 19 families affected. This also needs to be progressed as quickly as possible. The matter is also subject to a referral to the Medical Council, which should allow the process to take its course. I understand that 509 scoliosis procedures were carried out at CHI Temple Street in 2022, up from 380 in 2019, before Covid. This is welcome but more needs to be done to improve services for children living with scoliosis and spina bifida and waiting lists, while also ensuring that treatment is in line with international best practice.

It is not acceptable for these children and their families to have to wait for treatment or to be further delayed by the situation. I request that the Minister ask his officials to review the services to see how improvements could be made in the short term.

I pay tribute to the advocacy groups for their work highlighting awareness. There needs to be greater communication between CHI, the HSE and these groups. Finally, I acknowledge the work of the medical community at CHI Temple Street. I know many of them and the great work they do for children. They will be just as disturbed as the rest of us by the allegations that are emerging and I am sure that, like us, they want to see the full facts established and services overhauled.

I thank my colleagues for sharing time with me. It is important I speak on this issue. Many Deputies have rightly spoken about the challenges faced by children in Temple Street hospital and those who are under the care of CHI and the certainty they need in terms of future procedures and operations. Those who were under private care of the consultant at the centre of this controversy and those who were being treated under that clinic are in just as uncertain a position. Many of them are completely unsure what the next steps are. I am seeking as much clarity as possible and for those parents to be contacted, where applicable, to ensure they receive clarity.

Fachtna is 16 years old and from west Cork. I have full permission from his parents to speak about him. He has a rare condition called Perthes disease, which impacts his hips. In essence, he is unable to walk, sleep or sit without severe pain in his hips. After many years of excruciating pain and after monumental efforts by his parents and family to get him treatment, Fachtna had a procedure on his right hip, which meant he was completely pain-free. It worked. Now, only six months away from a second operation, to treat his left hip, everything is up in the air. There is so much uncertainty. The controversy in respect of CHI and Temple Street has hit and Fachtna and his parents have no idea where to go. I acknowledge that I am bringing this case to the Minister on the floor of the Dáil and I do not expect him to have an answer on this individual case, but I ask that somebody reach out to Fachtna and his mother to offer clarity in respect of where they go from here. He was six months out from a life-changing operation, having had one hip done, and was getting ready to do the other hip. You can imagine the heartbreak and anxiety that family is experiencing. I ask that somebody from the Minister's office take the details of this family from me and reach out to them. Is there someone in Ireland with the skill set to carry out this procedure? Question marks have been raised in that regard. A second possibility that could be considered is for Fachtna to be looked after under the treatment abroad scheme. I understand there is a surgeon in Texas who is qualified to carry out this procedure. There is a significant amount of uncertainty and many unknowns here but I ask that someone reach out to Fachtna's family. The fact they have the support of Deputies and the Minister could go a long way towards providing a degree of certainty or support which they do not have at the moment. If that could be arranged, I would appreciate it.

Here we go again - another term and another scandal. When it comes to Ireland and systems, power and secrecy, it never really stops. It is long after the promise from the previous Minister that children with scoliosis would be treated within four months. We know how that went. I have spoken to some of the parents involved. I welcome them and their advocates to the Dáil. They are extremely concerned about how the current situation has been handled. They are worried about institutional secrecy, bargepoles and cover-ups. They are worried about the way they have been overlooked and excluded while investigations in respect of their children were conducted without their knowledge and over their heads. They have been kept in the dark, only too aware the State has endless sums of money to defend the indefensible and does not think twice about doing so. For them, every aspect of any and all investigations and reviews, internal or external, must be published. That is the only way they will have clarity and transparency regarding the treatment of their children, who have been treated disgracefully by the HSE and numerous Ministers for Health. All the while, their children's small organs are being crushed by delays in scheduling surgery.

Some of the children in this cohort are from my constituency of Kildare North. The day they came to my constituency office in Naas to meet with my colleague from Kildare South, Deputy Patricia Ryan, and the Sinn Féin health spokesman, Deputy Cullinane, was by far one of the nicest days we have had there. It was a magic day. They are full of joy, life, hope and expectancy. What fabulous children they are and what fabulous families they come from. I wish to mention those precious young citizens, namely, Seán, Alyssa, Éanna and Eddie. Conor, an older child, could not make it because of how the State had failed him. In any action that is taken now, their families and all the families affected must come first.

Is the Taoiseach to meet with the families? The Minister is confirming that is correct. That is good because there is nothing more important. I have great faith in the Irish people that, notwithstanding any appointments or whatever the Taoiseach had made for this Friday, nobody will stand in the way of his meeting these families. There is nothing more important than them having the Taoiseach's ear.

In 2017, the then Minister for Health, Deputy Harris, declared that no child would wait more than four months for surgery. In August of this year, the Tánaiste said he wanted Ireland to be the best country in Europe in which to be a child. Those comments ring hollow for children with spina bifida and scoliosis. Courtney Manning, a disability advocate, was supposed to be having surgery this week. She now has no consultant, plan or answers. Courtney has only stress and pain. The Government clearly has no urgency and no plan. Sophie Redmond, who is now 14, went through multiple surgeries to address her chronic back pain. It seems that Sophie is not one of the 19 but she and her family and families like them want, deserve and need answers. They must be wondering whether they can trust the system. That is a crucial aspect of all this. Trust has been lost by the Government. That is why the terms of reference need to be expanded beyond the current narrow focus. These parents are worried beyond belief and they cannot be left in limbo. They need answers as soon as possible.

There are 314 children currently waiting on spinal surgery. That is up six on the last report and it is climbing steadily. In the context of meeting with parents, it is not good enough to take an approach of squeezing them in this Friday. Parents must be included in setting the terms of reference for the next review. The families must be at the centre of deciding on the terms of reference. The terms of reference must be widened and parents must have confidence. Parents and families must be at the front of the bus. Deputy Durkan referred to the need to give families hope. We need to give them more than that. We need to give them action and a commitment that they can trust the system, it will get them out of their pain and we will deliver a genuine health service that works for children and young people, rather than leaving them in pain, which is what is happening now.

This has been a very sorry episode, to say the least. We talk about trust and confidence in our health service, and when families have been let down fundamentally, it can leave a terrible taste in people's mouths. Families should never be in this situation. There are families with children in complicated situations who need that intervention as soon as possible, and because of the fallout of this, that wait is going to be longer. That is the hardest thing for those families to accept. They know they have children who need an intervention as soon as possible, and now all surgery seems to be suspended. When you do not have trust, you do not have anything. If the reviews do anything, they have to rectify the mistakes that have been made in recent years and probably beyond that. I am no medical expert, but surely lines were crossed around clinical governance and criteria. There is no doubt about that. I am a member of the Oireachtas Joint Committee on Health and two years ago, a number of surgeons appeared before the committee in relation to this issue. It was one of the best committee meetings I have ever been at. It was extremely positive, and the people who spoke spoke very passionately about the situation they find their patients in. I think families drew confidence from that and from the assurances of previous Ministers that the situation was going to be resolved once and for all. Now, families find themselves going backwards rather than forward. That children are being let down is probably the cruellest thing of all. I will have a question for the Minister later on. If surgery has been suspended, and I know Bernard Gloster has said that is not the case, families will have to wait years upon years for this intervention. Surely, we have to look at different ways of intervening. I know it is quite complicated, but can specialists be brought from different countries to Ireland as a temporary measure? Again, I know it is complicated, but can children get surgery outside the State? I think we might have to look at those options. I know there are complications in relation to children travelling, but we may have to look at that. It is not perfect by any means, but families want the intervention as soon as possible. In relation to the reviews, it is extremely important that the families and advocacy groups have their say on how this has all played out. What has happened, particularly around clinical governance, is completely unsatisfactory. We need to learn the deep lessons from the mistakes of the past, and hopefully not the future.

This is obviously horrendous. It is horrendous for all the families involved and it is a horrendous failure by the State. I am going to ask a series of detailed questions of the Minister later on, but for now I just want to put some things on the record. Various people are asking questions and so on, and I happen to know the answer to some of them. For example, I know that three springs were used. One caused severe damage to a child's pelvis and ribcage, requiring multiple operations; one broke a few ribs; and one is still in a patient, having broken, and may have corroded as a result of not being made of titanium, the appropriate metal. In March, pressure was put on surgeons to restart this surgery by CHI management, despite the fact that they knew about the high level of complications and despite the fact that, tragically, one child had died. That is the case. I have an answer to a parliamentary question from CHI which denies that is the case. It states that CHI is not aware of any internal or external pressures on clinical staff to restart kyphectomy surgeries, but that is not accurate.

I have been pursuing this issue since April with a whole series of parliamentary questions. One of the troubling things, which raises a question about the governance of CHI, is that I repeatedly received inaccurate and wrong answers from CHI. When I first asked about the issue of unlicensed implants being used in surgeries in Temple Street, the answer I received from CHI was that to the best of its knowledge - and it struck me as strange when I got the answer that it contained that kind of qualification - everything was appropriately CE- licensed and so on. I went back to the person who had made the allegation to me, because I did not know whether it was accurate or not, and asked again. That person told me it was definitely the case, so I put a question in again. I got another answer, this time in late June, whereby CHI stated that to the best of its knowledge it was gone, and restated that it was not the case. It clearly was the case, and it is now accepted that it was the case. We have a very significant problem where parliamentary questions are being answered wrongly. Later, I will pursue with the Minister - I presume he is expecting it - the question of when he knew about it. Obviously, the line is that the Minister and the Department knew about it only in August. If it was not clear from the questions in May and June, on 13 July I put in a series of questions which left the Minister in no doubt whatsoever, asking how many spring implants had been used in Temple Street hospital for spinal surgery in patients with spinal muscular atrophy and spina bifida, how many had been removed, how many had failed in situ, and whether they were CE-marked. At the very least, by 13 July the Minister was aware of the issue. The question that will arise for the Minister is what he did about it in the intervening period.

I will finish by saying that throughout all this the impression that has been given is that following on from the last external review, a new external review would be called. That was not going to happen. The only reason we are here now, and the only reason it is not still happening, is a whistleblower and the articles we have seen on The Ditch.

First of all, like my colleagues, my thoughts are with the parents of any child who has to undergo surgery. I know that planning and getting a child ready for surgery is a huge challenge in itself for every parent. It is really difficult for any family when children have to go through a multiplicity of operations and surgery. They all need our full support. The major problem we now have is that even where surgery has been successful, parents now require reassurance. It is difficult to get that message out there. Hugely successful operations have been performed, but there is now a doubt in people's minds, and in parents' minds in particular. It is something about which they will always worry. It becomes frightening when you look at the report that was published. An analysis of 16 case files shows that 13 of the 16 patients, or 81.2%, required further unplanned surgery. The internal analysis shows that the overall infection rate in these 16 cases was 73.4%, based on microbiology and clinical findings. The overall rate of wound complication requiring further surgery was 75%. Overall, nine of the 16 cases had mechanical complications requiring removal of metal work. Those are frightening figures in real terms for the families and for all those involved. It is important we now work in the fastest way possible to reassure parents and make sure we do not have a repetition of what occurred here. We have had two reviews, one internal and one external. I know an external review is going to be started.

It is important that everyone be involved and reassured that every possible angle will be considered and that there be no doubt that the final report, when produced, will be comprehensive and deal with all the issues.

What is challenging in this whole debate is the fact that uncertified devices, springs, were used that had not got clearance and had not been approved. It is really worrying that this has occurred, leading to many of the complications.

It is important, however, to realise that much work has been done by very dedicated and committed staff in all our hospitals, especially Temple Street. The number of operations for scoliosis in 2019 was 380. In 2022, it was 509, which is ten operations per week. It is important to have no more of the delays the parents and children had to experience and that every possible effort be made to find an alternative. It is important to have the expertise, even if we need to get more people in from abroad. I am sure there are people with the expertise whom we can recruit. Now is the time to do it. We cannot allow postponements of operations ad infinitum. The sooner we can deal with this issue and produce the report to give reassurance, the better. It is important that we acknowledge that the vast majority of staff in all our hospitals are committed and dedicated and that they will provide the best possible care. Doubt has been created by what has occurred, so it is important that we be in a position to reassure parents and children at the earliest possible date.

I welcome the Minister's comprehensive statement on patient safety concerns and the review of paediatric orthopaedic surgery services. All too often, elected representatives are the final line of hope for parents and families who are anxiously trying to get surgery for their children. Unfortunately, recent events have greatly undermined belief in the service and, for parents and families, have triggered further unnecessary harrowing worries.

I acknowledge the Minister's many achievements in a short time in office, and I appreciate that in the past three years he has invested significant funding to help clinicians to reduce the amount of time children must wait for important hospital appointments and procedures. Scoliosis and spina bifida have been included as priority areas for funding in both the 2022 and 2023 waiting list action plans. Both conditions entail harrowing diagnoses and curtail the life expectancy and quality of life of many of our young people.

In recent days, I have spoken to the mother of a young County Longford boy who was scheduled for preoperative treatment in August. Unfortunately, this did not proceed as the consultant raised concerns over the child's heart. The family is now in limbo and uncertain whether the procedure will proceed at Cappagh. I will contact the Minister directly about this case and ask him to follow up and help the young lad. He recently started secondary school. He is a young boy full of hope and excitement about the new chapter in his life. His mother says she has never seen him as happy. I appeal to the Minister to ensure that we do not fail him and the other children awaiting surgery. As has often been the case, unfortunately, it seems it is our children and the most vulnerable who suffer most when the health service and HSE get it wrong.

I ask the Minister to consider a case I have raised in recent weeks. It relates to the nurse position at St. Christopher's Special School, Longford. The post is approved for just 14 hours per week to cover 40 pupils, many of whom have pronounced medical needs. Several of the children are PEG-fed. The school has sought approval for a 32-hour post and has struggled to get it from the management of the local community health organisation, CHO. It is a high-risk scenario, putting our most vulnerable at risk. I ask that the Minister ensure, at a time of rampant investment in the health sector, that the local CHO put in place immediately the necessary funding for a 32-hour nursing post at St. Christopher's Special School, Longford.

I thank the Minister for taking the slot today. Having listened to his speech and read page 2 of his script, I noted paragraphs 3 to 7 are quite chilling and alarming. The affected parents already have knowledge of several of these matters. Reading the script coldly, I found what it referred to truly shocking. More questions will be asked about this matter and more statements will be made about it. When colleagues in my party and I had been raising the issue of scoliosis with the Minister, we regarded the announcement some time ago that no child would be waiting for treatment for longer than four months as good news.

Like some of my constituency colleagues, I received an email today from a constituent called Ruth. She has a child who required surgery but who had it abroad, maybe because of some of the advice her family received based on Irish consultants' perception of the urgency of the surgery. Ruth has asked Deputies, including Deputy Paul Murphy and me, a number of questions. Deputy Paul Murphy has already spoken and I was very taken with his contribution. Ruth has eight points she wants to make that I believe are very valid, particularly regarding the children on the waiting list whose parents fear they will have to wait even longer as a result of what has happened and the pausing of some surgeries. She has several suggestions that I would like to put on the record, one being to bring international surgeons in to help with complex cases because of children being left waiting too long and another being to hire more surgeons to complete the more straightforward surgeries, if there are such things - in other words, the "50-plus degrees" cases, as Ruth calls them. She refers to a bracing centre for early intervention for younger children; surgery hubs across the country; the making available of physiotherapy and counselling for children who have to undergo surgery; the hiring of more theatre staff, because staff availability is often a reason for the cancelling of surgeries; transparency on lists; and answers to questions – I am sure they will keep coming – about who knew about the devices that were purchased. With regard to who knew, it is hard to believe it was just the surgeon, or just one person. The Minister has gone a long way towards dealing with this through his appointment of a professional, highly esteemed surgeon to conduct another review into what has happened. A truly alarming picture has been painted by the Minister, particularly on page 2 of his script for today.

This matter has shocked the entire country. The reports we have are truly shocking. The failure of the system's checks and balances to ensure appropriate treatment is, again, shocking. The use of non-medical springs is quite unbelievable. Children with scoliosis expected, sometimes after being on a waiting list for years and after disappointments, cancelled appointments and cancelled operations, that they would get first-class treatment but were let down time and again, with the CEO of the HSE admitting that communication with affected parents "could have been better". What an understatement. The spina bifida and hydrocephalus group held a remote meeting with over 100 families in Temple Street and in Crumlin. They are rightly angry about the situation and fear the surgery delays it is set to cause. It is rightly demanding that the review cover much more than medical issues. That has been heard time and again today. It needs to encompass licensing concerns, legal concerns, waiting list delays and the management of waiting lists. It is about much more than medical affairs. The group believes there has been an attempt to have a narrative around one surgeon and one issue instead of taking an opportunity to look at the wider piece, when it is widely known that the services have been in crisis for many years. We have heard this in the Dáil over the years. A review of spinal surgery at Crumlin hospital has been undertaken but has not yet been published by Children's Health Ireland. Who is running the communications for the HSE? An internal review has been carried out in Crumlin. The parents do not know which children's files are being examined; it could be anyone's child.

They said it could be their children. They have been left to assume. What way is that to treat the children involved and their parents?

Scoliosis is a medical condition that can cause significant physical and psychological distress. The history of its treatment in Ireland has been one of limited resources and long waiting lists for surgical interventions. Some children have had to wait many years before receiving the necessary orthopaedic surgery. The delay in treatment has devastating consequences for their overall well-being. Delayed surgery exacerbates the conditions of children with scoliosis. As time passes without intervention, their spinal curves worsen, leading to increased pain and discomfort. Delayed surgery not only fails to correct the curvature but allows it progress rapidly over time, leaving these children to endure prolonged periods of physical suffering due to insufficient medical attention. A protracted waiting time often results in a transition for these children from independent mobility to wheelchair reliance. The inability to undergo timely surgical intervention means they miss out on crucial treatments that could preserve or improve their mobility and significantly increases the likelihood of wheelchair dependence. The consequences of prolonged waiting times extend far beyond worsening physical conditions. They also include the need for more complex procedures as a result of delayed surgeries. For some, extended waiting periods can make surgical intervention impossible and the patient must bear lifelong pain and limitations resulting from untreated scoliosis.

The Government set a target of no longer than four months for people to wait for surgery. It has significantly failed to reach this target for children waiting for surgery for scoliosis or spina bifida. Certain surgical procedures have raised concerns and need to be fully investigated. The children and families must be put first. They are at the centre of this scandal and should be central to the Government and HSE response. After years of campaigning and pressure on the Government, there seemed to be some light at the end of the tunnel for these children. Unfortunately, it turned into a false hope for many of them. This is a crucial surgical procedure which is time-sensitive. The longer the wait, the more complex the surgery and the more likely lifelong complications become, all of which could be avoided with early surgical intervention. This looks likely to continue as figures show little, if any, improvement on waiting times for patients.

I welcome the opportunity to speak. The Minister's opening remarks give confidence that we will get things done to make sure that what has been happening will be sorted out and we will get to a stage where people will get confidence back in the services again. This has been a major setback for public confidence in the services in Temple Street hospital. As has been alluded to by many Deputies, it is harrowing to read in the reviews that have been published so far the extent to which things were happening. No one in this House has anything to say other than that. The unplanned interventions, infections and repeat surgeries all caused trauma for any child or person having an operation, never mind the trauma it caused the family waiting for the child to come out from surgery to see how things went. It is hard to understand in this day and age with all the rules, regulations and safety checks we have that things like this can still happen.

It is not everyone. Some of the finest people working in medicine work in surgery in this country. That must be said. It is important. The nursing staff are dedicated to their duties and their careers. It is important that is repeated because everything can get lost in the negative commentary. There has been a huge tragedy with the loss of a young life. We can say what we like, but that should never have happened and how it did must be extracted from the reviews and investigations that will be carried out. It is important in a situation such as this one that we have communication which is clear and which keeps the families of those involved in these surgeries and of those waiting for future surgeries completely up to speed with what is happening. Liaison officers must deal with them on the basis they feel they need to restore their confidence in services.

Four processes are ongoing. They are the reviews, investigations and so on; the families waiting, listening and reading about what happened; the families and children who have yet to go through surgery wondering what will happen for them; and the need to undertake a confidence restoration project to ensure people have confidence in the system. The biggest thing the Minister must do is to put in place with the HSE an interim plan for those who are still waiting for surgery - those who have been on waiting lists and do not know what is happening - so they have a clear, decisive interim plan to make sure these procedures are carried out with the utmost haste, safely and securely for the sake of these people. The longer they wait, the worse the torment will be. I am not sure how that will be done, but we have the expertise in the HSE and the Department of Health to put a crack team together to make sure it happens as a matter of urgency. The parents and families must also be part of that plan.

In 2023, we are reading about people dying in surgery for no reason other than it not being good practice. How can we make sure these things do not happen again? We allow for human error when people are carrying out procedures. We have every kind of digitalisation, robotic surgeries and everything else. We are going down a huge progression of modernising surgeries but if we are not doing it correctly, not doing the basics correctly, not using the proper instruments, coils and so on, I must ask how it slipped through the net. The biggest question people have is how in the name of God this happened.

This is a wake-up call for medicine to ensure enough people are in place to carry out these surgeries in a timely fashion for children and that the operations can be carried out without people being under undue pressure. There must be simple checks in place for everything that is done across the board. It might take an investment of money. It is not a cost, it is an investment. Everyone is together on this. It must be resolved and we must ensure it never happens again. We keep saying that but I hope this is the last time we are speaking about something like this in our health service.

I appreciate that the Government is attempting to ensure every possible measure is taken and examined to reduce spinal surgery waiting times in CHI at Crumlin and Temple Street. This includes exploring the transfer of a small number of patients with complex spinal surgery needs to appropriate skills centres in other countries. Perhaps the Minister will fill us in on what the timescale and actions for that are going forward. We have learned that our children are our future. It is important we have proper communication and information for families. Perhaps the Minister will come back to me on that. We must immediately address capacity through the implementation of the scoliosis and spina bifida action plan. It is not enough to tell parents who are watching their children suffer that approximately 257 surgeries took place last year.

These are children, human beings, who are being left untreated and not looked after by our healthcare system. Parents are tired and burnt out and still have to fight. I believe the system is failing. We need to address that and make changes to the system. The proposed review is not enough. It is not wide enough. The parents and patients have to be listened to more. For too long, they have been unheard. They are not being adequately considered. Not only are their children being left on really long waiting lists, but they are also not being supported locally to ensure the best life possible while waiting. I recently met with some families. I see this in my own constituency. There is no occupational therapy or speech and language therapy available. People are waiting on access to child and adolescent mental health services, CAMHS. Children's disability network teams are not fully in place. There are only a certain number out there and we need a lot more. Parents come to me and they are watching their children get worse. In some cases, children's scoliosis is worsening by as much as 10° while they wait. Families I have spoken to are at breaking point. They really are. The Minister of State will be well aware that some families have to go to crowdfunding for help. Families need support. This is a new thing they have now. We have to listen to these families.

There is another question I want to ask the Minister of State. An additional operating theatre is opening at Children's Health Ireland, CHI, at Temple Street this week, on 29 September. What staffing is in place? What about the aftercare team and the step-down service? Additional medical and nursing staff, health and social care professionals and administrative staff to support capacity are being sought. That is welcome but how many posts have been filled? Will the theatre be at full capacity when it opens? Is it 100% certain that it will open on 29 September?

I really believe the Minister of State and the Minister, Deputy Donnelly, are fully committed to sorting this, as is the Government. Children who need this operation are in a horrific situation and they should not be left waiting. The staff work extremely hard. Nurses, doctors and other staff get attached to children too. They see children waiting for this operation when they should not be. This needs to be sorted now. We need to do all we can. The parents and patients have to be listened to. Communication and information are going to be the key here. We all need to work together to make sure this is sorted now and that we get this done as quickly as possible. All of us must work together and do our best to support the families going through this with their children.

I will start as other Deputies did and offer my condolences to the family of Dollceanna Carter and my sympathies to the 19 families affected by what is detailed in this shocking report. Every parent in Ireland was stopped in their tracks by the emergence of this news. When you find yourself ending up in the care of our health system, even if it is just a run-of-the-mill referral to hospital or passing through a maternity ward, there is a handing over of trust on entering into that system. We step into an environment in which we literally hand over our bodies or the bodies of our children to the care of these professionals, trusting that they will deliver the best outcomes possible.

There are two things that jump out at me as the upshot of yet another scandal. The truth of the matter is that, when you access services in Ireland and get in front of a doctor or into a hospital, for the most part, the standard of care you receive and the quality of the outcomes are absolutely exemplary. We have outstanding staff across all of our health system. It must have also stopped them in their tracks to see another story about how, when you enter the health system, something awful can happen to you when, in point of fact, the care received within our health system is, for the most part, of the highest quality.

The second point is that trust is eroded. When you put your life or the life of a child or loved one into the hands of the health system, you want to be able to trust that you are going to get the best possible outcomes. The details of this story have been very damaging to that trust. It is something that must be rebuilt. I absolutely accept that the Minister wants to make the best possible progress in going through the fact-finding process and getting to the root cause. However, I cannot help but have a certain sympathy for the families who are asking why we are having another review, a review of a review, moving the timeframe out another 12 months, as Deputy Shortall noted. I therefore very much welcome the Taoiseach giving a commitment that he and the Minister for Health will sit down with the affected families and talk this through with them. We should look at the terms of reference so that, if we are entering into another review process, at least the parents will understand what is happening, the need for the review and what the outcome will be.

The other essential element in rebuilding trust is something other Deputies have talked about, the limbo that now exists for people who are still waiting on these surgeries. We know that, particularly with things like scoliosis and spina bifida, the longer you wait, the greater the impact on the life of the child, the more invasive the surgery and the longer the post-operative rehabilitation process. The other thing that all of us across the House would like to see is heaven and earth being moved to ensure the families who are waiting on surgery get clarity on what is going to happen in the immediate future. While I am quite sure the Minister and CHI at Temple Street are exploring all possible options, reference was made previously to the Government commitment to reducing the waiting list to four months and we should do everything we can do to shorten the timeframe for the provision of this life-changing surgery for these children.

This is another in a succession of scandals in our health system. They always seem to affect the most vulnerable in our society, women or children. It erodes trust. I again assert that, once you actually end up in front of a doctor or a nurse in the hospital system here in Ireland, the outcomes are, for the most part, absolutely excellent. We need to take whatever steps we can to rebuild that trust, which has been greatly damaged by this incident.

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.

I am delighted the Minister, Deputy Donnelly, is here before us today because this is a hugely serious issue. I recently received a heartfelt email from one of my constituents, a concerned mother whose child is a patient at Temple Street hospital. In her message, she expressed profound anxiety regarding her child's well-being. She conveyed her utmost appreciation for the surgeon who treated her child, describing him as honest, professional and transparent in explaining both the possibilities and the limitations of treatment. This mother's deepest concern lies in the lingering uncertainty surrounding the ongoing inquiry. She fears that her child, along with others in a similar situation, might slip through the cracks of the healthcare system. The surgery her child underwent has been truly transformative, offering a new lease on life. However, the child's journey is not yet complete as further surgery is required, and the only other specialist capable of performing it is located in the United States. In her poignant message, she expressed: "We are in total shock and dismay ... We don't know where to go for answers. We don't know what to do." These words capture the profound sense of helplessness and uncertainty she is experiencing, highlighting the urgent need for guidance and a resolution in this challenging situation.

The interests of patients and their families cannot be properly served until the full facts are known. We find ourselves in the midst of a deeply concerning paediatric spinal surgery controversy at CHI, a situation that has brought worry, trauma and anguish to the affected children and their parents. I fully support Amanda Santry's call for the review findings to be made public and endorse the need for a comprehensive investigation into the use of non-medical springs.

I would like to thank everybody who works in the HSE. Great work is done in many hospitals, including by front-line nurses, doctors, surgeons, secretaries and everybody else. However, there are huge issues around the whole running of the HSE and the Department of Health. I also want to sympathise with the Carter family and the other 17 families involved here. It is truly horrific by any standards. It is a horror story. One would imagine that one was in a Third World country.

When I came here first in 2007, I think - and I can check the figures - the budget was between €8 billion and €10 billion a year. Now it is more than €21 billion or €22 billion, and we are facing a €1 billion overrun. Money is being gobbled up, wasted, abused and misused. It is shocking. We still have not got any accountability for what happened and what went wrong here. I am not on a witch hunt against this surgeon but where are the oversights?

The former Minister for Health, Deputy Simon Harris, who was in the Minister, Deputy Donnelly's chair in 2017, said that no child would wait more than four months for a scoliosis operation. Today, there are 120 waiting more than 12 months. Does the Minister ever check back on the statements made and the messages of hope that might be given in those statements to the patients, their parents and families? Does he ever examine that? Can he sleep at night wondering? It is not money that is the problem with the Department of Health and the HSE. It could not be money.

Then we look at the national children's hospital, a runaway gravy train for God knows who, at the fact that those contracts were signed, at what is going on there and at the way it is left. The children of Ireland deserve more.

We just came from a mental health briefing in the audiovisual room, and the child and adolescent mental health services, CAMHS, situation in south Tipperary is just appalling. It just goes to show that children in our country are not being valued. Young people cannot get driver's licences. They cannot get any kind of facilities and for mental health, above all else, they cannot get them. They have not got the resources.

We saw the childcare people protesting outside today. Why are our youngest, brightest and most vulnerable being blackguarded by this Government and administration and by several administrations, the Department of Health and successive Ministers? Blackguarding is all I could call it. It seems that there is some kind of an uncaring attitude. Our Constitution talks about cherishing children equally and we all want to aspire to that. Anyone with children and grandchildren knows that. This is truly shocking and I fail to find the words to describe the true horror of this.

I have read all of the reports. I have read the three reports specifically and I have read two reports from the Ombudsman and a statement. I want to say at the outset that the authors of these reports should read the Ombudsman's report and learn how to write a report in clear, readable English, setting out the situation. That has not happened in a single report. It is absolutely disgraceful to read these reports that have set out to obfuscate, confuse and hide the issues rather than setting out when the incidents or events referred to came to their attention, how they came to their attention, who brought them to their attention, what the documentary trail is, and what happened. None of that is set out.

The first review, which is internal and which we cannot rely on at all, told us that there is not enough documentation and that the review should be used for consultation. That is the only thing raised in this report, and there is a mention of the rods but no analysis of them. That is the only thing that came out of that report. Then it was followed by a so-called independent report by the Boston team. We do not know what that cost or who the names on that were but we know that it was under the direction of Children's Health Ireland. There is no independence there whatsoever. That was followed by Children's Health Ireland putting its narrative on the story, analysing the two previous reports and adding to it with the literature.

The Minister for Health is asking us here today to trust this system. None of these, of course, were published proactively. They had to be forced through political pressure. I thank Deputy Paul Murphy for his series of questions and for persisting with it. We are here today with a response from the Minister telling us that his Department learned in November. What we know from the reports is that the two surgical incidents happened back in July to September and then more happened in September, October and November. Was the Minister alerted then? Was his Department alerted then?

Then we have a Boston expert committee telling us what should happen in the future, and an utter failure to analyse what is there. We are left reading between the lines, as the former CEO of the HSE told us. What we read between the lines is an utter failure to have an environment where people felt safe to complain. Can one imagine that? In the 21st century, after all the reports, we must create an environment that is safe for people to complain.

In all of this then we have Children's Health Ireland and the board of directors. I ask the Minister to look at the make-up of that board of directors and if I have a chance, I will come back to it in my questions. It is led by an engineer, the former head of a university. The mixture on that is property experts, accountants and so on, with very few doctors. That is what is presiding over Children's Health Ireland and the number of hospitals that are under its control. Was this discussed at board level? Did the CEO report back to board level regarding these incidents? Where are the minutes? At least the HSE publishes its minutes.

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.

I am disgusted as I rise. As a Member of this House and as a mother, I am stuck to find the appropriate language on this issue. I welcome that this debate is taking place but I am disgusted that it is necessary. I must question what on earth HIQA is doing. If it did its job properly, would half of the sorry excuses for acute settings we have in this country even pass the test?

I commend the advocacy group 221+, representatives of which were here with Deputy Kelly last week. What we are discussing here today further reminds us of why the patient safety Act is so vitally important. I commend the 221+ group on its work to that end. I highlight that implementation is always the end goal and until that work is at that stage, it is unfinished.

Will the Government please finally listen to, and take heed of, the overarching message that patients and advocacy groups are the most important groups in any health scandal, especially in times of crisis, which is what we have here? Lessons must be learned by the Government. Patients and advocacy groups should be given the utmost respect, compassion and civility. They must be central from the moment we become aware of a crisis until the terms of reference of an inquiry are set. We must almost take them by the hand in response to the difficulties they have faced. Any advocacy group having to take to social media platforms in an effort to secure a meeting with the Minister at these times is truly difficult to swallow. Any delay in response causes a reaction. Will the Government please bear that in mind?

I extend my heartfelt condolences and those of the people of Clare to Michael and Bridget, the parents of Dollceanna Carter. There are no words I can say, only that I hope the Minister can bring them justice. My thoughts are, of course, with all of the families who have been impacted by this issue.