Tuesday, 26 September 2023
Children's Health Ireland - Patient safety concerns and reviews in paediatric orthopaedic surgical services: Statements, Questions and Answers
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 is 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 three-fold. 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 if there is a wider group of patients that 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, but 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, 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 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.
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 children 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.
To conclude, 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, are vital parts 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 pre-judged 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 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 the past number of 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 by whom they were approved. 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 was a natural consequence after such a long time, and after being on such a long waiting list, where there was so little information in the public arena, that their bereavement has been accentuated by the lack of any kind of consultation, explanation and 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.
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 anymore 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 Ditchwas 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 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 speciality 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 been already 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 distributing 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 Doctor 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 the 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 on 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 only has 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 difficult 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 the past number of 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 Joint Oireachtas 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 got 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 of 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 the 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 of 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 becasuse of a whistleblower and because of the articles we have seen onThe 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, includingDeputy 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 whoever, at the fact 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.
In 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.
We will move now to the question-and-answer session. The Minister, Deputy Donnelly, and the Minister of State, Deputy Butler, are with us. There are seven and a half minutes for each question-and-answer block. I take it we will do a bit of back and forth, if that is what suits Members. Our first seven and a half minute block is for Government Members.
There is a lot of uncertainty in the media coverage in respect of the consultants who are available in the hospital to perform these operations when one consultant is no longer available and a file has gone to the Medical Council. What consultants and teams are now in place to continue the work that is required? What effort is going to be made to recruit additional people with the relevant expertise to fill the void?
In 2022, €19 million was provided for current and capital expenditure to tackle the waiting lists in paediatrics. What progress has been made since then? Will the whole programme now be put on the back burner because of what has occurred?
I thank the Deputy. I will be able to provide colleagues with a list of the current workforce and consultants across CHI. As colleagues will be aware, we have paediatric orthopaedic consultants who work across numerous sites, including Temple Street, Crumlin and Cappagh hospitals. There is also some activity for which Blackrock Clinic is used. There are various surgeons involved there. While I fully appreciate there are broader questions around paediatric orthopaedics, what initiated the issue at hand was spina bifida procedures in Temple Street hospital. The reality is that there are only two surgeons who do complex spina bifida work in Temple Street hospital, one of whom is not engaged currently in clinical activity. I, the Department and the HSE are all engaged with CHI on this issue. It is being examined at the most senior level and at a variety of levels. Can we hire into these posts? Can we expand posts? Are there people who might come in temporarily? Can we bring in surgeons from abroad to do individual sessions or who might agree to stay here and work with the children over a period of time? Can we reactivate the programme where the care is provided abroad? I think we should where the patients and their families agree to it. That might be appropriate for less complex work where less follow-up is required. There is no getting away from the fact that when it comes to complex spina bifida care, there are two surgeons involved. Extensive work is now ongoing to find additional surgeons who can do the work.
The Deputy also asked about the progress being made. Next week and in the coming weeks, significant additional capacity will come online. I allocated €19 million last year in current and capital expenditure. I asked CHI to come up with a comprehensive plan, which it did. That €19 million was a big ask and the plan was fully funded. Since then, the workforce has increased, additional beds have been made available and post-operative supports have been put in place. Because of that, there has been a substantial increase in the number of surgeries performed, notwithstanding the fact that waiting lists have not come down, as we talked about earlier. A substantial amount of additional surgery has been performed. In addition, a fifth theatre is opening in Temple Street hospital this day next week. It is staffed and ready to go. There are many sessions reserved specifically for spinal treatment and orthopaedics. A second MRI is being staffed in Crumlin hospital and we believe it will be operational in November. Some 24 additional beds were funded under the plan, including nine acute medical beds and two orthopaedic elective surgery beds. Those beds opened in Crumlin hospital in August. Two more beds are due to open next month. Seven short-stay beds are to be fully operational in Temple Street hospital in October, along with four orthopaedic elective surgery beds that will be fully operational from November.
I do not need to tell the Minister the concern this issue has raised. I am aware he has been moving with might and main since this happened to address it but one of the main concerns which arises from this issue is the public's trust and confidence in the system. It is so important for preventative medicine, in particular, that we encourage the public to engage with services provided, be it for check-ups, scans, diagnostics, vaccines and all of the different procedures and preventative treatments that are so important to having a proactive healthcare system. When these issues occur, it undermines and risks the confidence and trust of the public and makes it so much harder for all of us to collectively rebuild that and get the message and word out there that people must engage with the health system and go to one's scans, check-ups and follow the procedures that people are advised to take up.
I have a couple of questions on this issue. How did it actually come to light? I believe the Minister has touched on it already but how did it specifically break? How soon after was it addressed by those actions being halted? I would have thought that there were sufficient checks and balances in a system which is a high risk and high impact system. If something went wrong in surgery, I would have thought there would have been a significant degree of oversight, be that from a monitoring consultant, from an audit or from sample reviews because it is difficult to understand how something like this could happen in what one imagines is a highly regulated, monitored, and managed system. I am struggling to come to terms with how that could have happened in the middle of all this.
When I have asked all of the questions, can the Minister then come back to me? Is that the best way to do it?
I will cut to the chase. Were these patients or their parents invited to consent to these procedures? Did they consent and was there a discussion or a decision at some point where they were told what they were signing up to here and what was going to happen and were they then misinformed? Was consent given which was based on false information? What engagement happened between patient and surgeon for this to happen? How was that managed and was that then vitiated by false information?
What is the next step when the initial findings come out? I know there will be many different investigations but when are the initial findings likely to be available? I thank the Cathaoirleach Gníomhach and the Minister. I thought I had much more time and I was only warming up.
Before we go any further, I wish to make clear that this is a questions and answers session. There will be direct questions and direct answers, over and back, rather than statements. I ask the Minister, therefore, to give a summary-----
It is an important question. It is not a short answer. The Deputy is referring to a number of different children across a number of different surgeries, several of which have been identified as serious patient safety incidents and others which have not. I might come back to Deputy Lawless and to colleagues in writing to ensure that there is a detailed response to this.
In the Minister's opening statement he said that in November 2022, his Department was notified that two serious patient safety incidents had occurred in Temple Street hospital and that he was informed around that time, some time in November. In the CHI report, which was prepared for 8 August this year and which is a composite of a number of reports, it states that in July and September two serious incidents in spinal surgery were reported at CHI in Temple Street. If it was July when the first incident took place, and the Department was not notified until November, that is a period of four months. Is that accurate?
I thank the Deputy for his question. I note the CHI report states July and I believe it is November for the two patient safety incidents. I will check the exact timing but the process which will have been followed is that when those incidents were notified, the Department will have been notified. Importantly, I have also checked that the parents were followed up, close to when those serious patient safety incidents were notified.
I accept that but the point is that if it was the case that in July, CHI first became aware but it was not until November that the Minister and the Department became aware, that is serious. When the Minister became aware in November of these two incidents and other related issues, did he inform the Taoiseach at that point?
No, I did not. As per the opening speech, we would be notified of perhaps 20 or 30 of these incidents in a typical year. We deal with them, the Department engages with the HSE, I am updated on them, and then I interact as appropriate.
Addressing this question to the Minister, this is a very serious issue. He has accepted in his opening statement that there is much trauma in respect of the families involved and I do not dispute the Minister's sincerity in this. Given the seriousness of these issues, people will want to know whether the Minister did his job right and whether he informed the Taoiseach and others in government as to the seriousness of these issues. This is not about communication between his officials and, yes, that would be helpful to get that information, but when did the Minister inform the Taoiseach?
I will check exactly when that was but the Deputy may understand that there is official communication. That is how I am informed and how the Taoiseach is informed. The Taoiseach and I spoke in detail about this last week but there was previous communication in August, and, potentially, before that with his officials and his Department.
These are questions we will put to the Taoiseach to discover what exactly his recollection is of when he was informed.
In relation to the non-CE spring implants, the Minister stated in his opening statement that this first came to light in August. Is that when the Minister was informed?
Given the short time and the fact we have Children's Health Ireland appearing before the Oireachtas Committee on Health on Thursday, I believe there are also serious questions for Children's Health Ireland on that particular issue which has been referred to by many colleagues in their statements.
The big issue for the Minister at the moment is to ensure that the external investigation has the full confidence of the parents and the advocacy groups. He has acknowledged today that he will meet with these groups and with parents, and the Taoiseach has also done so. They will want to know whether these will be serious and meaningful discussions and whether the Minister is open to changes to the terms of reference to ensure that we can get the buy-in and the support of the parents and the advocacy groups in respect of those terms of reference.
The short answer is "Yes". It is also important to say that the reviewer will meet directly with the families and groups. In fact, it is specifically within the terms of reference which includes consultations with patients' families and staff. The intention was that Mr. Nayagam would meet with them and he has full discretion within the current terms to adjust them according to what he hears directly from the families.
I also want to say that with the benefit of hindsight, I believe the draft terms should have been not just shown to the families and groups - they were shown to them but only just before publication - but there should have been a deeper consultation with the families and groups on the terms. I reiterate that the review was set up such that the reviewer himself would meet with the families and groups and not hear via me or anybody else, but would hear directly from them as to what they want. He then has full discretion to adjust the terms as appropriate.
It is important that the Minister acknowledges that because many people looking at this issue, myself included, will be wondering how is it that a Minister for Health, when a scandal like this happens with all of the trauma that it involves for families, crafts the terms of reference which the HSE had input into and which we understand Children's Health Ireland had input into, but that the families and the advocacy groups had no input into. Nobody can stand over that, nor can the Minister. I just want to follow that up where I have a question-----
In the spirit of questions and answers and I appreciate that the Deputy has a question, so I will be short. I hear and agree with the Deputy and say that should have happened but it is important to state that it was and remains the intention that would happen, but that it would happen directly with the reviewer. In addition to that, yes, it should have happened with the Department and with me ahead of that as well.
The reason I say that is that I spoke earlier about all of the reports that have been published. I am asking the Minister now whether he can give a commitment to publish the report into Crumlin. That should be published in the interests of transparency.
On the Boston report, the advocacy groups are angry about the fact they had input into that report but there is not a mention of that anywhere in it.
That adds to the scepticism they have over the terms of reference of the review, which is why that is so important. Will the Minister publish that report on Crumlin? What services are not happening in Temple Street? There is considerable speculation on it. It is really important for that to be clarified also.
The Crumlin review will be published. The families are being engaged with tomorrow. Crumlin hospital did this review off its own bat given the concerns raised in Temple Street. The very clear advice I have from CHI is that that review did not show higher return rates or complication rates than would have been expected internationally. Yes, we will publish the broader review. We will not be waiting a year. I will expect interim reviews and I will publish those interim reviews. Both Bernard Gloster and I intervened directly to ensure the reviews - the internal review and the Boston review- were published in full. I never agreed to their not being published. I do not agree with the position taken by CHI and that is why Mr. Gloster and I intervened directly such that they were published.
I seek clarification on the last point on the Crumlin report. Is the Minister saying it was not commissioned because of potential poor outcomes, as happened in Temple Street, but it was commissioned because Temple Street had done a report? I ask the Minister to expand on and clarify that.
That is right. Representatives of CHI will appear before the committee on Thursday. The advice I have is that Crumlin hospital took it upon itself to do a similar review on the basis that concerns had been raised in Temple Street. The advice I have is that it was not based on concerns being raised and that it did not find an unexpected level of complication.
The waiting list has not reduced despite the number of surgeries increasing. Does the Minister have any information as to why that is the case? Could it be that patients having unexpected further surgeries are being added to the waiting list? Therefore, they never come off or come off only for a short period of time because they have to go on.
This is one of the core questions we need to get to the bottom of. I am deeply frustrated that I do not yet have a satisfactory answer because I have posed this question to Children's Health Ireland on more than one occasion, as have my officials. We know there has been a very large investment and a really fantastic clinical workforce has turned that money into far more surgeries happening. However, the waiting list did not fall as it should have fallen. We have no evidence there is a higher incidence of scoliosis or spina bifida in the country. Therefore, why are additional reviews coming in? Is it because now that there is additional capacity, children with lower levels of acuity are being referred in who might not have been referred in previously? The Deputy's question is exactly the same question I asked. Is it actually because the children involved are receiving more care and the number of children involved has not increased at the same level as the number of surgeries? I assure the Deputy this is being pursued rigorously with CHI. It is one of the things I will be raising with the reviewer on Monday. At this stage I want an independent external expert answer to the question the Deputy has raised and the question I have been posing for some time.
It is incredible because the questions are simple. There are large waiting lists for those with spina bifida and scoliosis, but we are not dealing with tens of thousands of children. It is a quantifiable number. It does not provide any confidence when the Minister cannot get answers. They do not need to be detailed answers, but just general answers to those questions. Surely these clinicians will know if the children on these waiting lists are coming in for repeated surgeries or are brand new. Surely someone senior in CHI should be able to tell the Minister that over the course of a short conversation. It is quite concerning that he has been unable to get that information.
The Minister said that will be subject to a review. Is that part of Mr. Nayagam's review or will it be part of a different investigation or review?
It will be part of Mr. Nayagam's review. The third objective is "To assess the governance of the Paediatric Orthopaedic Surgery Service and to make findings, [that is right across the board] and to make any necessary recommendations in regard to improvement in governance including quality, safety, outcomes and performance metrics." Dr. Colm Henry and I have spoken directly on this. I have instructed very clearly that this issue be looked at and that waiting list management be looked at. The State has invested the money. We have really dedicated healthcare professionals who are working very hard and doing extra sessions and using the extra resources. They are doing much more surgery.
I share the Deputy's frustration. I have asked the question repeatedly. I have asked it of officials who are engaging with CHI and I now want the external reviewer - as well as CHI - to come back to me with a very detailed answer to this question. To date I have had answers, including reference to increased referral from other parts of the country - people seeing that the service rate is expanding and referral rates increasing. I agree entirely with the thrust of the Deputy's questions.
CHI has been at pains to stress that spinal surgeries are continuing. Is the specific procedure, kyphectomy, continuing at the moment or is it paused for lack of the relevant expertise, for want of a better phrase?
I will double check the exact details, but my understanding is that it was paused last November. It is still paused and the last kyphectomy procedure happened in the middle of last year, perhaps in July 2022. It was officially paused in around November, but we can get the Deputy the exact dates.
Does the Minister have information on the impact for that particular procedure? I am not sure if it is captured in a particular waiting list. Has the waiting list for that particular procedure increased in that time?
I will get the Deputy exact details. I do not have it in terms of individual surgeries that are being recommended for particular patients. However, the reality is that we have two surgeons who do complex spina bifida care and it is done in Temple Street. One of those surgeons is currently not doing those surgeries. Will that have an effect and is it already having an effect on the time these children are waiting? Yes, unfortunately it is. That is being taken deadly seriously. As I alluded to earlier, all potential solutions are being looked at.
On the procurement procedures in Temple Street as it related to the non-regulated springs, has the Minister asked for any immediate measures to be taken there to ensure that no loose procurement or loose procedures are taking place for any other devices for any other types of surgeries in this hospital or in any other hospital?
Yes, I have. The clinical director is very clear that in CHI and in Temple Street additional communications and additional protocols were put in place. As they would say very clearly, there are already numerous protocols in place in every operating theatre in the country to ensure things like this do not happen.
We need to appreciate that the backdrop to this is that the State has failed the children who are most medically challenged. Despite repeated promises, the scoliosis plan, three Ombudsman's reports, three reviews which have been completed, umpteen Dáil debates and umpteen media reports, we still do not have adequate services for those vulnerable children. It is no wonder that trust has broken down and this week's events have not helped in any way. There is an impasse there at the moment. We need solutions and we need to be able to move on.
The advocacy groups have asked for two things. The first has been conceded, which is that the Taoiseach will meet them this week, and I welcome that. The second is that the terms of reference for the latest review have input from them. I think that is perfectly reasonable. I know what the Minister is saying, that it is up to the doctor concerned to extend the terms of reference if he believes that is necessary. I want the Minister to go further than that and the parents want him to go further than that. They want him to mandate the doctor to take on board their concerns about the terms of reference. Will he do that?
Let me state clearly that it is absolutely the intention and has always been the intention that the families directly meet with the lead reviewer. The terms have been crafted such that he adjusts them depending on what they say. As I said to Deputy Cullinane earlier, with the benefit of hindsight, that process should have happened twice. It should have happened before the draft terms were published rather than just being shown the draft terms. I fully accept that should have happened. That was a mistake. It was intended and will happen exactly as the Deputy said.
Deputy Shortall said something very important. Has the State failed these children? Yes. Yes, the State has failed these children and the State has been failing these children for years. Of the €19 million we put in last year, and I ask the Deputy to bear with me for one second if she does not mind, 168 additional healthcare workers are funded and 151 of those are in place. We will not rest until those waiting lists are brought down.
Okay. That is very welcome. I thank the Minister. On the matter of the Crumlin report being published, I welcome that. I tabled a parliamentary question on it and look forward to seeing the answer on Thursday. Can the Minister clarify if that report will cover the use of what are known as the magic rods in some surgeries?
Okay. Many different reviews are being referred to. Can the Minister tell me who in Temple Street was aware of the proposed use of the non-medical devices? Was their use discussed with management? Has he any information about that? As far as he knows, did they go through the procurement process and the standard protocols?
I thank the Deputy. This is exactly what the additional review is looking at right now. Of course I have spoken to CHI and the HSE. My officials are engaged. I have a view on some of those questions. However, I am very much of the view that we have to establish the full facts. We have to establish who, at a management and a clinical level, knew what. This relates to several questions. First of all is the use of the springs in the operation. We know it was an operation that was being trialled in Utrecht, for example. Probably more pressingly, the fact is that they were not medical grade and were not authorised for this use. A review is going on now to establish exactly who knew what on all of those areas.
The framework timeline is four months. I ask the Deputy to bear with me. When I heard that, I made it clear to CHI that I and the Oireachtas would not wait for four months to get answers to these questions. I have asked for it to be accelerated for that reason.
That is not acceptable. Allegations are being made that this was all known about within Temple Street at a senior level. I do not know whether there is a basis to those allegations or not, but they should not be left hanging in the air. We also know that there is an end-to-end procurement procedure, from the purchase of them, and I understand the hospital paid for them, up to the sterilisation of them before implantation. We need to know how they were implanted in three patients. What were the discussions, if any, around those? It is critically important that is an independent process in which people have confidence.
We need very clear answers to every question the Deputy just raised and many more, end to end. What has happened here is very serious. There is an external group which is reporting to the CHI board. However, I take the Deputy's point and agree with her point about trust. There must be trust in the answers. I absolutely take that on board. In addition to that, if we need to do an additional short, independent one, we can. Dr. Nayagam's review is also looking at the issue of the springs and all of these questions.
We have been told it could be a year, if not longer, until Dr. Nayagam reports. The general principle is that justice delayed is justice denied. Too often, we see a major problem being put into a review and who knows when we will ever get the results of that review, and it will be redacted. All of these things generally happen. That is not good enough in these circumstances. Will the Minister ensure that either the HSE or his Department takes oversight of this report? This goes to the heart of the question of trust.
Two separate groups are looking at this. We have discussed one. The second is Dr. Nayagam. We need to be clear that nobody will be waiting a year for a view from Dr. Nayagam and this review. There will be interim reviews and it is being set up such that the pressing clinical issues are reported on this year. The reason people are saying the review in its totality may take a while is that I and others have insisted it is a broad review. That takes time. The clinical safety issues we are discussing right now will be reported on to me and I will report to this House much quicker than that.
Of allegations that this was happening. Is 4 August literally the first time the Minister heard that there were allegations and when it was confirmed? Did he hear about an allegation at any point previously?
What I had was Deputy Murphy's parliamentary questions. He can correct me if I am wrong but the information I have is that the first time his parliamentary questions were specific to the point that these could be identified was 27 July. If I am wrong, please feel free to correct that.
Okay. They were submitted in July. I have looked carefully at this. As I see this, the Deputy asked a series of escalating questions. To begin with, they were quite vague. They are all on the record. They were about whether CHI uses non-medical grade equipment. I believe it replied in good faith that, to the very best of its knowledge, of course it did not use non-medical grade equipment. It was only in the second week of July, I believe, and I am more than happy to be wrong on this, as I read it, that the Deputy's question became specific enough for CHI to look exactly at what he was pointing to. When it found that, it responded on 27 July and I was informed the following week. I do not know what the Deputy was given but if he had that specific information earlier, I could have acted on it and CHI could have acted on it. If the Deputy has information to the contrary, that is absolutely fine. It is important to say that I believe it was only in July, when his question became specific enough, that CHI was able to identify what he was pointing to.
Let us even take that. The Minister says 4 August, but on 25 July, the Minister responds to detailed questions. He does not respond with detail and he kicks it off to CHI, which is the process, and I still do not have an answer to those questions from CHI. Therefore, the Minister was aware of the allegations at what time - was it 25 July?
I asked the Taoiseach about it on 5 July in the Dáil and I spoke about the allegations that unlicensed implants had been used in children, and the Taoiseach said he was going to talk to the Minister about it. Did the Taoiseach talk to the Minister about it?
I will have to check and I will have to check if his officials passed on those comments, as that would normally be what is done. Again, the details to CHI that allowed them to find what it was the Deputy was pointing to happened in the second week of July. It was discovered in the following weeks, when they looked into it, and I received a report on it on 4 August. I then asked a series of detailed follow-up questions on the report that I got.
The Minister said he always wanted to see the publication of the external review. I asked him about that in mid-July. I asked about publication and, at that stage, the Minister did not say that, although he said it would be communicated to people appropriately. Why did he not say at that stage that he was going to publish the report?
I will have to take a look at the parliamentary question answer. The chief clinical officer got a copy of the report in July, a copy of the report will have been sent to me in August, there was a disclosure process gone through with the families and then there was a proposed publication date after full disclosure had been gone through with the families. The report in The Ditchwas ahead of full disclosure having happened with the families, which led to the report’s publication being accelerated. Specific to the publication of the report, it was not the view of CHI that the internal or the external reports were going to be published. Their view was that they were going to publish this condensed version. That was never acceptable to me and it was never acceptable to the HSE, and both the chief executive and I intervened directly to state that both reports needed to be published in full.
Then the question is why it took so long. A specific question was put to the Minister and I got an answer from CHI in May, so the question must have been put in April. The question “...asked the Minister for Health if he is aware of any external or internal pressure being placed on clinical staff at Temple Street to restart spina bifida-related surgeries in advance of the conclusion of the external review”. It concerned restarting kyphectomies despite the fact they knew about these complications and they knew that one person had tragically died. CHI says it is not aware of any internal or external pressure. Did the Minister just accept that like he just accepted all of CHI's answers, which I had to accept as I did not know anything better? CHI is telling me that everything is normal to the best of its knowledge and that it is not using unlicensed implants. Does the Minister now accept there was pressure put by management on surgeons to restart?
On the parliamentary questions, I know this is never satisfactory, and I got the same answer when I was on that side of the House and I never found it particularly satisfactory. However, I receive about 15,000 to 20,000 parliamentary questions a year, so colleagues will appreciate that none of us can write all of our own responses to every parliamentary question. However, I am responsible for them and it is my name at the bottom of the page.
On the question the Deputy asks, I am not aware, nor am I aware of any suggestion that has ever been made to me, about pressure – presumably, we are talking about inappropriate pressure - being put on clinicians to do procedures which they did not believe were clinically appropriate to do. If that is the thrust, no, I am not aware of any such pressure.
I am telling the Minister that was the case in March. I want to go back to the timeline. I think the Minister accepted the reason things were published and processed was because of the article in The Ditch. I want to go all the way back to last year. Does the Minister know that the first freedom of information requests, FOIs, from the journalist, Pádraig Ó Meiscill, were submitted in October, then the surgeries or kyphectomies were suspended in November and then the internal review started? Does the Minister accept the reason this whole thing kickstarted was not because of some internal process, it was because of external FOIs from a journalist?
I am very open to an external review telling me whatever it finds. What I can tell the Deputy right now is that this is the first time I have heard this. This is the first time I have heard about an FOI. The clear advice I have been given is that there were serious patient safety incidents, the protocols were followed, the patients and the families were engaged with and I was informed. To Deputy Cullinane’s earlier point, arguably, I was informed in too tardy a manner on the July one. In the September-October-November period, two things happened. There were patient safety incidents which were being looked at and the spina bifida multidisciplinary team in Temple Street raised concerns. On the back of that, two reports were commissioned, an internal CHI report and an external Boston Children's Hospital Group report. I am very open to any external reviewer telling me that FOIs played a role. The Deputy’s question is the first time I have been aware there were any such FOIs.
I want to check the timeline between the Minister and the Taoiseach on the communication. To be honest, it is extremely nebulous. The Minister stated that he learned of it for sure at the start of August and that he told somebody in the Taoiseach's office. Who did he tell in the Taoiseach's office?
That is not what I said at all. What I said is that there will have been communication between officials and advisers between the Department of Health and the Department of the Taoiseach. I believe there was communication in July and August and, obviously, in September, and we can provide a full timeline as to those exact communications.
It is important to say, though, that we receive 20 to 30 of these patient safety incidents on an ongoing basis. Yes, it is worthy of communication. There was communication, I believe, in July and August, and the Taoiseach and I obviously spoke about it in person in September.
The Taoiseach said today on Leaders’ Questions that he found out about the specifics of the spring implants only in the past couple of weeks. The Minister has not been able to recall the fact the Taoiseach was asked a question on this in July. He said he was going to refer it to the Minister but the Minister cannot recall whether the Taoiseach referred it to him.
Again, that is not what anybody has said. I have the transcript between Deputy Murphy and the Taoiseach and I have looked at that. I became aware of the issue with the springs in August. It was not part of either of the reviews. It would appear, based on everything we have seen, that CHI and the reviewers did not know there was an issue in terms of these springs not being medical grade springs. It was through the parliamentary questions submitted by Deputy Murphy that work was done and that was uncovered, and that happened in August - I am sorry, the work happened in July but I was informed in August.
The whole communication pattern obviously did not work because the Minister did not learn fully about the Taoiseach's question and the Taoiseach did not learn of the Minister's experience until the past couple of weeks. That is a problem in its own right.
The Minister specifically asked CHI why lists were not falling. When did he ask CHI why lists were not falling despite the extra investment that went in? When was the first time he asked and who in CHI did he ask?
I can try to get a timeline for the Deputy but this is an ongoing conversation between myself, my Department and CHI. The Deputy will be aware of the waiting list action plan. We have three high-priority clinical areas-----
I am answering the question. This is relevant and speaks directly to the Deputy’s question. There are three clinical areas specifically called out within the waiting list action plan, and they are bariatrics, gynaecology and paediatric orthopaedics, so there is an ongoing conversation at a very senior level in the Department, the HSE and Children's Health Ireland on this. Paediatric orthopaedics, including spinal, has been a top priority right through the waiting list action plan, so these conversations are going on all the time.
I am talking about a date, roughly.
The other point to be made here is that spinal surgery can be incredibly complex. The international best practice on this indicates that quality is achieved through specialisation. My advice is that the Irish spinal surgery system is actually generalist in nature, so the culture in spinal surgery training is that you need to do everything. To what extent has this led to the crisis?
The Minister did not answer. First, Mr. Nayagam is not a specialist spinal surgeon, and yet he is the external reviewer. He does not have the clinical expertise to actually ask the hard questions of the expert surgeons. How does that happen?
-----to undermine an internationally renowned paediatric orthopaedic surgeon we are bringing in to do this review. It is entirely up to you to do that. You are, of course, free to try to discredit the reviewer.
-----is not very helpful, and I will respond, if you do not mind. Mr. Nayagam was specifically identified by the chief clinical officer. It was important to the chief clinical officer that this would not be someone who was just a spinal orthopaedic expert. It was important that the totality of paediatric orthopaedics was reviewed. It was important that was done by someone who has broad experience. Of course, if the reviewer wants to bring in specific external spinal orthopaedic expertise, he can and will do that.
Can I just ask that we do not in this House try to undermine the credibility of the reviewer who is coming in to do this work?
You would have to be foolish to think that, simply by requesting that the reviewer has expertise in complex surgery, which is a qualification, I was in some way undermining that individual. I am not. It is clear that the individual who is the external reviewer in this situation does not have the same qualifications as the individuals he is reviewing. The reason I stated that is because the Minister said to me just a few seconds ago that he did not have the clinical expertise to be able to ask certain questions. Obviously, clinical expertise is very necessary to be able to carry out a review such as this. All I am asking is why we do not have an external reviewer with the necessary qualifications to carry that out.
I just want to be very clear on this, if I may. This is important, because Deputies have quite rightly spoken about trust. The reviewer does have the clinical expertise to conduct this review. I most certainly do not.
Okay. We are going to have to disagree with that. Again, on the specialist element, Scotland has a large number of surgeons who specialise in complex spinal operations. Again, Ireland does not have that level of expertise. Ireland has all-rounders. It is understood that Temple Street did not have enough focus on that expertise. Is that not an issue we have to resolve coming out of this whole review system as it stands?
That is a very fair question. The question around generalists, specialty, subspecialty as well as the amount of work and patients in that is a very important one. It is one that the reviewer will look at and provide advice to me and, in turn, to the Oireachtas on.
First, I cannot express enough to the children themselves, the parents involved, the aunties, the uncles and the grandparents, that when we are having this debate and this question-and-answer session with the Minister, we have to keep those lovely people and lovely children in mind. They are the most important thing in all of this. We can ask and answer all the questions we like, but the pain, the suffering and the turmoil those little children and those families have gone through should be the most important thing in every one of our heads. While CHI has refrained from commenting on the allegations regarding unlicensed implants and the suspension of spina bifida surgeries, we now know that one surgeon has now been suspended from the hospital since May of this year. Can the Minister say any more about that at this time?
What I can say is that he has not been suspended. There are clinical protective measures that have been put in place, including as part of the consultant contract. Some of them are contained in the reports. For example, having a second surgeon involved when there is complex surgery is one of them. The surgeon is currently not doing any clinical work, but it is important to say, and I do not believe any of us in this House are guilty of it, there have been no findings made against this doctor.
It is absolutely clear, and we do not need any report to tell us this, that non-medical materials should not have been used. That is a given. The Irish Medical Council is in a formal process. That is a legal process when it comes to the review of clinicians. We have to let that process go through.
Yes, that is a very important clarification. One troubling allegation is that the non-medical springs, which were made from low-grade steel rather than the required titanium alloy, were used in surgeries involving at least three young patients. These springs were not intended for medical use. Am I correct in saying that? This raises questions about their origin and intended purpose. This reminds me, and the Minister will be very well able to remember this also, of the situation of people who had hip replacements. The Minister will remember how low-grade materials were used in the hip replacements, and then there were all those cases, etc. I am comparing one with the other. Can the Minister give any clarification on that?
I thank the Deputy. What I can tell him is this: the springs that were used were not authorised for medical use, which is very serious. We do not know - the review is now establishing this - how that happened in terms of procurement and getting into theatre. There are protocols for checks on everything that is used in theatre. Exactly how all of that happened is being established right now, but we know that these were not authorised. Furthermore, we know there are processes in place through the Health Products Regulatory Authority, HPRA, which authorises the health devices, to be able to identify materials that can be authorised for medical use. This is obviously subject to a battery of tests and regulations.
Yes. I do not like using this analogy, but in the past hour I have spoken to a person who has been involved in the automobile industry. That person said to me that when a motor car is being made, there are awfully strict criteria about the materials that are used. How could this actually happen, when these are going into people’s bodies? It just does not make sense. I am not asking the Minister to answer me on that because I do not want to eat into Deputy Danny Healy-Rae’s time.
First, I, too, commiserate with the families involved and with the Carter family for the loss of their lovely child. It is so sad. So many people do so much good work, such as doctors, nurses and the health service. It has to be acknowledged that they do. It is sad to see that trust is being broken in a case like this. We see the same with the child and adolescent mental health services, CAMHS. I want to ask the Minister about who in the chain of command is responsible for what. This is a scandal. Is anyone going to be held culpable? Was there someone in charge of the surgeon? We do not know. What is the Minister’s responsibility? He is the Minister for Health. Should he be overseeing what has gone on here and have known more about it a lot sooner?
I thank the Deputy. It is a very fair question. The answer to that is that there are extensive patient safety and clinical governance mechanisms in place in all our hospitals to do with every procedure. In this case, two serious incident reviews have been kicked off. They will be reporting very shortly. They have done extensive work on what happened in two particular cases. Concerns were raised through the multidisciplinary team. That kicked off an internal and external review. A complaint has been made to the Irish Medical Council. The Irish Medical Council is now carrying out its own work.
Neither the chief clinical officer nor I were satisfied that the internal and external reviews sufficiently answered the questions. I agree with much of what has been said this evening about the reviews not identifying what went wrong. Those two reports are useful in terms of ensuring everything that should be happening is happening, but as Deputy Shortall alluded to, they did not call out what went wrong. As such, Dr. Colm Henry and I were not satisfied that the questions had been answered to the level they needed to be. That is why this additional review is being carried out.
This review was triggered by complaints from clinicians and staff last October about problems with infections and complications following surgeries. That was almost 12 months ago. It is frightening to think so many children were affected. I am not sure if the number is 16 or 19, but one has died. One is too many. This is serious.
We must narrow down who was responsible. The HSE is getting an awful lot of money, and it needs that money, but we must ensure something like this never happens again. We are told not to put spurious parts in certain vehicles, but to be crude about it, that is what happened in this instance. Who ordered what and at whose discretion was it to purchase these devices?
That is exactly what two reviews are looking at – an external review commissioned by CHI and an external review commissioned by the chief clinical officer, with the reviewer reporting to the chief clinical officer and meeting me regularly. This is exactly what we need to establish.
I welcome the clarification given to Deputy Shortall about how families will have an input into the terms of reference. That is on the Dáil record.
According to the report carried out by the Boston group, we needed to increase the use of formal adverse event reporting. Was it used effectively in time, given that there were two serious postoperative surgical incidents in July and September 2022? When was the adverse event reporting used?
My advice is that Crumlin decided to examine its own caseload on the basis of Temple Street having done the same. The advice I have is that it was not kicked off by an adverse event or concerns being raised.
I beg the Deputy’s pardon for interrupting, but in case there are families listening whose children were involved in Crumlin, what Crumlin and CHI have said is that they did not find concerns through their own review.
The Minister has said that. In the article by The Ditch, there is a reference to a report carried out last year by the Royal College of Surgeons in Ireland. Has the Minster read that report, is it available and is it published?
CHI speaks about an implementation plan and refers us to appendix 1, but when I go to appendix 1, there is no implementation plan. Has the Minister seen that implementation plan? It is a yes-no question.
Okay. Let me just say that I have gone to the trouble of reading them, my staff has gone to the trouble of downloading and reading them, and I see no implementation plan. That does not give me any confidence.
The short answer to the Deputy's question is that the implementation plan that I am aware of refers to the implementation of the Boston report recommendations. Yes, those recommendations are being implemented at the moment.
We are told to find the implementation plan in appendix 1 and that it is an iterative document that will be updated regularly, but it is not there. This is just an example of what CHI is doing.
I will finish, as my time is ending. I am concerned about CHI’s board. Is the Minister going to review its composition, seek to have minutes published and determine whether these issues were ever raised at board level?
I know that the board has been involved. For example, I am advised that the external review on the springs is reporting to the board. There is a broader conversation to be had on another day about voluntary hospitals and the level of control the State has over hospitals it fully funds.
Given that many of these unregulated medical devices were used as early as 2021, has Temple Street hospital’s management given any explanation as to how this happened without its knowledge? This could not have happened without at least some members of a surgical team being aware of it. Has Temple Street conducted an internal review? We have its latest report, which is full of statistics, but there is not a word about accountability in terms of who, what, when and where.
My question is more about timing. This happened quite some time ago. Members of a surgical team had to have known. It could not have happened in front of their eyes without some of them knowing. Maybe management did not know. Has there been any review as to how this could have happened? Is the Minister just saying that the hospital is only reviewing the matter now?
People would have been aware of the use of the springs. It was based on work done in Utrecht. As far as we could see, though, people were not aware – certainly at hospital level – until late July that these were not medical-grade springs. That is one of the serious questions.
Yes. I presume that information will come out.
My next question in on the HPRA. It is the notified body and is in charge of what is happening. It is up to the HPRA to ensure the robustness of the supply chain. Has it started an investigation? Has it reported this breach to, for example, the European Commission? What is the HPRA doing? Is it updating any of its processes, including procurement processes, or is it just standing to one side waiting to see what will happen?
It is fair to say the HPRA is concerned about what has happened. As far as we can tell, the HPRA had no knowledge of this, so this is not a lapse on the part of the HPRA. What it has stated clearly is that, if a surgeon wants to create authorisation on something that is not a mainstream medical product----
The process was not followed. In that context, is the HPRA going to notify the European Commission? Is it going to look right now at what happened to ensure it does not happen again? That is the HPRA’s responsibility as the notified body.
I take the Deputy's point, although I would say that the responsibility for ensuring medical-grade materials and supplies are used lies first and foremost with the medical teams and the hospitals themselves. The HPRA is the regulator and it will intervene as it deems appropriate. It is concerned that the processes were not followed in this case.
There is a lot of detail here. At the core of this are boys and girls and young men and young women, some of whom have had surgery and are very distressed about what has happened and, unfortunately, many of whom are still waiting too long for surgery. Every single thing that we have done, will do and are doing in response to this is to serve the patients, in the first instance, and their families. That is the only thing we are motivated by. As I said previously, a vast investment has been made by the Irish people through the Government into these services, including €19 million, 150 extra healthcare professionals who have already been hired, a fifth theatre will open next week and a second MRI machine will come online in the coming weeks. Numerous hospital, medical and surgical beds have already been brought online and fully staffed, and there are more are coming. With this additional activity coming next week and in subsequent weeks, we must see a step change in the number of procedures being performed for these children. Critically, that must translate into us beginning to move as fast as we can to every child being seen within four months, unless it is clinically indicated.
Various issues have been raised. I am going to use the time to go back over some to give absolute clarity. On the inclusion of families and advocacy groups in the terms of reference, the answer is absolutely. They will meet the Taoiseach and myself this week and the reviewer when he begins. The review is independent. The lead reviewer is an independent international expert. He has full discretion to do whatever he wants. He can go as wide and deep as he wants. He will have my full support. He will not report to CHI; he will report to the chief clinical officer of the HSE. I will meet the reviewer and if there is any hint or whisper that anybody is trying to steer this reviewer in any particular direction, within our health services, he can bring that directly to me. I state very clearly that there is a zero tolerance approach to this. This reviewer has full discretion to go where he wants and review what he wants. He will be adequately resourced to do that.
The Crumlin review will be published on Thursday and the families will be met tomorrow. The review is of a small number of children; I have been advised that nothing unexpected was found in terms of additional complications.
Yes. There are wider issues regarding governance. This review is not just looking at the 20 children involved in this situation. The review is looking at that and at the use of non-medical equipment but he will go much wider, not just on Temple Street but across Children's Health Ireland and right across paediatric orthopaedics so that I, and all of us, on behalf of these children and their families, can be satisfied that every single thing that can be done is being done for them.
The investment includes both surgery and post-operative care. We do not have the level of surgery and post-operative care we need to fully deal with waiting times. More resources are coming online, much of it in the next number of weeks. Some Deputies asked what the additional resources are. I think I covered that; it is about 160 extra staff, 150 of whom are in place, the second MRI scanner in Crumlin and the additional operating theatre in Temple Street.
One thing I had not mentioned was that some of the less complex procedures, such as intrathecal chemotherapy, are being moved out of theatre to procedural rooms, freeing up more theatre space for more complex work. Many beds have been added, along with additional staff, including registrars, consultants, radiographers, nurses, physiotherapists, occupational therapists and associated posts. We went through the timing. If colleagues have any further questions based on today, we will get whatever is required. I also wish to offer a briefing from the Department, if members of the Joint Committee on Health would like it. I am happy to organise that.
Temple Street is now implementing the recommendations from the Boston review. I expect there will be a more actionable response from the independent review. The chief clinical officer and I expect the first interim report before the end of the year, which I will publish and share with patients, families, Members of the Oireachtas and more broadly.
That concludes statements and questions and answers on Children's Health Ireland Children's Health Ireland - patient safety concerns and reviews in paediatric orthopaedic surgical services. I thank Members for their co-operation in getting this business done.