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Seanad Éireann debate -
Wednesday, 4 Oct 2023

Vol. 296 No. 4

Children's University Hospital Temple Street: Motion

I welcome the Minister and his officials to the House. We are now moving on to discuss the motion regarding Temple Street children's hospital. I call Senator Conway to propose the motion.

I move:

That Seanad Éireann, in light of the extremely serious revelations at CHI Temple Street and the consequent suspension of surgeries pending the outcome of an investigation in that hospital and the further consequent erosion of trust and confidence in parents, demands that:

the External Reviewer:

- prioritises and reflects the concerns of the parents of affected children in the terms of reference;

- ensures that the terms of reference also:

- includes a requirement to make a recommendation to ensure that confidence is restored into the future;

- examines why the CHI internal review, and the Boston Hospital review, did not find the use of non-medical devices;

the HSE:

- takes urgent action to make alternative arrangements to ensure children are not left waiting further for urgent surgeries;

- undertakes an examination of how to improve how parliamentary questions are answered by CHI;

the Minister commissions an immediate independent review of the adequacy of codes of ethics and codes of conduct, together with a review of their oversight and quality control mechanism to include a review of the adherence to governance and protocols in all hospitals.

Go raibh maith agat, a Leas-Chathaoirligh. The Minister is very welcome-----

You are sharing 16 minutes. If Senator Joe O'Reilly is not here, I will ask Senator Doherty to second the motion. I assume you will share the time equally.

Absolutely; 100%. Thank you very much, a Leas-Chathaoirligh. The Minister is very welcome to the House. We were all very saddened and shocked by what was revealed about Temple Street children's hospital. We are all human beings and members of families, and what happened in Temple Street is totally unacceptable and must be reproached.

The Joint Committee on Health last Thursday afternoon had significant engagement with Temple Street children's hospital and with the CEO of the hospital group. It was a very difficult experience for all of us. Nobody can justify what happened or in any way downplay the difficulties, challenges and upset caused to families. I know the Minister, like all of us, considers what happened reprehensible and that he is committed to getting to the bottom of what went wrong in terms of process and behaviour. How we deal with these things is upsetting and terrible. I do not blame anybody because I do not think anybody is to blame but the system is to blame. It has been reprehensible in terms of what happened to these children and how their lives have been affected going forward.

This motion is designed to amplify and to try to get some answers. The answers are probably not there but the review, I hope, will get answers. This motion proposed by me and my party is designed to try to achieve some answers or clarity.

It is designed to give some hope to the parents and children who have been affected. It is an issue that is very difficult to discuss. It is very difficult for any of us to understand because it is children whose lives have been affected. I sincerely hope this motion will play a part in ensuring the State owns up and reflects on what has gone wrong. All we can do is hope that change will happen. The health system has let these children down. I get emotional when I think and talk about it. I know everybody else does as well because it is so difficult and challenging. What has happened is so awful.

The Minister is not to blame for this. I respectfully suggest that the HSE is not to blame for this, but there are people who need to be held accountable. Those people who are accountable need to be held accountable. We need answers and solutions. We need an improved process going forward so that something like this can never happen again. We should not be in the Seanad talking about these issues. We should not be here talking about children who were let down by the State not 20 or 30 years ago but two, three or five years ago. We need to ensure that the corporate governance and structures and checks and balances that are in place work. We cannot allow a situation like this ever to happen again. I want from the Minister a commitment that we will change what has happened in the past and change the processes going forward to ensure something like what we have experienced over the last number of weeks and months, and for those children the last number of years, will never happen again.

Before I move on to the seconder, I extend a céad míle fáilte to a former Senator, Fidelma Healy Eames. She was a very active Member when she was here. It is nice to see her back. She is a good west of Ireland person like myself. I hope she enjoys her day.

Senator O'Reilly is seconding the motion.

I second the motion. I welcome the Minister, Deputy Stephen Donnelly. Senator Conway's exposition was of such quality that I cannot add to it. I will, therefore, formally second the motion.

Does Senator Doherty wish to make a small contribution?

If the Chair does not mind, I would be grateful. I thank the Minister for coming here today. I do not doubt for a second that he will get to the bottom of this issue.

I have been around here since 2011. We have had incredible medical scandals including one in which a procedure called a symphysiotomy was conducted on female patients, which is the most horrendous thing anybody can even consider. We have had medical scandal after medical scandal because of deference in medical circles. I thought we had unrooted all of that in that insofar as we now live in a modern society and nobody would be afraid to say when something is not right. Yet, questions are arising, and there are plenty of them in the list today.

When Deputy Paul Murphy spoke in the Dáil and thereafter tabled parliamentary questions, that did not immediately trigger to the credible senior management we have in Children's Health Ireland, CHI, that something was amiss and they should investigate. They just answered questions inaccurately in the first instance, which really puts a mirror on our parliamentary question system. They answered insofar as to what they expected to be the truth, but we know now it was not the truth. We know now that they were lies. They were inaccurate and the questions were just answered, which puts the whole credibility of that system under scrutiny, first of all. Second, the senior management in CHI did not think what is probably one of the most serious accusations that could be made was enough of an issue to warrant an investigation back in July of last year.

We can go on from there and talk about the number of people who would be involved in medical teams. We know there was not just one but multiple operations. We can start now multiplying the number of people who knew something was amiss. Even if we were to go back, and we genuinely believed this was some new far-reaching experimental thing that could significantly impact in a positive way the lives of those children and it was discussed with the parents, even still, it should have triggered somebody somewhere saying, "Hold on a second. We need to dot our i's and cross our t's." Yet, the most senior management in the most senior offering of services we have for children in this country did not do it.

Not only are we going to try to have one investigation after another, whether they are internal or international, but people are responsible for delivering and overseeing the care and having the governance and oversight of the care. There is a board of management. Every single part of this system failed, starting right with the people who were in the room when the very first operation happened or those who were in the room when multiple operations arising from the use of these springs had to have happened. It kills me to say this but I have such huge admiration for his tenacity - the only reason we are even standing here talking about this today and the Minister will be conducting the international investigation is because Deputy Paul Murphy would not let it go.

Otherwise, we would still be getting replies to parliamentary questions that say X, Y and Z and we would be none the wiser. Hats off to Deputy Paul Murphy. I do not agree with probably most of the things he advocates but we certainly owe him an absolute debt of gratitude for his tenacity. Otherwise, these kids would still be suffering and maybe these operations would still be going on.

I genuinely wish the Minister every success. The one concern I have is that these things tend to drag on for months. That would compound the disservice we have done to the children and families at the centre of this scandal in 2023 because that is all it actually is. I do not know how he will do it, but I ask the Minister to make sure we are not sitting here months from now with interim reports and drip feeds. He must get to the bottom of this and give all of the powers to the investigator. He must give the new gentleman who has come to help us with this all the powers he needs to uncover this as fast as he absolutely can. That is the very least we can do to try to salvage a part of our medical system that has had the spotlight on it for far too many reasons and for far too many years, mostly due to underperformance and underdelivery.

We have gotten some speed in the system in the last number of years. It is mired in a whole mess that it is now down to the Minister to sort out. I wish him well, but I ask that we do this with speed and that there are repercussions. We do things in this country - we uncover facts and learn from our findings - but there are never ever repercussions. The repercussions are bare for us to see in the botched operations and lives that will have to be lived by those little people for whom we are here to supposedly make things better. I genuinely ask the Minister to make sure that we do it fast and that there are repercussions. We need to put in place a system in future that is foolproof and does not allow fake responses to parliamentary questions and does not necessitate a whistleblower somewhere in the centre of this - thank God - to keep hounding Deputy Paul Murphy to make sure he gets to the bottom of it. The sum total of my contribution is to look for speed and seek repercussions and get a new system in which we can have confidence and the families and children who are suffering day in, day out can have confidence as soon as is physically possible.

I will explain to other Members, not that anybody sought an explanation, why I let Senator Doherty in there. Senator O'Reilly was here to second the motion and use his eight minutes. He had other things to do so he just came in to second the motion and did not use the time available to him. It was only fair that we gave that time to Senator Doherty because she was lined up to do it.

We will move to the next speaker on my list. Senator Tom Cloonan has sé nóiméad.

It is Clonan, not Cloonan.

That is okay. Some of us get things wrong from time to time.

Cuirim fáilte roimh an Aire go dtí an Teach. I spoke at the meeting of the Joint Committee on Health last week and asked questions of the chief medical officer, CMO, and the CEO of CHI. I am a parent of an adult son who had surgery in Temple Street hospital. Like so many children on that list, he had his surgery way too late. He was on that waiting list for years. This is the situation for hundreds and hundreds of other children and young adults as we speak. I am not a member of that committee. I was not aware that committee was taking place only that I met some families there and went down. Notwithstanding what I said, I have had some time to reflect on the responses given by the CMO and the CEO.

In the past week, it has been brought to my attention by all sorts of paediatric surgeons in many different disciplines that the use of non-standard devices in procedures on children is commonplace, not just in Ireland but throughout the world. For example, in the case of an eight-month-old baby who needs a stent put in his or her heart, the medical device manufacturers do not make stents for children of that age. In such instances, it is common practice for a surgeon to take an adult stent and, in consultation with the hospital management and the quality management system, QMS, to alter or modify that device to fit the small child. This is commonplace and is considered best practice throughout the world. It saves hundreds of thousands of young lives every year. We can take that practice from cardiology and make the same observations in respect of urology and every other surgical discipline. This is not an unusual or strange occurrence. It is consistent with international best practice.

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

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

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

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

Whatever I say today will be completely inadequate next to Senator Clonan's contribution. I can hear the passion in his voice because he has been through this with a very vulnerable child who had to face a number of serious surgeries. Senator Conway, when he was a child, faced some very serious and life-altering surgeries. Like Senator Clonan, he has personal experience of this. We have all been shocked to the core by the revelations. We are still grappling in the dark because we do not know what happened. It is very confusing.

I commend the Minister on appointing the UK expert and giving him very wide terms of reference to investigate this matter. To reiterate the point made by colleagues, this needs to happen as quickly as possible. These children and their families have been utterly failed by the State. It is difficult to understand what they have been though or how they can ever overcome this utter failure. Young lives have been set on a completely different course from what should have been. Their lives, their lifespan and their quality of life have been altered. At a time when these small children are supposed to be carefree and enjoying life, they have been weighed down by the awfulness of their medical condition and numerous painful and disruptive surgeries, only to be then caught up in a national scandal. It is just too much.

I urge the Minister to ensure we get answers to the questions posed by Senator Clonan, other Members, including members of the health committee and, most importantly, the families and advocacy groups. They need answers as quickly as possible. I know the Minister will do his best. We must get to the bottom of this. Faith in the system must be restored. We need surgeries to resume and we need these children and their families to be put in the best possible position after such a deeply traumatic occurrence. We must ensure this does not happen to any other families. We have talked in this House about various national scandals down through the years, but this is one of the most shocking. We are all here today because we have a deep interest in the matter and a deep desire to find out what happened. Any system failure, and there clearly were multiple system failures and cultural failures, must be identified and rectified. I look forward to hearing what the Minister has to say. I urge him to act as quickly as he can because this is an horrific vista for all the families. All of us who have young children who could possibly be facing into surgeries down the line, as well as everybody in the health service, want to be sure the most vulnerable patients in the service, these very sick children, receive the best of care and that the best possible life stretches out in front of them.

Curim fáilte roimh an Aire. Over recent weeks as this scandal has unfolded, everybody has been shocked by it. Like previous speakers, my thoughts are with the children and their families who have been affected by the scandal. Those families need to be assured now that they will get the supports they need. It is too often the case that parents of sick or vulnerable children in this country have to fight tooth and nail for services that are basic human rights, including healthcare and education.

They are often forced to go public about their children's condition, purely to get those services. That is not right. Parents have been put through the mill repeatedly by successive Fianna Fáil and Fine Gael Governments just so their children could access the basic services that they, like every other citizen, should have.

Nineteen families have found themselves at the centre of a national scandal and their children's healthcare is the subject of repeated news cycles. However, the reality is that this goes much deeper than the 19 families and the care they received; rather, it results from the decade-long failure on the part of the Government to deliver on the commitment of the former Minister for Health, Deputy Harris, to the effect that children in need of spinal surgery would receive it within four months. That Fine Gael commitment was never realised. There is almost an attempt by some to scapegoat a single consultant in this scandal, whereas the truth is that we have a complete system failure that has continued for years. The failure to provide children with pre- and after-care and the failure to reduce waiting lists have meant children's conditions are in some cases inoperable, as we have heard from Senator Clonan. It is a shocking indictment of a country as wealthy as Ireland that children have now found themselves inoperable due to delays in offering healthcare. We know that delays affecting those children who can still receive surgery make the surgery more complex and dangerous, and the recovery times are longer. Their skin, which is delicate because of their condition, is at greater risk of infection. This is a system-wide failure of the children and their healthcare.

Nobody wants to politicise the tragic situation of the families affected and all those other families who have children with spinal conditions and who have had additional stress and worry heaped on them in recent weeks regarding the care their children are receiving; however, the reality is that we are here tonight because Fine Gael has introduced this Private Members' motion to the Seanad. It is Fine Gael that has been in government for the past decade or more. It is the former Fine Gael Minister for Health who gave the commitment to the families that things were going to change. I do not see any acknowledgement of that in the Private Members' motion. The first step is for the Government to acknowledge that the commitment made was not delivered upon and put its hands up and say it is sorry for that and will change the way it does things. It is regrettable that this admission was not in the motion.

We need to know why we are hearing that consultants felt pushed to conduct more surgeries per month than they were comfortable with. Who was pushing? Consultants associated with CHI, not just the consultant under investigation, have consistently raised concerns about the lack of recovery capacity, supporting nursing staff and the availability of ICU capacity across Temple Street and Cappagh hospitals. We all know that tackling waiting lists is not simply a case of increasing the number of surgeries; you have to resource all the ancillary services, such as ICU beds and the nurses and physiotherapists. I hope the outcome of the review will shine a light on these matters and why the consultants were not listened to when raising concern that there were risks involved in carrying out so many surgeries per month in the absence of putting in place all the backup services.

That said, we do not need to wait for the outcome of the review for the Government to take action. Children on waiting lists today need care today. They need no further delay and their parents and patient advocate groups need to be assured of the quality of the care. What we need from the current Minister, Deputy Donnelly, is the putting in place of an urgent domestic plan. He did not make the commitment of the former Minister, Deputy Harris, but we now need him to put in place the urgent domestic plan across our hospitals to address the backlog. Likewise, while treatment abroad is not appropriate for many of the children awaiting treatment, we need the Minister to find a new EU partner with which to recommence the service for those for whom it is an option.

It is essential that we get the terms of reference of the independent review right. The Minister and his Department need to take ownership of that review. The HSE and CHI are the bodies under investigation, so the reviewers should be reporting back to the Minister. The terms of reference must be crafted with the advocates and families to ensure they have full confidence in the review. Too often, parents of sick or vulnerable children have to fight the State tooth and nail to realise those children's rights and needs. The Minister should not make these families fight on this matter.

The Minister is welcome. What is wrong today is that he is sitting in the chair opposite. The system in this country is totally and utterly wrong. The Minister is answerable to the House here but the people who caused this problem have swanned off or are hidden in the system. Admittedly, one was referred to as having withdrawn from surgery. I believe he is now suspended. At the end of the day, we have a system in this country that sees us, as soon as something goes wrong, wheel in the Minister, fire him and kick him out the door, whereas the people who cause the problems continue in their roles all the time. Therefore, we have a system that continues to be rotten. What is wrong is that we are able to hold only the Minister answerable. There is no oversight of anything in this country. In this regard, we could go back to the crash of the R116. There was no oversight, nothing, and nobody was taking any notice. The same applies to CHI. Surely somebody somewhere knew what was going on. Why is there not an avenue for staff to go directly to the Minister and state such a thing is happening in their hospital and that they are really uncomfortable with it? Only last week, people were screaming for the Minister to come back from Washington and answer questions here. I do not believe that by coming here today he can answer the questions. Although we have managed to scratch an itch by having him in here, ultimately the people responsible are still up the road doing their jobs, apart from one sacrificial lamb who has been isolated so far. Why was the Minister not able to walk in and fire the bloody lot of them? Why could he not do that? He is answerable but has no power over those concerned.

We have left 17 families in absolute pain, trying to figure out their future. We have politicians who want to dance on each other's graves but at the end of the day it does not answer or solve any question. We have to change the system in this country so we can hold wrongdoers to account. I do not care how senior they are. I have spent my life defending people in trade unions and their jobs but I would never have defended a wrongdoer, and neither would any trade union anywhere have done so.

Ultimately, we have a Minister in here trying to explain away something when I do not believe he is anywhere close to even getting to the start of where it all went wrong. There were people involved in purchasing, nursing and clinical tests, including blood tests – you name it. How did we finish up with a situation in which nobody opens their mouth? Perhaps my colleague Senator Clonan has hit the nail on the head in that we have what is almost a gentleman's agreement to deviate from what is required to get the job done. In this regard, Senator Clonan mentioned the heart stents for babies. If there is a need to do these things, why is there not a procedure in place? I do not ask the Minister to be responsible; I ask the Secretary General of his Department to be responsible, but we cannot question the Secretary General here in the House. We cannot ask him why he has no procedures in place.

Deputy Stephen Donnelly is Minister for Health. When I look around the Cabinet, I see Ministers with seven, eight and nine areas of responsibility. If we were running a company, we would fire the chief executive and restart from the beginning, having everybody responsible for one thing and able to oversee it. There is no oversight, and as long as there is none people like the Minister will continue to come into this House to try to answer questions that they themselves have not been able to get answers to and try to appease the political system. The political system is not where this needs to be; it needs to be in the criminal system and it requires a full investigation. When the Minister starts the investigation, covering staff from the purchasing officer to the surgeon who carried out the operation, the whole goddamn lot should be fired.

They have put children's lives at risk. They have damaged families who are trying to answer questions. There are families who are asking themselves whether their child treated properly when he or she had surgery in the past and whether he or she got one of these devices that is not clinically approved put into his or her body.

I am sorry the Minister is here. He should be off doing his job somewhere. The people who are responsible should be here but, alas and alack, our system does not allow for that. The Minister is present and he has got to answer the questions. Returning to what Senator Doherty said, all the Minister can do is make sure the inquiry is speedy and that people are identified and held to account. Holding them to account means saying "Thank you for your service and goodbye."

I do not know how we will appease the families that have been subjected to this. It is really sad, but I will not play the political game and start blaming one Government over another. The system has been rotten for years. We are being danced on by a powerful Civil Service and our Ministers are turning out to be puppets put in to answer questions. It is just not the way it should be.

I thank Senator Craughwell for that thought-provoking contribution. I call Senator Currie. I believe the Senator has the Porterstown gang in the Gallery. I have a name here. They are the Porterstown Panthers. Is that correct?

They are the Porterstown Panthers, yes.

They are very welcome. I will hand over to Senator Currie.

I thank the Minister for coming here today to listen to the debate on my party's motion. The shock is obvious. The distress is obvious. There has been a lot of focus already on the review, the need for it and the need for answers and swift action. I suppose I will focus primarily on the parents who are out there waiting for surgeries at present and are in a very dark place. They have come to me to ask the Minister today for an update and for him to outline him what his plan is in relation to the second half of this motion, namely, that the HSE "takes urgent action to make alternative arrangements to ensure children are not left waiting further for urgent surgeries".

One constituent of mine has a daughter who is three years of age. She was born with congenital scoliosis and congenital heart defects. They were put on a semi-urgent list over seven months ago. In three years, the curvature of her spine, which is now at 65°, worsened by 25°, that is, approximately 8° per year. The communication that they get is not where it should be. They cannot get an answer on when they can even expect surgery. This is traumatising for everybody involved. It is also traumatising for those families who desperately need treatment for their children. One of the questions they have asked is why the number of spinal procedures are not increasing with the number of children on waiting lists and what impact the review relating to Temple Street will have.

What is the position in respect of the €19 million investment that was made by the HSE in 2022? Can the Minister provide an update on that budget, where it stands and if he thinks it is effective? I ask because we made a promise that no child would wait longer than four months and we must stand over that. While my other colleagues will focus on the rightful shock that this matter has caused, I want the Minister to single out the parents who are in the dark at present and give them some answers.

The Minister is welcome. I suppose, at the start of the summer recess, the Minister did not think this would be an issue he would be facing in government. More importantly, it is an issue for the parents and children impacted over a long number of years who, unfortunately, are now suffering, although through no fault of the Minister.

Previous speakers mentioned the need to examine how parliamentary questions are answered by CHI. I would go further and state that not only the Department of Health but also all other Departments have outsourced parliamentary questions to State agencies and bodies. In some cases, direct hotlines are used to answer questions rather than having the relevant Minister involved. That protects Ministers to some degree but it also allows for a certain distance from oversight. That should be looked at. I am not saying that the Minister for Health has the time to be involved in dealing with all parliamentary questions, but outsourcing them to the HSE because it is the service provider gives a certain leeway to the latter and to other bodies. Across Government, that could be looked at again.

The use of springs relates to scoliosis procedures. It is part of the investigation, but concerns have been brought to my attention regarding the conduct of CHI in the context of other areas of care. I do not refer here to scoliosis but, rather, to the impact on children who have defects in their legs and who had rods, etc., inserted and to follow-up care they received. Regardless of whether that is, as others have said, due to the pressures on the system and the fact that there was pressure to get procedures done - we all want to see the maximum number of procedures performed - we do not want to see haphazard work and we do not want to see follow-up care not being provided for those who have received procedures. I have evidence, from a parent whose child was obliged to wait months and then years for treatment regarding the follow-up care received. Despite reporting that there were issues with flexion of the leg, when they finally got an appointment on a Thursday, they were brought in for a procedure on the Monday. It was welcome and fast once the appointment was obtained, but that child should have been seen the previous year. There should have been a follow-up after the procedure. I have passed that matter on to CHI. As for the impact, there was further infection. There was all sorts of things that could have been prevented if follow-up treatment had been received. That matter is separate from scoliosis, but falls within the remit of CHI. There are more issues at play other than scoliosis.

We have seen in a range of issues within the Department of Health. There are internal reviews and there is expertise sourced from outside. One of the issues in my party's Private Members' motion is why these reviews did not pick this up and the number of instances where it has occurred. I accept Senator Clonan's point on modification. That is interesting. The Senator states that there is international best practice, but in this case where an uncertified product was used, for instance, was it in their pocket or how was it brought in and how did it bypass all the different procedures that should be in place for the provision of adequate healthcare and surgery? How all this happened defies logic. It is important that we get to the bottom of this matter as quickly as possible and that we ensure it cannot happen again, not only within CHI but also across our public and private hospitals.

The Minister is welcome. He is here to deal with a very difficult subject. I acknowledge Senators Doherty and Seery Kearney, who worked with our group to put forward this Private Members' motion. It is crucial that the Minister sees that motion calls for action on the part of the HSE in the context of these families that are awaiting surgery. It really is about taking urgent action to make alternative arrangements in order that families and children are not waiting any longer. It is an extremely difficult situation that we and the Department are in.

There are multiple challenges and questions that arise. The Minister has pushed for the publication of reports.

I am aware of that. The Department has pushed for open publication of these reports on the activities in the children's hospital.

We will need to consider the steps we can take. Obviously, there will be steps taken to evaluate and examine all of the activity and what needs to be done in regard to that. That is one part of this. The other part is how we move forward without increasing the waiting list time and requiring children to wait for months and months. Are there ways we can look at this in order to move some of it forward?

We need excellence in orthopaedics. We need to know that medical devices, implants and so on have gone through all of the necessary procedures. In terms of the HPRA and so on, we know the regulations around medical devices. When it comes to clinical trials we know the time involved and how important they are in order to get to approval, including FDA approval. The process is thorough. What has occurred here is something that will require close examination.

How do we move forward from this? The Minister's insight will be appreciated. When it comes to research, there are considerations around ethics, such as ethics approval and committees. They exist in most universities which work with hospitals on research studies when they consider carrying out tests, pilots and so on. Ethics approval is required for a certain type of research. This is something separate within a hospital. We need to know the policy around ethics and so on.

The Minister has heard from many of us in regard to this Private Members' Bill. The key ask comprises two parts, namely the examination of what occurred and the actions that need to be taken. Most important is how we can move things forward for families who are awaiting surgery to deal with curvature of the spine. We will be here to listen and support the Minister on that.

I have listened to a lot of debates in Dáil and Seanad Éireann. This one has struck me as being one where my colleagues on all sides are hurt by what happened, in particular Senators Conway and Clonan. I know from speaking to party members and the Minister how deeply upsetting this is for him. He has been unfortunate in that a lot of things have landed on his desk. Most people accept he is a very good and hard-working Minister and is determined to get the bottom of this. I wish him well. I now call on him to address the House.

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

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

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

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

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

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

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

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

This moment must be a watershed moment in terms of addressing the issues in our paediatric orthopaedic services, which everyone knows have been tolerated for too long in our country.

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

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

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

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

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

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

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

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

I thank the Minister for his address. I do not think there is anybody here who doubts his sincerity, commitment, call to action and, ultimately, what will be his delivery. I thank Senators Clonan, Boylan and Craughwell, my colleagues, Senators Doherty, Kyne, Currie and Dolan, for their input, and indeed Senator Clifford-Lee.

I was thinking that I tend not to share my personal story too much. However, Senator Clifford-Lee mentioned it and she is a dear friend and colleague, somebody I am very fond of.

In 1974, when I was born with congenital cataracts, my dad had no faith in the Irish system and decided to bring me to London. He did not have the price of it but he got me to London for the surgery I needed. Had I not got that surgery back then, I would not have the limited eyesight I have today. Fast-forwarding to 2023, would you believe in the system we have today? I actually would. I believe our healthcare professionals, particularly in the area of ophthalmology, are incredible. What we have delivered as a country is incredible but there are shortcomings. What we have been discussing for the past hour is a serious shortcoming. I think of the families of those little children. I apologise for the absence of my usual free-flowing articulacy earlier on. It was because I was thinking back to when I was born in 1974 and the challenges my parents faced. We need to do better and we can do better.

The review the Minister has commissioned is a watershed moment and will make a difference. He will preside over that difference and we will make this country a better place. We will hold people accountable. I really do believe things will ultimately improve and the families who have questions that need answers will get those answers. Ultimately, the process will be different and will make a difference and we will not be in this situation in future. We will not be here in the Seanad discussing such a national scandal. I sincerely hope the Minister's belief and mine will be reflected in a result.

I commend the motion to the House. It was a very important debate and engagement. We have to ask hard questions of the Minister and he has to ask hard questions of the HSE, but ultimately, we are all here for the one reason, which is to make a difference and to ensure something like this will never happen again in our country's future.

Question put and agreed to.
Cuireadh an Seanad ar athló ar 5.53 p.m. go dtí 9.30 a.m., Déardaoin, an 5 Deireadh Fómhair 2023.
The Seanad adjourned at 5.53 p.m. until 9.30 a.m. on Thursday, 5 October 2023.
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