Stephen Donnelly (Wicklow, Fianna Fail) | Oireachtas source

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.

See this speech in context