Next is the Independent Group. Deputies Connolly and Harkin have three minutes and 45 seconds each.

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?

There was an adverse event reported in July and there was an adverse event reported in, I believe, September. Let me double-check.

When was the formal adverse event reporting used?

Does the Deputy mean when was the serious incident review kicked off?

Yes.

I believe it was kicked off in July as soon as the serious incident was notified.

I thank the Minister. I welcome that he will publish the Crumlin report on Thursday. Did it follow on from a similar event? How did it come about?

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.

In relation to-----

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?

I would need to check to see what report that was.

The Minister is not aware of it at this point. I am only aware of it through reporting by The Ditch. It related to allegations of bullying.

My advice is that it was a small note on an accreditation visit. If that is what it was, then I have not read it.

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.

Is the Deputy referring to an implementation plan for the recommendations from the Boston review?

I am referring to how CHI told us to go to appendix 1 to find the implementation plan, but there is no implementation plan.

I just do not know to which report the Deputy is referring.

From CHI. The third one.

Does the Deputy mean an implementation plan of the Boston recommendations?

I have no idea. CHI tells me to go to appendix 1 to find the implementation plan. When I go to it, though, there is none.

I am going to take it that it is the Boston review recommendations.

Has the Minister seen that implementation plan?

I would need to see what the Deputy is pointing at.

This is the report. Appendix-----

Deputy, I-----

I am not going to waste my time on it.

I am trying to answer the Deputy’s 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.

Or not.

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.

Temple Street has commissioned an external review to answer those questions. Our external review with Dr. Nayagam is looking at those questions as well.

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.

There are no medical-grade springs for children. There just are not.

Yes. I presume that information will come out.

My next question is 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 surgeon did not.

-----there is a process to do that, but that was not done in this case.

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.