17 March 2025
(10.30 am)
Lady Hallett: Mr Stoate.
Mr Stoate: Thank you, my Lady. The first witness this morning is Mr Chris Stirling. May he please be sworn.
Mr Christopher Stirling
MR CHRISTOPHER STIRLING (sworn).
Questions From Counsel to the Inquiry
Mr Stoate: Thank you.
Good morning, Mr Stirling, could you please give the court your full name.
Mr Christopher Stirling: Christopher Andrew Stirling.
Counsel Inquiry: Thank you.
You very helpfully provided the Inquiry with a witness statement, the reference for which is INQ000561670. It’s 41 pages long and dated 25 January 2025. Is that statement true to the best of your knowledge and belief?
Mr Christopher Stirling: It is.
Counsel Inquiry: Thank you very much. Just by way of professional background, and before we get to your roles and responsibilities during the pandemic, you say that by profession you’re a project manager and programme manager; is that right?
Mr Christopher Stirling: It is.
Counsel Inquiry: Over the last 15 years you have led some major government programmes?
Mr Christopher Stirling: Yes.
Counsel Inquiry: Prior to the pandemic, that included in roles at director level at the Ministry of Justice and, through 2019, at the Department of Health and Social Care?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: Two of your previous roles have what you call connections to the broader preparedness agenda, and those are that in 2014, you supported Public Health England around the National Pandemic Flu Service?
Mr Christopher Stirling: Correct.
Counsel Inquiry: And in 2015/16, you led the design of the future and now current operating model for NHS Supply Chain which included things like supply chain resilience and inventory management; is that correct?
Mr Christopher Stirling: It is.
Counsel Inquiry: During the pandemic, you played two, you say, related and overlapping roles which were of relevance to this, the procurement module, and they are, firstly, that from March 2020 to September 2021 you were programme director of the joint DHSC and NHS England Covid oxygen, ventilation, device and clinical consumables response; is that correct?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: And from April 2021 to October 2022, you were interim director of Medical Technology for DHSC?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: So very relevant to the parts of the scope of this Inquiry I’m going to be asking you about.
Just to complete the picture, is it correct that you no longer work at DHSC?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: Thank you very much.
Mr Stirling, in your very helpful witness statement, you provide, and I’m just going to look at it very briefly, a flavour of the procurement landscape of medical devices like ventilators prior to the pandemic. You say at the time the Medicines and Healthcare products Regulatory Agency, MHRA, had approximately 2 million pieces of medical technology licensed for use in the UK market, of which, you say, it was crudely estimated that around 100,000 are in regular use within the NHS every year; is that right?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: And as we have already heard, in the pre-pandemic environment it was the role of NHS Supply Chain to support trusts to source those items effectively; is that right?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: Moving into the pandemic, again, just to give us a flavour of what happened, you say that at the start of the pandemic, issues started to be experienced with suppliers being unable to fulfil demand and trusts being unable to source the required volumes of those pieces of kit through the usual channels; is that right?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: You say that led to early, small-scale, examples of trusts panic-buying, hoarding, and of instances of competition between trusts which drove up prices; is that right?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: You say that while those were initially small, there was an expectation that things would get significantly worse as stock positions and the global trade landscape, as you put it, deteriorated; is that right?
Mr Christopher Stirling: Yes.
Counsel Inquiry: Now, in clear terms in your statement you say that it appeared that the existing NHS structures, both locally and nationally, would not be able to cope effectively, and that an enhanced national-level intervention was required; is that right?
Mr Christopher Stirling: Correct.
Counsel Inquiry: What was the response to that, then?
Mr Christopher Stirling: The response from that from the department was to create number of parallel streams of activity of which the Oxygen, Ventilation, Consumables Response that I led was one of those streams.
Counsel Inquiry: Thank you. I think that was on 3 March 2020 that became active; is that right?
Mr Christopher Stirling: Correct.
Counsel Inquiry: And the scope of that programme, in terms of the key products, we’re talking, aren’t we, about ventilators and associated capital equipment, clinical consumables and oxygen; is that correct?
Mr Christopher Stirling: That’s correct. Initially, the scope was purely ventilators but that grew over time to encompass all the things you have just mentioned.
Counsel Inquiry: Thank you. I want to ask you first, please, in relation to that programme, the programme that you led, some questions about how targets were set and about how the scale of the requirements of these key products was understood. First, in your statement, you say that it was not the responsibility of the programme you led to actually estimate likely Covid inpatient numbers; is that right?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: And so what was it that your programme was responsible for estimating?
Mr Christopher Stirling: So my programme was responsible for taking the demand estimate of Covid cases and converting that effectively to a bill of materials that would be required to enable an intensive care unit to operate.
Counsel Inquiry: What you say in your statement about that is that there was significant uncertainty around trying to get to that number and that bill of materials; is that right?
Mr Christopher Stirling: There is. I think there was significant uncertainty both around what the number was, and therefore, what the bill of materials would be, but also in the early days, significant uncertainty about the treatment patterns and pathways that would be most effective and therefore what materials were required for each patient regardless of the number of cases.
Counsel Inquiry: If I may say, Mr Stirling, some of the figures you give in your statement are quite stark in terms of the requirements estimates.
Mr Christopher Stirling: Mm.
Counsel Inquiry: You say that between 12 February and 17 March 2020, the requirements estimates vary between 59,000, 90,000, and 138,000 ventilator beds. On paper, that’s quite a significant variation, isn’t it?
Mr Christopher Stirling: Indeed it is.
Counsel Inquiry: Now we’ve already heard in evidence – the Inquiry has heard from Sir Gareth Rhys Williams that there was, at the outset of the pandemic, no central list of how many ventilators were held by the NHS, what model, spec, whether they were functioning, things like that. That’s right, is it?
Mr Christopher Stirling: That’s correct. And one of the very first things that NHS England launched prior to my involvement was a survey of the ventilator estate which returned the results on the 6 March.
Counsel Inquiry: Sir Gareth told us in his evidence that there were tentative estimates by DHSC and NHS England that the NHS could have access to something like 6,000 to 8,000 ventilators, but looking at the numbers that were being communicated to you, clearly, again, demand for ventilated beds and the associated kit was looking likely to significantly outstrip supply?
Mr Christopher Stirling: Yes.
Counsel Inquiry: I want to ask you about this, because something you specifically note in your witness statement, and I’m just going to read paragraph 39 and then ask you a question about it, if I may. And that’s about these requirements estimates. You say:
“Whilst they have been subsequently published, distribution of official estimates at the time was highly restricted, even within the health system. Whilst the conclusions of these analyses were shared, typically verbally, the supporting information and analysis was not. This coupled with the uncertainty surrounding speed of pandemic progression, and efficacy of potential interventions created a highly uncertain target-setting environment.”
What can you tell us about the reasons for the restrictions on estimates?
Mr Christopher Stirling: I believe the restriction on estimates were primarily designed to reduce circulation and avoid some of those estimates reaching the public domain and causing panic.
Counsel Inquiry: What might be surprising, Mr Stirling, is that they were restricted even to somebody in your position, you’re doing your –
Mr Christopher Stirling: Yes.
Counsel Inquiry: – best at that very early stage to get from estimates to, as you say, bill of materials. Why were they even restricted to somebody in your position; do you know?
Mr Christopher Stirling: I think people were very happy to share the conclusions of those activities, and that was sufficient to enable me in my role to pursue all avenues available to increase the ventilation capacity in the country. But I think the desire was to reduce circulation, even amongst individuals such as myself, so that the prospects of any communication would be centrally managed.
Lady Hallett: I’m sorry to interrupt, I’m not following. What do you mean by restriction on estimates?
Mr Christopher Stirling: So I was shared the conclusion of the numbers, so the numbers that you’ve just read out people would tell me “We estimate that they are 59, 79, 138”. I was not able to see the documents that led to those conclusions. And so I was working from the headline conclusions rather than seeing and having access to the supporting information that had created them.
Lady Hallett: So the rationale was restricted?
Mr Christopher Stirling: So the –
Lady Hallett: Distribution of the rationale was restricted?
Mr Christopher Stirling: The logic and the modelling that had created those estimates was not available.
Mr Stoate: Right. And to be clear, we’re talking here about estimates of the number of ventilated beds so your job, how are we going to get from what we’ve got –
Mr Christopher Stirling: Yes.
Counsel Inquiry: – to what we might need. I just wanted to check with you whether there was any sort of hindrance to your work upon these restrictions on estimates. I will – (overspeaking – understand that the panic is and restriction – (overspeaking) –
Mr Christopher Stirling: Surprisingly, I don’t believe that that impeded our response. Because the numbers were all so large that they required you to do – take every and all means available to increase that capacity. And so I think, if the numbers were of a scale where you are considering whether you need to do certain things or not, then having access to the logic and the evidence may have helped us make better decisions.
As it happens, all of those targets were so far in excess of the capacity that we had at the time, that I think I can honestly say it didn’t influence our decision making as to whether we were going to pursue one route or another route. We were clearly needed to pursue all available routes.
Counsel Inquiry: Just looking to the future, do you think that fewer restrictions on not just the data but the analysis, the modelling, to somebody in your position, looking to scale up medical technology at speed, would it be useful to try to reduce those restrictions or do you think it’s not a major issue?
Mr Christopher Stirling: I can’t honestly say that that was a major issue in this sense. As a generally inquisitive person, I would have loved to have seen those figures at the time but I can’t honestly say I would have done anything differently if I’d have had them.
Counsel Inquiry: Looking at the procurement of ventilators in particular, you do note in your statement that the word “ventilators” does cover or is often used or misused in the coverage of a lot of different types of treatment. We are hearing from Professor Moonesinghe later today who is probably better placed to cover that, but just for context, we’re talking about a range of oxygen therapy treatments to support Covid patients, aren’t we?
Mr Christopher Stirling: Yes.
Counsel Inquiry: In terms of the purchasing environment pre-pandemic, what you tell us is that before we got to the pandemic, getting a new intensive care ventilator was typically, is this a fair characterisation, a fairly long and slow process?
Mr Christopher Stirling: Absolutely.
Counsel Inquiry: Deliberately and by design?
Mr Christopher Stirling: Indeed.
Counsel Inquiry: Can you set out the main steps.
Mr Christopher Stirling: Typically a trust would identify that they had a need, either because they were creating new intensive care capacity or existing devices were reaching the end of their life. Clinicians would usually engage in a reasonably lengthy testing and assessment process, normally involving getting physical test devices from suppliers, forming a set of testing and evaluation criteria. A specification would be developed, a procurement process would then ensue. Once that had completed, a contract would be let, and a reasonably extensive training, familiarisation and onboarding process would then take place. For a trust adopting a new make or model of ventilator, this process could easily take a year or 18 months.
Counsel Inquiry: It hardly needs saying, I suspect, that you didn’t have that kind of time when it came to the start of the pandemic. How would you describe the changes to that procurement process amid, as you say, “a compressed timescale, amid a global stampede of demand”. What were the key changes that you had to …
Mr Christopher Stirling: I think there were changes that we made and there were also changes that the market and the environment made for us.
Counsel Inquiry: Yes.
Mr Christopher Stirling: I think the predominant change we had to make was we were buying at a distance. We were often buying devices that we had never physically held in our hands before, and we were buying from specification.
We were also initially engaging with a large range of intermediaries who had come into the market at that time, and the nature of the market demand was such that this was often a cash-up-front make a decision within hours, otherwise someone else will buy the device.
So the normal process of challenging suppliers and checking “Does your device do this? Can it do that? How does it respond in this situation?” was not available to us, and we had to largely buy off-paper specifications at a distance.
Counsel Inquiry: So you’ve gone from literally months to hours, effectively, in some cases?
Mr Christopher Stirling: And in some cases, minutes.
Counsel Inquiry: One other change, we’ve already touched upon NHS Supply Chain procurement. You note in your statement that it was NHS Supply Chain that held a number of standard framework agreements for the provision of ventilators. I was interested by the aspect of the timeframe on that. You say this:
“From programme inception on 3 March, requests for availability went to suppliers on 4 March, first contracts were placed on 9 March and this route was largely exhausted by 12 March.”
So in a matter of days, the normal NHS Supply Chain route for the provision of these ventilators was just – had evaporated?
Mr Christopher Stirling: I think that should also be taken as a success of NHS Supply Chain.
Counsel Inquiry: All right. Why do you say that?
Mr Christopher Stirling: They provided, I think, close to 40% of the devices that we ended up using. All of those devices had previously gone through extensive testing and due diligence and had commercial value-for-money benchmarks on them, so we weren’t paying Covid premiums for those devices. And they were able to very quickly deliver. So you could say it would be lovely if they had been able to deliver all of the requirements, but we were able to get, I think it was, 38/40% of our intensive care ventilators that we ended up purchasing through that route in a very secure way very quickly. So I think those dates and that speed is an example of the supply chain procurement process working really well. The problem was that it couldn’t give us everything that we needed.
Counsel Inquiry: It couldn’t meet the demand?
Mr Christopher Stirling: Couldn’t meet the demand.
Counsel Inquiry: One of the strategic issues – in your quite reflective statement you talk about some of the lessons you’ve learned about strategic issues facing medical technology, and you say that one of your key lessons learned from the pandemic experience is that:
“NHS Supply Chains needs to either be given a clear mandate (and associated funding) to act as ‘supplier of last resort’ or not. At present, it is not commissioned to do this, but should issues arise, is expected to do these.”
In the context of answers you’ve given there, could you just expand on why you say that and what your lesson learned is about NHS Supply Chain here?
Mr Christopher Stirling: Well, NHS Supply Chain is designed effectively as an opt-in service that trusts can choose to use or can choose to do different things if they wish. There is no part of NHS Supply Chain which is designed or scaled to act as a provider of last resort.
Counsel Inquiry: And just to be clear, what is it you mean by that?
Mr Christopher Stirling: So when the – when NHS trusts go to NHS Supply Chain, they go and say, “I would like you to get this for me.” And in the relationship between trusts and NHS Supply Chain, there is no commitment or no guarantee from NHS Supply Chain that they can supply those items.
NHS Supply Chain is set up as effectively a best endeavours service: “We will try to get you those items if we can.” It’s not set up as a service where we are guaranteeing, as NHS Supply Chain, to provide those items to you.
They could provide that function, but they’re not currently financed, scaled or resourced to provide that function. The problem was, in a pandemic, all of the NHS trusts suddenly turn to NHS Supply Chain and say, “Please give me these things”, and NHS Supply Chain demand suddenly goes through the roof and they’re not scaled, planned, expecting to deal with that scale of response.
Counsel Inquiry: Thank you very much.
One of the workstreams we’ve heard about and that you alluded to earlier was the call to arms and we’ve already heard from Sir Gareth Rhys Williams about that. You do – just in relation to that, you do make the observation, in your paragraph 66, that you recall saying to Steve Oldfield at DHSC that you:
“… saw no reasonable prospect of achieving the demand projection using the standard projection/NHS Supply Chain means, and that to materially improve our current projection, we would need significant additional support from across government.”
Is that right?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: So we heard about the make drive, we’ll be discussing later with another witness some of the work of the FCDO.
Mr Christopher Stirling: (Witness nodded)
Counsel Inquiry: Foreign and Commonwealth Office, which was mobilised to support the purchase of ventilators from overseas. You also note that the Ministry of Defence was tasked to offer additional support on procurement, logistics and transportation; is all that right?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: You make this point: that on 25 March, your department and NHSE issued guidance to trusts setting out the scope of the national procurement effort and in effect asking them not to buy ventilators directly; is that right?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: Why was that done?
Mr Christopher Stirling: Partly it was done to try to avoid trusts competing with each other and with us to procure ventilators. At the time, intermediaries and suppliers who had devices were very keen to offer them to as many different people as possible, in order to drive the price upwards, and we were actively discouraging throughout the entirety of March trusts from seeking to engage directly with suppliers and intermediaries.
So I think the guidance that was issued on 25 March really formalised the position that had in fact been in effect from significantly earlier, if not from the start of that month.
Counsel Inquiry: In terms of offers that came through UK-based suppliers, you say, your paragraph 75, that you and your programme were:
“… given a clear steer from ministers in line with agreement from [the Treasury], that the primary consideration was ensuring capacity to save lives over value for money.”
Is that right?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: So the Inquiry has already heard from the chief secretary to the Treasury at the time, Mr Barclay, about how that applied to PPE; possibly, for obvious reasons, that clearly applied to your programme too, did it?
Mr Christopher Stirling: Yes.
Counsel Inquiry: You make this observation:
“In this context, decision making was dominated by confidence and delivery risk, rather than price considerations.”
Could you just give us a slightly more simple explanation of what that means?
Mr Christopher Stirling: I think that means we accepted that we were going to be paying over the pre-pandemic price for all goods, and typically, we often paid up to double the pre-Covid price for items. That is not to say that price did not have any impact upon our decision making, and there were many items that we were offered that were at, you know, 10, 20, even 50 times the pre-pandemic price, which we chose not to pursue.
Counsel Inquiry: So if and when the Inquiry looks at the question of what was spent, value for money, those types of key procurement questions –
Mr Christopher Stirling: Yeah.
Counsel Inquiry: – there was some measure of control exercised, was there?
Mr Christopher Stirling: Indeed, and I think, you know, the average price of the ventilator that I think we purchased through this initiative was £22,000 for an intensive care ventilator. The pre-pandemic norm for that was around £15,000. So we did pay a Covid premium, but we didn’t pay exorbitant or extortionate amounts of money to secure stock at any price.
Counsel Inquiry: Thank you. I’d like to ask you some questions about clinical due diligence, if I may. Now, appreciating you’re not a clinician, you’re very clear about that, but you’ll understand that it was obviously an important part of the procurement process, wasn’t it, for –
Mr Christopher Stirling: Indeed.
Counsel Inquiry: – a machine like a ventilator that has such obvious implications in terms of clinical safety? In terms of clinical due diligence you say that once machines and equipment came in, is this right, they came to MoD Donnington where they were quarantined and it was a team of clinicians who undertook a clinical due diligence process?
Mr Christopher Stirling: Yes, there were two stages to the final process.
Counsel Inquiry: Right.
Mr Christopher Stirling: For all new items that had not previously been used in the NHS, they would arrive at MoD Donnington, they would be unpacked, and there was a clinical due diligence team with clinicians, and they would unbox a sample of the devices. They would check for obvious damage, and also check that all of the necessary components were there, and identify any issues with the devices that they could tell from a visual inspection. Things like, you know, we need an adaptor for this thing, we need a different type of oxygen sensor, it doesn’t come with an expiratory block, we need to include one of those. We would then seek to rectify those issues and the devices would then be sent to either MD-TEC in Birmingham.
Counsel Inquiry: With Professor Clutton-Brock?
Mr Christopher Stirling: Indeed. Or to Nottingham with Dan Clark. They would test the devices in a lab environment, you know, connecting them up to sensors, simulation equipment, to assess their performance, and they would put the devices in one of four distinct categories. And that was the end process. That process was not in place on day one. That process was in effect in there from about, I think, week three or so. So one or two devices did arrive before that process had been set up –
Counsel Inquiry: Right.
Mr Christopher Stirling: – which we may come to –
Counsel Inquiry: I suspect we may come to. But looking at those outcomes, then, at risk of dwelling too much on figures here, I would like to know, there are – you say there were four different outcomes. So once you’ve – you’ve unpacked it, you’ve remedied the immediate issues, and then there are, is this right, four –
Mr Christopher Stirling: So the four outcomes are after the second – (overspeaking) –
Counsel Inquiry: – understood. Outcome 1: de-quarantine the device and release them into the allocation process without further guidance. Is that right?
Mr Christopher Stirling: Correct.
Counsel Inquiry: That’s the hope, presumably, that’s the best outcome?
Mr Christopher Stirling: Yes, although, frankly, these are very complicated devices.
Counsel Inquiry: Of course.
Mr Christopher Stirling: And very few of those devices would require no further guidance whatsoever.
Counsel Inquiry: Understood, although you say that accounted for four of the new models of ventilators purchased and assessed by your programme – yeah?
Mr Christopher Stirling: Correct.
Counsel Inquiry: Outcome 2: de-quarantine and release into the allocation process, as you say, accompanied by some guidance, a guidance note, about what you call “necessary workarounds to assist in safe operations”. What does that mean, please?
Mr Christopher Stirling: That means that we were able to deploy them, but there was a set of guidance notes that went out. Now, those guidance notes could have been as simple as, I remember for one device, the power button was in an unusual place on the back of the device, and the guidance note literally was “The power button is where you don’t expect it”.
Counsel Inquiry: Right.
Mr Christopher Stirling: You know, it’s of something that’s of no real consequence. And indeed, some of those ranged to more complex feedbacks saying, you know, “This setting works like this rather than like this, and if you’re going to do this, you probably need to do that as well.”
Counsel Inquiry: Right.
Mr Christopher Stirling: And some of that is more complicated, some of that is more simple, but these are, you know, green lighted to go out into the system as a result of that testing process.
Counsel Inquiry: With a note attached?
Mr Christopher Stirling: With a note attached.
Counsel Inquiry: Again, that’s another four of the models purchased through the programme; is that right?
Mr Christopher Stirling: Yes.
Counsel Inquiry: Outcome 3:
“Hold the device in quarantine pending supply of additional components, communications, or resolutions to issues identified.”
That might be obvious. “It looks okay, but we haven’t got the right pipes,” or something like that.
Mr Christopher Stirling: It could be that, or we haven’t got the right oxygen sensor, or actually, the training manual needs these things to be clarified, and there is work to do before we can safely distribute and deploy these devices.
Counsel Inquiry: That was six models?
Mr Christopher Stirling: Yes.
Counsel Inquiry: Finally:
“Do not release the device into the allocation process”.
Mr Christopher Stirling: Yes.
Counsel Inquiry: Reasons of safety, presumably, clinical concern?
Mr Christopher Stirling: Or that there were potentially issues that we didn’t believe we could address in a reasonably quick or easy timeframe.
Counsel Inquiry: In time, understood. And that was two?
Mr Christopher Stirling: Yes.
Counsel Inquiry: Two models.
Mr Christopher Stirling: Yes.
Counsel Inquiry: Importantly, you say in terms of the spend on these models, outcomes 1 and 2, they were what you were hoping for, presumably?
Mr Christopher Stirling: Yes.
Counsel Inquiry: That covered 92.5% of the device spend, did it?
Mr Christopher Stirling: Correct.
Counsel Inquiry: Outcome 3 was 3.7%, and outcome 4 was 3.4%. Significantly smaller figures. What, Mr Stirling, did the figures, in terms of the categories that these new devices ended up in, tell just, in your view, about the overall value of – value for money of the programme?
Mr Christopher Stirling: I think in terms of our ability to secure appropriate quality advices, I think it shows that we overcame the challenge of trying to buy at distance reasonably well. You know, we were buying off a specification off a piece of paper, and when the devices turned up, and we then put them through a test process –
Counsel Inquiry: Yes.
Mr Christopher Stirling: – some of them didn’t do what we wanted them to do, but the majority of the money we spent was on devices that did what we were expecting and hoping they would do.
Counsel Inquiry: That were safe and useable within the NHS context?
Mr Christopher Stirling: And were deployed into and then used by the NHS.
Counsel Inquiry: You note that as part of the initial surge response, as you call it, trusts were requesting, again, perhaps for obvious reasons, that your programme send them ventilators as quickly as possible.
Mr Christopher Stirling: Yes.
Counsel Inquiry: You say at that point speed of arrival was their overwhelming priority in order to build capacity ahead of expected demand.
Yes?
Mr Christopher Stirling: Yeah.
Counsel Inquiry: And in line with that priority, your initial operating process was to deliver to trusts without undertaking any additional testing or checking process steps. Is that what you were saying, is that that three-week period before those –
Mr Christopher Stirling: Agreed, yes. So in the very early weeks, the pressure from trusts was to deliver devices to them directly, and in that period, we had not yet set up the testing processes –
Counsel Inquiry: Understood.
Mr Christopher Stirling: – and systems. So for a very small number of devices that arrived in those first weeks, they were delivered to trusts without the testing and checking process that we’d just gone through.
Counsel Inquiry: You say that for devices that trusts were familiar with, generally that was fine, I think, is the –
Mr Christopher Stirling: Yes.
Counsel Inquiry: – the tenor of your statement. Clinical and engineering teams understood them, had previous experience, and they could deal with any anticipated challenges.
But you say that for devices that were new to trusts or, indeed, new to the NHS that approach created a variety of issues –
Mr Christopher Stirling: Yes.
Counsel Inquiry: – from the relatively straightforward but time consuming, things like the wrong plug or the wrong connector, through to what you call “deeper concerns about device quality and safety”; is that right?
Mr Christopher Stirling: And I think there I am principally referring to the Shangrila devices, which I’m sure you will come to.
Counsel Inquiry: We will. You’ll understand that the context for these questions, Mr Stirling, is that the Inquiry has received a number of statements from across the NHS and representative bodies, some of which, you will have seen, do –
Mr Christopher Stirling: Yeah.
Counsel Inquiry: – raise concerns.
I want to look first, please, at INQ000536367.
This is the witness statement of Ashley Shaw, the medical director of Cambridge University Hospitals NHS Foundation Trust. Paragraph 28. I’m just going to read it to you if I may, Mr Stirling.
“Adult critical care ventilators were provided by the government which were a completely new model to the Trust. While initial support for the installation and training of these devices was provided there did not appear to be long-term plans in place in relation to ongoing training, maintenance, spare parts and consumables provision. Many teams had to take the minimal training materials and train themselves in the specific nuances of the devices, based on previous experiences. In addition, many of the devices and consumables came from China, and the instructions for use and associated documentation was accordingly in Chinese. On occasion, DHSC/NHSE endeavoured to obtain translations of the documentation, but these varied in quality.”
Before we get to any specific devices, do you recognise those types of issues arising? Did that of feedback reach you and your team?
Mr Christopher Stirling: I absolutely recognise the issues, and initially we did not have long-term support and maintenance plans in place. Over time, they were put in place, as you would expect, but the initial focus was very much on securing the capacity and then providing those support arrangements subsequently.
There is a reference here to “minimal training materials”. I think that is very fair. I think we need to put that in context though, in that normally the training process for a new ventilator device would be very extensive and that in the time and pressure that trusts were under, clearly we were not able to undertake that degree of training and familiarisation that we all would have liked. I think the training materials themselves improved over time, largely due to feedback from trusts.
So I very much recognise these issues. I think we worked to try and address them, but certainly on day one, a lot of these things were not in place, as you – well.
I think this statement – this is Cambridge, isn’t?
Counsel Inquiry: Yes.
Mr Christopher Stirling: So they predominantly took a device which had a long-time support relationship from Ortus, and so those things appeared but were not there on day one.
Counsel Inquiry: Before we turn to any specific devices, I want to give you a chance to set the context, because in your statement you say as follows – it’s your paragraph 122 if you need the reference:
“It is important to recognise that ventilators are highly complicated technology devices requiring regulator support and maintenance.”
That was the focus of that paragraph there, wasn’t it, from Dr Shaw?
Mr Christopher Stirling: Mm-hm.
Counsel Inquiry: You say this:
“As such, it is not unusual for devices to encounter problems and there were, and continue to be, a regular stream of upgrades, safety notices and refinements to instructions etc, regardless of product quality. Similarly, product recalls are not uncommon, and typically reflect clinicians’ and suppliers’ desire to reduce potential risks, however small they … be.”
Yes?
Mr Christopher Stirling: Yeah.
Counsel Inquiry: So we will bear that in mind when we look at these devices. You’re effectively saying people are hypervigilant about safety in such complex advices and in the context in which they’re used; is that –
Mr Christopher Stirling: That’s correct. And also, I think – I think it’s important to recognise that many of the safety notices that are published are examples of suppliers being diligent, and making sure that they are flagging potential risks. I’m also aware of some perception that if you have a high number of safety notices related to a device, that that device is therefore unsafe. It is often, actually, on the contrary: what that is showing is that the supplier is being extremely diligent in publishing and communicating any potential issues about devices.
Counsel Inquiry: All right. Well, we’ll take that as background context when we look at the device you mentioned earlier known as the Shangrila 510S. Yes?
Mr Christopher Stirling: Yes.
Counsel Inquiry: I want to turn up, please, first, INQ000520831.
This is the witness statement from another trust, Mr Stirling. This is Toby Lewis, chief executive at the time, of the Sandwell and West Birmingham Hospitals NHS Trust.
Paragraph 6:
“Our need for ventilators had been duly registered in the submissions made to NHS Midlands. Our projected figures were wholly consistent over time, and consistent with our agreed plans. Until the time specified in the following paragraph [which we’ll come to], I had no forewarning of who, how, or when decisions about allocation or specification would be made. This made it difficult to prepare teams of staff for receipt or manage their understandable anxiety about our future readiness.”
In respect of ventilators, yes?
Just pausing there, one of the things that you note in your statement and one of the key parts of your programme was communications; is that right?
Mr Christopher Stirling: Correct.
Counsel Inquiry: You say:
“A key aspect to the programme was communicating positions to Trusts both directly and through regional networks.”
Yeah?
Mr Christopher Stirling: (Witness nodded)
Counsel Inquiry: This here, I don’t want to be unfair but it looks like an incident, doesn’t it – an instance where communication with a particular trust was less effective than it might have been, to put it neutrally?
Mr Christopher Stirling: Agreed.
Counsel Inquiry: Was that something that you were able to improve over time, overall communication with trusts about what they’re getting, when they’re getting it, who made the decision and why?
Mr Christopher Stirling: I think the allocation process worked predominantly with regional stakeholders, and regional stakeholders managed the majority of the communications to individual trusts. Our team would deal with individual trusts around specific delivery arrangements and specific issues and challenges, but the majority of the request allocation process was dealt with at a regional level.
We published on a daily basis the lists of devices and the inbound schedule of devices that we were to receive, and trusts would engage with their regional teams about their requirements and put in, effectively, requests for devices from those.
Now clearly in this example that communication has not worked as effectively as it should. I perceive that generally it worked better than this particular example would demonstrate. I think it also got better over time, and there were a number of significant communication activities to representatives from all trusts saying, “This is how we are working, this is what we are doing.”
Counsel Inquiry: All right.
Mr Christopher Stirling: I think there is – also, the last point here is I think probably, in my view, the most important one: we were, through this point, not having sufficient stock to meet all of the requests that we had in. And I think somewhere else in this statement the author refers to it as a just-in-time model. We would love to have had sufficient quantities of devices to not operate a just-in-time model, but unfortunately the reality of our stock position and the number of demands that were coming in, is that we weren’t able to do that.
Counsel Inquiry: Moving on to the specific advices, we can see at paragraph 7 on the screen:
“On 6 April, 2020, we received ventilators, which we had been alerted to on [the 3rd].”
“8. We received 30 Shangrila 510 ventilators … directly sourced by DHSC/NHSE … from the Chinese supplier …”
And delivery came, as you said, through MoD Donnington.
The point made in the next paragraph is that:
“The scale of [that] delivery made to the Trust was 25% less than we had asked for and required for our approved plan.”
Again, what’s said there is that it was unclear how this decision had been made or by whom. I think you may have covered that in your last answer.
Mr Christopher Stirling: I think we frequently delivered people less than they asked for, but we believed we always delivered them more than they needed. And I think later on in this statement that point is echoed about the trust having sufficient ventilation capacity.
In terms of how the decision has been made, we operated a process of daily device allocation panels which were chaired by Professor Keith Willett, and had regional representation, typically regional medical directors or their delegates representing the requests and needs of their region.
Counsel Inquiry: If we could go over to paragraph 11, please.
“On receipt [this is of this particular device], our engineering and clinical team sought to assess the functionality and capability of the equipment received. Limited information was available to work with. Initially the Shangrila ventilators were unusable as supplied, as the oxygen piping/connectors were not UK standard, the oxygen fuel cells were unusable without modification, and the supplied breathing circuits were multi-use but had no sterilisation instructions. There was no UK representation of the parent company and no one we could obtain advice for consumables from. We then invested significant time modifying the ventilators so we could even test them in our engineering workshop, let alone use them on a patient. We also invested significant time trying to construct a disposable breathing circuit that could safely be used by utilising available components from assorted UK suppliers.”
And over at paragraph 14, please.
“The delivery of ventilators we received came with just two days of consumables necessary to use such ventilators and no information about future consumable supply. This, in addition to the underlying issues above, meant that we were unable to plan to use the ventilators to the extended extent. Any use of the machines was exploratory and under close senior clinical supervision over the latter part of the week commencing April 5 …”
Clearly, Mr Stirling, quite significant concerns from the clinician’s –
Mr Christopher Stirling: Indeed.
Counsel Inquiry: – point of view. What is it you want to say about this particular device, why it ended up where it did and what was done to address those concerns?
Mr Christopher Stirling: So this was the very first device that arrived.
Counsel Inquiry: Right.
Mr Christopher Stirling: And it arrived prior to the establishment of the testing processes and, as we talked about before, was delivered straight to a trust without having gone through that test. It was a device that was from a new supplier, new to the NHS. It was also a transport ventilator which we thought could potentially be used in an intensive care environment.
I think it’s also important to say that the device itself is extensively used in other parts of the world, particularly in China and the Far East, and is from one of their very reputable ventilator manufacturers.
The specification for the device had been given to clinicians to see whether they believed it could fulfil a need, and on the basis of the paper specification, we had decided to procure these devices.
These were also very low-cost devices. As I mentioned earlier, I think the average price of an intensive care ventilator we bought was £22,000 a unit. I think these devices were around £3,000 a unit. They were purchased on the basis that we were currently at that point in time projecting to be incredibly short of devices, and looking to see whether devices such as this could fulfil a gap in an emergency.
The feedback we got from the West Midlands from their testing evaluation of this device was very disappointing. And I think that was communicated to Professor Moonesinghe, who you’re seeing later, on 12 April, and the ventilators were withdrawn from the allocation process and re-called on 13 April.
Counsel Inquiry: Yes. And, in fact, if we look, please, at INQ000514215 – I’ll show you that page, that’s your name and the date of 13 August 2020?
Mr Christopher Stirling: August, yeah.
Counsel Inquiry: If we go up to the top, please, the first page. We don’t need to go into any detail here but we can see this is a note from you called “Shangrila 510s Cancellation Refund Position”. So by August you were seeking to cancel the orders, which you describe as now surplus to requirements, and if this recommendation, your recommendation, is that right, Mr Stirling, was accepted, DHSC would expect to receive a refund in the sum of 2.8 million and make a loss of approximately 1.2 million on that transaction?
Mr Christopher Stirling: That’s correct. There are some things between then and this letter that probably should be noted.
Counsel Inquiry: Okay.
Mr Christopher Stirling: We immediately worked to cancel down future orders.
Counsel Inquiry: Yeah.
Mr Christopher Stirling: We then subsequently put this device through the testing process that we discussed earlier.
Counsel Inquiry: Mm.
Mr Christopher Stirling: And it is one of those two devices that ended up in outcome 4.
Counsel Inquiry: Didn’t make it.
Mr Christopher Stirling: The least preferred outcome.
Importantly, we also used that process to understand whether there were any discrepancies against the specification, things that we could go back and say to the manufacturer “Your device did not do what it was supposed to do.”
And importantly, the conclusion from the test lab was that whilst they were equally disappointed with the performance, there was no smoking gun that they could say, “It didn’t do this, therefore you can, you know, have a contractual recourse of some nature.”
Therefore, we engaged with the manufacturer of those devices and sought to negotiate a refund, and I think further down in this note I think it says they offered us I think it was a 70% –
Counsel Inquiry: Yes, exactly that.
Mr Christopher Stirling: – refund.
Counsel Inquiry: Yes, we don’t need to go in detail to the note but you achieved, and one of the documents you provide in your statement suggests that that was in fact received, not long after. So a 70% refund was achieved.
Importantly there you say you used – did you use the learning from that experience to try to –
Mr Christopher Stirling: I think this, as the first device to arrive, was instrumental in helping us set the processes up.
Counsel Inquiry: Right.
Mr Christopher Stirling: To make sure that future devices, as they arrive, were properly tested, no matter what the pressure from NHS trusts to receive devices promptly might have been.
Counsel Inquiry: Thank you. I want to look very briefly, please, before we break, at issues which arose around another device and how you sought to tackle those and the learning that was taken forward there. This is the UCL Ventura, a continuous positive airway pressure, or CPAP, form of oxygen therapy; is that right?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: You tell us that early work for that device had been carried out as part of the Ventilator Challenge, about which we’ve already heard, but it ultimately didn’t come through that process. Can we look, please, at INQ000514162.
This – yes.
Mr Christopher Stirling: Yes, I recognise this.
Counsel Inquiry: You recognise this. Very good. This is your submission for the purchase of these devices, is that right, in treating Covid-19 patients?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: Could we go to page 4, please. Can you see under this, I wanted to briefly ask you about this – let’s set the context. There’s a CPAP device, you’re recommending in this document that they are purchased; is that broadly it?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: Under the heading “Publicity” at paragraph 22 here:
“The Chancellor of the Duchy of Lancaster has already announced (31 March) that the NHS has already ordered a quantity of these devices. This was in line with the ongoing contractual discussions at the time.”
Can I ask you, did the fact that that had already been announced in any way affect your decision to recommend the purchase? This wasn’t, was it, procurement by press release in some way?
Mr Christopher Stirling: No. We had already – the contractual paperwork, including this formalisation submission, took a while to complete, as these things do, and so we had previously discussed and engaged in discussions with UCL around our intention to buy these devices. So I think this is a press release getting slightly ahead of factual, and I think if he had announced that we intended to, or that we were planning to, or working with UCL to, then he would have been absolutely spot on. At that point we had not technically ordered the devices or placed the contract to do so.
Counsel Inquiry: I want to know whether this created any form of ministerial pressure that led to some of the later issues?
Mr Christopher Stirling: I don’t think this created any pressure or influenced the decision in any way, shape or form. It was something that we were committed to working towards, and this is the submission that formalises that.
Counsel Inquiry: Thank you. That’s very clear.
If we just look at paragraphs 19 to 21 then briefly, this is under the heading over the page “Risks”, is what’s headed above there.
Some risks were noted, weren’t they, in relation to this device, which you’ve clearly set out?
Mr Christopher Stirling: Agreed, although these are not risks that are exclusively associated with this device.
Counsel Inquiry: Absolutely.
Mr Christopher Stirling: Risks with all CPAP devices. And indeed, one of the key benefits of this device was that it used less oxygen than some other CPAP devices, even though in relative terms, that is still quite a lot of oxygen.
Counsel Inquiry: You say:
“Whilst oxygen systems have alarms designed to prevent this happening …”
So trusts’ systems failing, we can see in 19.
Mr Christopher Stirling: Yeah.
Counsel Inquiry: “… even relatively short interruptions in supply could have significant patient safety impact.”
Again, for quite obvious reasons.
“To mitigate this, extensive work is being done with Trusts to ensure that they understand, and work within, their oxygen flow constraints. Devices will be appropriately labelled and contain significant warnings to ensure that they are only used in the appropriate situations.”
So that was what you noted. Unfortunately, what we can see from one trust is that that labelling and warning became one of the issues with this device, didn’t it?
Mr Christopher Stirling: I think the labelling was always more restrictive than the usage authorisation.
Counsel Inquiry: I see.
Mr Christopher Stirling: So there were three labels at different times that should have been on these devices.
Counsel Inquiry: Can I pause you there, Mr Stirling, if I may?
Mr Christopher Stirling: Yeah.
Counsel Inquiry: Let me put the context for that question and then give you an opportunity to answer it in a way that you may have just been about to.
The context for this question is another trust statement, I think the last I’ll refer you to. This is the Royal Surrey NHS Foundation Trust.
Lawrence, please INQ000512921, paragraph 6.6.
It’s the statement of Louise Stead and Jacqui Tingle of that trust.
“… [DHSC] provided us with …”
And then a number of different figures are given about different devices. We don’t need to go through all them but there’s ten of a GE device, 80 Flo-Ox oxygen monitors, 26 VisionAire 5 portable concentrators. And in the middle there, we see 80 of these UCL Ventura CPAPs that you and I are discussing.
What Ms Stead and Ms Tingle say is that:
“Other than the Visionaire 5 Portable Oxygen Concentrators, these devices were not used, primarily due [to] safety concerns of non-standardised devices, lack of appropriate consumables, and no competency training for clinical teams. For example, the UCL ventilators had labels advising they should not be used for clinical use.”
That’s quite the restrictive label.
Mr Christopher Stirling: I’m not sure that is the complete text of the label.
Counsel Inquiry: All right.
Mr Christopher Stirling: So my recollection is that there were three labels. The first label said, “For test and evaluation purposes only”, which was the most restrictive of the conditions, and that was to enable the devices to be used specifically in line with MHRA testing requirements.
The second label said, “Should not be used for clinical use outside of the pandemic.”
And I think this may have chopped the last few words of that only.
Counsel Inquiry: All right.
Mr Christopher Stirling: Because MHRA exceptional use authorisation, once granted, had been given for Covid-19 patients only.
And the third label was a general “You can now use this for anything” label in line with the standard things.
The normal process for re-labelling devices is that you recall all of the devices, get them sent back to you physically, you change the label on the device yourself, and then you send the device back out.
Given that in many cases these devices were being used for patient care, that was clearly inappropriate to do that, and it was agreed with MHRA that we should have a modified process where we sent the labels out to the trusts for them to over-label the devices.
Clearly in a pandemic environment, re-labelling the devices was unlikely to be the trust’s priority action, and I’m aware that many of those devices were not re-labelled and so effectively had, potentially, an earlier label rather than an older label – I said that wrong.
Counsel Inquiry: The next witness from whom we’re hearing, or one of the next witnesses, I should say, as you’re aware, is Professor Ramani Moonesinghe.
I want to bring up one paragraph of her statement, please.
INQ000518349, page 31, it’s paragraph 115.
And just to conclude this section of questions before, my Lady, if we may take our break, Professor Moonesinghe will tell us, I’m sure, that she had quite a significant role, didn’t she –
Mr Christopher Stirling: She did.
Counsel Inquiry: – in deciding which bits of kit and in particular which ventilators and associated consumables were procured and weren’t. She says this:
“Although the target number of machines was achieved, the quality of the machines and their suitability for use in the NHS, to treat Covid-19 or other conditions was variable. There were also shortages of other essential items, including some medicines and consumable items. These limitations meant that clinicians were not always able to treat patients with their first choice of interventions.”
Now, on clinical choice, you might be happy, everyone might be happy to hear is my suggestion is that we deal with that after we have had a break because I suspect there is a bit to say, Mr Stirling, but on the quality of what was procured, Professor Moonesinghe’s view is it’s variable and that certainly seems to be the flavour of the statements I’ve put to you.
Mr Christopher Stirling: Mm.
Counsel Inquiry: Do you agree with that conclusion?
Mr Christopher Stirling: I think it clearly was variable. The simple reality was, we would have loved to have only procured the highest quality equipment all of the time, but we were simply not able to achieve the targets by doing that, so we had to look for alternative sources, and I think if you go back to the Cambridge statement from earlier, they ended up with a mixed fleet of Servo devices that they had originally, and devices that we had procured for them. I don’t think there’s any doubt they would have much preferred to have had an entire fleet of their first choice Servo devices. I would have, if I was in their position. However, we were not in an ability to supply that, so we had to supply other devices that were not necessarily as fully functional, and didn’t have all of the features that their first choice device would have done. I think that’s reasonably self-evident.
Counsel Inquiry: Do you think this variability in quality was a result of having to procure in such large numbers at such speed?
Mr Christopher Stirling: Yes. Clearly if we’d have had, you know, ten years to build up the numbers that we needed, we would have been able to operate differently and secure more first choice devices for trusts.
Mr Stoate: My Lady, just before we turn to the next topic, that might be a convenient moment.
Lady Hallett: Certainly. You were probably warned that we take a break but I promise you we will finish your evidence before lunch.
11.45, please.
(11.29 am)
(A short break)
(11.45 am)
Lady Hallett: Mr Stoate.
Mr Stoate: Thank you, my Lady.
Mr Stirling, I’d like to turn now, please, to some questions possibly foreshadowed by the last answers you were giving about allocation of goods and the question of clinical choice, in other words, did the clinicians get a choice? To what extent did they get that choice, and how was that challenge addressed?
You say in your statement that an allocation process was developed to ensure that the devices we’ve been discussing were appropriately and fairly distributed. Yes?
Mr Christopher Stirling: Correct.
Counsel Inquiry: Could you talk us through that – what process was developed?
Mr Christopher Stirling: So the process worked as follows: we would distribute to trusts via regional teams a list of the ventilation devices and equipment that we had available, together with a projection of our incoming stock, so they could see what was coming down the line.
Counsel Inquiry: What you had and what was coming?
Mr Christopher Stirling: What we had and what was coming.
Counsel Inquiry: Yeah.
Mr Christopher Stirling: Yeah. And obviously in the pandemic environment we didn’t always get what was coming exactly right but at least we had an idea of what was coming.
Trusts were then invited to put in requests for equipment and those requests were – arrived at us through the regional teams, and so the requests that we ended up considering were ones that had come from trusts, had the support of the regional teams. And those were requests for individual devices and device types, because they could see the makes and models of things.
And obviously, some of the devices we had were incredibly popular, and some of the devices that we had were less popular.
We operated two different models, one for during surge conditions where we distributed devices on the basis of urgent clinical need. And in those situations we would look at a trust’s ventilation and intensive care capacity, we would look at the number of patients they had within that and what degree of free capacity they had and the rate of change of that, and on the basis of that, we would say, “Yes, you have an urgent need for additional capacity”, in which case we would prioritise that request.
Outside of surge times, we operated a capacity-building model where we would seek to help trusts build and correct capacity for the next surge.
In terms of the devices, we would try and make sure that wherever possible, trusts were using familiar devices or using a small number of different devices. Clearly, if we are going to give people unfamiliar devices, it’s better for us to give them 20 of the same unfamiliar device, rather than 20 different devices. And we would also prioritise those organisations that had small needs and small capacity over those that had very large needs.
So, for example, the Cambridge example we were using earlier, I think they ended up, from that statement, with 67 VG70s that we supplied.
Counsel Inquiry: That’s a model of ventilator?
Mr Christopher Stirling: That’s a model of ventilator that we sourced as part of the new, novel sourcing process.
We had a very small number of Servo devices, which I believe would have been their preferred make and model, but we would have delivered them to an organisation that maybe only needed two or three extra ventilators, in which case we were able to keep them on their same device type, whereas with Cambridge they were going to have to use two different device types because there was no way we were going to be able to supply them with 70 additional Servo devices. So we would try and prioritise the models to reduce variation from people’s initial device choices.
However, we weren’t always able to do that and there were situations where we had to give people more variability in devices than they would have liked.
Counsel Inquiry: You talk in your statement about the national ventilation allocation panel.
Mr Christopher Stirling: Yes.
Counsel Inquiry: First of all, what was that and how did it fit into this process you’re talking about, please?
Mr Christopher Stirling: So the national ventilation allocation panel was the decision-making group that was comprised of regional representatives and chaired by Keith Willett or one of his deputies, that made the decisions about which devices were sent where. So, effectively, the culmination of the process that I’ve described of we provide lists to trusts of what makes and models we’ve got coming in when. They put requests in. Those are considered by the regional teams and then at that national ventilation allocation panel, typically 3 o’clock, seven days a week, the decisions would be taken on which devices would be sent to which trusts.
Those would typically be communicated to the warehouse by 4.00, and the devices would be delivered either that evening or, typically, early the following morning.
Counsel Inquiry: We’ll come back to the question, in a moment, please, about which devices, and who wanted what, in terms of models and makes, and so forth. In terms of the question of how many, was that also a question for the national ventilation allocation panel? “We’ve got this many, we can see your need, you can have X”?
Mr Christopher Stirling: Exactly.
Counsel Inquiry: I want to put to you, please, a part of the statement of Professor Banfield, chair of the British Medical Association, the BMA’s UK council.
It’s INQ000562457, paragraph 262.
I just invite your views, if I may, please. Professor Banfield tells us:
“Intensive care provision was stretched across the UK during the pandemic, despite capacity being increased in a variety of ways, including using spare and new ventilator machines, altering staffing patterns, redeploying doctors from other departments and expanding into other clinical areas beyond the normal ITU footprint such as theatre recovery areas.”
And then this:
“There were, at times, localised shortages of ventilators which necessitated the transfer of patients between hospitals, and the use of anaesthetic machines in lieu of ventilators, and the use of anaesthetic machines …”
Forgive me, that’s the end of it. I think it might be duplicated in the sentence there. But the point is he’s saying there were at times, in the BMA’s view, localised shortage of ventilators –
Mr Christopher Stirling: Yes.
Counsel Inquiry: – which necessitated transfer between hospitals.
And then if we look down, please, at paragraph 264, “Impact on members”:
“Shortages of ventilators for the numbers of patients who might benefit, combined with a lack of government or NHS guidance on clinical prioritisation, put additional pressure and uncertainty on doctors during an already highly stressful period. Circumstances in which demand outstrips supply raise serious ethical and professional challenges and give rise to the potential for moral injury among those doctors responsible for making final decisions on care escalation, as well as wider concerns about the potential for discrimination in the application of criteria.”
Focusing, then, on what’s said here, because I’m asking you again about the ‘how many’, localised shortages of ventilators which necessitated transfers and caused this impact on BMA members. Firstly, do you recognise that a concern which arose?
Mr Christopher Stirling: Could we go back to 262.
Counsel Inquiry: Yes, of course.
Mr Christopher Stirling: The previous one. That would be very helpful. Thank you. So I think I’ve got a slightly different view on this. A critical care transfer of a ventilated patient is a considerable and difficult undertaking, and not something the system would do lightly.
It’s comparably significantly easier to move a ventilator to where it’s needed. So I don’t dispute that there were transfers of patients between hospitals to places where there was greater clinical care, critical care capacity. I am not aware of any situation where the reason for that transfer was that there was no ventilator.
I think it’s very clear that at times in different part of the system, critical care was extremely challenged. What I’m not aware of is any time where there was critical care capacity – there’s workforce, oxygen, medicines, beds – all set up but no ventilator. To the best of my knowledge, that did not happen.
So I think there’s a bit of a sort of switching between shortage of ventilators and shortage of critical care capacity here.
Counsel Inquiry: For which ventilators is a vital part?
Mr Christopher Stirling: It’s a component –
Counsel Inquiry: A component?
Mr Christopher Stirling: – but a part of –
Counsel Inquiry: Exactly, but one component of –
Mr Christopher Stirling: – that broader picture.
Counsel Inquiry: All right.
Mr Christopher Stirling: So I think, you know, I think that – the use of anaesthetic machines in lieu of ventilators I think was relatively common at the time, and clearly not optimal. I’m not the person to talk to the clinical appropriateness of that or not.
Counsel Inquiry: No, indeed.
Mr Christopher Stirling: But I’m aware that that was part of what was quite widespread at the time. So I think that – agree with that bit of it. And clearly, on 264, there is no doubt that not having a – not having the machine that you are familiar with, and lots of it available, will increase stress and pressure in the clinical community.
So these points about, you know, the fact that you haven’t got your ideal first choice and you haven’t got confidence that you’ve got a lot of it, clearly that’s going to create pressure.
Counsel Inquiry: Yes.
Mr Christopher Stirling: But I do disagree with the core premise that there were localised shortages. If there were, I’m not aware of it, and that’s not something that we’ve seen evidence previously.
Counsel Inquiry: Thank you. Let’s look, then, at the question of clinical choice. Just to set the background, you make a number of points in your witness statement about clinician choice. First, paragraph 12, you call it a “key, structural, element of the UK health system”; yeah?
Mr Christopher Stirling: Agreed.
Counsel Inquiry: Paragraph 57 you say:
“Within intensive care environments, clinicians generally have strong preferences about the ventilators they use, and a reluctance to change. These preferences typically arise from the impact that familiarity and consistency have on reducing patient risk.”
So, in other words, an understandable preference?
Mr Christopher Stirling: Agreed.
Counsel Inquiry: And at paragraph 116 you say this about the process we’ve just been talking about:
“In determining what makes and models of devices to provide [to trusts], attempts [you say] would be made to provide consistent device types, reducing variation and complexity for clinicians.”
So not always possible, I think that was the conclusion of what you said about that; is that right?
Mr Christopher Stirling: Yes.
Counsel Inquiry: I want to look briefly, please, at the position that we’ve been told about in Scotland.
Mr Christopher Stirling: Okay.
Counsel Inquiry: Can I bring up INQ000498141.
This is the witness statement, Mr Stirling, of Caroline Lamb, chief executive of NHS Scotland and Director General of Health and Social Care.
I’m going to look at paragraph 314.
Ms Lamb here is talking here about the Scottish Government ICU Resilience and Support Group, which in Scotland led coordination and decisions on procurement and distribution of ventilators. And she says this:
“For ICU ventilators and equipment, the focus was equipping up to the maximum surge Level 3 ICU beds to deliver double the capacity (406 beds) up to the maximum surge Level 3 ICU beds (714 beds), caveated by the ability to staff ICU beds.”
And then this:
“The approach adopted by the ICU Resilience and Support Group [in Scotland] from the start was to take a human factors approach – ie purchasing and using only familiar brands or brands that NHS boards were using already where possible. This meant that staff working under extreme pressure were not also having to learn to work with new specialised equipment and enabled the equipment to be utilised by Boards post-Covid.”
Does that in any way differ from the approach that was taken in England, Mr Stirling? Does that sound like, in any way, a different approach?
Mr Christopher Stirling: I’m not sure it does sound different. I think the keywords I would use – look at, here, are “already where possible”.
Counsel Inquiry: Yes.
Mr Christopher Stirling: So clearly I think, both in Scotland and more broadly in the UK, the preference was to use familiar brands and models that people are familiar with. However, the challenge was, I think either in Scotland or in the rest of the UK, whether we were going to achieve those high-volume targets with those familiar brands.
I don’t think anyone was trying to introduce new things because we thought that was a good thing to do. We thought that was a necessary thing to do.
Counsel Inquiry: One of the reasons I’ve been asking you these questions, Mr Stirling, is because of an observation you make in the reflections and “Lessons Learned” section of your witness statement. This is your paragraph 203(c), you say this:
“The pandemic has highlighted the cost of choice …”
I’ll just put what it says here and then ask you to expand on it, if I may. You say this:
“… the importance, advantages, and disadvantages of choice have long been debated. The pandemic experience has shown that clinicians can, even under pressure, successfully switch products. It has also highlighted the significant cost and complexity of operating the current ‘choice max’ [as you call it] environment. Clearly, clinical choice needs to remain central to both clinical practice and innovation, but overall [you say] the pandemic has materially weakened the case for choice.”
What do you mean by that? Can you just expand on why it is you say the pandemic has weakened the case for choice by clinicians in terms of these devices?
Mr Christopher Stirling: I think, when looking at device selection, there’s a number of factors that influence that. And, historically, the NHS system has always prioritised clinical choice above almost all other factors.
Resilience implications, industrial strategy considerations, are typically not part of that broader clinician choice consideration. And I think the pandemic has highlighted the quite considerable costs, both financially and in terms of performance, of having such choice embedded at a fundamental level within the system.
Clearly, I’m not advocating that we should move from an environment where we have, you know, choice max, as I describe it, to one where you say everybody must use this product, because clearly that has resilience implications of its own. But I think, if there is this, you know, this spectrum of choice from, you know, direction here through to maximum choice over here, the NHS is here [indicating].
And I think there is an opportunity for us, in our long-term procurement supply of these devices to move towards a little bit more where we can have structured, long-term partnerships with a smaller number of suppliers that enables us to have longer-term resilience, and also enables us to respond more effectively to situations like this, and to simpler things like, you know, staff moving between hospitals, finding they have to familiarise themselves with completely different sets of equipment. And that has quality and safety implications of its own.
So I’m by no means advocating a more draconian approach, but I think we have to be honest that the degree of choice which is embedded within the NHS system has a cost, and the pandemic has shown us, both in terms of quality and pound signs, what that is.
Counsel Inquiry: Thank you. Just to conclude this area of questions, I want to show you a document, again drafted by you. It’s INQ000541370, titled –
Mr Christopher Stirling: Ah –
Counsel Inquiry: You know this one?
Mr Christopher Stirling: Yes, know this one.
Counsel Inquiry: It’s always pleasing when you know, a document, Mr Stirling.
Mr Christopher Stirling: It is.
Counsel Inquiry: That’s my aim. This is one – it’s got your name on it so it’s from you to Steve Oldfield, who we know –
Mr Christopher Stirling: No, this one is to –
Counsel Inquiry: – (overspeaking) – forgive me, to the Secretary of State, forgive me. And it’s a document titled “Medium term strategy to ensure continued availability of Oxygen, Ventilation and Medical Consumables, including procuring a stockpile of Covid-19 related ICU consumables.”
If we could just look, please, at page 2, paragraphs 2 to 3.
This seems to be your summary of this first part of the work of your programme.
“During the first surge of Covid-19, the Oxygen Ventilation, Medical Devices and Clinical Consumables Programme has delivered a wide range of activities … to ensure [the] availability of Oxygen Therapies and associated critical care treatments within the NHS.
“Whilst this work has been successful, in that there has not been any reported shortage of Oxygen or Ventilation adversely impacting patient outcomes, it has, on occasion, been uncomfortably close.”
It was that phrase I wanted to ask you about, Mr Stirling, if I may. What was uncomfortably close about the work of your programme with regard to what we’ve been discussing this morning?
Mr Christopher Stirling: I think, you know, both in terms of ventilation equipment, oxygen and consumables, the quantities that we had available, we managed to prioritise and deploy across the system. If Covid cases had been 10% or 20% higher, we might not have been in the stage where we were able to make the first half of that statement and say that we had no reported shortages of those items.
It certainly wasn’t comfortable. I don’t think there is any particular deeper meaning to that statement than saying, you know, we were uncomfortably close, in many cases.
Counsel Inquiry: That’s very clear. Thank you.
Does that apply as much to the devices we’ve been talking about as it does to oxygen?
Mr Christopher Stirling: I think the timeline of shortage or maximum constraint was different for different items.
Counsel Inquiry: All right.
Mr Christopher Stirling: So for ventilation devices, our position of greatest shortage was on day one. For consumables, it was probably towards the end of the first wave, and for oxygen, it would have been the peak of the second wave in January 2021.
Counsel Inquiry: That’s very clear. Thank you, Mr Stirling.
I’m going to ask you then briefly about oxygen.
Thank you, Lawrence.
A key challenge, you say, in your programme when you started out was that – this is you paragraph 169, Mr Stirling, to orientate you.
Mr Christopher Stirling: Thank you.
Counsel Inquiry: – was that there was no central system-wide understanding of how the healthcare oxygen infrastructure worked. It rather mirrors the concerns about not much data/no data on ventilators. You say there was no central system-wide understanding of the oxygen infrastructure; is that right?
Mr Christopher Stirling: That’s correct.
Counsel Inquiry: No clear national owner, you say, or centre of expertise, and within trusts systems had often been configured and set up a very long time ago. Yeah?
Mr Christopher Stirling: Agreed.
Counsel Inquiry: And you say also that some of that expertise, such as it was, had declined over time. That was your paragraph 169.
This is from your paragraph 25:
“The additional capacity built over the summer period [of the pandemic] placed significant extra pressure on Oxygen infrastructure which became a primary constraint. In line with expectations, there was significant usage of the consumable stockpiles, and limited use of residual capacity (excepting oxygen infrastructure). Despite daily oxygen management process and resources being severely tested [your words], at a system level, Oxygen capacity plans held.”
So can we turn to that, then. What was the nature of the severe test of the oxygen infrastructure system?
Mr Christopher Stirling: So I think at some point in the statement – I’m struggling to find where – there is an illustration of that in terms of the number of trusts that were using, you know, 50%, 8%, 100% of their oxygen infrastructure.
Counsel Inquiry: Yes, I think it’s your 182, if that –
Mr Christopher Stirling: 182?
Counsel Inquiry: Around there.
Mr Christopher Stirling: Thank you. You know this better than I do … yes.
So in normal times, pre-Covid, a trust would expect to run at 20, 30, 40% oxygen capacity.
Counsel Inquiry: Right. Just explain to us in simple terms what that means. You’ve got a – oxygen is produced, isn’t it, in very simple terms, between non-clinicians here, Mr Stirling, through something called a vacuum insulated evaporator or VIE?
Mr Christopher Stirling: So not quite.
Counsel Inquiry: Right, help us out.
Mr Christopher Stirling: Oxygen is typically produced in, effectively, a factory called an air separation unit.
Counsel Inquiry: Okay.
Mr Christopher Stirling: Which looks, to all extents, like a factory, makes oxygen. And from there it is shipped in cryogenic tankers, to trusts, and is put, in liquid form, in the vacuum insulated evaporators, which is where you were –
Counsel Inquiry: I got that bit.
Mr Christopher Stirling: That’s where you were.
Counsel Inquiry: Very good.
Mr Christopher Stirling: And this effectively a huge tank that sits outside the hospital with very cold liquid oxygen in it. There is then a set of equipment called an evaporator and a control panel that converts the liquid oxygen to gaseous oxygen and pumps it into a series of pipes that run through the hospital to get to the bedside.
So, from an oxygen infrastructure perspective, there are a number of things that can go wrong: at your factory you can not make enough; in your distribution, you can not get enough to the tank in the hospital; your tank in the hospital can run out; the equipment that converts the liquid to gaseous cannot operate at sufficient capacity, so you just can’t turn it into gas fast enough; or you can have insufficient pipework in the hospital to be able to serve all the different places that you need to deliver it, at any given time.
So those are the sort of potential points in failure.
Now, the first of those, we managed to mitigate very effectively, and our biggest –
Counsel Inquiry: Pausing there, you mean getting enough oxygen to the tank?
Mr Christopher Stirling: Making enough oxygen, delivering it, getting it to the tanks was – I don’t believe that we have any issues across the pandemic environment with those stages. There’s a lot of people worked very hard to make sure that was the case, but I believe that was fine.
Where we had the biggest issues were in the technical equipment that converts the liquid to a gas, and particularly in the pipework within trusts.
Now, it’s relatively easy – I say “relatively easy” – you know, again, in peacetime it would still be a 6/9-month project, but we had people doing this in days and weeks – to upgrade the equipment so that you can make more gaseous oxygen quickly. And our industrial partners became very adept at high-speed upgrades of those components.
What is much more difficult is to replace the pipework, typically buried within the walls of the hospitals, some of which were designed a very long time ago, because you’ve got to get to the pipes and then you’ve got to make them bigger, typically. And that’s very hard to do at the best of times, and even harder to do if you’re mid-pandemic.
So that’s was where the majority of our discomfort comes, and that’s why the figures that you have here –
Counsel Inquiry: Yes, can you just set those out for us?
So normal capacity you’re looking at 20 to 40, you – (overspeaking) –
Mr Christopher Stirling: 20 to 40.
Counsel Inquiry: Yeah?
Mr Christopher Stirling: Yeah.
Counsel Inquiry: And how did that change over the pandemic and why?
Mr Christopher Stirling: So, as intensive care and also the general oxygen support to Covid patients not in intensive care increased, oxygen usage within trusts increased significantly. And so the rate of conversion of liquid to gaseous oxygen, went – you know, the figures as per point 182, in January ‘21 we had 55 trusts: ten over 80 and five trusts over a 100%. So those are trusts that are, according to the paperwork, running their system far higher and hotter, or in this case cooler, than was ever intended.
Now, thankfully, there is some resilience in those specifications, so people were able to successfully operate oxygen systems at above 100% but that is clearly not sustainable, recommended –
Counsel Inquiry: Or potentially safe?
Mr Christopher Stirling: Or potentially safe. However … I’ll leave it there.
Counsel Inquiry: Okay.
Just in terms of the steps taken, then, to bring that down, so we’ve got a situation by January ‘21 –
Mr Christopher Stirling: Yeah.
Counsel Inquiry: – that you’ve told us about. How did your programme briefly, please, mitigate those effects? In procurement terms, what was done?
Mr Christopher Stirling: So in procurement terms, we worked with oxygen-providing organisations to upgrade components of infrastructure. And NHS England provided a variety of financing to trusts to enable them to remove bottlenecks within their pipework systems. Our team also produced a series of oxygen best practice guidance to help trusts use less oxygen.
Counsel Inquiry: Yeah.
Mr Christopher Stirling: Which was actually surprisingly effective, because prior to the pandemic nobody had really put much effort into optimising oxygen usage.
And I think we also worked to swap out higher oxygen flow usage devices for lower oxygen flow usage devices.
So these are devices that have the same clinical benefit but simply consume less oxygen to do that. So those were the different sort of strands of activity that took place over summer and autumn of ‘20 in order to be ready for January ‘21.
Counsel Inquiry: In terms of the lessons you learned from that work, your paragraph 204, thinking specifically now about oxygen, one of them is, you say, that something called the MGPS HTM needs updating. What is that, please?
Mr Christopher Stirling: That’s the Medical Gas Pipeline System Healthcare Technology Memorandum, which is effectively the critical document which defines the dos and don’ts for oxygen systems in hospitals. You know, it is the manual of how to specify and run a hospital oxygen system.
Counsel Inquiry: And why do you say it needs updating?
Mr Christopher Stirling: You know, because it’s 20 years old and there have been significant technical advances during that period and also, in particular, there is something within it called the diversity assumptions, and that’s flow diversity, and this is a ratio that says how many of the endpoints in a hospital do you have to be able to support at any given time? And that influences the size and quality of pipework.
Counsel Inquiry: Right.
Mr Christopher Stirling: Now, the assumptions pre-pandemic are clearly not appropriate for a post-pandemic environment, and I believe they need to be revised.
Counsel Inquiry: That’s very clear. Thank you.
Secondly, you make this observation: UK oxygen production will naturally decline over time.
Mr Christopher Stirling: Yes.
Counsel Inquiry: Why is that and what do you say we should do?
Mr Christopher Stirling: So we were relatively lucky in the UK, as a former steel-producing country that used to make large amounts of steel. Steel consumes large amounts of oxygen in its production. So the UK was incredibly well endowed with air separation units, the oxygen factories. And that was a significant boon to this pandemic.
In the absence of there being a consistent demand for that oxygen, the UK industrial ability to produce oxygen will naturally decline as plants reach their end of life, and there is no economic rationale for people to replace them. So in 10, 20, 30 years’ time, we will have significantly less oxygen capacity than we have today.
The government has a variety of things it could do. It can either, you know, take steps to incentivise the retention of that capacity, or seek to invest further upstream, you know, if we had a steel industry in the UK, we would be in no danger of seeing a reduction in our oxygen capacity.
Counsel Inquiry: Thank you. Turning to a different topic again, please. Not much longer to go.
I want to ask about work with the devolved administrations. You say the programme worked closely with the devolved administrations.
Mr Christopher Stirling: Yes.
Counsel Inquiry: Some activities undertaken like the procurement of additional ventilation capacity and the one we’ve been discussing, the boosting UK oxygen production, were done at a UK-wide level. So clearly took in the DAs as well, yes?
Mr Christopher Stirling: Yes.
Counsel Inquiry: You say that the strategic intent was to do as much together as practical and beneficial whilst respecting the devolution of authority.
Mr Christopher Stirling: Correct.
Counsel Inquiry: And you talk about a typical discussion with devolved administrations. What would that look like?
Mr Christopher Stirling: Typically, we would outline our plans to them, and they would decide whether they wanted to participate in those or not.
Counsel Inquiry: In any given part of the programme, or as a whole?
Mr Christopher Stirling: Generally, in specific elements of the programme. We would say, “We are about to do this thing, we can either do it UK wide or we can do it as England. What do you, Scotland, Wales, Northern Ireland, think about that?”
And in some situations, all of them participated. In some, at times there was often very good reason for Northern Ireland doing things quite differently, partly because of their connections to Southern Ireland and the way gas operations in particular work over there. But generally, people would be happy to work with us on elements and also do their own things as well.
Counsel Inquiry: One more question, having promised none, on allocation. You say that the devices we’ve been discussing procured by your programme on behalf of the UK, were offered to the devolved administrations on what you call a crude but widely recognised per capita basis?
Mr Christopher Stirling: Yes.
Counsel Inquiry: And you say, given differing administration needs and equipment profiles, actual devices delivered would often change delivering more of some items and less of others whilst remaining broadly within the intent of that per capita distribution. Yes?
Mr Christopher Stirling: Agreed.
Counsel Inquiry: My question for you is this: as far as you were aware, did any officials or anybody else from the devolved administrations raise concerns with you about that allocation principle?
Mr Christopher Stirling: No.
Counsel Inquiry: I want to turn briefly, then, to some concluding points as lessons learnt. One more bit from Professor Moonesinghe, if I may.
INQ000518349. This is her paragraph 187. This is her reflection overall. She says:
“I do not consider that there was a robust system in place to ensure an adequate supply of key healthcare equipment and supplies to the NHS during the initial phase of the pandemic. As far as those areas in which I was involved – specifically equipment, consumables, medicines and oxygen, the efforts made by DHSC, Cabinet Office and NHS England were remarkable and effective in many ways; however, because of a lack of availability of resources to meet the demand in the first wave, clinicians were required to use unfamiliar or less than ideal equipment, medicines and consumables, which will have augmented the pressure under which they were working. These factors combined posed a potential risk to patient safety and may have added additional psychological burden to staff who were working under conditions of unprecedented challenge.”
I want to focus on that very first sentence, the “robustness of the system in place.” what’s your reflection on that, Mr Stirling? Do you agree with Professor Moonesinghe?
Mr Christopher Stirling: I think it’s very easy to say that we would have been in a stronger position if we’d have had more supplies of the items that we needed on the shelf already. In terms of the ventilators, and the consumables, I think the second point she makes about using items that were unfamiliar or less than ideal. I think that’s the key bit that I would focus on and take here, because in many situations it wasn’t that we didn’t have an item, we did have an item. But it wasn’t necessarily the item that people were familiar with or would have considered their first choice.
So I think, practically, I think we would struggle to see what a system would look like that would guarantee clinicians their first choice item in a time of unprecedented demand and pandemic.
So I certainly think it could have been more robust, there’s certainly greater levels of preparedness and stocks that could be held in advance. And that would go some way to easing these pressures. I’m not sure whether it’s realistic to have as an objective that everybody always gets their first choice item. I think that’s quite – whether that’s an achievable objective I’m not certain.
Counsel Inquiry: Your personal recommendations: first, at paragraph 187, you talk about the requirement for a stronger national medical technology capability. So zooming out from ventilators, putting ourselves in the situation of a future pandemic, which requires scaling up some piece of complex medical technology at pace, what do you mean by – it might be obvious, but a “stronger medical technology capability”?
Mr Christopher Stirling: So if we compare medical technology to medicines, medicines has had, for an extended period of time, a core national team, both within the Department and within the NHS England, that have, as their enduring remit, making sure the country is in an appropriate place with medicines.
Prior to the pandemic, no one had that remit for medical technology, and one of the things that I did in my later stages of my involvement with the Department, was create the Directorate of Medical Technology, which was aiming to provide a central point of leadership for that going forward.
I think that has benefits in both a pandemic resilience environment and also more broadly, supporting issues around choice, availability, and innovation.
Counsel Inquiry: You say this:
“Medical technology needs clear ownership: it is now too big, and impactful to patient outcomes not to have clear direction and leadership.”
Is that what you were seeking to address through this directorate?
Mr Christopher Stirling: Yes.
Counsel Inquiry: You’re not there any more but was that work under way as you left?
Mr Christopher Stirling: Prior to my leaving, I acted as the interim director of Medical Technology for the Department, and also supported the Department in recruiting a permanent successor, who is still in post.
Counsel Inquiry: Very good.
Another of your observations is this: interoperability of medical devices and technology should be mandated.
Paragraph 203.
Mr Christopher Stirling: Yes.
Counsel Inquiry: Could you just tell us what you mean by that, please?
Mr Christopher Stirling: So a number of these devices, device manufacturers will often use bespoke connectors, bespoke plugs, slightly different formats and styles of doing things.
Counsel Inquiry: And is that where we can see some of the problems that the clinicians I’ve put to you – (overspeaking) –
Mr Christopher Stirling: Absolutely. And if you talk to suppliers, they will say that that is done in the name of patient safety. And there are very important patient safety benefits of making sure that you can’t accidentally plug the wrong thing in. That doesn’t necessarily mean that every supplier needs to have their own bespoke piece. And there are also obvious economic benefits to you as a supplier if your device only works with one connector and you have to therefore get all of your consumables back from the device.
Now, certain suppliers have features which enable you to use their devices in interoperable modes, and my belief is that it should be a requirement for all future medical technology that if there is something that is bespoke or unique, or prevented as part of normal operation, there is a way of turning that feature off in a pandemic environment where you may have to plug it into something else. It’s not particularly conceptually difficult, but what it does mean is you don’t have to run completely different supply chains for breathing circuits. All of the filters are inoperable: the oxygen sensors, all of the little bits and pieces that actually make this work, you don’t have to have ten different types of each of those. I also think that would make it a lot easier for clinicians.
But again, it’s a change that would need to be brought in in a phased and measured manner.
Counsel Inquiry: Thank you.
Finally, please, I want to put one of the author recommendations of Professor John Bell, who was our supply chains expert. It his author recommendation 17. I don’t need it to be put up on the screen. What Professor Manners-Bell says is this:
“If new health and care equipment is required as part of pandemic response, efforts should be focused on providing existing medical equipment manufacturers with the resources to scale up production rather than encouraging designs from manufacturers with no relevant experience. Production under licence should be a consideration.”
What’s your take, your view on that, please, Mr Stirling?
Mr Christopher Stirling: I understand where he’s coming from. My experience of having been through the pandemic is that, actually, existing medical device manufacturers tended to be slower and more risk averse in their willingness to try unusual and challenging things that need to be done, whereas suppliers from other industries are potentially more flexible and willing to operate on the basis of “This is what I can do”. We did have discussions with many medical device manufacturers about scaling up their capacity, and probably better taken up with Gareth and the Ventilator Challenge team.
Counsel Inquiry: Yes, we did do so, yeah.
Mr Christopher Stirling: But my experience was that non-healthcare suppliers were faster, more nimbler and agile at responding to our needs than existing medical suppliers. And I was surprised by that. So I can see where he’s coming from, but that doesn’t tie with my experience.
Mr Stoate: Thank you.
My Lady, those are my questions, I think –
Lady Hallett: Thank you.
Some questions first of all from Ms Morris, who is just sitting there.
Questions From Ms Morris KC
Ms Morris: Thank you, my Lady.
Mr Stirling, good afternoon. I represent the Covid Bereaved Families for Justice UK, and I have two topics, please, to ask you questions about. The first is on the topic of preparedness, particularly in relation to consumables, not ventilators, not devices, but consumables.
You say at paragraph 141 of your statement that when we entered into the pandemic – in a strong position at all levels, there’s – you say ward covers were well stocked, I think is the phrase. The concern in your statement was about being able to sustain that supply –
Mr Christopher Stirling: Yeah.
Ms Morris KC: – should there be a protracted surge or further larger surges as part of the pandemic; is that right?
Mr Christopher Stirling: That’s right.
Ms Morris KC: So, from that analysis, I’d anticipate that you’d accept that the stockpile of medicines available at the beginning of the pandemic was not modelled around the provision of a high or protracted surge demand in the event of a pandemic. It was well stocked but couldn’t face the surges that the pandemic inevitably brought?
Mr Christopher Stirling: I think I agree with you. Can I just check one thing? I can’t comment on medicines. So I can absolutely respond on consumables, but in terms of the medicines stockpile, that’s not something I was responsible for.
Ms Morris KC: Okay. I am going to ask you now about a report from the Swine Flu Critical Care Clinical Group. So, after the 2009 swine flu pandemic, the Department of Health had received feedback from clinicians within that group in which they expressed some concerns about the need to stockpile supplies of consumables and medicines in their example. This is a report that’s been shared with you as part of the Inquiry’s disclosure to you.
In that report they said that in a pandemic of greater severity, sustained production, including that from outside of the UK and haulage, would be in jeopardy. So they were sort of foreshadowing beyond 2009 that, in a more severe pandemic, there’d be a problem with the sustained production of consumables and medicines.
They said that a sustained surge of critical care capacity would be very difficult to maintain without the building up of stocks in local units.
One of the items they mentioned in their report was propofol, an active sedative component of intravenous anaesthesia, so part of critical care provision.
So my questions are this, please: is it correct, then, that the Department of Health was well aware that there would be a lack of sustained production and supply of medicines and consumables during a pandemic, and this would predictably affect ICU medicines like propofol?
Mr Christopher Stirling: Okay, so my involvement in this started on 3 March ‘20, and I was not involved in the pre-pandemic preparedness activities prior to that date. So I appreciate that document was released as part of the evidence process. I had not seen that document prior to that, nor would I have expected to have done.
In terms of the core point around the sustained production of consumables, we import the vast majority of our consumables from overseas. Large quantities of that, in fact the majority, comes from the Far East. So I think you are absolutely correct and fair to say that in a pandemic environment, where global trade and travel is disrupted, and that supply of consumables is not able to be brought in on a consistent basis from other parts of the world, the UK would struggle to maintain ICU capacity.
Ms Morris KC: Thank you.
Is it correct, therefore, to say that the only really predictable anyway of ensuring that supply is maintained in a pandemic is through having adequate stocks, through adequate preparedness, having the cupboards well stocked from the outset?
Mr Christopher Stirling: I think stockpiling is always going to be part of the answer. I think, increasingly, if we’re looking for a longer-term and more sustainable answer, on or nearshore manufacturing opportunities, particularly in flexible production capabilities, potentially offers a more cost-effective and sustainable route of achieving that.
Stockpiles are very effective, but they are incredibly expensive.
Ms Morris KC: But they are part of the solution, you will accept?
Mr Christopher Stirling: I think it is difficult to see any credible solution where a degree of stockpiling is not part of that.
Ms Morris KC: Thank you. That’s helpful.
My second topic is about the operational management of the NHS Supply Chain. In your statement you recognise the NHS Supply Chain lacked the resources to respond to increased demand during the pandemic. Those are your paragraphs 19 and 21.
You said in evidence earlier on this morning that in the pandemic all the trusts turned to the NHS Supply Chain and said, “Give me X”, and then they weren’t expecting necessarily to deal with the scale of the response during the pandemic, the requests from those trusts. However, do you accept that the DHSC had not assessed the supply chain’s readiness and capacity to cope in the event of a pandemic and that subsequent demand that that would entail?
Mr Christopher Stirling: Again, I’m sorry, but I can’t really talk to the pre-pandemic preparedness point. I think, to your, you know, NHS Supply Chain was operating I think around 60-ish per cent of NHS capacity, you know, higher on some lines, lower on other lines. In the Covid environment, we both had an increase in demand, and also those remaining 40% of trusts seeking to source from NHS Supply Chain. So effectively there was a double increase for Supply Chain, and having previously been involved in, you know, the NHS Supply Chain Future Operating Model planning process, that degree of change would normally be ascribed in years, and I think there is no doubt that NHS Supply Chain could have scaled or provided that service. The challenge was doing that from a standing start at very short notice.
Ms Morris KC: Understood.
Final question, please. We’ve heard from Professor Sanchez-Graells about, sort of, the complex network of contracts and governance that was involved in the supply chain. Is it correct, in your view, that without sort of a clear picture by the DHSC about the governance and operational management of the supply chain, it would have made it more difficult to assess the need and the impact of the demand in the pandemic?
Mr Christopher Stirling: So the supply chains associated with ventilator productions are typically incredibly complex.
I think we tried to streamline our engagement with that supply chain by, at various times, taking decisions not to engage with intermediaries and try to engage directly with the factories producing the devices to attempt to shorten that.
More data earlier would have been helpful. However, I think we need to just take a slight degree of caution around the availability of data, because, you know, there are hundreds of thousands of products in use in the NHS and we probably needed and used data for maybe 2 to 300 of those products. It would be very easy as a knee-jerk reaction to say we need the data for all of the products, and create a very significant reporting burden and challenge.
What we were able to do with the consumables was to introduce a system where we were able to add and remove products to the list that we got data for, as and when market conditions enabled us to do that. So capturing data when we needed it, and, you know, I think we just have to be careful not to have the knee-jerk, we need all of the data, all of the time for everything, because otherwise we will need another thousands of people just to manage sets of data that we’re not actually going to use.
Ms Morris: Understood.
Thank you, my Lady.
Lady Hallett: Thank you, Ms Morris.
Mr Thomas.
Mr Thomas is over there.
Questions From Professor Thomas KC
Professor Thomas: Good afternoon, Mr Stirling, can you hear me?
Mr Christopher Stirling: Loud and clear.
Professor Thomas KC: I represent FEMHO, that’s the Federation of Ethnic Minority Healthcare Organisations, and like Ms Morris, I have two topics that I would like to explore with you.
Mr Stirling, given your role, and given the disproportionate impact of the virus on ethnic minority communities, it’s certainly important for those who I represent to explore how considerations of equality influenced the procurement and distribution decisions. So with that in mind, my first question is this: in paragraph 17 of your statement, you outline the primary aims of the oxygen, ventilation, medical devices and clinical consumables, including ensuring resources were located “in the right place [according to] clinical need rather than strength of voice or procurement capability.”
Mr Stirling, how were these principles applied to ensure fair and equitable distribution of medical supplies, particularly to healthcare facilities in regions or communities with high concentrations of ethnic minority populations who might have been disproportionately affected by the virus in healthcare facilities serving high risk, ethnic minority communities? Can you help us with that, please.
Mr Christopher Stirling: Okay. So our allocation process, as described earlier, was focused on looking at the volume of critical care ventilated patients in any area at that time. And we used that to support decisions around allocating ventilators for urgent clinical need. Between surges, the capacity building activities, we had an explicit objective to level up capacity, and by that, I mean increasing critical care capacity in those areas that had least capacity, more than in those areas that already had higher levels of capacity. And so the intent, through that, was to reduce any discrepancies in capacity levels between regions.
We also looked at that through the lens of specification of devices, and discussed with clinicians what, if any, differences needed to be made to the specification to ensure that all parts of the population were served, and that included buying – the primary area of their feedback around that was that age and weight were considerations, and a number of devices were bought specifically to support the paediatric and neonatal markets.
Professor Thomas KC: Thank you. You mentioned age and weight were specifically considered. Just piggybacking on that last answer, was the race considered, ethnic minority? Was that considered?
Mr Christopher Stirling: So we asked our clinicians to help us get the appropriate specifications, and we asked them what differences we needed to make to support the population. The only time that I’m aware that race became an active consideration was around pulse oximeter devices. But from your reaction, I think you’re already aware of some of the discussions and discussions around that.
Professor Thomas KC: Yes, we are.
Let me ask you my next question. During these phases, were there any impact assessments conducted to evaluate how the distribution and accessibility of critical medical supplies affected ethnic minority healthcare workers and communities differently? So did you do any impact assessments?
Mr Christopher Stirling: So I don’t believe we did any impact assessments of the distribution of these devices, no.
Professor Thomas KC: Okay. Let me move on. In paragraphs 27 to 30 of your statement you describe significant challenges related to the use of ventilators that were unfamiliar to staff, and had documentation primarily in Chinese.
Question: how were decisions about the procurement and distribution of these devices assessed to ensure compliance with the Public Sector Equality Duty, particularly in ensuring that fair treatment and safety for all healthcare workers.
Mr Christopher Stirling: So we recognise that some of the instruction manuals and supporting documentation was in other languages. We arranged for translations of those to be produced. We didn’t translate them per se; we produced what we called quick-start guides in English. We did not provide any support to individuals that were not able to read English. I’m sorry, I might have misunderstood your question, but we didn’t, for example, translate those documents into Welsh or other languages of any kind. We translated them into English.
Professor Thomas KC: Okay. Can I move on to my second and final topic, please, and this is looking forward, being future looking. As we reflect on the pandemic’s challenges and the lessons learned particularly concerning supply chains, resilience and resource allocation, it’s imperative to consider how future policies can be designed to be – more effectively to support ethnic minority healthcare workers to ensure equitable access during a crisis.
So that leads me to this question: in paragraphs 201 to 204 of your statement, you discuss the lessons learned from the pandemic’s challenges, particularly the need for a broader stockpile and improved manufacturing capabilities within the UK.
Given these reflections, how do you propose future policies be adjusted to ensure more inclusive support for minority groups, such as minority healthcare workers, who might be disproportionately affected in such crisis?
Mr Christopher Stirling: I think, clearly, if we have a stronger stockpile and more availability of first-choice advices, to use the phrase from earlier, less individuals will be asked to use devices that they are not familiar with, and I think that will benefit all healthcare workers.
In terms of the appropriateness of those devices, I think we were, and would always want to be, clinically led by what was appropriate to be procured. And so we were working from the guidance of Professor Moonesinghe, who you’re seeing later, and others, as to what would be needed for the entirety of the healthcare worker population.
So I think there is clearly things that we can do to make sure we are better prepared, and I think they will benefit all parts of the workforce.
Professor Thomas: My Lady, thank you, those are my questions.
Lady Hallett: Thank you very much, Mr Thomas.
Those were the questions we had for you, Mr Stirling. You’ve described your role in procurement during the pandemic in very calm, measured and fair terms. You haven’t highlighted the pressure that you and your team were under; I’m sure it was severe and sustained. So thank you for all that you did during the pandemic and thank you for the help that you’ve given to the Inquiry.
I think you must be a stenographer’s dream witness, if I may say so.
The Witness: I’ve tried not to go too fast.
Lady Hallett: Thank you very much indeed.
The Witness: Thank you.
Lady Hallett: I shall return at 1.50.
(12.47 pm)
(The Short Adjournment)
(1.50 pm)
Lady Hallett: Mr Stoate.
Mr Stoate: Thank you, my Lady. Good afternoon. The next witness is Matthew Style. If he could please be sworn.
Mr Matthew Style
MR MATTHEW STYLE (affirmed).
Lady Hallett: I hope you were warned we wouldn’t get to you until this afternoon, Mr Style.
The Witness: I was warned, my Lady. Thank you.
Questions From Counsel to the Inquiry
Mr Stoate: Thank you. Could you please give the court your full name.
Mr Matthew Style: I can. My name is Matthew David Style.
Counsel Inquiry: Thank you.
Mr Matthew Style: If I may, given that this is the first time I’ve appeared before the Inquiry, just take a moment at the start to express my condolences to all of those who lost loved ones during the pandemic and all of those who were affected and endured hardships in other ways during the pandemic.
And just to add that during the period that we’re looking at today, I was a member of NHS staff at that time and I was particularly conscious of the pressure and the, kind of, profound sacrifice of many of my colleagues at the front line during that period – I was not employed at the front line myself – and I just wanted to mark that with your permission at the start, if I may.
Counsel Inquiry: Thank you very much indeed.
You have very helpfully provided the Inquiry with a witness statement, the reference for which is INQ000513708. It’s in fact your fourth statement, and for the purposes of this module, the corporate statement for DHSC concerning oxygen and ventilation; is that right?
Mr Matthew Style: That’s correct, counsel.
Counsel Inquiry: It’s 39 pages long, and is it true to the best of your knowledge and belief?
Mr Matthew Style: Yes, it is.
Counsel Inquiry: Thank you very much.
Just by briefly by way of background, you first became a civil servant in 2001 and joined the Senior Civil Service in 2008; is that correct?
Mr Matthew Style: That is correct, counsel.
Counsel Inquiry: You have been the Director General of the NHS Policy and Performance Group, now known as the Secondary Care and Integration Group, since you joined DHSC in November of 2021; is that right?
Mr Matthew Style: That’s also correct.
Counsel Inquiry: You’ve just given us an insight that you were not in fact at DHSC for the majority of the pandemic; you tell us you were in the NHS?
Mr Matthew Style: That’s correct.
Counsel Inquiry: But you do say that the Medical Technologies Directorate, about which Mr Stirling gave some evidence earlier, did transfer to your responsibility in October of 2022, after the closure of the Oxygen, Ventilation and Devices Programme we’ve been discussing. Is that right?
Mr Matthew Style: That’s correct.
Counsel Inquiry: So well placed, I hope, to answer some of the questions that I’ve got for you, which in large part sit around, to some degree, that of Mr Stirling’s evidence. A bit about preparedness beforehand and a bit about looking to the future.
Turning then to the preparedness and pre-pandemic ventilator capacity. You say in your witness statement at paragraph 30 that previous modelling had been undertaken that included estimating ventilator demand at various periods before the pandemic to improve DHSC’s knowledge and understanding, including, for example, you say, consideration of recommendations about bringing ventilators that had been placed in storage back into use; is that right?
Mr Matthew Style: That’s correct.
Counsel Inquiry: Can we look at one of those, please, one of the documents that informs that. INQ000514140.
This is a document to which you very helpfully referred us, a report of the Swine Flu Critical Care Clinical Group and key learning for future surge planning. If we could look at page 33 of that document, please.
This is the section entitled “Equipment issues” and looking at ventilators in particular. It says at paragraph 10:
“Where plans include the following issues then it is important that they have been tested and local actions identified”. Firstly:
“Using reserve ventilators. Where ICUs are planning to use ventilators that have been kept in storage after being replaced then there should be attention to ensuring that mothballed equipment has been recently serviced and that any specific equipment required for their re-use is available in sufficient numbers to enable repeated usage. As current staff may not be familiar with this equipment there should be arrangements made to update training, and also provision of appropriate paperwork instructions.”
Pausing there, I don’t know whether you heard Mr Stirling’s evidence, you’re probably familiar with the content of it?
Mr Matthew Style: I am, I am.
Counsel Inquiry: It touches there, doesn’t it, upon some of what he was talking about?
And then again, looking at equipment from outside ICUs:
“If introducing equipment and devices that are not normally used by existing critical care staff, there should be systems created to provide appropriate [updated] training sessions.”
And gives an example of, including instructions in the use of anaesthetic machine ventilators.
In your statement, Mr Style, you note there’s – an increasing capacity in terms of these types of devices was not required during the 2009-10 swine flu pandemic; is that right?
Mr Matthew Style: That’s correct.
Counsel Inquiry: Ventilator baseline capacities were therefore not further tested; is that right?
Mr Matthew Style: That’s correct.
Counsel Inquiry: And in fact, an increase in the baseline capacity was not considered necessary in a pandemic influenza scenario, is that right?
Mr Matthew Style: Yes. I should add that of course not – I mean, this is implicit in the conversation – in my evidence at the very start. I was not responsible for these issues at the time so I am piecing together the history from going back and looking at documents that the department holds, as it were, but as you have set it out, as it is in my statement. Yes, that’s my understanding.
Counsel Inquiry: You’ve done so, if I may say so, very helpfully. The fact that it wasn’t considered necessary to increase the baseline capacity of ventilators, you say, was based on specific learning around how many ventilators were needed for events such as the 2009 swine flu pandemic. Is that your understanding from looking back across these documents?
Mr Matthew Style: That is my understanding, yes.
Counsel Inquiry: One other document to which you refer us is this one, please, INQ000057495. I’ve somewhat plonked you in the middle here –
Mr Matthew Style: I’m familiar with it.
Counsel Inquiry: I hope you would be. It’s an NHS briefing entitled “NHS Surge and Triaging”, a briefing to the Chief Medical Officer and Chief Scientific Adviser from September of 2017, which considered ventilator capacity.
If we see at the very bottom of that page, under “Critical care surge”, I wanted to see if you can, please, help us with some of these figures:
“The baseline NHS capacity for critical care at that time was said to be around 3,500 ventilated beds. Increased demand for critical care beds above this, (nominally [it says] by doubling capacity up to 7,000 ventilated beds) can be met through using areas within hospitals that are not usually used for long-term provision of such care (eg, theatre recovery areas, operating theatres …)”
Just pausing there, you note in your statement and we’ve already hearing, that DHSC and NHS England, as you say, had a limited understanding about the number of ventilators available at that time; is that correct?
Mr Matthew Style: Yes, that’s correct.
Counsel Inquiry: Looking at this, and the other document we looked at, you say that these previous studies regarding the impact of an influenza pandemic hadn’t considered it necessary to increase, as we’ve discussed, and you say this:
“Ventilator availability was not therefore identified early on as a priority given the exercises that fed into pandemic planning. This was [you say] also the reason why data on ventilator availability was not available until the end of February 2020, as the Department did not receive regular data on equipment stock levels from NHSE prior to the pandemic …”
Mr Style, we’ve heard from various witnesses now, Sir Gareth Rhys Williams and Mr Stirling, we’re going to hear from another one this afternoon, Professor Moonesinghe, about the lack of available data as the pandemic hit in 2020, upon how many ventilators there were, where they were, the condition they were in, what model, what age. All the things you might think become so crucial, in particular to clinicians.
Looking at this and this use of the words “nominally by doubling capacity” even back then, in 2017, what has been done by the department looking forward to address this issue and understanding of the baseline ventilator capacity, where it is, what state it’s in?
Mr Matthew Style: Thank you. I think I would draw out three things in respect of how the situation has changed since February 2020. But before I do that, if I may, I – because I – as I say, I’ve been back and looked in some detail at the documents that are available and are on the records, and I think the overall picture, as you say, is the whole report from July 2010 talks about the need to be able to double critical care capacity but there are no numbers specified within the whole report as to what levels that would – you know, that would entail.
The memo to which you refer and which remains on the screen from September 2017, as you say, has the figures 3,500 and 7,000, and there were no recommendations in this memo for a baseline increase. That’s the basis on which I make the statement I do in my statement.
But to your question, the three things I think that are different – I hope I’m meeting the stenographer’s needs, by the way, sorry – to your question of the three things that are different today compared to February 2020, the first is I believe that Ramani – forgive me, sorry, Professor Moonesinghe, from whom you’ll hear later – refers in her statement to an annual sort of survey and census of ventilator capacity that NHS England now carries out. Clearly a lesson learned and implemented there.
The second is that in your – in the evidence given by Mr Stirling to the Inquiry earlier today, Mr Stirling talked about the creation of the Medical Technologies Directorate in the Department of Health, and one of the activities that that directorate has undertaken, working with NHS Supply Chain, is the establishment of a system called NETIS. I believe that stands for the National Equipment Tracking and Inventory System. But this a system, an online system, that now enables us to track the make, model, and location of key bits of medical equipment across the NHS estate.
And as I say, that system is in the process of being rolled out, it’s already in use in some trusts but not with full compliance as yet. The nature of the – (overspeaking) –
Counsel Inquiry: Just pausing there, is that wider than just ventilators and associated consumables? It’s medical technology more generally –
Mr Matthew Style: It is – it is wider than just ventilators and consumables, yes. I couldn’t give you, as I sit here now, the full – the list of – I mean, Mr Stirling in his evidence refers to the sheer scale of the medical technology supply chain and industry, but it is, you know, a reasonably comprehensive system.
So I think, you know, that would be the second thing I would mention that I think would put us in a better place this time round to be able to understand the sort of starting point, and indeed, to be able to tackle some of the issues that you referred to with Mr Stirling around ensuring that, as far as possible, where it was necessary to provide additional equipment, that matched the experience and expectations and familiarity levels in existing organisations, because we’d know what they already had, as it were.
So, sorry, that would be the second thing that I think would lead to an improved position.
And then the third is to say that, as my evidence makes clear, ventilators – surplus ventilators were acquired during the pandemic, which have subsequently been distributed to NHS trusts, and we know, I believe – I may get the exact figure wrong, but approaching some 7,000 ventilators have been distributed to the NHS from the stockpile. And clearly we know where those have gone and the make and model of those ventilators.
Which I think speaks to another of the sort of lessons learned to which I refer in my statement, and to which indeed Mr Stirling referred earlier, which is that balance between holding resilience centrally and holding resilience at the front line, so that that process of ensuring that clinicians can be familiar with the equipment they’re holding in reserve, can pay due attention to its maintenance, and to the issues of inoperability and so on. So, as I say, that resilience has been transferred from the stockpile out into NHS trusts.
Counsel Inquiry: Thank you very much indeed.
Just before we turn off this document, can I ask you about one other aspect of it, please. It’s – if you can assist, given the context of your evidence that you’ve told us.
Can you see halfway down the second paragraph that’s on the screen now, the sentence beginning:
“The trigger point within surge plans for moving to the withdrawal of permanent ventilation would be when there is no more capacity and increasing numbers of patients who are likely to require it. This could be nominally set …”
Again, that use of the word “nominally” we’ve seen twice there, just pausing there, would that be something less likely to feature, now you’ve got a handle, as it were, on all the types, numbers, makes and models of ventilators across the system?
Mr Matthew Style: So I think I would say that I think we are better prepared in this respect now than we were in February 2020. I think beyond that, I am here as a corporate witness today in respect of Module 5 and the procurement activities undertaken, I’m perhaps not the best witness to speak to the issues of pandemic preparedness in the round. I think that best falls, that best falls to others.
I would note that I believe that the September 2017 document was a draft document at that time. I have not seen, in the evidence that has been available to me, any further, you know, updates to the documents or variants prepared since.
Counsel Inquiry: All right. We’ll stop there in relation to that topic then and I just want to turn briefly with you, if I may, to complete our understanding of the certain aspects of the procurement of ventilators. Briefly, please, on the numbers which are procured. This is your paragraph 51.
We know that in March there were the tentative estimates of 6,000 to 8,000. You tell us that by 9 April there were 9,600 ventilators available, yes.
Mr Matthew Style: Yes.
Counsel Inquiry: By 14 April, the department had procured a total of 10,993 mechanical and 19,338 non-invasive ventilators, although many hadn’t arrived in the UK. We’re talking significant numbers at significant speed here, aren’t we?
Mr Matthew Style: Yes, and I think – and again, I think this came up in your evidence with Mr Stirling earlier, and it’s perhaps easier for me to say it, as someone who wasn’t involved in the programme at the time, I think once the programme was mobilised on 3 March, you know, the programme was very successful in mobilising quickly to expand supply by very significant volumes –
Counsel Inquiry: Just to –
Mr Matthew Style: – and that people involved at the time can be duly proud of their efforts in doing so.
Counsel Inquiry: Just to complete the picture, INQ000494406, a slide that you provided within your evidence about these numbers.
So we’ve gone through April. Now we’re at 19 May. This is a stocktake of ventilators, circulated on that date, the 19th.
By now we can see that the total number of ventilators, including mechanical, NIV, and CPAPs is in the region of 34,800 comprising, as we see, 13,000 mechanical, a bit more than 11,000 bilateral or BiPAP ventilators, and 10,100 CPAP ventilators, compared to a pre-pandemic stock of 4,954 ventilators.
Can I ask you this question briefly: we can see the numbers that were achieved and we can see the speed in which they were achieved. Does the department agree with – do you, Mr Style, agree with Mr Stirling and Professor Moonesinghe about the variably quality of which those ventilators were, given the speed?
Mr Matthew Style: I think that’s, it’s clear from the evidence that there was indeed variable quality. That was clear from Mr Stirling’s statement earlier and, indeed, in the documents I reviewed and have exhibited against my statement there are – there was evidence of that very much from frontline colleagues at the time.
Counsel Inquiry: Thank you.
One aspect of this procurement was that of ventilators from overseas. This is your paragraph 85.
I want to show you one document, I believe. It was referred to in Mr Wald KC’s opening. INQ000493942. This is a document entitled “Ventilator Sifting Wash-up Report” by the Department for International Trade. It’s dated 24 April 2020. And within here, there is a section reflecting upon the period at the end of March and the beginning of April and what’s said is this:
“… there was huge international demand, greatly outstripping supply. Speculators, opportunistic intermediaries and individuals had piled in, trading up prices exponentially. Some of the units that we looked at had changed ownership over five times in the past two weeks. The prices quoted were on average triple the usual retail price and at the peak of the market, many times over.”
And then this phrase which I think is quite vivid:
“We had entered a ventilator procurement ‘Wild West’ …”
Now, appreciating you – that wasn’t part of your remit at the time, is that a – looking now at the procurement of ventilators from overseas, is that a picture that you recognise, having looked back across the documents?
Mr Matthew Style: I think it’s undoubtedly the case. And again, I think that was clear from Mr Stirling’s evidence and from the exhibits attached to my statement that it was an incredibly challenging commercial environment, both domestically and internationally, and colleagues, both in the Department of Health and Social Care, from the Government commercial function more broadly, and indeed from the then Foreign and Commonwealth Office worked together and went to, kind of, great lengths in order to secure supply and sort of protect the taxpayer in what was a very, as I say, a very challenging commercial environment.
I wouldn’t comment on the language used by the author of this particular report.
Counsel Inquiry: Fair enough. But you say at your paragraph 85, just in terms of how this process happened:
“… officials from the Department indicated that they would be asking [the Treasury] for delegated authority … to order ventilators …”
And that included on condition that there was an assessment of international suppliers in writing from both the FCO, as you’ve said, and DHSC, to show that they were satisfied with the level of any risk of that purchase. Is that right?
Mr Matthew Style: That’s right. So teams worked together very closely, both to, you know, receive offers and sort of expressions of supply, and make sure those were acted on swiftly, and UK-based teams worked with FCO colleagues both to obtain documentation as to the sort of clinical specification and for the compliance with standards of any offers to try and extract information as to the location of devices, where they were being held and so on. And indeed, as I think the exhibit you just put on screen makes clear, often you were dealing with re-sellers rather than manufacturers, indeed, possibly multiple re-sellers.
And again, FCO colleagues were instrumental in trying to get to the bottom of that thread, as it were, and helping to inform judgements being made about the credibility of those offers.
And again, as someone who wasn’t involved in the programme at the time, in going back and reviewing the evidence – and again, you can see this in my exhibits – what is striking is the speed with which colleagues were having to make judgements and liaise between, for example, Mr Stirling, who appeared before the Inquiry earlier today, his accounting officer and finance colleagues in the Department, Treasury colleagues, FCO colleagues both in London and in-country to sort of pool information and make those judgements very quickly, as prices were escalating mid-deal. Some of these examples I referred to in my statement, as you know.
Counsel Inquiry: Can we look briefly at one of those examples, please. Your paragraph 91. Just talk us through this if you would, please. This was at the end of March 2020. You were made aware of an offer from a company in Malta, the number of ventilators doesn’t matter, but just talk us through this example, if you would, and then I’ll ask you some questions about what it might tell us.
Mr Matthew Style: Sure. So on 26 March 2020, the FCO made the department aware of an offer from a company in Malta, I was about to say its name but I probably ought not to, to supply ventilators initially for fewer than is stated in my statement here, but the number available rose to 3,000, you know, very – the number purported to be available rose to 3,000 in the first, you know, stages of those discussions.
There was extensive contact with the company in Malta from the department, but also Stuart Gill, who at the time was the British High Commissioner in Malta had contact both with the company and with the Foreign Minister in Malta in order to do due diligence and arrive at a view as to the reputability of the company, which appeared to sort of stack up in the first instance.
It then became clear, as the deal evolved, certain bits of information came to light, for example, that the stock was held in China and would be transferred to the UK from Shanghai using Qatar Airways. And the original agreement was that a deposit would be paid of just short of €40 million.
Once that had been paid, there was then – two changes were then made to the deal on the table. One was to seek an increase in prices. I believe that was on 1 April that that approach was made, and to require an immediate letter of credit.
We – the department proceeded at the time working with the Government legal department and its bankers, NatWest, to prepare a letter of credit, but made clear that the usual requirements in terms of confirmation of a delivery schedule and the location of the items for inspection and so on would be needed.
Those were not forthcoming, and on both 4 April, I believe, and 10 April, the department repeated its requirements to the supplier. Ultimately, given that there was no confirmation of delivery date and no confirmation of the other details requested, on 16 April we informed the company that we wouldn’t proceed with the deal and requested a refund of the deposit.
That was – a refund was ultimately obtained. As my statement makes clear at paragraph 93, we did sustain a loss on that deal as a result of exchange rate fluctuations. I believe the loss amounted to approximately 500 – it might be £540,000. But it was of that order.
Counsel Inquiry: Yes. So if you don’t mind me saying, really quite a significant loss. That’s not a small amount of public money, is it?
Mr Matthew Style: It is not a small amount of public money. I think this is a good example of the very difficult judgements that the team were having make in order to secure the best possible supply.
Counsel Inquiry: So “Wild West”, not your phrase, but a very difficult purchasing and procurement environment from abroad. You’ve very helpfully talked us through one example and the loss that was sustained.
Do you, looking now, and does the department, think that in advance of any future pandemic, it’s the stockpile question, that there should be a stockpile of equipment like ventilators and associated hardware. Appreciating there’s a balance there, would that help to lessen the risk of situations such as this one arising?
Mr Matthew Style: So the first thing I’d say is I believe we are in a more resilient position today than we were in February 2020, not least because there was increased resilience held, you know, at the – locally, as it were, as opposed to in a national stockpile. And clearly, if we were having – if we didn’t have such a significant need to procure additional ventilators in the sort of commercial environment that we’ve rehearsed, then we would be, sort of, less exposed to potential, sort of, losses and exploitation in that environment.
But there is, of course, a balance to be struck, and I think Mr Stirling in his evidence this morning referred to the – you know, the sort of cost of storage, if you hold a national stockpile. So, in a sense, it’s not a sort of – you know, this is not a one-way balance as it were.
And also, the risks of – you know, the difficulty of maintaining equipment, ensuring that the equipment, you know, keeps pace with – ensuring the equipment keeps pace with changes in clinical preference and indeed technological change as most effective equipment to hold.
And indeed, and again this is – you’ll have heard, the Inquiry, and perhaps even you, counsel, will have heard other evidence from colleagues in the department about, you know, you don’t know specifically which equipment you’re going to need depending on which pandemic is going to hit you. And it’s particularly striking in this case, I think, to – and again, this was rehearsed extensively in the technical report which is an exhibit to my evidence, and indeed Mr Stirling referred to it earlier today – the clinical model of care evolved significantly throughout the pandemic. At the start of the pandemic, the focus was very much – and indeed the procurement focus of the programme – was very much on mechanical ventilation.
Towards the end of the – or even after the very first phases of the pandemic, the emphasis, clinical practice – and again, technical report rehearses this – clinical practice switched towards non-invasive ventilation.
So we could have had a sort of, you know, huge, huge stockpile of mechanical ventilators and we may not have had, you know, as many CPAP machines as we eventually decided that we needed. So I think it is very difficult to foresee every single requirement for every single sort of potential pandemic, and hold those centrally in a kind of physical stockpile.
These are very difficult judgements. I think, you know, one of the lessons of the – one of the lessons of the pandemic is that those judgements need to be subjected to, you know, very careful scrutiny and to be made and subject to very regular review, as it were. And I think that’s sort of critically important because there is no – there was no easy answer to this question.
Counsel Inquiry: Thank you very much.
Turning briefly, please, to one other aspect of your statement and that’s about attempts to mitigate fraudulent behaviour in the procurement of this equipment.
One of the documents to which your statement refers is INQ000514235.
Just going to talk through it very briefly, please. This is a letter from David Williams, second permanent secretary to the DHSC, to the Public Accounts Committee in October of 2020, and a response to requests to write to that committee setting out instances of fraud when attempting to procure ventilators. Just a couple of points that are made.
Can you see here in this last part on the screen in the last section:
“Often it was difficult to differentiate between over-optimism in complex supply chains and deliberate fraud. The due diligence process undertaken to test the proposed was designed to protect both against over-optimism and fraud.”
This is effectively suppliers claiming to have stock that they didn’t; is that right? That’s what’s being aimed at here?
Mr Matthew Style: I believe so, yes. And this is the – the PAC – the letter to the PAC from David Williams, then I think second permanent secretary at the time, to the PAC, yes. Yes, that’s my understanding.
Counsel Inquiry: Next section, on “Fraudulent Documentation”, we can see that:
“In order to assess the validity of offers, the Department requested documentation from potential suppliers, [including] CE certificates …”
And other things.
Mr Matthew Style: Yes.
Counsel Inquiry: You say:
“Whilst some of these documents could be independently identified … others were more challenging …”
Then this:
“There were a very small number of cases where clearly fraudulent documents were supplied: [and] these were not taken forward.”
Mr Style, for obvious reasons, I don’t want to get into the specifics of any particular case, but I wanted to get the department’s view on, overall, to what extent was fraud something that impacted upon the procurement effort of this type of medical equipment?
Mr Matthew Style: Well, look, we – clearly, fraud on any scale is something of very significant concern, and I take my responsibilities – as would David Williams, as the accounting officer responsible at the time, have taken our responsibilities – for safeguarding taxpayers’ investment very seriously indeed.
Overall, I think this particular procurement programme was less vulnerable to fraud than some others may have been in these circumstances, simply because it was, sort of, easier to detect, possibly, some, sort of, clearly fraudulent or clearly over-optimistic offers, as it were. If people were suggesting that they could suddenly supply three times the typical annual output of a manufacturing facility of a ventilator, when it was – clearly didn’t withstand scrutiny, as it were.
As others have rehearsed in the evidence, these are – ventilators are complex pieces of, sort of, you know, clinical engineering, and you’ve got to have a certain degree of, kind of, established capability in order to be a credible supplier. And I think that helps to limit the programme’s exposure to fraud overall. And as the letter to the PAC says, there was only one sophisticated suspected case of fraud identified.
But as I say, I think that’s – in some ways, that’s a testament to the efforts of staff in London, in-country, and so on, to perform as much due diligence as they sort of possibly could. I won’t go over the details of that, I rehearsed it a little bit earlier on. And I think it was those teams working together that helped to, you know, minimise these risks of fraud very successfully during the programme.
Counsel Inquiry: Thank you.
Just one question now, please, and I’m sorry to have moved you round sort of in short time between a whole series of topics, but you’ve been very helpful in your answers, if I may say. It’s a topic upon which your witness statement and the evidence of Mr Stirling this morning touches. It’s that of clinician choice, and it’s something you touch upon in your paragraph 155.
Mr Matthew Style: Mm.
Counsel Inquiry: First, there’s this acknowledgement which I’m just going to read to you:
“Given clinicians can have strong preferences for particular equipment models and brands, greater account could perhaps have been taken of these preferences in determining the appropriate balance between stimulating the production of existing designs and developing novel designs.”
So you explicitly acknowledge that.
But looking forward, talking about interchangeability and interoperability, what’s the up-to-date position as far as the department is concerned?
Mr Matthew Style: Thank you. I think the first thing I’d say is I think my colleagues working on these issues at the time were right to pursue all of the available options. The scale of the demand projections – and again, I believe, Mr Stirling rehearsed you with this earlier – the scale of demand projections was such that I’d think colleagues in the programme and their colleagues in the Cabinet Office working on the parallel programme were right to pursue all options. And, you know, that was – that’s – that’s, as I say, that was the right thing to do.
I do think it is very important to bear in mind the issues of familiarity with machines’ interoperability and so on. I think the key thing I would point to there is the sort of inventory and tracking system I referred to earlier. So we would be starting – were we to find ourselves in this position again, we’d be starting with a better understanding of which devices, of which make and model were in use, in which organisations, as it were, and therefore we would be better able to ensure that we were sort of matching clinical preference and so on.
But I think the other thing I would say is the importance of these issues, the importance of these issues of interoperability and familiarity with a range of devices, you know, the pandemic experiences absolutely shone a light on that, and I think those clinical teams at the front line in thinking about their own resilience will clearly be much more mindful of those issues, you know, based on those lessons than they kind of may have been previously.
Mr Stoate: Thank you very much.
My Lady, those are my questions. There are some more –
Lady Hallett: Thank you very much.
Ms Banton, I think you’ve got some questions.
Over that way.
The Witness: Thank you.
Questions From Ms Banton
Ms Banton: Thank you, my Lady.
Just for some context, Mr Style, I represent FEMHO, and in your capacity over seeing critical aspects of pandemic response, particularly related to ventilators and oxygen therapy devices, it’s crucial to explore how considerations of equality impacted decision-making processes. FEMHO would like to understand the extent to which the needs of black, Asian and minority ethnic healthcare workers were considered in procurement and policy formulation, helping to shape recommendations for improving resilience and equity in future health crises.
So my first question is in relation to paragraphs 40 and 61 of your witness statement, where you describe the processes and shifts in strategy regarding the allocation and management of ventilators and oxygen therapy devices.
How did the national ventilator allocation panel ensure compliance with the Public Sector Equality Duty when making allocation decisions?
Mr Matthew Style: Thank you. And it’s obviously a very important issue, and one of those on which the pandemic has, you know, shone a particular light on the need to consider the differential impact that, you know, different health emergencies will have on populations.
I think two things are important in response to your question. The first is that the decisions that the programme, through the national ventilator allocation panel were making were first and foremost informed by the clinically-led projection. So, as you will know, you know, as you will understand much better than me, that understanding about the differential impacts of the virus on different sections of the population, including the particular impacts on people from ethnic minorities as well as other factors such as age and, sort of, geographical factors and so on, that understanding evolved over the pandemic, but as that evolved, that increasing understanding was then being fed into the clinical work that was being done to make projections of future demands, and those projections of future demand were then fed into the allocation panel in order to make its decisions.
Similarly, and again as Mr Stirling said earlier today, the key inputs into that allocation process came from regional medical directors and their teams, who – I mean, I was not part of the process at the time, but I have worked extensively with regional medical directors over the years, and I think that they, you know, were sort of well placed to have that sort of very up-to-date connection with differential pressures and the very localised impacts on particular communities and therefore on particular, you know, hospital trusts and healthcare providers that wouldn’t necessarily have been picked up in sort of aggregate data, but the national – the relevant medical director would have known that particular pressures were being experienced in that institution because of the demographics of its sort of local population.
So I think those are the ways in which the factors you describe, and in particular the differential impact on people from ethnic minorities would have been appropriately reflected in and, sort of, had input into decisions made by the national ventilator allocation panel.
Ms Banton: Right. Okay. Thank you.
I’ll ask my next question. In the governance of the O2VMD&CC programme that you mentioned, various decision-making bodies and their roles, and this is at paragraph 60 and then 63 to 66, so in respect of that I’ve just got just two points to raise.
The first one, how were representatives from ethnic minority-led healthcare providers included in these forums, if at all, to ensure their specific needs were addressed?
Mr Matthew Style: From the top of my head I couldn’t tell you whether or how specific representations from ethnic minority communities were reflected in the governance of the programme. I think the thing which I – if I may, one of the things I would draw attention to – and I referred earlier to the fact that this is something in which learning and understanding has advanced significantly as a result of the pandemic experience, you know, we have since established, as you will no doubt know, the NHS Race and Health Observatory under the leadership of my colleague Professor Habib Naqvi, and that’s now a very well established channel for ensuring that policymakers, operational decision makers, can access analysis insight and representations to make sure that’s absolutely at the heart of decisions that are now – as they are now made across the system.
Ms Banton: Right. So was there any mechanism to gather input from healthcare providers serving predominantly ethnic minority communities to inform procurement strategies?
Mr Matthew Style: I think the principal vehicle for doing so would have been through the – both the clinical and operational representatives of – from NHS England. So for example, Dr Dame Emily Lawson, as SRO for the programme, and Professor Sir Keith Willett as the National Director for Emergency Preparedness in NHS England were both members – were both represented in programme governance, and, and both Keith and Emily would have been in daily, several times daily contact with frontline providers and therefore had that very sort of swift intelligence as to the differential impacts and particular providers struggling to meet the needs of particular communities. It would have been through those mechanisms that that intelligence was available to the programme.
Ms Banton: Right. My next question. Considering the preparation for future health threats and lessons learned going forward, and not just only from the pandemic, as discussed in paragraphs 166 to 168 of your witness statement, the first point is, how does the government assess its effectiveness in protecting ethnic minority healthcare workers during the pandemic?
Mr Matthew Style: Well, as I said, if I may, as I said at the start of my evidence, I was a member of NHS staff at the time and I was particularly conscious of the challenges faced by colleagues at the front line, and, as you say, some people were more affected than others, and experienced greater challenges. I think – it’s not something on which I am – I mean, I’m not the appropriate witness to speak to this in detail, but what I would say, my understanding, is that colleagues in the various different sort of operational cells responding to the pandemic acted as swiftly as they could once the – once the sort of data and, you know, intelligence began to show that there were – that some staff were experiencing, you know, greater challenges than others. And I saw, again, colleagues in NHS England at the time acting, sort of, swiftly to, sort of, very rapidly learn those lessons and change the way they were, you know, leading and managing staff, including to take account of the preference – the preferences of individual employees about their own deployment and so on through the pandemic, precisely to ensure that, you know, a full account could be taken of the sorts of differential impacts to which you refer.
Ms Banton: And following on from that, what sort of specific measures are being implemented to ensure better preparedness and protection for these workers in response to future health crises?
Mr Matthew Style: Forgive me. I mean, this is a critically important issue. It’s not something that I am the best person to speak to, as a corporate witness for the procurement module, as it were. But I – it’s clearly a critically important issue.
Ms Banton: Right.
How, would you say, are the lessons learned being integrated into current and future policies to enhance the resilience and safety of the healthcare system, particularly for ethnic minority communities?
Mr Matthew Style: Well, I think I would go back to my overall assessment is that we have – we now have in place a system that allows us to much better understand the resilience of all of our hospital trusts across the country. So we would – were we to find ourselves in this – in a similar position again, we would start from – with a much better understanding of resilience.
We also, as I said, not least through the work of the Race and Healthcare Observatory, you know, we have established mechanisms to ensure that we’re thinking actively about differential impacts on different communities, including different communities within our staff. We’re much more conscious of it, we have established mechanisms to ensure that’s reflected in our policy making and our operational decision making.
Ms Banton: Thank you.
Thank you, my Lady. Those are my questions.
Lady Hallett: Thank you, Ms Banton, very grateful.
Mr Stoate, I think that completes the questions for Mr Style.
Mr Stoate: It does.
Lady Hallett: Thank you very much indeed, Mr Style. I’m very grateful to you.
The Witness: Thank you.
Lady Hallett: Mr Stoate, I’m in your hands, it’s early for a break but we’re making very good progress.
Mr Stoate: Yes.
Lady Hallett: It’s entirely up to – you’re calling the next witness I think?
Mr Stoate: I am.
Lady Hallett: It’s entirely up to you whether we get on to the next one or take the break now.
Mr Stoate: I can certainly make a start, my Lady, if that would …
Lady Hallett: Mm-hm.
Mr Stoate: Thank you.
The next witness, please, is Professor Ramani Moonesinghe.
Professor Ramani Moonesinghe
PROFESSOR RAMANI MOONESINGHE (affirmed).
Lady Hallett: Professor, I don’t think we have kept you waiting too long. I hope we haven’t.
The Witness: Thank you.
Questions From Counsel to the Inquiry
Mr Stoate: Thank you.
Please could you give the court your full name.
Professor Ramani Moonesinghe: Ramani Moonesinghe.
Counsel Inquiry: Thank you. You’ve very helpfully given the Inquiry a statement, the reference for which is INQ000518349. It’s 54 pages long and dated 28 October of last year. Is that statement true to the best of your knowledge and belief?
Professor Ramani Moonesinghe: Yes, it is.
Counsel Inquiry: Thank you.
Professor, the Inquiry has had some impressive CVs, but yours, if you don’t mind, will take a little while to go through.
You are a doctor who has worked in the NHS for some 27 years, including 20 working clinically in critical care; is that right?
Professor Ramani Moonesinghe: Correct. Thank you.
Counsel Inquiry: You were appointed a consultant in critical care, anaesthesia and perioperative care in UCLH in 2009.
Professor Ramani Moonesinghe: Yes.
Counsel Inquiry: Where you worked in a multi-disciplinary team providing care for critically ill patients in one of the largest services in the UK.
Professor Ramani Moonesinghe: Yes.
Counsel Inquiry: You’re a fellow of the Royal College of Physicians, the Royal College of Anaesthetists and the Faculty of Intensive Care Medicine, and a senior fellow of the Faculty of Medical Leadership and Management?
Professor Ramani Moonesinghe: I am.
Counsel Inquiry: You were appointed as a national speciality adviser for perioperative care at NHS England in 2019?
Professor Ramani Moonesinghe: Yes.
Counsel Inquiry: You started, you say, providing input on clinical and operational matters related to the Covid-19 response within NHS England on 2 March 2020?
Professor Ramani Moonesinghe: Correct.
Counsel Inquiry: And you were formerly appointed to the role of National Clinical Director for Critical and Perioperative Care at NHS England on 19 March 2020 to provide national clinical leadership for adult critical care in the pandemic, and in fact, still now?
Professor Ramani Moonesinghe: That is correct.
Counsel Inquiry: And are there any other positions you currently hold?
Professor Ramani Moonesinghe: I am currently also the interim National Director for Patient Safety for the NHS in England.
Counsel Inquiry: Thank you very much indeed.
As the first clinician today talking about some very complex pieces of kit, you may or may not wish to set us right, but when we’re talking about the procurement of ventilators, and associated kit, we’re talking about a fairly complex range of specialist equipment, aren’t we, for treating critically ill patients; is that right?
Professor Ramani Moonesinghe: That is correct.
Counsel Inquiry: Could you give us a brief but, sort of, overall flavour of what is that stuff that’s needed?
Professor Ramani Moonesinghe: Thank you. So critical care treats patients who either have organ failure or are at risk of it. The organ failure that we most commonly associate with critical care is respiratory or lung failure and the treatment for respiratory failure is either mechanical ventilation, where one places a breathing tube into a sedated patient and then the mechanical ventilator either fully breathes for the patient or supports the patient’s own breathing effort.
The next step down from that is non-invasive ventilation, where a patient would use a tight-fitting facemask, and air and oxygen would be blown into them through that.
The next stage down from that is continuous positive airway pressure, or CPAP. Some people may be familiar with CPAP because we use it as a treatment for obstructive sleep apnoea, so many people have CPAP machines at home, but in the hospital environment, and indeed during Covid, we also use it to treat respiratory failure, again through a tight-fitting facemask, or sometimes a helmet or hood.
Critical care also treats organ failure or risk of organ failure of all our other organs. So that includes our cardiovascular system, usually with drugs but sometimes with mechanical devices; the kidneys, with renal replacement therapy, a type of dialysis, and so on and so forth.
And obviously critical to all of that is the staff, because this is the absolute sharpest end, I suppose, of what we offer in terms of ward-level care in the hospital, and so the staff that work within critical care have been trained to use all of these machines, understand the context of failing or failed organs, and provide that holistic care to the patient, and also to their loved ones.
Counsel Inquiry: Thank you. And as well as the staff, and the machines themselves, there is a wide range of other consumable items that go alongside that, aren’t there?
Professor Ramani Moonesinghe: That is correct. So capital equipment like monitors, so we can see the blood pressure, and so on, continuously. Consumable items. So I’ve already mentioned breathing tubes, but the drips in our hands and all sorts of other things, catheters, and so on.
So one of the things that we had to do at the beginning of the pandemic was actually to itemise everything that we might use in a critically ill patient, how much we would use, how many we would need per individual patient based on projections of how long we thought patients would be in hospital requiring that kind of help, and so on. It’s a very, very complex task.
Counsel Inquiry: One of the tasks that we’ll go on to discuss that you had was clinical leadership in the procurement of this stuff, wasn’t it, that we’ve been discussing?
As part of the preparation for this Inquiry, you were provided with a statement by Professor Philip Banfield, chair of the British Medical Association’s UK Council.
Professor Ramani Moonesinghe: Yes.
Counsel Inquiry: Perhaps we can bring it up. It’s INQ000562457 at page 85, at paragraph 274. I’ve got it on the screen for you there, I hope, Professor?
Professor Ramani Moonesinghe: Yes.
Counsel Inquiry: The observation of the BMA here is this:
“… the UK started out on the back foot in relation to the supply of intensive care [ventilators], having failed to sufficiently consider ventilation capacity as part of pre-pandemic planning and preparedness. This is because recommendations set out an Exercise Cygnus were largely overlooked, despite concerns around the ICU ventilator capacity then … The failure to action the recommendations meant that, at the pandemic’s outset the UK was already at serious risk of running out of ventilators, with all 4 governments noting a very significant shortage of ventilators compared to estimated potential need. Indeed, the UK entered the pandemic without enough ventilators and ICU beds for normal levels of emergency and elective care; the lack of a staffed ICU bed was (and remains) a frustratingly common reason for the cancellation of major surgical procedures.”
Speaking from your position, do you agree with all/part of that picture presented here?
Professor Ramani Moonesinghe: So I can’t comment on the recommendations from Exercise Cygnus because I have not seen that.
Counsel Inquiry: Okay.
Professor Ramani Moonesinghe: However, there’s no doubt that the NHS in England and I think across the UK has lower critical care capacity on a day-to-day basis than comparable countries, so OECD countries. And this has been noted previously, my Lady, in Module 3 by Professor Chris Whitty and also by the expert witnesses for intensive care.
So we went into the pandemic with approximately six beds per 100,000 population in England, and today, having increased our intensive care capacity as a result of Covid and since then some investment being made, we’re at about seven.
But many other countries are at nearer ten or eleven. And we can perhaps talk about that more later.
Counsel Inquiry: Yes.
You came in – you started providing, as you already told us, clinical input on operational matters on 2 March, took up your formal role as national clinical care director on the 19th. I wanted to ask you about the picture it presented to you.
There was, as we’ve heard from others, really quite a stark lack of data about the availability of all the kit that we’ve just discussed. Do you share that assessment?
Professor Ramani Moonesinghe: So a stockpile was undertaken towards the end of February which gave us an understanding of the number of critical care beds and ventilators in the system, and also the number of anaesthetic machines, which were a secondary source of ventilatory equipment, not ideal, but a reasonable next choice, and also gave us an understanding of the number of transport ventilators, which were, again, not an ideal choice for ventilating critically ill patients but a means of doing so.
So that was organised by our emergency preparedness response and – EPRR team at the end of February, and that gave us the numbers, which were, from memory, in the order of around 7,000 ventilators – I may have got that slightly wrong – of which about half were true critical care ventilators and the rest were second choice equipment.
Counsel Inquiry: The witness statement to the Inquiry of Dame Emily Lawson, chief commercial officer of NHS England during the pandemic, as I’m quite sure you know, says as follows – I don’t think I need to bring it up – can I just put this point to you? It’s her paragraph 99. She says, of exactly this time:
“One of the initial problems I encountered after joining the team [this Mr Stirling’s team] was that there was no recent indication of the number of existing ventilators, their make or their capabilities, available to the NHS. This information was needed to inform purchasing.”
Then this:
“A ventilator survey had been conducted in 2017 and needed updating. I had no concerns about this; ventilator numbers are not data that I would have expected us to routinely collect and hold nationally.”
Did you have any concerns about the fact that there hadn’t been a survey since 2017, the lack of data? Was it concerning to you?
Professor Ramani Moonesinghe: I suppose by the time I got involved we already had the numbers. So I think it’s surprising, perhaps, that we did not have more up-to-date information than 2017. It is something that we have learnt from, and the NHS and NHS England conducts a survey – has conducted a survey three times, so annually, since Covid, to understand the number of intensive care beds, the number of ventilators in intensive care units, and also our immediate surge capacity as well. So beds that could be stood up within 24 to 48 hours to support critically ill patients should it be required outside a normal context.
Counsel Inquiry: In any event, you say it was clear – and I think we’ve heard this now from number of people – that there were insufficient numbers of ventilators to meet the demand?
Professor Ramani Moonesinghe: That is correct. So when I was first involved, in early March, one of the first jobs that I did was to support looking at lists of ventilators that we could potentially procure, and I’m sure we’ll talk about that in a moment, and our strategy, collectively, was to map every single thing that would be required to treat a critically ill patient, and make sure that not one individual thing would be the rate limiting step in being able to treat as many people as possible.
So the first – the reasonable worst case scenario data that I was presented with on around 15 March 2020 indicated that we would need at least 30,000 intensive care ventilators, and possibly many tens of thousands more than that. So starting with a baseline of 7,000, it was clear that we had a long way to go.
Counsel Inquiry: Yes. We’ll come, probably after the break, to the Ventilator Challenge. We’ve heard a bit about that. That was designed, wasn’t it, to fill that gap between –
Professor Ramani Moonesinghe: Yes.
Counsel Inquiry: – supply and demand. But just before we get there, I want to ask about this observation of yours that in parallel with the idea of manufacturing new ventilators through the challenge, you say this:
“… an increasing number of innovation proposals were being received by NHS England, DHSC and professional bodies, necessitating the [deployment] of a systemic approach to evaluating”, other options, effectively.
What were those other options that were being considered?
Professor Ramani Moonesinghe: So it speaks to the ingenuity of my colleagues and the effort that everyone was trying to put in to meet the challenge that some very unusual ideas came to the fore. For example, repurposing veterinary ventilators and anaesthetic machines for humans. That was reviewed by somebody from the Royal Veterinary College and dismissed. The idea of splitting a ventilator, which would always be used to treat a single person between two people. Again, something that we considered and dismissed.
Then the third idea was to try to make ventilators. And that – and we were – multiple people were thinking, as I say, in the same way. That is what lengthily let on to the Ventilator Challenge.
Counsel Inquiry: As well as speaking to ingenuity, does it also speak, in your view, to a lack of preparedness?
Professor Ramani Moonesinghe: A hundred per cent.
Mr Stoate: My Lady, that might be a convenient moment.
Lady Hallett: Certainly. I shall return at quarter past.
I hope you were warned about our break.
The Witness: Yes.
Lady Hallett: It depends on the witness. We do have perfect witnesses occasionally, as we did this morning. I shall return at 3.15.
(2.58 pm)
(A short break)
(3.15 pm)
Lady Hallett: Mr Stoate.
Mr Stoate: Thank you, my Lady.
Professor, before the break, we were just turning to the Ventilator Challenge. We have already heard in the Inquiry quite a lot of evidence from Sir Gareth Rhys Williams –
Professor Ramani Moonesinghe: Yes.
Counsel Inquiry: – with whom you worked very closely in that endeavour?
Professor Ramani Moonesinghe: Indeed.
Counsel Inquiry: So I only want to ask you about a couple of specific aspects of it. One of the initial things you did as part of the Ventilator Challenge was to produce a draft of what you call the Rapidly Manufactured Ventilator Specification. What was that?
Professor Ramani Moonesinghe: It was the minimum requirement for a ventilator to be made through the Ventilator Challenge. It didn’t set a maximum requirement; but it was the minimum clinically acceptable requirement for a ventilator.
Counsel Inquiry: And what key features were you looking for in that requirement?
Professor Ramani Moonesinghe: So if may, I just want to provide a little bit of additional context. We’ve talked about how complex ventilators and that type of equipment are. And although as a clinician, I know quite a lot about how a ventilator works, I don’t know a great deal, and even to this day, I don’t know a great deal, about how they’re made. And they include complex parts, electronics, software, and so on.
So because of the speed with which we were going to require machines to arrive into clinical practice, we had to moderate some of the clinical ambition about what these machines would be able to do, because otherwise we would set a specification that was unachievable, and patients would die as a result of not having machines available to them.
So the specification that we wrote gave the basic requirements of a machine that could keep a patient who needed it alive for a few days, potentially, until something better was available.
So the basic requirements included a machine that would be able to support a patient who was fully sedated, unable to make any respiratory effort themselves, and an optional requirement for a machine that would be able to support the breathing of a patient who was making some respiratory effort.
Now we take both of those modes for granted in normal practice but the second one of those is really quite complicated because the machine could potentially interfere with the patient’s respiratory effort, and it would not – it would be a disaster. So we set the minimum requirement as just the machine would do all the breathing for the patient.
Similarly, the amount of oxygen that we give patients – normally, on any ventilator, we can dial up at any percentage between 21%, which is room air, and 100%. But that requires a degree of engineering, potentially software, that we considered would be unachievable in the timeframes that we were working to. So we set a minimum requirement of 40 to 50% oxygen or 90 to 100% oxygen, and that, we felt, was achievable and also, as safe as it could be, and so on and so forth.
Counsel Inquiry: Yes, and I’m sure there were many others. And some of them were about, is this correct, trying to mitigate clinician unfamiliarity, as well, were they, sort of trying to make something universal?
Professor Ramani Moonesinghe: Something that would be easily adopted into practice, something very simple that would be failsafe, and potentially deployed with clinical staff that were unfamiliar with the critical care environment, as well as with the machine.
Counsel Inquiry: You were asked to produce this, you say, within one working day on 13 March 2020?
Professor Ramani Moonesinghe: That is correct.
Counsel Inquiry: Which with some under-statement, you say, “This was duly provided”. So you did that very quickly. It was something you say you did in – you developed together with your husband, Mr Pennington-Ridge, Edward Pennington-Ridge; is that right?
Professor Ramani Moonesinghe: That is correct.
Counsel Inquiry: You say he’s an independent design consultant who fulfilled the role of “inventor in residence at UCLH” and had extensive and relevant design experience.
Professor Ramani Moonesinghe: That is correct. He is a designer that has specialised over the years in technology solutions for low resource settings, and that’s pretty much the situation we were in.
Counsel Inquiry: One of the statements we’ve received, as you’re aware, is from Professor Tom Clutton-Brock, a name we’ve mentioned a few times, director of the Medical Devices Testing and Evaluation Centre with whom, ultimately, you would work quite closely again, wouldn’t you, on testing the designs that you’d said, “yes” and “no” to?
Can we just turn that up, please, INQ000515729.
Can you see, halfway through paragraph 4, Professor Clutton-Brock says:
“In 2020 other members of MD-TEC and the Trauma MIC [which is the Trauma Management MedTech Co-operative] did not have expertise in mechanical ventilation, they assisted with phone calls and deliveries, but did not take part in any ventilator testing during the ‘Challenge’. To assist with administrative duties and to act in training videos, my two daughters, history undergraduates who had come home from university, volunteered to come into MD-TEC each day with me.”
Now, on the one hand you working with your husband, Professor Clutton-Brock pulling in his undergraduate daughters, again, it’s that spirit of ingenuity and resourcefulness in a crisis, on the one hand, isn’t it?
Professor Ramani Moonesinghe: Absolutely.
Counsel Inquiry: But again, does this tell us – the next clinical care director may not have a husband or the next director of MD-TEC may not have willing daughters to come and help him in the crisis. What does this tell us? What lessons can we learn, looking forward, about (inaudible)?
Professor Ramani Moonesinghe: My overarching lesson is that we went into the pandemic really unprepared in terms of the technology that we had available to us. We were really unprepared to be able to scale up critical care capacity in the way that we had to, and woefully unprepared for what we thought might be our reasonable worst-case scenario. So in order to avoid the luck, or in order to not need the luck that we had through these sorts of – in these circumstances, it’s all about planning, and preparedness, and spending a year or even five years doing what we had to do in a few days.
Counsel Inquiry: To some extent a similar theme runs through the – your assembly of the Technical Design Authority. We’ve heard a little bit about that. This was group of senior clinicians you assembled between – within a very short space of time between 15 and 18 March for which you provided clinical leadership and which served, is this right, as the independent expert advisory panel to the Cabinet Office in the Ventilator Challenge?
Professor Ramani Moonesinghe: That is correct, and some of them also assisted with the procurement effort of devices that were already CE marked and were being procured from overseas, as Mr Stirling has described this morning.
Counsel Inquiry: You say this:
“… no formal appointments process was undertaken, due to the speed with which we needed to assemble [that] panel.”
It was you, was it, asking who you thought could help?
Professor Ramani Moonesinghe: Yes, and there was a bit of rhyme and reason to it in that I asked clinical colleagues who, first of all, I trusted and I knew would have the required expertise. I asked one colleague with a respiratory medicine background as well as intensive care; another colleague with an anaesthetics background as well as intensive care. We have slightly different training and so slightly different experience. Another anaesthetist intensivist who had been involved in procurement decisions in his own trust which I thought would also be useful. And a senior, what we would call resident now, who was already working with NHS England in other matters, and also was able to provide a sort of hands on, the residents are always there around the clock. So that perspective as well.
And the other thing I had to take into consideration when asking these colleagues to help was their availability.
So I did actually ask others, obviously people in my own hospital, as you would expect, but they were all too busy either delivering clinical service or planning for delivering clinical service to be able to give their time to this.
So availability and expertise were the key considerations.
Counsel Inquiry: I’m going to take you forward to one of the reflections you have, and the lessons learned, and it’s your paragraph 200(c), you say:
“In advance of any future emergency, a panel of experts, including engineers and clinicians should be commissioned to develop the minimum acceptable specifications for a range of scenarios, based on the demand and the timeframe for manufacture …”
Which, you can say:
“… would improve the feasibility and effectiveness of our response [in] a significant surge …”
And we’ll come to the reasons in a minute. But would that avoid the need for husbands, daughters – no doubt qualified – but somewhat hastily assembled panels?
Professor Ramani Moonesinghe: It would, and it would also give clinicians more trust in what was going to be delivered to them. There was a lot of an anxiety – so there was a phrase that I heard earlier on that I was troubled by, which is that “a bad ventilator is worse than no ventilator at all”. Now, perhaps counter-intuitively, even if you need mechanical ventilation, because you’re effectively suffocating because of your respiratory illness, ventilators can cause further damage to the lungs. If we put too much air and oxygen into you, you can cause what we call volume trauma, you inflate the lungs too much. If you apply too high a pressure you can cause barotrauma, pressure damage to the lungs. So in normal practice we are all trained to apply just the right amount of volume and just the right amount of pressure to the patient in order to try to optimise their oxygen and carbon dioxide levels without causing further damage to the lungs.
And we’ve done many randomised trials to try to find the right sweet spot. The problem is that, in order to get that sweet spot, you need the most complex, the most sophisticated of intensive care ventilators. And we were not in a position to be able to make, and indeed even procure, a lot of the time, ventilators of that sophistication.
Therefore, we had to make some difficult choices to provide a pragmatic specification that would be achievable by industry, and save some lives.
And so that statement of “a bad ventilator is worse than no ventilator at all” was completely untrue, in the complex of the pandemic, because there would have been potentially, if the surge in demand had been as much as we had feared it would be, patients who would have simply been left to die without that support. So we had to make those choices.
Counsel Inquiry: Now, I’m not going to go into the detail of the evolution, but it’s fair to say, isn’t it, that the specification you provided developed?
Professor Ramani Moonesinghe: Yes.
Counsel Inquiry: It developed quite significantly over time?
Professor Ramani Moonesinghe: It did. And that is because the circumstances changed. So the specification that was initially published by the MHRA on 18 March, based off that initial one that my husband and I produced, was the most basic, anticipating that we would have to have product, as Sir Gareth mentioned, within two to three weeks.
Now, what happened was two things. The first is that, thankfully, the catastrophic surge in demand that we anticipated did not happen. And that was largely, if not entirely, down to the non-pharmaceutical interventions, the lockdowns.
So that bought us some time. And what that meant was that we could then afford to push for a slightly more sophisticated minimum specification, because the people that were developing the ventilators had more time to develop that degree of sophistication.
Then the second thing that happened was that our understanding of Covid as a disease was improving, because we were actually treating patients in their many hundreds and thousands, and so we could identify the specific things that it would be particularly important to try to prioritise in a more sophisticated design.
So one of those, as Sir Gareth mentioned a couple of weeks ago, was the ability to put a tube down the breathing tube and suck out the phlegm, essentially, because the patients were – they had a lot of what we call secretions on their chest.
That’s a ‘nice to have’ on the context of 18 March, but it became essential as we bought more time.
Counsel Inquiry: Now, one of your roles, clinically, was to provide what you said a ‘go/no go’ recommendation?
Professor Ramani Moonesinghe: Yes.
Counsel Inquiry: So you’re presumably testing offers of procurement from everywhere, overseas, the UK and through the Ventilator Challenge, and testing them against this specification, are you and then deciding “Yes, procure” or “No, don’t procure”?
Professor Ramani Moonesinghe: So the procurement and the Ventilator Challenge required slightly different approaches.
In procurement, we were looking at devices that all had CE marks, and so they’d been through some sort of regulatory approvals process, perhaps not in the UK, but internationally, and my colleagues and I reviewed the publicly available materials, so the instructions for use from manufacturers and other materials from manufacturers’ websites, and, based off that information, categorised the ventilators into proper ICU intensive care ventilators versus anaesthetic machines versus transport ventilators, in reducing levels of sophistication, and then provided that ‘go/no go’, based entirely on clinical grounds, to Chris Stirling and his team.
Counsel Inquiry: So your considerations were entirely clinical, but, from what you say, this is your paragraph 97, that information from manufacturers, you were entirely dependent on that, given the circumstances of the procurement?
Professor Ramani Moonesinghe: Yes, if they were machines that were not already in use in the NHS.
Counsel Inquiry: Was the quality of that information provided by manufacturers variable?
Professor Ramani Moonesinghe: As it turns out, it was variable.
Counsel Inquiry: You also say this: the clinical review could not involve putting the devices to actual use, as you had presumably to make such rapid procurement decisions in the context of high international demand and shortage?
Professor Ramani Moonesinghe: That is correct. And going to do back over my records, I – you can see the pace with which everybody was working. The procurement team would send us huge spreadsheets and sets of documents to review, and then, in the nicest possible way, were pushing us very, very hard for decisions because the market was so volatile that we had to make those – collectively had to make those decisions quickly in order to not miss out on the opportunity to buy the machines.
Counsel Inquiry: We don’t need to dwell on this in particular detail because we’ve heard evidence, but did you hear some of the evidence of Mr Stirling this morning?
Professor Ramani Moonesinghe: I did.
Counsel Inquiry: Including about the Shangrila model, the 510S?
Professor Ramani Moonesinghe: I did.
Counsel Inquiry: You will have heard then, I expect, the consternation that caused to the particular trust to which it was delivered?
Professor Ramani Moonesinghe: Yes.
Counsel Inquiry: You in fact received, didn’t you, correspondence from that trust directly to you?
Professor Ramani Moonesinghe: I did.
Counsel Inquiry: With those concerns?
Professor Ramani Moonesinghe: At my request.
Counsel Inquiry: At your request, right.
So if we look very briefly, please, INQ000508296. This a letter from Dr Jon Hulme, dated 13 April 2020, just the first couple of lines:
“Dear Ramani,
… Feedback summary of [this particular model of] ventilator.
“We spoke with you today as part of a group of clinicians and senior managers within the Birmingham and Black Country region about our serious concerns that the 250 Shangrila 510 ventilators delivered to us are not fit for purpose within an intensive care setting.”
Then this:
“We believe that if used, significant patient harm, including death, is likely.”
So these were really significant concerns, weren’t they?
Professor Ramani Moonesinghe: They were, and I think this is an example of how our systems were actually – although this outcome was obviously not desirable, this is an example of how our systems were working well, in that this issue had been brought to my attention the previous day by a regional medical director for the Midlands region who had expressed it at one of the daily meetings that we had with medical directors that Mr Stirling described this morning. I then requested a meeting with the clinical trials so I could hear their concerns firsthand.
Having heard them, and taking them very seriously, I asked them to write this letter, which they did, summarising everything, and also summarising where the – their experience of using the machines differed from what the expectation should have been from the manufacturers’ materials.
So I subsequently, having received this letter, sent immediate notice to the procurement team and the team dealing with ventilator allocation to say, “Please don’t allocate any more, please don’t buy any more,” and “We need to do some more due diligence.”
I then, the next day, went to the next of these meetings and heard from colleagues in the south-east, from Portsmouth, where they had also received one of these machines. And we basically collated through this, and from Portsmouth the evidence that we needed to confirm that we should not be trying to deploy these machines into clinical practice. And we then sent one of these machines to MD-TEC, to Birmingham, to do bench testing which then eventually led to our final conclusion that we should not deploy these machines.
Counsel Inquiry: Part of the statement of the BMA suggests that there was a rush to procurement process. First of all, do you agree with that characterisation?
Professor Ramani Moonesinghe: “Rushed” feels pejorative. We worked at pace.
Counsel Inquiry: Do you think it was – a device like this where you hadn’t been able to undertake the due diligence was a consequence of that pace, then?
Professor Ramani Moonesinghe: If we had years – so if I was to support my colleagues at my hospital in buying a new intensive care ventilator today, that process would take months. My colleague in charge of procurement would seek the best models, the manufacturers, they would come to the hospital, they would give us one to play with, or a few, and then the team would make a collective decision. There was clearly no time for any of that.
So again, preparedness was one thing that might have assisted in this.
But again, for further context, the programme that Mr Stirling was in charge of, by the middle of 2021, had deployed more than 45,000 capital pieces of equipment into the NHS, of which about 11,000 were mechanical ventilators, non-invasive ventilation machines, CPAP machines, and so on, and others were things like analysers for blood at the bedside and so on.
To my knowledge, this is the only procurement that failed in this way. So I think, given that context, yes, we worked at pace, but it was to meet a need that actually was largely met.
Counsel Inquiry: Final aspect of questions on this particular model. If we look, please, at INQ000514240, this is the MD-TEC report on this particular model and it’s just these concluding paragraphs. So this is by Professor Clutton-Brock who says:
“The extraordinary circumstances facing the NHS and many other healthcare systems in March 2020 made the usual process of device procurement (selection, medical engineering training and assessment, clinical training and assessment, detailed procurement instructions) difficult, if not impossible, to follow.”
Referring to the particular model the Shangrila, he says:
“As a result, hose incompatibility, oxygen sensors, casing and breathing system choices were not properly identified.”
And I wanted to ask you about this next line:
“Even in pandemic times rapid external review of new technology procured for the NHS should be undertaken to identify suitability and training needs.”
Do you have a view on that?
Professor Ramani Moonesinghe: Yes. And, first of all, I agree entirely with Professor Clutton-Brock and what he describes as the process that we evolved towards that Mr Stirling has described this morning, where we procured the technology based on written materials, because there was no time to do anything else, but partly as a result of the Shangrila episode, we set up the system that meant that in Donnington where the supplies were received, there was then a process that was undertaken with clinical due diligence and an engineering assessment, and potentially bench testing either at MD-TEC or in Nottingham to test these devices before they were deployed into the system.
So we adapted our processes to get nearer to what Professor Clutton-Brock describes here, or to meet that request.
Counsel Inquiry: I want to turn to your reflections, please, and put three short parts of your witness statement to you, some of which you may already have heard.
First, paragraph 115. You say:
“Although the target number of machines was achieved …”
Presumably you’re talking about through the Ventilator Challenge and the other procurement routes.
“Although [that] target number of machines was achieved, the quality of the machines and their suitability for use in the NHS, to treat Covid-19 or other conditions was variable.”
Professor Ramani Moonesinghe: That is evidently true.
Counsel Inquiry: “There were also shortages of other … items, including some medicines and consumable items. These limitations meant that clinicians were not always able to treat patients with their first choice of interventions.”
Professor Ramani Moonesinghe: That is also true.
Counsel Inquiry: That’s important, is it, or –
Professor Ramani Moonesinghe: It is, because familiarity is one of the – so human factors in healthcare is a significant thing, and you are less likely to make errors if you’re using equipment and everything that you’re familiar with. You’re also less likely to make errors if you’re not stressed, you are not over worked, you’re not having to look after twice as many patients as usual, and so on and so forth. So clearly the circumstances of the pandemic meant that all of those things that on a normal day like today we would be able to deal with didn’t happen. So all the human factors aspects of care were challenging.
Counsel Inquiry: Next this, in terms of the number and the allocation. It’s your paragraph 120:
“[You’re] not aware of any specific incident where a patient who needed a ventilator was not able to access one.”
Is that still correct, to the best of your knowledge?
Professor Ramani Moonesinghe: That is still correct.
Counsel Inquiry: You do go on to say, however – you make a further observation, don’t you: you can’t be sure that individual decisions weren’t affected by this – the aspect of what was available.
Can you just explain what you mean by that.
Professor Ramani Moonesinghe: Yes. Even on a normal day, capacity constraints in the intensive care, and quite possibly in other aspects of healthcare, do affect decision making. So, for example, you have, in the morning, five patients who have been reviewed by an anaesthetist and a surgeon before coming in for surgery, and it’s been considered that they should go to intensive care after their operation for the benefit of their outcome, but you’ve only got two intensive care beds available.
So then the clinicians on the day have to make a decision about which to do, which two patients to put those beds and what to do with the other three. Do we cancel their procedure or do we proceed and send them to the normal ward? So that’s an example of where capacity affects decision making on a day-to-day basis.
Now, you take the specific circumstances of the pandemic and it is possible that anticipated pressure or real pressure may have changed subtly the way that clinicians thought about whether or not to send patients to intensive care or escalate their care.
And we have heard in Module 3 from a survey that the experience of clinicians was that escalation decisions varied according to the demand in the system.
Counsel Inquiry: Finally this, in terms of your reflections. You talk about the efforts made by colleagues across DHSC, Cabinet Office and NHS England as being remarkable and effective in many ways. But you say this at 187:
“I do not consider that there was a robust system in place to ensure an adequate supply of key healthcare equipment and supplies to the NHS …”
What’s the basis for your observation there?
Professor Ramani Moonesinghe: I think that Mr Stirling, Dame Emily and others set up systems and processes rapidly that were as effective as they could be in the circumstances. But at the risk of being boring, we were not well prepared. And ideally, we shouldn’t have had to have stood those systems up in haste at the end of February or beginning of March 2020; we would have had a plan that could have been executed earlier.
Counsel Inquiry: I want to turn now to what you say are the lessons to learn. This is your paragraph 200.
Could you just talk us through some of the key aspects starting with paragraph (a), about stockpiles.
Professor Ramani Moonesinghe: So there are some items that it’s relatively straightforward to stockpile: PPE, some consumable items. Ventilators and other capital equipment, it’s a much more difficult proposition, for multiple reasons. The first is they’re bulky, big items, so they take up a lot of space, so storage is challenging.
Second, they actually don’t stay in the box and – you can’t keep it in the box and then ten years later open it and expect it to work properly.
Some of the components of ventilators, oxygen sensors, and so on, have a life expectancy. And so if they’re not used, they won’t work.
And then the third is that familiarity aspect. Ideally, these sorts of equipment should be being used in clinical practice so that the clinicians are familiar with them, and we reduce the human factors risks.
That said, we could do more to have at least a bit of a buffer in terms of stockpiling and supply. The most obvious way to do that is actually just to expand critical care capacity.
I said at the beginning we have fewer critical care beds per head of population than comparable countries. If we increase that, we would use it, because we would send more patients to critical care after their operations, for example, and we would then have a bigger, sort of, buffer in the event of a pandemic surge or another emergency.
We could also have reserve stocks in hospitals that were stored and rotated through the attachments a regular basis. There’s a challenge, because one of the things in almost every hospital that is always at a premium is storage space, but it is surely – if we were able to do things like the Ventilator Challenge, then we should be able to do things like work the storage space out.
So I think that we can do more. I think today, because I looked at the numbers this morning, we have 4,000 critical care beds available. We have about an 80% occupancy of those beds, and we have another 800 beds that we could open in the event of a surge, an unexpected surge.
We could do a bit more than that and build a bit more of a buffer, I think.
Counsel Inquiry: Thank you. You talk about this, you say an unhelpful narrative developed in the press and:
“… disagreement between professionals and professional bodies which focused on the quality and quantity of ventilators and other items which were procured or manufactured to meet surge demands. This could be avoided through better preparation and advance planning and agreement on the potential risks and benefits of different approaches with all relevant stakeholders – including the general public.”
What do you mean by “disagreement between professionals and professional bodies”? How widespread was that and how deep? What was that?
Professor Ramani Moonesinghe: So there were disagreements in discussions which related back to that point I made earlier about a bad ventilator being worse than no ventilator at all. That kind of notion. And some of that then spilled into the press, and that was pretty challenging, actually, given the efforts that we were making, simply to – even just save one life by having an additional machine that could fulfil a basic purpose.
So – but I do understand why colleagues felt that way, because that’s the way that we’ve all been trained, and this was an extraordinary situation that was – none of us were ready for.
So the future lesson is: be ready. Have these conversations in peacetime, not when we’re all rapidly trying to change the way that we work in anticipation of these huge surges in demand.
Counsel Inquiry: I have asked you about your suggestion for a panel of experts, including engineers and clinicians. You go on in that paragraph to talk about a number of other factors: regulators, hibernating contract. Do you want to pick out any of those that you think are relevant to this –
Professor Ramani Moonesinghe: Yes, so for – so we know that one of the great successes of the pandemic in this country was the research, was the RECOVERY Trial, was the ISARIC study, which studied the epidemiology of Covid and so on. Part of the reason why those endeavours were so successful is because, in the case of the ISARIC study and REMAP-CAP, which was an intensive care study, the protocols for the research were already written. So when the researchers got wind of the fact that the pandemic was coming, they just activated those. The regulators were ready, and the processes that would normally take six months took six days, for example.
So if we tried to adopt a similar approach with this, then we might be better prepared in the future. We could have – we could model different scenarios. So we could look at the scenario that faced us in sort of 15, 16 March 2020 where we thought we might need 30,000 ventilators within two to three weeks, and then you could also model a different scenario where you only needed 5,000 ventilators in six weeks, and so on and so forth.
And then you develop both the specification that meets professional and, importantly, patient and public approval, and then you take that to the regulator and you say, “Okay, so this is what we think we need to do. What’s the process going to be for getting this approved?”
Get the regulatory approval in advance, and then the whole process can get going quicker. And then all of the work that Sir Gareth and others did, approaching manufacturers, finding all the bits to go in the ventilator, that can all be done in advance. You could potentially plan to pivot industry from what it was normally doing, building Formula One cars or whatever, over to this, if anticipated.
So all that this is talking about really, is taking a more considered, measured, long-term approach to the challenge that we faced and doing it over years rather than days.
Counsel Inquiry: Just finally, please, your paragraph 202, the lack of manufacturing capability for medical devices, consumables and medicines, was a key limitation of your response in your view?
Professor Ramani Moonesinghe: Yes.
Counsel Inquiry: What do you say should be done to look forward to that?
Professor Ramani Moonesinghe: So, for example, one of the things that we ran short of in the first wave was the fluids that are required to support kidney failure. So in intensive care we use a type of dialysis called haemofiltration, I don’t want to get too technical, but essentially you wash the patient’s blood, and you replace electrolytes, so potassium, sodium and so on.
Now, to do that you need various bits of kit but the most essential is just big bags of clean fluid with some potassium and some sodium, and so on. This is not a difficult thing to make. But we didn’t have that capability in the UK. And as a result of that, and the supply pressures from the two manufacturers that make those fluids that serviced UK critical care, our clinicians were required to adopt completely different practice to how they managed kidney failure in intensive care. They changed – even down to using something called peritoneal dialysis, which is a way of providing support to kidney failure patients at home, which I don’t think we’d ever used in intensive care before, but again the ingenuity of my colleagues, they adapted and they did it.
But that was a really good example of something that actually I couldn’t quite understand why we couldn’t do it ourselves, we couldn’t manufacture the fluids ourselves.
Ventilators are right the other end of the spectrum in terms of complexity. In fact, the two manufacturers that, won, if you like, the Ventilator Challenge, were Penlon who make anaesthetic machines based in the UK, and Smiths Medical who also have a factory in the UK and they make transport ventilators.
So we had that capability that was adapted to the Ventilator Challenge, but we didn’t have any intensive care ventilation ventilator makers in the UK. So that’s a limitation.
Counsel Inquiry: Having said “finally”, I hope my Lady will permit me a final “finally”, but briefly if you will, just looking at the time, clinician choice. Choice max, as Mr Stirling said it. Given that you’re here, can you give us the clinical perspective from where you are on that particular aspect of the debate?
Professor Ramani Moonesinghe: I can see it from every angle. So Lord Carter did a review in 2015 of the unwarranted – what he perceived to be the unwarranted variation in procurement. He looked at orthopaedic surgery and the huge variation there was in the types of prosthetics that were used to replace a hip between different trusts and hospitals and the huge variation in price. And from that came the getting-it-right-first-time initiative, which is about trying to rationalise that huge variation, initially in procurement, but it’s moved into other things as well.
So too much variation, or too much choice max, is probably undesirable, both from a cost perspective, but more importantly from a safety perspective, because I’ve been in the same place for 15 years or something, but our residents rotate, our nurses will increasingly rotate. And so if they rotate through different places and they have to get used to different equipment, then there’s clearly a safety challenge there.
The flipside of that, is the scenario that I just described with the renal replacement therapy fluids, because there’s two manufacturers that make those, and all the kit associated with renal replacement therapy in intensive care, and because of the international demand for those, we ran out or we were close to running out, and we had to modify our practice.
So Mr Stirling had a sliding scale like this this morning, and he said we’re over here in terms of choice max [indicating]. So I’d like to be somewhere a bit closer to the middle. And I think that what’s required is giving the clinical choice but in a sort of more organised way. So get clinicians together to make decisions across different institutions. There may be – I’m not a procurement expert – there may be some financial benefit to that as well, and I would anticipate that there would be a patient safety benefit.
Mr Stoate: Thank you, my Lady. Those are my questions. There are some –
Lady Hallett: Thank you. Just a few more questions for you, Professor.
Ms Morris, who is sitting there.
Questions From Ms Morris KC
Ms Morris: Thank you.
Good afternoon, Professor. I ask questions on behalf of the Covid Bereaved Families for Justice, and my first topic is going to be about the impact of the procurement problems as you’ve described them overall, and I think you’re likely to agree with me about this, but if I can just take you to a couple of paragraphs of your statement.
You said at paragraph 171 of your statement that the outcome of procurement of equipment supplies wasn’t sufficient to enable healthcare workers to meet the same standards of care to patients treated during the surges of the Covid-19 demand compared to non-surge or pre-pandemic times.
Would you agree with that?
Professor Ramani Moonesinghe: I would.
Ms Morris KC: You said that patients were treated with equipment or medicines which were either not designed for that purpose or didn’t provide best practice, and were treated by staff who were not necessarily fully trained to do so. Again, would you agree with that?
Professor Ramani Moonesinghe: I would. So on equipment, that was, for example, the repurposing of anaesthetic machines or transport ventilators to treat critically ill patients. In the case of medicines, that was, you know, we – you’d mentioned propofol earlier, so that was in short supply and so we had to moderate. And the staff, critically – and my colleagues worked under unbelievable pressure and we had to bring in people that were not used to working in intensive care to support the intensive care effort and it was extremely hard for them, and you’ve heard other testimony across the modules on that.
Ms Morris KC: Yes, thank you. And thank you for those examples.
You’ve said that these risks would have been cumulative, and potentially have had an impact on patient safety.
Professor Ramani Moonesinghe: Yes.
Ms Morris KC: Thank you. Would you agree that this impact on patient safety was created to a large extent by the lack of proper planning, the lack of preparedness, and the lack of procurement supplies ahead of the pandemic?
Professor Ramani Moonesinghe: I think that better planning and preparedness could have avoided at least some of the challenges that we had. If we had, for example, the surge in ventilator demand, if that could have been met with equipment that people were more familiar with, then yes, that would have helped.
Ms Morris KC: Thank you. I’m going to touch on familiarity again in a moment, because at paragraph 173 you exhibited a Coroner’s Prevention of Future Deaths report?
Professor Ramani Moonesinghe: Yes.
Ms Morris KC: For the East London Coroner in relation to two gentlemen, Mr Kishorkumar Patel and Mr Kofi Aning, who both died in April of 2021, in which the wrong filter was used with a breathing system in their intensive care ventilator at the Nightingale Hospital.
That coroner’s report highlights that these two incidents were reported to be part of a cluster of incidents of a similar nature. And you’ll recall from that report that there was a number of issues. There was the non-standardised colour-coding of the filters, I think, different types of filters with different names, and sort of optional and variable positionings of the filters. I think the coroner’s words were it “resulted in a very confusing situation”.
Is that an example you’re giving there of where, lack of availability of resources and demand in the first wave, clinicians were using unfamiliar or less than ideal equipment, medicines and consumables, as you say in your statement?
Professor Ramani Moonesinghe: I think it’s actually a broader point than even that. So these human factors, as I’ve said, are cumulative. There’s the James Reason Swiss cheese model of how these things line up and cause really big problems.
With the filters, as an example, this is a problem across lots of different consumable items, medicines and so on, that – things that do – bits of kit that have vastly different, or even slightly different, purposes can look very similar.
So we have that problem with medicines. So you can have a vial of two different drugs, one of them is basically water and one of them is something that might stop you breathing, and if you’re in a rush and you look at them, they’ve got the same colour on the bottle, and, you know, mistakes can happen. It’s a similar example here with these filters, where one manufacturer makes a filter that does this, red, and the other one makes it green, and there’s confusion.
So this is a wider point than just Covid pandemics and so on. And it speaks a little bit to what Mr Stirling said this morning about interoperability. We need some basic standards for all of the equipment that we use, and particularly the consumable items. That means that if you pick up something that’s green, it always does the same thing.
Ms Morris KC: Yes. So the broader point that applies in normal times, business-as-usual times, and then there’s particular need, isn’t there, in surge times, pandemic times, when the psychological burden that I think both yourself –
Professor Ramani Moonesinghe: Yes.
Ms Morris KC: – and Mr Stirling referred to is even more acute in frontline workers who are maybe in that rush and there’s additional pressures to make those critical decisions. So you would agree that that kind of lack of familiarity in those issues are even more acute in pandemic times?
Professor Ramani Moonesinghe: Absolutely. And you have staff that are not normally working in those environments working in them – under supervision, but it’s not ideal.
Ms Morris KC: Thank you. And I think just to complete the thought, as it were, you say in paragraph 187 of your statement that:
“These factors combined posed a potential risk to patient safety …”
And now, as the interim director of patient safety at NHS England, this is still your view?
Professor Ramani Moonesinghe: It is.
Ms Morris: Thank you very much.
Thank you, my Lady.
Lady Hallett: Thank you, Ms Morris.
Mr Thomas. Mr Thomas is over there.
Questions From Professor Thomas KC
Professor Thomas: Good afternoon, Professor, can you hear me?
Professor Ramani Moonesinghe: I can, thank you.
Professor Thomas KC: Professor, as a little bit of context, I represent FEMHO, the Federation of Ethnic Minority Healthcare Organisations. Your insights, Professor, into the procurement processes for ventilators and PPE during the pandemic are invaluable, especially given the challenges faced by ethnic minority healthcare workers in accessing suitable equipment.
So the focus of my questions will be to understand how considerations of diversity, particularly concerning ethnic minorities, were integrated into the procurement process and design of these critical resources. So that’s just to give you an indication as to where I’m going.
So, at paragraph 54 to of your statement, you mention that the approach to procurement of ventilators had sufficient regard to equality and diversity including the Public Sector Equality Duty ensuring that different ventilators may be required for children than adults, and you say this was factored into the procurement decisions.
Professor Ramani Moonesinghe: Yes.
Professor Thomas KC: Could you elaborate, please, on how considerations for diversity particularly concerning ethnic minority healthcare workers and patients were integrated into the ventilator procurement process, please.
Professor Ramani Moonesinghe: Thank you, yes. So when it comes to the capital equipment, like ventilators, non-invasive ventilation machines and so on, there are no differences between the types of machine that we would use in patients based on their ethnic – ethnicity. There are differences in the types of machines that are suitable for patients of different weights, predominantly, and therefore age.
So neonates – people up to 3.5 kilograms, there’s a particular sort of category. Beyond that, from 3.5 kilograms basically up to any weight, most ventilators would be able to cope with, although some of the transport ventilators and the anaesthetic machine ventilators that we had to repurpose for use in critically ill patients would have been less able to cope with very – with patients of a very heavy weight.
There’s a slightly different consideration in terms of some of the consumable items, particularly facemasks, and particularly the tight-fitting facemasks that we use in patients requiring CPAP or non-invasive ventilation.
Professor Thomas KC: And we’ve heard a lot often evidence about that.
Professor Ramani Moonesinghe: Yes, and so the main consideration is facial hair, and if you have facial hair, these masks do not fit as well. The mask fit is not brilliant for all patients all of the time at any time. I don’t know that that’s got anything particularly to do with ethnicity. I think it is some patients have different facial features.
A solution to that problem, potentially, is to use an alternative what we call interface to provide non-invasive ventilation and CPAP. So instead of a mask that fits tightly on to the face, you can use a helmet or a hood. And we tried to procure helmets and hoods at high volumes as well as masks.
Apart from the facial hair and facial features aspect, actually, some patients just prefer hoods and helmets, because having a tight-fitting facemask on can be really unpleasant. So we tried to procure a diversity of interfaces.
What I don’t know is whether the preferred interface would have been available for every patient every time.
Professor Thomas KC: All right. Let me move on to my next question, which is what specific measures were taken to ensure that the considerations in relation to the Public Sector Equality Duty, that you reference in your statement, were upheld when making those procurement decisions?
Professor Ramani Moonesinghe: So, as I say, I think with – with the capital equipment, that – I don’t think that patients of different ethnicities or, indeed, of other protected characteristics would have been advantaged or disadvantaged by particular devices in different ways.
When it comes to healthcare workers themselves, we followed the approach that we do with normal procurement, which is that we tried to deploy into the system either equipment that there’s a degree of familiarity with, or provide training materials to support that. And so I think Mr Stirling mentioned quite exhaustive work that we did on developing quick start guides, training videos, and all sorts of things to go out into the system to support staff to use these new bits of kit safely.
Professor Thomas KC: Okay. I think you’ve touched on and answered my second question, so I’m going to move on to my third.
You note the diversity of the NHS workforce and the need for PPE design to accommodate all protected characteristics, including ethnicity, as mentioned in – that’s paragraph 177 of your statement. So, in relation to that, how were the diverse needs of the NHS and
social care staff considered in procurement in the
design of PPE during the pandemic?
Professor Ramani Moonesinghe: I am afraid I can’t answer that question, because PPE
was not an area that I was involved in at all.
Professor Thomas KC: All right. I shall move on, then. Just bear with me.
Lady Hallett: I think the rest are all PPE, aren’t they,
Mr Thomas?
Professor Thomas: My Lady, you’re right. If you can’t
assist on that, those are all my questions.
Thank you, my Lady.
Lady Hallett: Thank you, Mr Thomas.
Those are all the questions we have for you,
Professor. Thank you so much for all you did during the
pandemic to try to assist your patients, and your
colleagues’ patients, and thank you, also, to your
husband.
The Witness: Thank you.
Mr Stoate: Who obviously stepped up to when he was asked
to, or maybe you insisted that he did. Anyway, thank
you very much for your help.
The Witness: Thank you.
Lady Hallett: Thank you, Mr Stoate.
I shall return at 10.00 tomorrow morning.
(4.09 pm)
(The hearing adjourned until 10.00 am the following day)