Guidance updated to support the safe management of funerals
Do not meet others, even friends or family.
You can spread the virus even if you don’t have symptoms.
Do not meet others, even friends or family.
You can spread the virus even if you don’t have symptoms.
An article in FT Weekend on 18 April 2020, ‘Muddled thinking punctures plan for British ventilator’, includes multiple inaccurate and misleading claims about the UK’s work to procure and manufacture ventilators in response to the COVID-19 public health emergency.
An opinion thread on Twitter by one of the article’s authors contains further inaccurate claims and assertions.
A detailed rebuttal of the article and the associated Twitter thread can be found below.
First of all, the Government wishes to pay tribute to the manufacturers who, in just four weeks, have provided vital additional ventilators for patients at unprecedented speed, to the businesses and others who have responded to the Ventilator Challenge, working tirelessly, and to the public for staying at home, playing their part in protecting the NHS and saving lives.
The Government’s strategy to increase ventilator capacity has always focused on three pillars: first, procuring more devices from existing manufacturers overseas; second, scaling up production of existing ventilator suppliers, and third, working with industry to design and manufacture new devices. It has also involved seeking specialist support in other areas including logistics, component and peripheral procurement, and technical expertise.
While during the course of this public health emergency the NHS has had spare ventilator capacity for Covid-19 patients, scientific modelling nonetheless suggested an urgent need for further capacity still. In response, and alongside wider work, the Ventilator Challenge was launched.
At present, two devices from the Ventilator Challenge are ready for use in hospitals, with the Penlon ESO2 device this week becoming the first newly-adapted device to receive approval from the regulator, the MHRA. A number of other devices are currently undergoing tests for regulatory approval.
The Cabinet Office has previously corrected inaccurate claims made by FT Weekend: our earlier response can be found here
Detailed rebuttal of claims made in the FT and on Twitter:
What emerged was a procurement effort which insiders say was plagued by disjointed thinking that sent off non-specialist manufacturers designing products that clinicians and regulators deemed unsuitable for treating Covid-19 patients.
This assertion neglects to mention that designing and manufacturing new devices was always only one pillar of the Government’s strategy.
Non-specialist manufacturers were engaged alongside specialists because there was an urgent risk that NHS ventilator capacity would prove insufficient for the rapidly-growing demand, and that the other two pillars would not, by themselves, provide sufficient new ventilators to meet that growing demand.
In many cases, the non-specialist companies teamed up in consortia with medical technology firms who obviously have specialist knowledge. Senior and leading NHS clinicians and the regulator, the MHRA, have been intimately involved at every stage of the Ventilator Challenge. Through the testing phase, designers have received feedback on their designs. While it is the case that several designs have not yet received regulatory approval that is not to say they will not.
At the heart of the problem was that Britain does not produce sophisticated devices for intensive care units. But at the outset, the aim of the initiative was unclear: to boost production of existing designs or to try to reinvent the wheel with homegrown products.
This is inaccurate. As has been repeatedly made clear, the aim of the challenge has always been to do both.
The press release issued after the Prime Minister’s call on 27 March said: ‘The government has partnered a number of the UK’s leading technology and engineering firms with smaller manufacturers to rapidly build existing, modified or newly designed ventilators at speed.”
At the Downing Street Press Conference on 31 March, the Chancellor of the Duchy of Lancaster, Michael Gove, said: ‘thanks to the dedication of existing medical supply companies and the ingenuity of our manufacturing base, we have existing models being produced in significantly greater numbers and new models coming on stream’.
The same point was made in a Cabinet Office press release issued on 16 April which said: ‘Last month, the Prime Minister called on some of the biggest names in British manufacturing to help step up ventilator supplies, in order to save lives during this coronavirus pandemic. Following this, the government has partnered a number of the UK’s leading technology and engineering firms with smaller manufacturers to rapidly build existing, modified or newly designed ventilators at speed.
As mentioned above, as part of the Challenge, several non-specialist companies have teamed up in consortia with those with specialist knowledge.
As business leaders prepared for a conference call with Boris Johnson…on March 16, industry experts issued warnings about what was realistic and desirable. Stephen Philipson, chief executive of manufacturers group Make UK, said British companies would be better placed to make proven models “under license”.
No one was under any illusions at the time of launching the Challenge that producing new designs for domestic production would be anything other than a significant and exacting test.
Ventilators are highly complex medical devices requiring hundreds of individual components. That was precisely the point of issuing a public Challenge. Alongside new devices, the Challenge has pursued scaling up a number of existing, proven ventilators, including Smiths paraPac devices which are already in the NHS. And we are working with other companies, including Breas Medical, to further increase production of existing ventilators.
“They were at pains to stress, this needs to be simple designs – no ICU ventilators – and we’ve got to get them through basic regulatory approval,” said one person who was on the Prime Minister’s call with business leaders on 16 March.
This is simply incorrect. No minister or official on the call on 16 March said that designs needed to be simple, nor that they were not looking for ICU ventilators.
The first formal specification published by the Medicines and Healthcare products Regulatory Agency (MHRA) on March 20, [specified] the “intended purpose” of the device was for ‘short-term stabilisation for a few hours’ extendable to 24 hours “in extremis”.
This quote is misleading and misses key qualifications. As NHS England’s Chief Commercial Officer, Emily Lawson, specified on the Prime Minister’s call with business leaders on 16 March, the devices will ‘need to be able to operate 24/7’.
The specification published on 20 March by MHRA outlined ‘clinical requirements based on the consensus of what is “minimally acceptable” performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators. It made clear that these devices were for ‘the initial care of patients requiring urgent ventilation’. The specification ‘proposed these ventilators would be for short-term stabilisation for a few hours, but this may be extended up to 1-day use for a patient in extremis as the bare minimum function. Ideally it would also be able to function as a broader function ventilator which could support a patient through a number of days, when more advanced ventilatory support becomes necessary.
“The initial focus . . . was very much on novel designs, not scaling up existing designs,” said a person familiar with the internal deliberations. “But questions were then raised about why we were trying to reinvent safety-critical devices. This should not have been a job for non-specialists.
Response:
This is incorrect. The Government’s strategy has always been focused on three pillars: procuring more devices from overseas; scaling up production of existing ventilator manufacturers; and designing and producing new devices.
This strategy has been based on NHS clinical need, with experts and NHS clinicians – including those from the regulator, the MHRA – involved in shaping it. This is why, as part of the Ventilator Challenge, the Government paired Penlon, an existing UK manufacturer of high spec ventilators, with High Value Manufacturing Catapult, Ford, a number of UK-based F1 teams and Siemens, in order to scale up their production. In just four weeks the newly adapted Penlon ESO2 has received regulatory approval and is being delivered to the NHS frontline to save lives.
Claim:
The government spin is the clinical need changed, but the reality is that it was always misguided to think you could develop and create these ventilators’, an insider with direct knowledge of the process said.
Response:
It is correct, responsible and only right that the Government ensures that what it procures meets clinical need, and that this is kept under constant review.
Clinical experience of COVID-19, both in the UK and other countries, has inevitably grown rapidly over the last month. It is now clear that there are additional requirements for mechanical ventilators to support the effective critical care of patients.
Claim:
Two out of the UK’s three main ventilator makers told the Financial Times their contact with government officials only began in mid-March, around the same time as the general appeal.
Response:
Throughout this public health emergency, the NHS has always had spare ventilator capacity for patients. The NHS has been liaising with suppliers since February and the Ventilator Challenge has involved work with manufacturers around the clock to increase ventilator supply.
Designing, manufacturing and gaining regulatory approval for ventilators usually takes years. That so much progress has been made in such a short time underlines the incredible efforts made by industry. The first devices from the Ventilator Challenge have already received regulatory approval and been delivered to the NHS frontline. Over the past six weeks the government has increased ventilator capacity by thousands. This means that 10,600 ventilators are now available to NHS patients across the country, with hundreds being delivered each week and many more on order.
The author made further claims on a twitter thread.
But the question soon arises – WHAT should those manufacturers build? Do we build from scratch? “Reinvent the wheel’ so to speak? Or tool up/expand what existing capacity we have? Or seek to make stuff under licence? This is the BIG question….”
That was never, and is not now, the question. The Government pursued all avenues under the three pillars of its strategy, as outlined above. Given the unprecedented scale of the COVID-crisis, it sought both to scale up existing manufacture and build new designs.
And the answer comes on March 16 when @BorisJohnson does a conference call with all of the top industrial bosses. They want something simple, non-ICU that can be mass produced – as an insider on the call tells us.
This is simply incorrect. No minister or official on the conference call on the 16 March said that designs needed to be simple, or that they were not looking for ICU ventilators.
But when the regulator publishes the first formal “spec” for the new ventilators it is need super-simple [sic]. The “intended purpose” is that these vents should work for a “few hours” and “in extremis.”
This is misleading. The very document that the author quotes makes clear that ‘1-day use’ is the ‘bare minimum function’. This is visible within the tweet itself. Further detail is provided in response to a claim above.
The author then questions what he calls the Government insistence that ‘this was all done with the advice of both top doctors AND the regulators’ He goes on to ask: ‘What about the Regulators – the MHRA – what did they think?’. He quotes ‘insiders’ to suggest that ‘there was push-back about the utility of these basic vents, the damage they would cause, and their utility in weaning patients back to health’
This is particularly confused. The MHRA – the regulator – published the very specification that the author quotes above. Their logo is visible in the graphic which he himself tweeted.
Initially when … concerns were pushed up the chain, the reply came back “that’s what the customer wants”. Which begs a question. WHO was the customer? Not the docs. Not the regulator. Not the patients. The only answer that fits, is the Government. The politicians. EESH
This is entirely untrue and absurd. The specification was published by the MHRA. The ventilators are sought for the NHS.
It takes time for the penny to drop in Whitehall and the Cabinet Office – but by April 10, check out the “amended” spec that says “the greater proportion of devices” for treating coronavirus would need to be capable of supporting “spontaneous breathing modes.”
On the Prime Minister’s call with business leaders on 16 March, Emily Lawson, NHS England’s Chief Commercial Officer, outlined ‘the absolute clinical specifics of what these machines need to be able to do’, which included that they ‘need to have both mandatory and spontaneous breathing modes so that as people start to breathe for themselves the machine recognises and responds to that.
The result is that the Bluesky consortium – which HAD BUILT to spec is canned on April 11. And others like the ‘Oxvent’ scheme (another low-spec effort) is paused. Insiders tell us that quite possibly none of these ‘hackathon’ designs will get approval
As Cabinet Office officials made clear on the Prime Minister’s call with business leaders on 16 March, this “will be an iterative process….Some [designs] will not pass the clinical standards that we need of reliability and so on and so forth”.
The Government has always been led by NHS clinical need, and the best available medical and scientific evidence. When that advice evolves, the Government has responded accordingly: support was halted, for example, for the production of the BlueSky device on the advice of clinical experts – specifically following a review by the Technical Design Authority, including NHS Clinicians and the MHRA.
the government did change tack in the face of medical and scientific pressure and (mercifully) it was spared its blushes because ventilator capacity held up, clinicians used more (non-invasive) CPAP and (probably) more deaths happened in community.
We have been consistently clear that we have sought to increase both invasive and non-invasive capacity as part of the overall strategy, as set out by the Chancellor of the Duchy on 4 April at the Downing Street daily briefing. That is why the Government has also worked to increase CPAP availability with the University Colleges of London and Mercedes partnership, demonstrating the Challenge’s broad efforts to meet a range of clinical needs.
As a side note, this kind of treatment PISSSES PEOPLE OFF. My inbox is full of people who daren’t speak on record but are SEETHING at the way they were treated. People who worked 20-hour days for weeks; gave freely of their time, energy and spirit for nothing.
This is a huge national effort so, unfortunately, we are unable to respond to these claims without further details. It was always likely that as part of this Challenge some designs would not succeed but the Government recognises the tremendous efforts made by so many towards a shared goal of protecting the NHS and saving lives.
The government may look to try and find an outlet for these ventilators in other places – but you have to ask, if they’re not fit for UK patients (and we’ll see if any can get clearance) why would they work for poorer countries?
All ventilators from the Ventilator Challenge must undergo stringent safety testing by the regulator, the MHRA. This work is led by a panel of expert clinicians. It is incorrect to imply that ‘not fit’ devices would ever be used on patients from any country.
Because guess, a device that keeps you alive, that breathes for you IS flipping complicated. How hard can it be? Damn hard. It’s parts mustn’t catch fire in a high-oxygen environment. It’s software must anticipate a patients breathing. If it freezes, you may die’. This continues – ‘This was OBVIOUS AT THE OUTSET’.
This was indeed obvious at the outset and was made clear on the Prime Minister’s call on 16 March. Emily Lawson, NHS England’s Chief Commercial Officer, said then that the devices ‘need to be able to operate 24/7. They need to have a failsafe in case of fire. They need to provide oxygen and air at specified concentration, at set volume and to not exceed a set pressure. They need to be able to provide positive pressure at the end of exhaling, at a pressure set by the clinician. They need to have both mandatory and spontaneous breathing modes so that as people start to breathe for themselves the machine recognizes and responds to that’.
What worries me is if this “how hard can it be?” principle is applied to testing, to PPE procurement etc. The government needs to show some HUMILITY. It needs to LISTEN TO PEOPLE WHO KNOW STUFF. I think this is a clear example of where it did not.
This is untrue. As the Prime Minister made clear on his call to business leaders on 16 March, what business was being asked to do was a ‘huge undertaking’. This was acknowledged from the very outset. The suggestion that Government is not listening to people ‘who know stuff’ is entirely misplaced. There have been daily ‘meetings’ on the Ventilator Challenge bringing together ministers, officials and advisers with procurement experts, clinicians and the regulator. This was to ensure that the latest clinical and regulatory advice was being followed and to drive delivery, address obstacles and find solutions. While the difficulties have been immense, the Government is truly grateful for the tireless dedication and application shown by so many companies and individuals.
Paul Deighton, London 2012 Chief Exec, has been appointed by Health and Social Care Secretary Matt Hancock to lead the national effort to produce essential personal protective equipment (PPE) for frontline health and social care staff.
He will coordinate the end-to-end process of design through to manufacture, including streamlining the approvals and procurement process to ensure new domestic PPE supplies are rapidly approved and get to where they are needed. The “make” programme will start to deliver PPE supplies in the next week.
He will also support the scaling up of engineering efforts for smaller companies capable of contributing to the wider supply chain.
Lord Deighton previously served as Chief Executive of the London Organising Committee of the Olympic and Paralympic Games (LOCOG), the organisation responsible for planning and delivering the 2012 Summer Olympics and Paralympics. He also served as Commercial Secretary to HM Treasury from January 2013 to May 2015.
As part of the comprehensive UK-wide plan to ensure PPE gets to where it is needed most, unveiled by Matt Hancock earlier this month, Deighton will lead the “make” programme to unleash the potential of UK industry to scale up domestic PPE manufacturing.
Health and Social Care Secretary Matt Hancock said:
Our response to this global pandemic demands a national effort. Manufacturers big and small are already responding to the challenge but we must go further and faster. I am determined to do everything I can to get more protective equipment to the NHS staff who are fighting this virus on the front line.
Just as Lord Beaverbrook spearheaded the wartime efforts on aircraft production, the appointment of Lord Deighton will bring renewed drive and focus to coordinate this unprecedented peacetime challenge.
Lord Deighton led the delivery of the Olympics. Now he will lead a singular and relentless focus on PPE as the country’s top manufacturing priority, with the full weight of the government behind him.
Lord Paul Deighton, advisor to the Secretary of State on PPE said:
Countries around the world face unprecedented demand for personal protective equipment and this necessitates an equally unprecedented domestic manufacturing response.
I look forward to bringing together new partners in the pursuit of this single goal: to get our dedicated frontline workers the essential equipment they need.
This effort calls for exceptional teamwork and I am confident that we, together, will rise to this challenge.
As part of the national effort to focus the UK’s manufacturing industry on this immediate challenge, the government has issued a ‘call to arms’ for industry partners to make essential PPE that demonstrably meets our technical specifications. Companies such as Burberry, Rolls-Royce, McLaren, Ineos and Diageo have already started work to produce equipment including gowns, visors and hand hygiene products.
The government is working around the clock to give the social care sector and wider NHS the equipment and support they need to tackle this outbreak. As of 16 April 2020, we have delivered almost a billion pieces of PPE around the country.
This will be an unpaid position and will work across the Department of Health and Social Care, NHS England, and other government departments.
Disadvantaged children across England are set to receive laptops and tablets as part of a push to make remote education accessible for pupils staying at home during the coronavirus outbreak.
Devices will be ordered for children in the most vital stages of their education, those who receive support from a social worker and care leavers.
The government will also provide 4G routers to make sure disadvantaged secondary school pupils and care leavers can access the internet – where those families do not already have mobile or broadband internet in the household.
The country’s major telecommunications providers will make it easier for families to access selected educational resources by temporarily exempting these sites from data charges.
In addition, to support the hard work of schools in delivering remote education, the Oak National Academy is due to launch on Monday 20 April. This brand-new enterprise has been created by 40 teachers from some of the leading schools across England, backed by government grant funding. It will provide 180 video lessons each week, across a broad range of subjects from maths to art to languages, for every year group from Reception through to Year 10.
Education Secretary Gavin Williamson said:
I want to thank all the teachers and staff who are working so hard to ensure vulnerable children and those of critical workers are supported at this time.
Schools will remain closed until the scientific advice changes, which is why we need to support the incredible work teachers are already doing to ensure children continue to receive the education they deserve and need.
By providing young people with these laptops and tablets and enabling schools to access high quality support, we will enable all children to continue learning now and in the years to come. We hope this support will take some of the pressure off both parents and schools by providing more materials for them to use.
Schools and colleges will be able to keep their laptops and tablets once they have reopened. This means that they will play a crucial role in enabling children to learn while schools and colleges are closed, and will also continue helping children learn in the future.
Oak Academy joins a broad range of support and resources available for schools and parents. This includes a list of high quality resources recently published by the Government, as well as the existing tools and resources schools use to provide remote education. Many suppliers are making resources, both online and hard-copy, available to schools for free.
This week (Monday 20 April) the BBC is launching its own education package across TV and online, featuring celebrities and some of the best teachers – helping to keep children learning and supporting parents.
This is alongside new guidance published today (Sunday 19 April) for parents on how best to support their child’s education and development.
While families stay at home to reduce the spread of the coronavirus, some children and young people may face increased risk of abuse or neglect at home – or from strangers online.
The Government will make funding worth £1.6 million available immediately for the NSPCC to expand and promote its national helpline for adults.
While schools and social workers remain at the forefront of work to protect vulnerable children, including by supporting them to attend school, expanding the NSPCC Helpline will mean many more adults know how and where to raise concerns and seek advice or support about the safety and wellbeing of any children they are worried about.
7,000 more people will be able to get home from India, Pakistan and Bangladesh, after a further 31 charter flights were announced by the Foreign Office.
On Friday, the following charter flights were announced:
The UK has worked closely with South Asian governments to keep commercial flight routes running and airports open. It has already chartered 24 flights from the region to help vulnerable British nationals return home in previous weeks.
The Foreign Secretary, Dominic Raab said:
We are working around the clock to get British travellers home. Since the outbreak of coronavirus in Wuhan, we’ve helped more than a million British citizens return home on commercial flights – backed up by our work with the airlines and foreign governments to keep flights running.
Our special charter deal with the airlines has enabled us to return thousands more. Now, I can announce the next 31 flights from India, Pakistan and Bangladesh which will get 7,000 more Brits safely back home.
The addition of 31 flights will mean the UK Government has facilitated the return of more than 10,000 British travellers on 55 flights from the region since the coronavirus crisis began.
Around 5,000 British nationals will have returned to the UK from India between 8-19 April on 21 UK charter flights from 11 Indian cities. The 17 extra flights from India announced on Friday will be able to carry around 4,000 passengers, and bring the total number chartered by the UK Government from India to 38.
The flights from Pakistan will bring around 2,500 people home. More than 8,000 British nationals returned to the UK between 4-16 April, via 23 commercial flights, following extensive cooperation between the UK and Pakistan.
The four flights from Bangladesh will have the capacity to bring home up to 850 passengers.
Three charter flights from Nepal have also returned more than 700 passengers to the UK.
The UK Government is working with the airline industry and host governments across the world to help bring back British travellers to the UK as part of the plan announced by the Foreign Secretary Dominic Raab (on 30 March) – with up to £75 million available for special charter flights from priority countries, focused on helping the most vulnerable travellers.