Grey Havoc

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UK’s new ventilators still awaiting regulatory green light (ft.com, registration may be required)

None of the new mechanical ventilators developed for treating coronavirus patients have obtained UK regulatory approval, a month after the government issued a rallying cry for British industry to help plug a shortage of the devices.

Officials have given conditional commitments to purchase tens of thousands of the life-saving machines which assist patients with respiratory difficulties, subject to safety tests.

In addition to imports and established medical device makers increasing domestic production, big-name UK engineering companies are finalising ventilators designed from scratch and modifying existing products.

However, the new models — which include one by Dyson — have yet to receive the green light from the Medicines and Healthcare products Regulatory Agency (MHRA), according to a government official.

Among equipment awaiting clearance is a tweaked version of a machine already manufactured domestically by Penlon in Oxfordshire, which is in the final clinical stages, according to people aware of the matter.

The Cabinet Office confirmed at the weekend that it had withdrawn support for a ventilator under development by a collaboration of Formula 1 teams, called BlueSky, “following a reassessment of the product’s viability in light of the ever developing picture around what is needed to most effectively treat Covid-19”. In a letter of intent, the government had provisionally ordered thousands of machines from BlueSky. “We are continuing to work at unprecedented speed with a number of other manufacturers to scale up UK production of ventilators,” it added.

The delays appear to be linked in part to the changing clinical understanding of how to best treat the disease amid disagreements within the medical profession about when to deploy invasive ventilation for coronavirus patients.

[snip]
 

Orionblamblam

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None of the new mechanical ventilators developed for treating coronavirus patients have obtained UK regulatory approval, a month after the government issued a rallying cry for British industry to help plug a shortage of the devices.

And that's perhaps one of the biggest issues that the Wuhan Flu has driven to the fore: the problems of government over-regulation. While it's looking like Chinas gift to the world isn't the apocalyptic pandemic we've long been promised, that disease *will* inevitably come. And right now the desperately needed ventilators are looking like they're not that needed, so delays piled on delays by licensing and regulation probably won't kill too many people. But if this pandemic was the nightmare that many people have ulcerated over for decades, these sort of issues would lead to millions of excess deaths.

With luck the current prototyping, while likely not helpful for Wuhan, will be useful when the inevitable Really Bad Pandemic hits. Hopefully the US and UK and the rest of the western world will have not only rapid local manufacturing capability, but storehouses full of masks and respirators and who knows what all else.
 

edwest2

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I expect to see national if not a global central planning (yes, I used the phrase) structure set up. All the US had to do was to ramp up production. The "excess" devices being kept off the civilian market and becoming Government Issue. From an engineering standpoint, a parts list, a license, the end. Excess ventilators are already being made in the US to replenish the government's stockpile. Sadly, the B in NBC warfare was not as exciting as loud explosions. But given the level of secrecy surrounding it, who knows what changes will come for soldiers and military bases in the immediate future.
 

Grey Havoc

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A earlier Financial Times story on the program (registration may be required).
From inventors to academics, carmakers and aerospace companies, a race is under way to build hundreds of thousands of ventilators: the machines that help severely ill coronavirus patients breathe that are in desperately short supply worldwide.

The numbers required dwarf the normal industry output — New York State alone has said it will need 30,000 extra machines — so big names of industry such as General Motors, Airbus, McLaren and Dyson have offered their engineering expertise or factory lines, which in many cases have slowed or halted because of the pandemic.

Yet for all their technical expertise, the question is whether manufacturers inexperienced in the field can overcome the technical, logistical and regulatory hurdles in time to deliver an enormous number of life-saving machines.

“The actual scaling up to manufacture at a great level isn’t the tricky part — it’s having the supplies and components,” said an employee at a ventilator maker.
 

Zoo Tycoon

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It’s a great shame that there’s such a negative feeling within these referenced media articles, indeed the claim “ None of the new mechanical ventilators developed for treating coronavirus patients have obtained UK regulatory approval” is already arguably incorrect.

The cancellation only applies to one of three projects ie BlueSky being undertaken by the motorsport group, while two others have received production contracts.


The first new build Penlon Parapac 300+‘s, an iteration development of an existing unit, are already in use on the wards. There were pictures circulating last week of enough component parts to build 3500 at the final assembly line with the full 10000 part kit sets due to be delivered by the by the end of this week.
 
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edwest2

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Time is usually the problem. If possible, parts should be stockpiled or complete machines. I suspect more attention will be paid in future by the World Health Organization and the various national and other international groups. It would not surprise me if the US set up a Rapid Response Force consisting of epidemiologists, doctors, engineers and those from other relevant fields. Many lives, and a lot of money, can be saved.
 

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Zoo Tycoon

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The first new U.K. manufactured Ventilator has been fully certified today, and will be coming off three production lines, so is expected to deliver 15000 in a matter of weeks.

Within the U.K. effort there’s four further new rapid rapid manufacture Ventilators in development and one assisted pressure breathing system, all in various stages of advanced certification, I understand clinical trial stage.

Cracking effort :).
 

Grey Havoc

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