New UK fans still await regulatory green light

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None of the new mechanical ventilators developed to treat coronavirus patients have received regulatory approval from the UK, a month after the government launched a rallying cry to British industry to help fill a shortage of ‘devices.

Authorities have made a conditional commitment to purchase tens of thousands of life-saving machines that help patients with breathing difficulties, subject to safety testing.

In addition to imports and established medical device manufacturers that increase domestic production, large British engineering companies are finalizing the fans designed from scratch and modifying existing products.

However, the new models – including one from Dyson – have not yet received the green light from the Medicines and Health Products Regulatory Agency (MHRA), according to a government official.

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Among the equipment awaiting approval is a modified version of a machine already manufactured nationally by Penlon in Oxfordshire, which is in the final clinical phase, according to people familiar with the matter.

The Cabinet Office confirmed this weekend that it had withdrawn its support for a fan under development by a collaboration of Formula 1 teams, called BlueSky, “following a reassessment of the viability of the product at the constantly changing image light of what is needed to most effectively treat Covid-19 ”. In a letter of intent, the government tentatively ordered thousands of machines from BlueSky.

“We are continuing to work at an unprecedented speed with a number of other manufacturers to increase UK fan production,” he added.

The delays appear to be linked in part to the evolution of clinical understanding of the best way to treat the disease due to disagreements within the medical profession over when to deploy invasive ventilation for patients with coronavirus.

Penlon workers assemble fans in its Oxfordshire factory © UK Cabinet Office / Reuters

As a sign of the fluidity of the discussion surrounding the production of ventilators, the Department of Health released an announcement on Monday informing potential manufacturers that it was “updating” the specifications for the fast-manufacturing ventilation system.

“Until the new specification is available, you should continue to follow the instructions in this document, but be aware of the changes to follow,” added the note.

Government sources said officials would further narrow the shortlist of potential manufacturers on Tuesday in light of the new directions.

A government spokesperson said, “Designing and building a fan from scratch usually takes years, but in the four weeks since the launch of the Ventilator Challenge, we have made rapid progress, new models are currently being tested by clinicians to ensure they meet the standards necessary for patient safety and treatment effectiveness. “

However, the delay also casts doubt on the ability of the National Health Service to cope with the peak of cases and follows criticism of the lack of personal protective equipment, such as gloves and masks, for first responders. line.

Health Secretary Matt Hancock told the BBC Andrew Marr Show earlier this month, 18,000 fans would be needed in the coming weeks, up from an initial target of 30,000.

The NHS now has access to 10,120, including 200 acquired last week, up from 8,175 in mid-March. Germany is donating 60 fans and US President Donald Trump has said that the British government has requested 200 from Washington.

An official in Whitehall insisted that there was adequate capacity for intensive care. “There is early evidence of stabilization in ICU admissions. We have a lot of ventilation beds across the country, so we’re sure we can keep up with demand, ”they added.

Alison Pittard, the dean of the Faculty of Critical Care, who represents critical care professionals, confirmed that the medical profession initially requested that the UK industry focus on manufacturing simpler ventilators for the early treatment of Covid-19 patients.

The decision was made after it was not found that patients in Italy needed highly specialized ventilators in the early stages of their condition, and in recognition of the fact that non-specialized manufacturers would not be able to quickly manufacture high specification machines.

“It was decided that patients in the early stages would switch to simple ventilators, and if they were to continue for an extended period, they would switch to another [more sophisticated] “She said.

A senior intensive care doctor, however, warned that fixing the number of ventilators was not helpful. “In terms of providing intensive care beds, it is not just ventilators,” they said. “You need more equipment, hemofiltration machines, [and] personal too. “

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