Just eight days ago, Andrew Farmery, a professor of anesthetics at the University of Oxford’s Nuffield Department of Clinical Neurosciences, was discussing with a colleague and some Ph.D. students the dire need to produce more ventilators in the U.K. fast.
“My initial thought was that this just can’t be done,” Farmery said. “Ventilators are very complex devices and upscaling them is extremely difficult.”
He joined forces with a small group of academics — engineers and medics — to brainstorm a prototype. After rejecting dozens of ideas, they settled on one, named OxVent.
“It has very few parts, no motors to burn, no cogs to rotate or snap or bend,” Farmery said. “But it works and all we need right now is a basic product that keeps people breathing and stops people from dying.”
As the number of confirmed global cases of coronavirus has soared, doctors everywhere are searching for ventilators. In the U.K., the National Health Service has more than 8,000, but the government has said it needs at least 30,000 to fight the pandemic.
To deal with the shortfall, the government plans to immediately buy several thousand ventilators from abroad, take spare capacity from private hospitals, and work with existing manufacturers to try to scale up production quickly.
“We have been inundated with offers of help and have teams of several hundreds working through this. To solve the immediate shortage, we are picking the low-hanging fruit by bringing in as many models as we can,” a government source said.
Prime Minister Boris Johnson has called on the U.K.’s biggest manufacturers to help produce vital medical equipment like ventilators as the coronavirus crisis worsens. It has ordered 10,000 ventilators from British appliance maker Dyson, best known for groundbreaking vacuum cleaners. The custom-made devices are expected to be delivered to the NHS within weeks, subject to passing stringent medical tests.
The government has also taken another approach, issuing an open call for proposals for a quick-to-produce ventilator that could help fill the gap. Now hundreds of government employees are combing through more than 3,000 pitches from major manufacturers as well as smaller groups, including academics like Farmery and his team.
It is a daunting task. The designs must be based on rigorous criteria issued by the Department for Health and Social Care as specified by the Medicines and Healthcare Products Regulatory Agency, the U.K. department that approves medical equipment for use. Ventilators, for instance, have to connect to hospital gas supplies and need at least 20 minutes of backup battery in case of mains power failure. Such necessarily stringent procedures inevitably slow down the procurement and development process.
For Farmery and his team, it has been a tense time with their potential solution tangled up in a chaotic procurement procedure hastily arranged by a government under extreme stress.
Farmery says that he pitched the OxVent — essentially a small, squeezable bag inside a solid Perspex box, through which compressed air is injected, and which costs about £1,000 to make — on Monday to the cabinet and the MHRA.
Once the team is given the green light, Farmery thinks they will be able to make between 2000 and 5000 OxVents a week. They plan to trial 10 units at Guy’s Hospital in London and in Oxford within days.
Meanwhile, he got in touch with PA Consulting — a management consulting firm that is running the government’s proposal process — who asked OxVent to submit forms outlining the specifications of their prototype by the Sunday evening deadline of 7 p.m. However, OxVent says PA only sent the team the specific forms required for the tender process 20 minutes ahead of the deadline.
Farmery was then left hanging for a few days. On Wednesday, though, the OxVent team was informed by PA that it is still in the running and that its ventilator must be independently tested.
Meanwhile, Farmery also said that one issue is the MHRA’s high specifications. “The government says that ventilators require this feature and that feature, but really they don’t need anything complicated, they just need something that saves lives and they need it quickly because every day that passes hundreds more people will die.”
The OxVent does meet all of the essential specifications required by the MHRA, including providing mandatory ventilation, and all essential safety features. It meets some of the optional/desirable features too, such as a ‘pressure support mode’ that assists those who can breathe independently to some extent. “But to satisfy every optional feature exhaustively would simply delay the start of the build, and it being available to patients whose lives will depend on it,” Farmery said.
The MHRA said it is able to take swift action to allow medical devices without formal regulatory approval to be used in the U.K. in the interests of the protection of health.
“The MHRA will support the Government in drawing up appropriate specifications and will ensure that companies understand what standards they must be meeting in order for their products to be able to be used safely on U.K. patients,” a spokesperson told MarketWatch in an email.
In recent days, several companies including Formula One and Vacuum cleaner manufacturer Dyson have said they are trying to develop prototypes of medical ventilators.
But anesthetists like Farmery, along with other surgeons and engineers, have raised wider concerns about whether companies like these can retool their components quickly enough.
The designs must be based on criteria issued by the DHSC as specified by the MHRA.
Farmery suggests that the MHRA’s specifications are too high. “The government says that ventilators require this feature and that feature, but really they don’t need anything complicated, they just need something that saves lives and they need it quickly because every day that passes another 5,000 people will die.”
Still, the OxVent does meet all of the essential specifications required by the MHRA including providing mandatory ventilation, and all essential safety features. It meets some of the optional/desirable features too, such as a ‘pressure support mode’ that assists those who can breathe independently to some extent. “But to satisfy every optional feature exhaustively would simply delay the start of the build, and it being available to patients whose lives will depend on it,” Farmery stressed.
The DHSC has said it is considering whether some of the MHRA’s specifications can be “relaxed” because of the gravity of the situation.