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The UK’s medical safety regulator was warned at the height of the Covid-19 crisis that a government drive to build thousands of basic ventilators risked wasting resources and delivering “worse patient outcomes”.
A two-page memo written by an panel of external advisers seen by the FT raised concerns about the dangers of over-prioritising basic designs after Boris Johnson launched a “Ventilator Challenge” for British industry to come up with a simple design for mass production.
The document and further testimony from a Ventilator Challenge team leader raises fresh questions about the government’s handling of the coronavirus pandemic as it belatedly rushed to confront the disease in mid-March.
The risk that “rudimentary” ventilators might harm patients was flagged to the Medicines & Healthcare products Regulatory Agency (MHRA) by the external panel that was created to assist teams to navigate the streamlined regulatory process.
In the memo from the Clinical & Technical Advisory team to the MHRA, dated April 5, the panel warned that pursuing basic designs “will result in the need for more ventilators, more oxygen, more drugs, more ventilator days, more staff and almost certainly worse patient outcomes”.
At the time of the prime minister’s rallying cry to British industry in mid-March, officials were concerned that restrictions on global trade would hamper imports which the NHS relied on for its advanced intensive care ventilators. Ultimately none of the basic Ventilator Challenge designs were required as the NHS capacity was able to meet demand.
The government has vociferously rejected criticism that its programme was initially wasteful and plagued by muddled thinking, insisting its approach always envisaged a mix of new designs, boosting the limited domestic production of existing ones and importing the most advanced machines.
But the leader of OxVent, the Oxford university-backed consortium that rushed to build a basic ventilator to the original specification questioned the merits of the government running a “village hall” type competition to reinvent a complex medical device.
“At the start, honestly, I didn’t take it seriously. As someone who makes medical devices and spends a year just getting one tiny adjustment passed, I thought it wasn’t possible,” said Andrew Farmery, professor of anaesthetics at Oxford university, specialising in respiratory biomedical engineering.
“It was quite frustrating. If I was in government I would have gathered the people who could do this. I wouldn’t just put up a competition notice on the village hall wall, as it were.
“But if the knight in shining armour that comes to save us is British industry — the Dysons and the Rolls Royces — that’s a great story; much better than if some nerds got together and solved it quietly,” he said, referring to two of the big names in UK engineering that signed up to the Ventilator Challenge.
The April 5 note to the MHRA shows how clinical and technical experts voiced their misgivings about the “challenge” concept, on which £185m has been spent so far out of a total projected budget of £454m.
Sara Hamilton, a former NHS paediatric consultant with expertise in healthcare innovation who cosigned the memo, said frontline healthcare professionals were not sufficiently involved in the design process.
“While the teams showed incredible ingenuity, it was clear that we were going to end up with products that were not fit for purpose,” she said.
Matthew Rooney, an NHS consultant anaesthetist and another cosignatory of the memo, warned there was too much focus on the basic designs and the importance of more sophisticated ones was being overlooked.
“It became more apparent that these basic designs could harm some patients more than using other means of support. There was a real concern about weaning patients off basic ventilators,” he said.
Alison Pittard, Dean of the Faculty of Intensive Care Medicine, told the FT on April 15 that such basic machines were of “no use whatsoever”.
The Ventilator Challenge was announced on March 16 and included a competition to invent a new basic ventilator capable of being built cheaply and quickly.
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An initial MHRA design specification issued on March 18 called for ventilators that, at a minimum, would be capable of providing “short-term stabilisation for a few hours”, extendable for up to 24 hours “in extremis” with more advanced features listed as “desirable”.
In the memo, the independent advisers urged a shift towards more sophisticated devices that incorporated “spontaneous” breathing modes that could anticipate when a coronavirus patient tried to breathe for themselves.
“We are not advocating slowing down the initial wave of emergency ventilators, but rather advocating that some higher functionality ventilators are prioritised as part of the mix,” they said.
Five days later on April 10, the MHRA further amended the ventilator specification to say that “the greater proportion of devices” for treating coronavirus should have “spontaneous breathing modes”, which have been a feature of hospital ventilators for 30 years.
The government said that the MHRA specification had been updated throughout the pandemic to reflect the evolving clinical understanding of Covid-19.
“Most Ventilator Challenge devices had spontaneous breathing modes and every version of the MHRA specification indicated that this feature was desirable in any design,” it added.
Professor Farmery described the subsequent disappointment of a process where the design goalposts were moved midway through the process.
On March 31, OxVent announced that it had received the “green light” from the Cabinet Office to move to the pre-manufacturing testing stage, but a new specification published on April 10 forced them to redesign the device.
The group found itself scrambling to rewrite software in order to create a “spontaneous” mode for a device they had built to the government’s original specification, Professor Farmery said.
After six weeks of round the clock work, the OxVent device was formally “terminated” by the Cabinet Office on April 28, as it was no longer required. Ultimately none of the ‘novel’ designs received clearance by the MHRA for manufacturing.
“We had a feeling it was easier for the government to say ‘your device didn’t pass MHRA approval’, than for them to say ‘we got it wrong and we don’t want it any more’.” said Prof Farmery, who now hopes to get the OxVent device authorised by US regulators so it can be exported to Brazil, Mexico and other countries
With the risk of a second coronavirus wave this winter, Dr Hamilton said it was important lessons were learned from the whole process so other countries do not repeat the mistake of rushing to build basic ventilators.
“The government failed to create the right conditions to harness the rich resources of UK industry, regulators, engineers and intensive care representatives,” she said.
This article has been amended since publication to clarify that the projected budget for the Ventilator Challenge was £454m not £545m as originally stated.
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