New ventilators built by Penlon, an Oxfordshire-based firm, have been authorised by the Medicines and Healthcare products Regulatory Agency, with hundreds of units due to be built over the next week.
The device is the first to be given the go-ahead since Boris Johnson called on British manufacturers to turn their focus to making life-saving ventilators, which help coronavirus patients to breathe.
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It comes amid mounting concern over whether the government can meet its goal of 18,000 ventilators quickly enough – and whether new devices will be cleared for use.
Downing Street said there was a “significant amount of spare capacity” in the NHS due to the public obeying lockdown measures and allowing the health service to bolster its resources.
The prime minister’s spokesperson said there were 10,000 ventilators in the NHS, with 2,000 mechanical devices on order that will arrive shortly, as well as the new Penlon devices, of which 40 have already been sent to military distributors to deliver to the NHS.
The spokesperson said: “What you can see is that we are moving towards a position where we will have significantly in excess of 20,000 ventilators.”
The move comes after concern over the whether new devices will be cleared for use, after ministers cancelled an order for thousands of ventilators developed by a group including two F1 teams as they were deemed unsuitable for treating Covid-19 patients.
Clinicians decided the BlueSky device was unsuitable as medics were forced to change the settings frequently to remove fluid from patients’ lungs.
Michael Gove, the Cabinet Office minister, said the approval of the new devices highlighted “significant progress being made” in the government’s ventilator challenge.
“I pay tribute to the incredible ingenuity and commitment of our manufacturing industry, coming together as part of the national effort to protect the NHS and save lives,” he said.
An existing design – paraPAC devices, made by Smiths Medical – has had its production boosted by the Ventilator Challenge consortium and is already in use in NHS hospitals.
Dick Elsy, chair of the consortium, said the Penlon Prima ES02 device has been undergoing stringent testing and clinical trials for the last two weeks.
“Ventilators of this type are complex and critical pieces of medical equipment so ensuring the absolute adherence to regulatory standards and meeting clinical needs were always our priorities,” he said.
He said production would now be ramped up at production lines across the country in an attempt to meet their target of 1,500 units a week of both Penlon and Smiths models.
It comes after Matt Hancock clashed with Good Morning Britain presenter Piers Morgan over reports that the government’s request for ventilators which would stabilise patients for a few hours had been condemned as “no use whatsoever” by experts.
“If we had been told that that was the case, that the ventilators were only to treat a patient for a few hours, we’d have said: ‘Don’t bother, you’re wasting your time. That’s of no use whatsoever,’” Dr Alison Pittard, dean of the Faculty of Intensive Care Medicine, told the Financial Times.
Mr Morgan accused the health secretary of “playing games” during the exchange, which descended into a heated row between the pair.