Manufacturers which joined the race to design and build new ventilators for the NHS to help tackle the coronavirus crisis are still waiting for regulatory approval for their machines.
The government issued a ‘call to arms’ to industry in the middle of March, urging companies with manufacturing expertise to transform their production lines to build artificial respirators.
But one month after asking for assistance, none of the machines put forward by industry have yet been given the official clinical green light – the final barrier to putting them into production.
The delay has been partly blamed on the Department of Health updating the specifications for the machines because of the changing medical understanding of how best to treat coronavirus patients.
Original estimates suggested the NHS would need 30,000 ventilators but that was revised down by Health Secretary Matt Hancock to 18,000 due to the success of social distancing measures.
However, Downing Street said yesterday that the current number of ventilators available in NHS hospitals stands at just over 10,000 – far short of the target.
Health services around the world are scrambling to acquire the machines but some hospitals have reported unusually high death rates for people on ventilators amid fears they may do more harm than good for certain patients.
Coronavirus patients are put onto ventilators when their condition deteriorates and they struggle to breathe which means that a high fatality rate is expected.
But hospitals in New York City have reported at least 80 per cent of patients put on a ventilator died, with similar statistics recorded elsewhere in the US.
Dyson is one of a number of manufacturers to have answered the government’s ventilator ‘call to arms’. Pictured is the company’s CoVent ventilator on a hospital bed
Health Secretary Matt Hancock, pictured in Downing Street today, has set a target of 18,000 ventilators for the NHS
Ministers have placed provisional orders for thousands of new ventilators – including one developed by Dyson.
But without clinical approval the machines cannot be put into production and delivered to the health service.
A government official told the Financial Times that the Medicines and Healthcare products Regulatory Agency is yet to approve any of the machines.
The Department of Health is in the process of updating the guidance it issued to manufacturers as part of the ‘call to arms’.
It said on its website: ‘In light of the developing picture around the most effective treatment of COVID-19 we are currently updating the Rapidly Manufactured Ventilator System specification.
‘This specification is currently under review and will be updated shortly.
‘Until the new specification is available you should continue to follow the guidance in this document but be aware of changes to follow.’
Meanwhile, the government has cancelled a provisional order for a machine developed by a group including the Renault and Red Bull Formula One teams.
The Cabinet Office will not be going ahead with the purchase of the BlueSky model because of clinician concerns it is not suitable for treating coronavirus patients.
In more positive news, the first UK-built ventilators backed by a consortium of leading manufacturers have now been delivered to some hospitals.
A number of ParaPac machines, made by Smiths Medical and which were already being built before the Covid-19 outbreak, have now been delivered to the NHS.
The production of the machine was accelerated by the involvement of The Ventilator Challenge UK consortium which includes Forumla One racing teams Mercedes, McLaren and Williams.
The same group, which also involves Rolls-Royce and Airbus, has also put its expertise into improving another ventilator made by Oxfordshire-based Penlon which is now in the ‘final stage’ of the regulatory approval process.
The recent emergence of coronavirus means healthcare professionals are still learning how best to treat the disease.
Recent NHS data suggested that two thirds of coronavirus patients in the UK who need to be hooked up to a ventilator will die.
A report from the Intensive Care National Audit and Research Centre found ventilated patients succumb to the virus 66.3 per cent of the time.
That is double the mortality rate of non-virus patients who were put on breathing support between 2017 and 2019 before the outbreak.
Volunteers working at the new NHS Nightingale super-hospital in London were told that 80 per cent of patients on ventilators could die.
A government spokesman said developing a new ventilator ‘from scratch usually takes years’ and that in the four weeks since the Ventilator Challenge started ‘we have made rapid progress’.
The spokesman said the new designs were still being tested by clinicians to make sure they meet the ‘necessary standards for patient safety and effectiveness of treatment’.
The Prime Minister’s Official Spokesman said yesterday that the NHS still has spare ventilators and is below its capacity as the UK approaches the peak of the outbreak.
He said: ‘There are now over 10,000 mechanical ventilators available to NHS patients.
‘There has been an increase of around 200 over the past week and there are another 2,000 mechanical ventilators on order plus thousands of provisional orders for industry designed ventilators which are going through testing.
‘The key point here is obviously that the NHS continues to have spare capacity in terms of beds in intensive care units and ventilators and that anybody who needs intensive care treatment or a ventilator has access to it.’
In the Midlands, one of England’s largest NHS hospital trusts, University Hospitals Birmingham (UHB), last week said it had about 160 patients on ventilators but could cope with a surge to more than 1,000 if necessary, indicating there is still ventilator capacity.
The PM’s Official Spokesman confirmed today that the first ParaPac devices had now been delivered while the Penlon ventilators are undergoing their final clinical tests.
The spokesman added: ‘The crucial point is that we are confident we will have sufficient capacity to meet demand.’