The National Audit Office have published an investigation into how government increased the number of ventilators available to the NHS in response to COVID-19.
Prof Derek Hill, Professor of medical imaging science, UCL, and expert in medical devices, said:
“This audit office report provides fascinating detail on the UK government’s efforts to dramatically increase the availability of ventilators during the early weeks of the COVID pandemic in March and April. When the first wave of COVID arrived in Europe, Italian, then Spanish then French hospital intensive care unit started filling up with patients with severe difficulty breathing. The accelerating growth in numbers meant the capacity of breathing support equipment – including mechanical ventilators and oxygen – was overwhelmed in some cities there.
“The UK, which initially had among the lowest number of ventilators per head in Europe, realised it might be facing demand massively in excess of supply of properly equipped intensive care beds. Building the Nightingale hospitals in conference centres was done rapidly but the thousands of beds lacked the ventilators that would have been needed had those hospitals been needed.
“In total well over half a billion pounds was spent on trying to meet the demand for ventilators. In the event – perhaps because of an effective lock down – the great majority of this investment was for capacity that wasn’t needed.
“This budget was spent on three streams: buying new ventilators, scaling up production of existing ventilator designs, and encouraging British industry to develop novel, rapidly manufacturable ventilators, more or less from scratch.
“It was this last stream, the ‘ventilator challenge’, that received the largest amount of publicity as companies like Dyson, British Aerospace, BMW, the formula 1 teams, and some academic centres turned their hand to making ventilators for the first time. The ‘ventilator challenge’ cost £113 million for design and preparation for manufacture. This cost was high as all the teams were refunded their development and tooling-up costs. However, not only were these machines never used, they never went into manufacture. This was both because the final demand was lower than feared, and also because the middle stream machines – scaled up existing designs – proved a more effective route to increasing capacity. It is also clear that it seems very unlikely that any of these designs will go into production for normal use or export, as they would not be commercially viable. It is also interesting to speculate whether the ventilator challenge designs would have been considered acceptable in clinical use – as they never got that far: many of them were only suitable for use for a small number of hours, without causing harm to patients.
“Notably 12 million was spent on project management by PA Consulting during around 12 weeks that the challenge was running.
“The middle stream – scaling up production of existing designs – did result in many machines being made, if slower than hoped: 11700 Penlon ESO2, 1500 Smiths Parapac, and 2000 Braes were made by the end the summer. The great majority of these are in storage, and may be usable if a second or third wave is worse than the first. However, these machines are only for use during the COVID pandemic, and cannot be exported, as they were approved with a derogation from medical device rules specific to use in the UK during the pandemic.
“The unsung heroes of the whole process were the medical device regulators within MHRA, including staff they brought in to help. They put in place a highly innovative regulatory path, together with support and rigorous but rapid review to ensure that any ventilators reaching patients had an appropriate balance of benefit and risk. This was done by implementing a derogation from the medical device rules to allow a much more streamline process.
“In normal times, more than £500m spent on unused medical equipment would be seen as a massive waste of tax payer money, but in the context of COVID, and risk mitigation, the National Audit Office is not critical of the programme.
“There are, however, lessons to learn in terms of scaling up production of critical medical equipment and running large programs at pace. Not surprisingly, scale up of manufacture of existing designs proved more effective than novel designs from teams that were very talented, but inexperienced in ventilators.”
‘Investigation into how government increased the number of ventilators available to the NHS in response to COVID-19’ was published by the National Audit Office at 00:01 UK time on Wednesday 29 September 2020.
Prof Derek Hill: “No conflicts of interest. I was involved in advising some ventilator challenge teams (at the request of MHRA) but was unpaid.”