Rapid manufacture of hospital ventilators could cost lives if not properly designed, according to new guidelines

Experts have warned that the rapid manufacture of ventilators by companies with no prior medical technology experience could be harmful to patients.

The UK is in desperate need of the life-saving machines to treat people affected by coronavirus.

On Sunday, health secretary Matt Hancock admitted that hospitals might not have enough ventilators to cope when the spread of coronavirus peaks.

And today, according to Donald Trump, the British Government asked the US for 200 machines to help with the rise in COVID-19 related hospital admissions.

In a bid to close the gap on the shortages, a number of companies such as McLaren – the supercar manufacturer – have come forward and offered to create 10,000 new devices to aid healthcare professionals.

Ventilator Challenge UK, as the consortium is known, is made up of some of the country’s largest businesses including BAE Systems, Airbus, Thales, Ford, Renishaw, Rolls-Royce and Smiths.

However, the Chartered Institute of Ergonomics and Human Factors (CIEHF) has today given a stark warning for would-be manufacturers and published guidelines which set out safe and practical ways to design new ventilators.

A dedicated panel, led by Professor Sue Hignett, of Loughborough University, has also been set up by the CIEHF to directly advise on how best to design machines and is working with the Faculty of Intensive Care Medicine (FCIM) to produce the ventilator usability testing protocol.

Prof Hignett said: “The way the consortium has rallied together to tackle the shortage of ventilators is admirable and critical for providing the best healthcare for people struck down by coronavirus.

“However, creating new medical technology that works as intended – so that staff can understand and operate it effectively – is a huge challenge.

“Designing the machines for practical working conditions in hospitals is essential.

“Staff will be wearing personal protective equipment (PPE) and working longer shifts in stressful conditions and Nightingale hospitals could have up to 10 different types of ventilators.

“Wards will need devices that do not harm patients because staff are accidently pressing the wrong buttons or mis-read screens. The fewer chances for error the better for everyone.

“It is also really important the manufacturer use Suitably Qualified and Experienced Practitioners (SQEP) to maximise the likelihood of safe design and operation of ventilators.”

A number of firms from the Ventilator Challenge UK group have already approached the expert panel, which is sharing the usability protocols to speed up the design process.

Dr Noorzaman Rashid, Chief Executive of the CIEHF, added: “Ventilators are being designed and manufactured quickly by firms with little or no healthcare knowledge or manufacturing experience of medical devices.

“The rapid design and manufacturing processes for COVID-19 means that these complex devices are not undergoing appropriate usability testing, which means that they can cause unnecessary harm as a result of human error because they are poorly designed.”


Notes for editors

Press release reference number: 20/53

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