Reverse-engineered breathing aid gets swift regulatory nod
Image credit: James Tye / UCL
UCL and UCL Hospital scientists have worked with Mercedes Formula One (F1) to develop a new continuous positive airway pressure (CPAP) ventilator – a breathing aid which can be used outside intensive care units – and quickly received regulatory approval for the device, to help hospital staff in the fight against the coronavirus pandemic.
A CPAP is a type of ventilator for people who are able to breathe on their own, but who need support keeping their airway unobstructed. They push oxygen and air into the mouth and nose at steady pressure, helping to increase the amount of oxygen entering the lungs.
This type of ventilator has been used extensively to treat Covid-19 patients in Italy and China. The devices allow for patients with breathing difficulties to be treated outside intensive care units, bridging the gap between a basic oxygen mask and a full ventilator, which requires sedation, an invasive procedure and close supervision.
“These devices will help to save lives by ensuring that ventilators, a limited resource, are used only for the most severely ill,” said Professor Mervyn Singer.
Reports from Italy suggest that approximately half of patients given CPAP have avoided the need for mechanical ventilation. Many countries are scrambling to procure thousands or tens of thousands of ventilators as they prepare to provide for enormous numbers of Covid-19 patients hospitalised with breathing difficulties. The UK government has ordered thousands of ventilators from manufacturers, including companies like Dyson which do not have experience making the devices but have promised they can uptool their facilities and start manufacturing ventilators in a matter of weeks.
A team from UCL and UCL Hospital worked with Mercedes F1 engineers to reverse engineer a CPAP ventilator. Their CPAP took 100 hours of work to develop, from initial meeting to production of the first ventilator. The device was swiftly inspected by the Medicines and Healthcare Products Regulatory Agency and approved in a fraction of the time it would be expected to take under ordinary circumstances.
The government said that the NHS had been given the nod to order enough of the devices to meet clinical demand, on account of positive trial results. While CPAP machines are already in routine hospital and home use to support NHS patients with breathing difficulties, they are reportedly in short supply in the midst of the coronavirus pandemic.
“This breakthrough has the potential to save many lives and allow our frontline NHS staff to keep patients off [standard] ventilators,” said Professor David Lomas, vice-provost for heath at UCL. “It is, quite simply, a wonderful achievement to have gone from first meeting to regulator approval in just 10 days. It shows what can be done when universities, industry and hospitals joins forces for the national good.”
Professor Tim Baker, of UCL’s mechanical engineering department, commented: “Given the urgent need, we are thankful that we were able to reduce a process that could take years down to a matter of days. From being given the brief, we worked all hours of the day, disassembling and analysing an off-patent device. Using computer simulations, we improved the device further to create a state-of-the-art version suited to mass production.”
According to Peter Bannister, chair of the IET’s Healthcare Panel: “What is novel about the current situation is that companies from other industries known for high-volume precision engineering, such as automotive, are partnering with specialist medical device manufacturers in response to the urgent healthcare need to accelerate the mass production of these breathing aids.
“This is one of a number of examples of cross-sector collaboration brought about by the current pandemic […] It is likely that more new consortia will emerge to address other population needs as the situation develops.”
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