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With the coronavirus pandemic spreading to almost every country in the world, the number of hospital patients needing respiratory assistance is unprecedented. It is not easy for manufacturers to quickly manufacture a large number of additional fans, so there is likely to be an imbalance in supply and demand for the equipment needed to provide this support.
To alleviate this problem, a team of engineers from UCL (the university in London where I work) and Formula One engine manufacturer Mercedes-AMG HPP have been working to manufacture large numbers of continuous positive pressure devices in the airways ( CPAP). This machine, similar to those commonly used to treat sleep apnea, can help patients with severe respiratory problems, freeing ventilators for the most critical.
As with all things coronavirus related, speed is of the essence. The team has accomplished the task of moving from reverse engineering an original product to producing a new design, through testing and regulatory approval, to full-scale production in less than 10 days.
In one month, 10,000 devices were delivered to meet the UK government’s target, with Mercedes reusing all its facilities in Brixworth, Northampton to produce 1,000 per day. Designs and manufacturing instructions have now been released, free of charge, to governments, manufacturers, academics and health experts worldwide. In one week they had been shared with more than 1,300 teams in 25 countries.
The amazing pace of this project has been made possible by an alignment of established academic, industrial, and clinical collaborations working under the umbrella of the UCL Institute of Health Engineering. The team was quickly mobilized to focus on a clearly defined immediate need.
The project started when Tim Baker, a professor of mechanical engineering, contacted former collaborators Andy Cowell and Ben Hodgkinson of Mercedes AMG HPP. On March 18, they gathered at MechSpace, a recently opened facility in central London for mechanical engineering students.
Baker presented Mercedes engineers with a conventional CPAP flow generator given by Mervyn Singer, professor of intensive care medicine at UCL hospitals, with a simple instruction, “We need more of these.” Singer had been contacted by doctors in Italy and China who shared their CPAP experiences as an important aid in managing coronavirus patients.
Continuous pressure
Unlike mechanical ventilation, CPAP does not require a tube to be inserted into the patient’s windpipe. Instead, the continuous air pressure (slightly higher than normal atmospheric pressure) applied through a face mask keeps the airways open and provides the patient with oxygen-enriched air. This reduces the work they have to do to breathe without requiring them to be sedated.
A CPAP flow generator works by exploiting a phenomenon known as the Venturi effect. A high-flow jet of oxygen draws air from the room around it to generate an oxygen-enriched outflow of air. Mechanical valves allow you to adjust pressure and oxygen concentration.
The beauty of this design is that it has no moving parts. This meant that the team could reverse engineer the device by meticulously measuring each dimension and translating it into a 3D computer model and manufacturing drawings.
Over the next two days, MechSpace became the pit lane of the project with Mercedes team engineers using the experience gained from the F1 industry to accelerate prototype design and manufacturing. They built on the skills of three UCL alumni, Jamie Robinson, Alex Blakesley, and Ismail Ahmad. In particular, they used commercial software (Mashoom) that Robinson had developed during his undergraduate degree to manage and store the computer designs that would underpin the production process.
The racing mindset of the Mercedes team propelled the process forward at breakneck speed. Hodgkinson tossed the gauntlet of a 24-hour shift between him as he walked through the MechSpace gate and cut materials for the prototype on his commercial production line in Brixworth. The team failed this goal, but only for two hours.
With the team working all day, one of them was dispatched to stock up on essential supplies, including toiletries and a change of clothes. Jerseys purchased from the nearest store inadvertently provided a team uniform and the jersey logo was requisitioned as the name of the CPAP system, UCL-Ventura.
Regulatory approval
Regulatory approval for medical devices is a long process that can often take years, but the team deliberately focused on reverse engineering a non-patent device, the Respironics WhisperFlow, which had been used in the NHS for decades. This allowed the device to be quickly approved for use by the UK Medicines and Health Products Regulatory Agency (MHRA).
The partnerships already established through the UCL Institute of Health Engineering, led by Professor Rebecca Shipley, were also crucial to the speed of this project.
The team worked closely with various industry partners to verify availability and organize supply of other key regulated components, including oxygen sensors and masks. The Mark I design entered clinical trials on patients at UCL hospitals and sister hospitals on March 27, and the government order was confirmed four days later.
UCL mechanical engineers, including Tom Peach, Tom Rushton, Peter Weston, and James Weaver, have continued to work at full speed at MechSpace, sleeping in a hotel next door. A Mark II version of the device has now been approved that significantly reduces the system’s oxygen requirements. And it is this design that is now available for the global response to COVID-19.
Through collaboration, innovation, and translation, this interdisciplinary team has been able to proceed quickly enough to bring this vital healthcare technology to the forefront of the battle against this disease.
This article is republished by Clare Elwell, professor of medical physics, vice dean of impact, engineering, UCL, UCL of The Conversation under a Creative Commons license. Read the original article.
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