RAQA NEWS ROUND UP (APRIL)

29 March 2020

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5-Minute Coronavirus Test FDA Approved

The FDA has approved a coronavirus test developed by Abbott Laboratories that is capable of providing results in just 5 minutes. The portable test, which is small enough to be used in almost any location, searches and detects the coronavirus genome which is present at high levels in a patient infected with the virus.

John Frels, vice president of research and development at Abbott Diagnostics said "“This is really going to provide a tremendous opportunity for front-line caregivers, those having to diagnose a lot of infections, to close the gap with our testing,” Frels said. “A clinic will be able to turn that result around quickly, while the patient is waiting.”

Emergency Ventilator Submitted to FDA

A team of Massachusetts Institute of Technology (MIT) Engineers have developed a ventilator created from a bag valve mask, also known as an Ambu-Bag, and already available components, electronics and motors.

The ventilator, called E-Vent, has been submitted to the FDA under Emergency Use Authorization (EUA) and assists the patient by manually squeezing the pump on the mask using a plastic device to provide breathing support.

MHRA and NHS Work with Dyson to Develop Ventilators

Dyson has been liaising closely with experts from the Medicines and Healthcare products Regulatory Agency (MHRA) and the NHS during the design process for the new CoVent ventilator.

The battery-operated ventilator, which is portable and able to be bed mounted, conserves the amounts of oxygen used and has been designed specifically with the healthcare needs of Coronavirus patients in mind.

James Dyson, founder of Dyson said “Ventilators are a regulated product so Dyson and TTP will be working with the MHRA and the government to ensure that the product and the manufacturing process is approved. We have received an initial order of 10,000 units from the UK Government which we will supply on an open-book basis. We are also looking at ways of making it available internationally.

“I am proud of what Dyson engineers and our partners at TTP have achieved. I am eager to see this new device in production and in hospitals as soon as possible. This is clearly a time of grave international crisis, I will therefore donate 5,000 units to the international effort, 1,000 of which will go to the United Kingdom.”

CPAP Breathing Aid Approved for Use in NHS

Mercedes F1, University College London and clinicians at the University College London Hospital (UCLH), have worked together to develop a breathing aid that can help keep patients out of intensive care during the coronavirus crisis.

The device uses Continuous Positive Airway Pressure (CPAP) to push a steady flow of oxygen to the lungs without the need for a ventilator. This is done with pressure to ensure the lungs remain open and thus increases the level of oxygen entering.

The devices have previously been used on patients in China and Italy with up to 50% of patients being treated with them instead of more intrusive ventilators.

UCLH critical care consultant Prof Mervyn Singer said: "These devices are a halfway house between a simple oxygen mask and invasive mechanical ventilation which requires patients to be sedated.

"They will help to save lives by ensuring that ventilators, a limited resource, are used only for the most severely ill."