A Continuous Positive Airway Pressure (CPAP) device, which can help to keep coronavirus patients out of intensive care, has been created in under a week, and gained rapid approval by the Medicines and Healthcare products Regulatory Agency (MHRA).
CPAP devices are currently used in hospitals but have been in short supply recently. Engineers from University College London, in collaboration with Mercedes Formula One, have reverse-engineered the device which delivers oxygen to the lungs, without the need for a ventilator. Forty devices will be trialled in London hospitals this week, with success leading to the production of 1000 devices per day by Mercedes-AMG-HPP.
CPAP devices push a steady flow of high pressure air-oxygen mix into the mouth and nose, provided the patient is able to breath on their own. The extra pressure helps to open up the collapsed alveoli and push oxygen across the inflamed lung membrane. Therefore, CPAP increases blood oxygen more than just giving oxygen using a conventional oxygen mask.
“They will help to save lives by ensuring that ventilators, a limited resource, are used only for the most severely ill.”
Rapid approval of these devices is due to the novel approach adopted by the MHRA for acceptance of critical devices. The exemptions from the Medical Device Regulations during the pandemic allows fast-track approval of medical devices, through which manufacturers can seek approval of their devices before placing them on the market.
The MHRA have set out the minimum specification for clinically acceptable CPAP systems to be used in hospitals during the current pandemic. It must be noted that any lower specifications would provide no clinical benefit and may unacceptably risk patient safety.
Our regulatory affairs consultancy team specialise in medical devices. Our team are ready and willing to help new manufacturers of CPAP devices and ventilators to ensure they meet these minimum specifications.
For our assistance or just to have an initial conversation, please contact our medical devices team for expert advice.