An industrial consortium, which is developing ventilators to support the NHS amid the coronavirus outbreak, has secured MHRA approval for a ventilator design.
This means the medical device can now be used in hospitals across the country.
Ventilator Challenge UK, led by Dick Elsy, CEO of High Value Manufacturing Catapult, is accelerating the production of a new ventilator design based on existing technologies. The designs can be assembled from materials and parts in current production.
Component manufacturing and assembly of existing ventilator designs by Smiths Medical and Penlon are being scaled up across the country at different manufacturing sites.
Last weekend the first batch of the Penlon ventilator device, which has been rapidly adapted from other existing ventilator designs, were produced.
Now Penlon's ventilator, the ESO2 system, has secured approval from MHRA after undergoing stringent testing and clinical trials. The Penlon device is a newly-adapted ventilator design, adapted from previous models, that meets the rapidly manufactured ventilator system specification. It is a fully intubated mechanical ventilator designed to provide support to critically ill patients with a range of functions including volume and pressure controlled ventilation.
Following the device’s approval, the government has confirmed an order for 15,000 Penlon devices. Hundreds of units are expected to be built over the next week, with production being further scaled up in the coming weeks.
Mr Elsy said: "Ventilators of this type are complex and critical pieces of medical equipment, so ensuring the absolute adherence to regulatory standards and meeting clinical needs were always our priorities."
The consortium will now accelerate the ramp up of production at the Penlon site in Oxfordshire and the new production lines built in Broughton, Dagenham, Woking and Maidenhead.
The consortium has also commenced deliveries of the Smiths Group’s existing paraPAC plus design, which already has regulatory approval.
Ventilator Challenge UK is working closely with its supply chain partners to rapidly scale up production to achieve a target of at least 1,500 units a week of the combined Penlon and Smiths models.
Mr Elsy continued: "I want to take this opportunity to again thank every member of the consortium and the hundreds of dedicated colleagues who have been working day and night to get us to this point.”