Ventilator approval marks UK production ramp
Penlon’s Prima ES02 ventilator is now authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in hospitals.
Penlon has worked with the VentilatorChallengeUK consortium, which includes Airbus, Ford, a number of UK based Formula One racing teams and Siemens. The design has been adapted from the previous model to meets the UK’s 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. Changes included being able to siwtch the units off and on more often to help patients.
These changes required extensive final testing of these devices in hospitals to ensure that they are safe and effective and approval from the MHRA. This differs from the Smiths ParaPac portable unit that has also goine into production which was unmodified. Despite the immediate ramp of production, only 80 paraPAC units were produced last week. However the UK Ventilator Consortium says production is being ramped up into the hundreds over the next few weeks.
Following the approval, the UK Government has confirmed an order for 15,000 of the Penlon ventilator systems. Hundreds of units are expected to be built over the next week at Penlon in Oxfordshire, Airbus in Broughton and Ford in Dagenham, with production being further scaled up in the coming weeks. This highlights the challenges of gaining approval for completely new designs such as those from Dyson/TTP and the Reness open source design, and getting these into production quickly.
The first dispatch of 40 Ventilator Challenge Penlon devices was sent to a military logistics warehouse at Donnington yesterday to be delivered to NHS hospitals ‘very shortly’. This will put pressure on the supply chain of components over the coming weeks.
Next: Ventilator component supply chain
“I’m very pleased to confirm that we have now secured MHRA approval for the Penlon Prima ESO2 device which has been undergoing stringent testing and clinical trials for the last two weeks,” said Dick Elsy, Chief Executive of the High Value Manufacturing Catapult that is co-ordinating the consortium. “We will now accelerate the ramp up of production at the Penlon site in Oxfordshire and the new VCUK production lines we’ve built in Broughton, Dagenham and Woking. Having already commenced deliveries of the Smiths Group’s paraPAC plus devices, we are working closely with our supply chain partners to rapidly scale up production to achieve our target of at least 1,500 units a week of the combined Penlon and Smiths models.”
Currently, over 10,000 mechanical ventilators are available to NHS patients, which is set to increase further through these new devices as well as through additional orders from overseas.
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