Adapted ventilator model becomes first to get regulatory nod

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The first adapted ventilator design presented by the government’s Ventilator Challenge UK consortium has received regulatory approval. The Government has now placed an order for 15,000 units of the device.

The Penlon Prima ES02 model was adapted from previous tried-and-tested models, allowing for comparatively rapid development. It is a fully intubated mechanical ventilator of the sort appropriate for supporting critically ill Covid-19 patients under the strain of severe respiratory difficulties.

The Prima ES02 has a range of functions, including both volume and pressure-controlled ventilation.

The Medicines and Healthcare products Regulatory Agency (MHRA) - which has given high priority to medical products necessary for responding to the coronavirus pandemic - green lit the device following extensive final testing in hospitals. It was expected that this design would enjoy an untroubled approval process, as it is based on existing designs and presented by a well-established medical devices company.

Following regulatory approval, the government confirmed a vast order for 15,000 of the devices, which will more than double the number of ventilators the NHS currently has available.

It is expected that hundreds of units will be built in the first week of manufacturing, with manufacturing being scaled up in the coming weeks as the Covid-19 peak is expected to hit the UK. The first batch of 40 Penlon Prima ES02 ventilators will be sent to MOD Donnington today and subsequently delivered to NHS hospitals.

“The approval of Penlon’s device underlines the significant progress being made in the Ventilator Challenge,” said Chancellor of the Duchy of Lancaster Michael Gove. “I pay tribute to the incredible ingenuity and commitment of our manufacturing industry, coming together as part of the national effort to protect the NHS and save lives.”

Penlon worked with the Ventilator Challenge UK consortium to adapt, test and deliver the ventilator. The consortium – which was formed last month to provide thousands or tens of thousands more invasive ventilators for the NHS, to support critically ill patients through the coronavirus pandemic – is comprised of dozens of engineering companies and other organisations, including Siemens, Airbus, Rolls-Royce, Ford and some Formula One engineering teams.

Many engineering companies are working alongside their rivals to scale up manufacturing ventilators, adapt existing ventilators or design new ventilators entirely from scratch. For instance, Smith’s paraPAC plus – an existing model which already has MHRA approval – is having production ramped up dramatically to hundreds per week in order to help meet demand.

Earlier this week, the government cancelled a provisional order for thousands of 'BlueSky' ventilators: a new model designed by a group including Formula One teams. The model was found to be inappropriate for treating Covid-19 patients, as it is not suited to the frequent setting switches necessary to keep patients’ lungs clear of fluid.

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