COVID-19: First Newly-Adapted Ventilator Wins Approval

Peter Russell

April 16, 2020

Hundreds of new medical ventilators to help patients in intensive care with COVID-19 are set to be produced after one design was granted regulatory approval.

Penlon's Prima ES02 model is now authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in hospitals.

The device was adapted from previous models to meet the rapidly manufactured ventilator system specification and has undergone extensive testing.

The Government announced today it had ordered 15,000 Penlon devices.

Ventilator Challenge

Penlon is part of the VentilatorChallengeUK consortium, which consists of a number of groups including High Value Manufacturing Catapult, car-maker Ford, a number of UK-based Formula 1 teams, and Siemens.

Michael Gove, Chancellor of the Duchy of Lancaster, said: "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."

The Prima ES02 is a fully intubated mechanical ventilator with a range of functions including volume and pressure controlled ventilation.

Dick Elsy, chief executive of the High Value Manufacturing Catapult, 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 first dispatch of 40 Penlon devices was today being sent to MOD Donnington prior to delivery to the NHS.

Target of 18,000 Ventilators

Last month the Government called on manufacturers to boost the UK's supply of ventilators in advance of an expected surge in demand.

At present the UK has between 9000 and 10,000 ventilators, and health officials originally set a target of 30,000. However, earlier this month Matt Hancock, the Secretary of State for Health and Social Care set a new target of 18,000 after reviewing predictions of the number of people with COVID-19 who were likely to need critical care.

The latest order followed delivery to the NHS of an existing ventilator model, the paraPAC, made by Smiths Medical, which is also part of the VentilatorChallengeUK consortium.

Eighty of the devices were produced last week, the Government said.

As an existing device, the paraPC, which is used for less acute patients, did not require further MHRA approval.

Meanwhile, Dyson confirmed this week it would be able to make 10,000 ventilators to support the NHS.

The vacuum cleaner manufacturer said its production line in Wiltshire was making Critical Care Ventilator units for final regulatory approval.

Earlier this week, the Government announced it had abandoned plans to buy thousands of devices known as Blue Sky developed by a group including the Renault and Red Bull Formula 1 teams.

It was reported that the devices were rejected because they were not considered suitable for treating patients with COVID-19.

Formula 1 teams are assisting with several ventilator projects under the umbrella title Project Pitlane.

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