Inspection and Regulation

05.05.20

Government pledges to continue to support UK Ventilator Challenge

Eleven devices manufactured as part of the UK’s Ventilator Challenge, as part of the national drive to increase ventilator supply and protect the NHS, will continue to be supported, the Government have announced.

Following a review by an expert panel of clinicians, including NHS clinicians and the regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), support for four devices in the Ventilator Challenge will be ended by the Government.

The panel concluded other designs could better meet the clinical needs of the NHS at this time, though recognised the need from the Government to create effective ventilators at pace.

So far, the increased efforts to produce added capacity have seen an additional 2,400 mechanical ventilators made available to the NHS since the start of the pandemic, with over 250 coming from the Ventilator Challenge. Including both mechanical and non-invasive ventilators, the number of extra ventilators made available rises to 6,745 in total.

Across the UK, the NHS now has 10,900 mechanical ventilators available for use, as well as 4,300 non-invasive devices.

During the coronavirus pandemic so far, every patient who has required a ventilator has had access to one. However, the Government is committed to continuing to increase capacity through its three pillar strategy: procuring more ventilators from overseas, scaling up the production of existing or modified designs and working to design and manufacture new devices.

The Government recently announced an order of 15,000 Penlon Prima ES02 ventilators, the first newly-adapted device to receive regulatory approval in the Ventilator Challenge, with production set to ramp up in the coming weeks. Existing devices are also being manufactured at speed and at scale as part of the Ventilator Challenge.

READ MORE: NHS technology sees 38% surge in usage during coronavirus outbreak

READ MORE: NHS approved to use breathing aid to assist coronavirus patients

Devices that have been selected to continue as part of the Ventilator Challenge have been selected based upon expert clinical and technical advice. This advice includes feedback from rigorous testing of the ventilators by clinical experts to ensure they meet the necessary standards for patient safety and effectiveness of treatment, which is of vital importance for any new ventilator design.

While taking into account projections for ventilator demand, the selection criteria also balances that against the aforementioned safety and effectiveness testing, the availability of other devices which already have regulatory approval, the performance and clinical usefulness of each device and the progress to date on each device’s overall development.

Health Secretary Matt Hancock said: “Since we launched the Ventilator Challenge the ingenuity and innovation shown by so many companies has been truly awe-inspiring and has helped us continue to get ventilators to the frontline and keep capacity ahead of demand.

“Technology and innovation, operating hand-in-hand with the care and dedication of our fantastic health and social care staff, will help us overcome this virus.

“I want to thank every company, and their staff, for their phenomenal achievements in going forward to the next stage.”

Chancellor of the Duchy of Lancaster Michael Gove added: “The innovation, teamwork and commitment shown by manufacturers involved in the Ventilator Challenge has been inspirational.

“While the Government will be ending support for four of the devices in the Ventilator Challenge today, I want to put on record my sincere thanks to everyone involved.”

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