Government updates ventilator challenge minimum specifications in response to new COVID-19 clinical information

17.04.2020

As part of its efforts to ramp up production of medical ventilators by British manufacturing firms in response to COVID-19, the government published guidance in March on the minimum acceptable specification of a ventilator for use by the NHS, known as the Specification for Rapidly Manufactured Ventilator System (RMVS).[1] The idea was to provide a clear source of guidance on the minimum levels of ventilator safety and functionality required by the NHS to manufacturing firms with little or no prior experience in medical technology and regulation.

The government has continued to update RMVS throughout the crisis in response to new information on treating COVID-19 which has been gleaned from clinical experience, and the document is now in version 4, which was published on 15 April 2020. Despite the stated purpose of ventilators built in accordance with RMSV being to provide short-term stabilisation of patients, this update clearly indicates a shift in emphasis towards producing ventilators suitable for longer-term care, which may be due to criticism of the government’s ventilator procurement priorities to date.

This new information will be of interest to manufacturing firms participating in the ventilator challenge, such as Dyson, Rolls-Royce, and JCB. However, to date, only one model of RMVS ventilator (manufactured by F1 and Airbus) has been “approved” by the MHRA.[2]

We may see further updates to RMSV that require manufacturers to produce ventilators with more features and functionality, over and above the minimum which is currently prescribed.

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[1] RMVS can be found here: https://www.gov.uk/government/publications/specification-for-ventilators-to-be-used-in-uk-hospitals-during-the-coronavirus-covid-19-outbreak

[2] https://www.bbc.co.uk/news/business-52309294

Alex Denoon

Author

Jamie Hatzel - Trainee Solicitor

Jamie Hatzel

Author