Guidance

Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID-19) outbreak

This is a specification of the minimally clinically acceptable Continuous Positive Airway Pressure (CPAP) system to be used in UK hospitals.

From:
Medicines and Healthcare products Regulatory Agency
Published
29 March 2020
Last updated
28 January 2021 — See all updates

This publication was withdrawn on

For current information on the regulation of medical devices in the UK see Regulating medical devices in the UK - GOV.UK (www.gov.uk).

Documents

Specification for Rapidly Manufactured CPAP System (RMCPAPS)

PDF, 800 KB, 19 pages

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Details

This guidance is for devices which are most likely to confer therapeutic benefit on a patient requiring CPAP because of respiratory failure caused by the virus, used in the initial care of patients requiring urgent support.

We have set out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators given the emergency situation.

This is a fast-moving situation and this page will be continually updated.

Further information

We have published separate guidance on the specification for ventilators to be used in UK hospitals.

We have also published guidance on Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak.

The British Standards Institution have made their standards on ventilators accessible free of charge.

There is now a dedicated Yellow Card coronavirus website for reporting any incidents involving medical equipment relating to COVID-19 treatment.

MHRA guidance on coronavirus (COVID-19).

Published 29 March 2020
Last updated 28 January 2021 + show all updates

  1. Uploaded a new PDF to reflect changes to regulations following Brexit transition.

  2. Added a link to new dedicated Yellow Card coronavirus website for reporting any incidents involving medical equipment relating to COVID-19 treatment.

  3. First published.

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