UK & Europe
The UK Government has provided designers and manufacturers with protection from product liability claims which arise from new ventilators.
On 30 March 2020, a consortium of UK industrial, technology and engineering businesses announced that they had come together to produce medical ventilators for the UK in order to assist with the response to the COVID-19 pandemic.
Over the past several weeks the consortium has been involved in the design and manufacture of new medical ventilators, as well as the manufacture of existing medical ventilators (known collectively as 'Rapidly Manufactured Ventilator Systems' or 'RMVS's).
As of 28 April 2020 the Government has confirmed that it is currently supporting 11 different RMVSs. It has also ordered 15,000 Penlon Prima ESO2 ventilators, the first of the newly-adapted device to receive regulatory approval.
As there has been a clear and urgent need to scale-up the production and supply of RMVSs to the National Health Service, the Government has also declared that it will indemnify the designers and manufactures of the devices against any product liability claims.
The Medicines and Healthcare products Regulatory Agency has published guidance setting out requirements for RMVSs based on a consensus of what is a ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators. Furthermore, RMVSs require regulatory approval before they can be used in a clinical setting. These are both factors which the Court would consider carefully when deciding whether a product is defective in accordance with the Consumer Protection Act. The news of indemnity, however, should be welcomed by all the companies in the consortium, especially those who have little or no experience in the design and production of medical devices.
Author: Andrew Hannah