The path not taken.
- Oct 9, 2009
- Reaction score
This guidance sets 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.
UK’s new ventilators still awaiting regulatory green light (ft.com, registration may be required)
None of the new mechanical ventilators developed for treating coronavirus patients have obtained UK regulatory approval, a month after the government issued a rallying cry for British industry to help plug a shortage of the devices.
Officials have given conditional commitments to purchase tens of thousands of the life-saving machines which assist patients with respiratory difficulties, subject to safety tests.
In addition to imports and established medical device makers increasing domestic production, big-name UK engineering companies are finalising ventilators designed from scratch and modifying existing products.
However, the new models — which include one by Dyson — have yet to receive the green light from the Medicines and Healthcare products Regulatory Agency (MHRA), according to a government official.
Among equipment awaiting clearance is a tweaked version of a machine already manufactured domestically by Penlon in Oxfordshire, which is in the final clinical stages, according to people aware of the matter.
The Cabinet Office confirmed at the weekend that it had withdrawn support for a ventilator under development by a collaboration of Formula 1 teams, called BlueSky, “following a reassessment of the product’s viability in light of the ever developing picture around what is needed to most effectively treat Covid-19”. In a letter of intent, the government had provisionally ordered thousands of machines from BlueSky. “We are continuing to work at unprecedented speed with a number of other manufacturers to scale up UK production of ventilators,” it added.
The delays appear to be linked in part to the changing clinical understanding of how to best treat the disease amid disagreements within the medical profession about when to deploy invasive ventilation for coronavirus patients.