30 Ventilators

[Croesy Blue]

Just been reading that a UK consortium has worked around the clock to design and produce 200 a week. Dyson has also scaled up to produce their own......AND.....incredibly it could be weeks before they get certified by medical officials for use in hospitals. These UK officials need to pull their fingers out

What is the process used to certify them?

[Rjk]

What is the process used to certify them?

I guess that these will be classed as a "clinical trial", so in this case it is MHRA would review the data presented and decide whether it is sufficient to allow release of the product.
The deliverables would be similar to CE marking that you would need to fully release a product in Europe (or the UK), or a 510k in the states.
I think some of the CPAP dvices that people have tried to rush to market have struggled to present enough clinical evidence that the efficacy of the product is sufficient.
For ventilators the bar is even higher as there are rigorous standards for medical electrical equipment, usability etc, and things which are keeping people alive are going to be really scrutinised, as any mistakes will lead to death.

Medtronic have recently made the design of one of their ventilators open source, so that anyone can copy it, although even then you have to demonstrate that the production of the product is sufficiently in control.

[Feedback]

I guess that these will be classed as a "clinical trial", so in this case it is MHRA would review the data presented and decide whether it is sufficient to allow release of the product.
The deliverables would be similar to CE marking that you would need to fully release a product in Europe (or the UK), or a 510k in the states.
I think some of the CPAP dvices that people have tried to rush to market have struggled to present enough clinical evidence that the efficacy of the product is sufficient.
For ventilators the bar is even higher as there are rigorous standards for medical electrical equipment, usability etc, and things which are keeping people alive are going to be really scrutinised, as any mistakes will lead to death.

Medtronic have recently made the design of one of their ventilators open source, so that anyone can copy it, although even then you have to demonstrate that the production of the product is sufficiently in control.

decisions decisisons.

do we listen to someone like RJK who works in the industry and has vast experience of the process, or someone like Eric the half a bee who has a political axe to grind?