NEW: Where top ITU doc @AlisonPittard tells me that the MINIMUM standard ventilator specced in govt's 'ventilator challenge' would be no use in treating COVID patient in ICU - so question? Why did UK govt aim so low? 1/Thread

https://www.ft.com/content/365529f8-bff3-41d2-949f-d0eedff0cfbb

The spec on govt website says "bare minimum" for machines "would be for short-term stabilisation for a few hours, but this may be extended up to 1-day use for a patient in extremis" /2

https://www.gov.uk/government/publications/specification-for-ventilators-to-be-used-in-uk-hospitals-during-the-coronavirus-covid-19-outbreak#history

More importantly, the same formula is stated in the "intended purpose" of the machines in the spec checklist circulated to potential makers by the MHRA (Medicines & Healthcare products Regulator Agency) - and in medical devices world that is key/loaded term. /3

Now, to be clear, this is the minimum spec - but it begs an important question.

WHY were the govt shooting to make ANY ventilators that - as @AlisonPittard says - wouldn't be any use? Median time on a vent from #COVID19 is 3-4 days, she tells me. What use hours? /4

Already one consortium - BlueSky, backed by Renault and Red Bull - has had their project canned. They were supposed to be making c6,000 of these machines, but turns out they're no good. Even though, I suspect, quite possible MET the UK spec. /5 https://eandt.theiet.org/content/articles/2020/04/government-cancels-provisional-order-of-thousands-of-bluesky-ventilators-from-f1-team/

I understand from someone directly involved that only in the last week or so has expert pressure really been brought to bear to push the Govt towards backing more advanced machines. /6

We wait and watch to see the outcome of the Oxvent project which - per this on Mar 31 has been shortlisted for next stage of testing. Smith & Nephew will build if it's OK'd. But I understand it is also, at its core, a pretty basic device. /7

http://www.ox.ac.uk/news/2020-03-31-ventilator-project-oxvent-gets-green-light-uk-government-proceed-next-stage-testing

There is a wider problem with these simpler devices, which is that they lead - per med devices experts I've spoken too - to worse outcomes.

Devices that synchronise with a patients's breathing are much more effective.

AND to be fair, V4 of the spec does emphasise this /8

The question now - which the govt is reluctant to answer - is how many of the current projects that are close to regulatory clearance are on the clunkier end of the spectrum? How much time and money has been wasted on designing/making devices like BlueSky that are no good? /9

Because one longer-term aim, beyond the current emergency, was to build up a massive stock of ventilators that could be used if there was a future pandemic.

But no point in building junk - even IF docs were clear they could live without some fancier features. /10

We wait and see what is coming down the pipes now - it does seem, if BlueSky is an indication - that there is a shift to higher-end functionality now.

The govt argues that it needed to start somewhere - and didn't want a prohibitively complex spec - but why aim so low? /11