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
ft.com/content/365529…
@AlisonPittard 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
gov.uk/government/pub…
@AlisonPittard 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
@AlisonPittard 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
@AlisonPittard 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
eandt.theiet.org/content/articl…
@AlisonPittard 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
@AlisonPittard 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
ox.ac.uk/news/2020-03-3…
@AlisonPittard 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
@AlisonPittard 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
@AlisonPittard 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
@AlisonPittard 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
@AlisonPittard Would the govt have been better to mobilise high-end manufacturers to work with companies like Medtronic @Medtronic who have put the ENTIRE design spec for their PB560 vent online, open-source. /12
medtronic.com/us-en/e/open-f…
@AlisonPittard @Medtronic Hindsight is a beautiful thing, I know. Everyone was scrambling to help. There was a war one. All true. And it *looks* now as if the ventilator capacity will be OK. But you have to wonder if those dreaded *experts* were properly listened to. ENDS