Newsnight and ventilators.

[Roger Hayter]

Fortunately the responsibility, both moral and legal, will lie with the person operating the machine, who will be prosecuted, sued and struck off in various combinations if they use something not demonstrated to work. Maybe less well demonstrated than normal, but the approval process for medical devices is actually much less onerous than for drugs anyway.

Don't ask the patient if they want to use something unproven, they will volunteer for whatever solution a plausible snake oil (or, more likely, essential oil or cannabis oil) salesmen offers them.

[Cnut]

Patient: Doc, Doc, I'm drowning in my own snot. Please help me. Can you put me on MacGyver's ventilator.

Doctor: Sorry sir it's more than my job's worth to chance using uncertified machinary.

Patient: .... dead.

Doctor: Oh dear, how sad, never mind. At least I'm not in trouble.

It's all about probability, expectation, if the patient is likely to die we should relax our level of prudence. On the other hand, there is no way I would touch a rushed vaccine.

[Martin Brown]

It will be very interesting to see when and if they deliver. I expect they will be very stylish and cost 10x any other equivalent.

From my perspective having worked in the scientific instrument business on the edge of big pharma research and semiconductors if you want something in a hurry that just works you take a pre-existing design and tweak it slightly when you need a whole load of units in an emergency.

Starting from a blank sheet of paper without any previous experience in the domain results in tripping up over all the same teething problems as the existing manufacturers encountered in their own Mk1 products.

[nightjar]

It is not a question of reliability, but whether or not it is safe to use on humans. That requires testing. I used to make a reusable medical device and the DoH asked me to make a disposable version. They wanted it urgently and bent over backwards to assist. It still took more than a year to complete the trials and other steps necessary to get it approved for use.

[mechanic]

We don't seem to have a Barnes Wallis figure though. The hold-ups here seem to be bureaucratic and regulatory not manufacturing. Someone needs to get a grip.

[Steve Walker]

Yes, I know. But in an emergency where lack of ventilators will cause far more deaths than ventilators that are not 99.999% safe, government may choose to override the rules. Circumstances can dictate that such decisions need to be made.

SteveW

[Robin]

I am not sure the government can override everything (even with the nuclear option of derogation from the ECHR). It is nowadays much harder to decide the rights of the one are outweighed by the needs of the many.

[Roger Hayter]

Depending exactly what you are dealing with it is hard to decide whether an approval process is time wasting red tape or a vital precaution fo avoid killing dozens of people during the first few weeks of general use. Ventilators are ideally placed to kill people while apparently still working ok.

[Dave Plowman (News)]

Exactly so.

It is much easier to copy an existing design - even more so with the cooperation of the owners who will have all the drawing etc needed to control the manufacturing machines - than to start afresh.

To put it in terms more might understand.

You need, say, domestic boiler PCBs. If you have the CAD data for those, a factory who makes such things and has spare capacity could be on the job very quickly. Compared to designing your own from scratch.

[Dave Plowman (News)]

Sadly, exactly that decision will be made by doctors in the next few week.

[nightjar]

Without testing, we can't be sure that they are not completely unsafe and likely to kill more people than they save.

Some rules don't get overridden, particularly not where lives are at stake.

[T i m]

And one being made already by doctors in Spain and Italy. ;-(

Cheers, T i m

[Robin]

Doctors face horrible pressure but if they follow NICE guidelines won't face charges. Someone who authorises the use of kit that kills could face manslaughter charges.

[Jethro_uk]

And yet someone who authorises the use of guns and bullets doesn't.

It's a funny old world ...

[Steve Walker]

But if lives are at stake without additional ventilators, it becomes a comparison of risk.

SteveW

[Roger Hayter]

It is hard to compare a known risk of death with a completely unknown risk of untested equipment causing even more deaths. You don't want medical care decided according to emotion and yearning, but by facts. You can't compare a known risk with a completely unknown one that could be worse.

[Steve Walker]

If someone is dying without a ventilator, then it is worth trying anything.

SteveW

[Fredxx]

He employs 4,000 in the UK so would expect so.

How many have you had?

OMG, that chip on your shoulder is growing. You could get out there and make money yourself if you had the noddle.

[Jinky ...]

two and never again...Henry is best ...

[nightjar]

I dealt with the DoH and the NHS for most of my time in business. That isn't the way they do things. They will never knowingly put a patient at risk from untested equipment. I suspect it has as much to do with nobody wanting to carry the can if a patient dies because of faulty equipment as with patient safety, but the result is the same.