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by Continuous 2287 days ago
This is ridiculous!

Hacks are ok with web and app deployments where you are able to patch and fix to your heart's content and the damage is not life threatening.

I have worked with the medical industry, the amount of formal validation and verification that goes through on software is insane compared to what we have in the "move fast and break things" world.

Even if it is "temporary" and "desperate" I would stay away from this mentality as much as humanly possible.

5 comments

This is completely the wrong attitude.

Different circumstances with different levels of risk, require the ability to adapt.

Nobody is suggesting 'sharing ventilators' would be normal practice because in normal circumstances we want to make sure that equipment is 99.999% reliable.

But as you imply, this requires extensive testing and regulation. Within these regulations are also significant safety margins that can be exploited if conditions change. If we can multiply the usage and maintain 99.99% reliability, then this is probably a risk worth taking.

Also - if you've worked in the medical industry, you know how vastly overpriced and bureaucratized everything is.

The situation of 'not enough ventilators' is literally happening right in front of us, and it is causing death.

The risk tolerance for utilizing the gear in such a manner is such that it may very well be possible to create better outcomes.

The individuals involved are medical practitioners who are well versed in the equipment, procedures, and inherent moral dilemmas, they're not fools.

This is exactly the kind of procedural innovation required in times of crises - hopefully, a few doctors and especially the Engineers from the manufacturer can be involved. The people who built the gear may be able to give a much better articulation of the actual risks involved, and they may even be able to mitigate, for example 'the risk will be power consumption' or 'the risk will be this specific valve which could wear and break' thereby implying the 'new operational procedure' would involve daily checking of said valve etc..

The world is facing crises we absolutely must be adaptive while trying to quantify risk and outcomes.

>Also - if you've worked in the medical industry, you know how vastly overpriced and bureaucratized everything is.

Quality guy here,though not in medical devices... Yet. Still trying to get up to speed on all the regulations; but I know enough to be able to vouch for some of the bureaucracy around the industry.

The risks in medicine being what they are, when launching into any novel space, there is simply no substitute for A) data and B) audit trail.

Your data varies from lot numbers of source material from suppliers (contamination happens), batch numbers of parts (and revision numbers of the process involved in making that batch) from manufacturers, to serial numbers matched up to individual patients in order to be able to implement some form of high-level statistical process control, and rapid intervention when things go wrong in order to figure out why, what you can do about it, and who else may be at risk. No one wants to be the one told "whoops, someone goofed, and that thing we put you on is trying to kill you," anymore than anyone in the chain from treatment inception, to installation wants to hear that they missed something, and even worse, get caught not knowing what to do about it.

That means paperwork, signalling mechanisms, and procedures involved with marshalling whatever response is to follow, which is not at all a trivial process to orchestrate, and while all of us wish there wasn't so much bullshit, there are plenty of examples where "falling asleep on the job" has led to catastrophic outcomes.

I can't necessarily say I that justifies the overriding though. The markups are ridiculous, but without access to the books, I can't really discount it either.

In Northern Italy patients are being turned down on triage because there is not enough treatment capacity. They go home and many of them die.

Just like you would use a sweaty t-shirt over an open wound in a life or death situation if there is no certified sterile bandage at hand. The calculus is different.

On more than one occasion I have "broken the rules" or Macgyvered my way out of a life-threatening situation (for my patients), either with equipment or drugs. This is a crisis. Our systems aren't working fast enough to cope.
So if you end up in a situation where a doctor is deciding whether to put multiple people on a ventilator, is the idea that they would certainly pick you?

You don't seem to be reacting to the situations that the idea addresses, situations where there is an immediate shortage of ventilators.

Such a foolish statement, you clearly don't understand the number of lives lost due to ventilator shortages right now or you'd delete your comment in embarrassment. Doctors should be using absolutely any method available to them to maximize lives saved. You don't need to "have worked with the medical industry" to understand this perspective.
How many lives have been lost due to turning up at a hospital and not being able to find a ventilator so far? Do you have a precise stat?

As of about 48 hours ago Lombardy's hospitals were not turning anyone away:

https://www.cnbc.com/2020/03/19/italys-death-rate-reaches-re...

Medical facilities in Lombardy will “soon” be unable to help new coronavirus cases, regional Gov. Attilio Fontana said Wednesday, as he urged everyone to stay at home.