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by ksolanki 2285 days ago
I agree that we are in a unprecedented situation but I am not sure that the regulations will just be “damned”.
2 comments

Liability will be damned.

If there's a military requisition of ventilators, the government alone sets the standards and quality. And the government alone gets to complain about violations. Maybe it wants ISO 9000, but I imagine they'll take 1960s class ventilators if they can be ready by a date certain.

You, citizen, can sue the government and allege that the MASH ventilator spec was reckless and deprived you of your constitutional rights. And you will be laughed out of court at ISO 9000 levels. With few exceptions, soldiers don't get sued for shooting people with guns, and battlefield surgeons don't commit malpractice.

Just to add to this: We don't put pilots in jail for shooting down an enemy aircraft. In an extreme case, we cannot file a lawsuit for mistakenly launching nuclear missiles because of miscommunication - war would have ensued.

I think people are too hung up on the societal fabric, daily life and normal circumstances that when an emergency arrives at your doorstep, you're too clumsy, too weak and too ignorant of what the reality demands.

I am with you but the issue with medical devices and therapeutics is that if at least a base set of regulations is not followed than a potentially corrupt fix to the Corona virus (e.g. faulty vaccine) may introduce a lot of health issues and harm on a scale even higher than Corona just by itself.
That's how it's an emergency when regulations are ignored. If everyone's following regulations and life is as usual -- it's not an emergency
Honestly, you're spitting the truth... and I don't understand why people don't understand this point?