[kevingadd]

You're overlooking additional options like "The patient would have survived without a ventilator, but one was used to improve their condition and it turned out it was a defective GM ventilator because who needs regulations"

Also "the ventilator was fine but 12 months later it's still in service - who's going to throw out a working ventilator? - and now it's killing people because who needs regulations"

You can't just throw out all the regulations. "Any treatment" is not better than No Treatment. You have to identify which regulations are appropriate to discard in the situation - many, sure, but not all. You wouldn't want someone 3D printing your ventilator with materials that will off-gas toxic fumes and kill you when you would have survived (barely) without the ventilator...

[fermienrico]

> You can't just throw out all regulations

It needs to be emphasized over and over that this is a national emergency. Think "War". Would you rather have a surgeon operate your wounded brain matter with rusted implements or watch you die?

When youre living in a city where every hotel, every gymnasium and every school is full of ill people going through pneumonia - I am sure you would change your mind.

Another way to think is - if COVID-19 had a mortality rate of 100%, and R0 of 3; what would you do about regulations? We are lucky this virus isn't as deadly as Ebola (50% CFR) and as contageous as measles (R0 6-7). If there is death to humanity looming in the future, that's the virus its waiting for a human contact in some bat cave. What regulations then?

[omar_a1]

Medical devices have a lower fault tolerance and higher need for traceability because manufacturing defects mean lost lives.

In your example using rusty tools for brain surgery is a good analogy, as it highlights the false dichotomy you've created. A surgeon could also potentially stabilize you for long enough to search for less obviously deadly impliments. Or decide that, rusty tools or not, you're too far gone to help, and divert their attention to people who have a fighting chance.

Emergency doesn't mean we abandon common sense and decide rogue medicine is the only way forward. Even during a time of war, you'd need your tanks to operate as intended, not randomly fire or seal off the interior so tightly it causes suffocation.

This isn't fiddling with your laptop's inner workings. Medicine has a high enough need for precision that doing it poorly, or even forgetting one minor, necessary step in the process will cause more death and suffering than if you had just sat on your hands. The tight regulations are there for a reason. That doesn't mean we need bureaucracy for sake of bureaucracy, but some skeleton regulatory infrastructure will need to be observed for manufactuers efforts to save more lives than it loses.

Rogue medicine is a waste of resources and lives that will only serve to make this situation worse, as will unreliable medical devices.