401–410 of 584 posts
To everyone saying "great, but why didn't this start months ago?" Well, sure, but the second best time to start is now.
It’s getting incredibly frustrating seeing people make this tired point. Yeah, we SHOULD have started a month ago, but we didn’t, and wasting time at a press conference trying to write some gotcha story about it helps nobody.
Manufacture of medical devices has specific regulation around Good Manufacturing Processes [1] (GMP, one of many GxPs). This requires a Quality Management System [2] (QMS) and very specific training for everyone involved. Pretty much any manufacturer that is not already manufacturing in accordance with 21 CFR Part 820 [3] and related regulations will have a ton of work to establish a suitable QMS. I'd like to think t…
I think you are a bit confused about the position the country is in right now. Regulations and regulators can and will be damned in an emergency. Of course, all reasonable precautions should be taken when producing medical equipment. But if someone needs a ventilator, they are going to die without it. It doesn't matter that there is a small chance that complications arise or some flaw in the ventilator causes it not…
We cannot wait for 18 months for a vaccine.
Wouldn't it make more sense to make masks and other PPE first? You don't need a ventilator if you don't get sick in the first place, masks are much faster to put into immediate production, and impacting the curve earlier is going to have a much bigger effect than later. I mean make everything. But I have family members working in hospitals right now and they are asking me to search the internet and find masks for the…
Earlier quoted context omitted.
In addition to enacting the CDC effort to distribute tests. That some of those tests were contaminated, or that the FDA may have made a hard call in proceeding with redistribution or calling an audible to multi-sourced testing, is a strategic problem. But let's not say nothing was done. I'm sure there were plenty of sleepless nights at the CDC, before we even had confirmed US cases. (Happened to drive by it today. An…
The US refused the WHO tests and wanted to create their own.
That's kind of like saying "I've got a motherboard, am missing an Intel CPU, but AMD has CPUs, so I'll just put one of those in there."
Rolling out testing on the scale that was obviously needed even then is a non-trivial thing, requiring coordination of multiple parties, all in a climate of dubious information.
So, yeah, I think it's understandable (a) to stick to a prearranged plan (to avoid the risk of debilitating testing chaos), (b) to desire a domestic supply of tests, & (c) to avoid drawing on a global resource when there was expected to be no need.
As Dr. Fauci says, hindsight is 20/20.
Earlier quoted context omitted.
> Throwing it out entirely and allowing anybody to manufacture and sell medical devices from their garage is not going to happen. The situation we are in is the same as a doctor doing an emergency tracheotomy in a restaurant using a pen sterilized with some gin. No one really wonders what the serial number is of that pen or whether it was made with the high quality requirements of surgigcal equipment. The machines pr…
If GM makes 10,000 ventilators and they all turn out defective, that could be worse then never making the ventilators at all.
A vaccine that is supposed to be deployed across the board will affect many millions of people and if even a minuscule issue exists we may cause way more harm than good!
The situation is dire and we need fast countermeasures but regulations exist for a reason. This is about health & safety after all.
Earlier quoted context omitted.
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…
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 t…
Earlier quoted context omitted.
> Throwing it out entirely and allowing anybody to manufacture and sell medical devices from their garage is not going to happen. The situation we are in is the same as a doctor doing an emergency tracheotomy in a restaurant using a pen sterilized with some gin. No one really wonders what the serial number is of that pen or whether it was made with the high quality requirements of surgigcal equipment. The machines pr…
If GM makes 10,000 ventilators and they all turn out defective, that could be worse then never making the ventilators at all.
I'm hoping that what they are asking car manufacturers to do is allow the medical industry to use their equipment (e.g. plastic molding equipment) to supply parts that either can't be sourced at all because of the crisis, or can't be supplied in the volumes needed.
Earlier quoted context omitted.
https://www.navsea.navy.mil/Home/Shipyards/Norfolk/Departmen...
I was going to say: surely the US military maintains a manufacturing core? I’m a metal fabricator by trade, and one thing you quickly notice is: with a machine shop and a fabrication shop you are tooled up to build the machines to manufacture almost anything.
Earlier quoted context omitted.
Same reason there are rules about ships going between US ports been manufactured in the US - to keep strategic ship building capacity in the event of a war.
That well meaning law means there’s one cruise ship that fits the requirements, all the others visit one foreign port. https://en.wikipedia.org/wiki/Pride_of_America It looks like the cargo ship law, Jones Act, is more successful in creating capacity.
A line at the top says "Musk tweets Tesla will make ventilators if there’s a shortage". Well, the "if" part does not really seem to be a question. With US cases at 10^4 today, and a doubling time of 2.5 days (note 1), and with the estimates of available stockpile, it seems well past time to get started on this. I doubt that making a ventilator is as simple as knitting a scarf. Another way to contribute would be to fi…
Viral spread is more complicated than a simple exponential curve. This is even visible when just eyeballing graphs in log space, e.g. here: https://mackuba.eu/corona/#total
Better look at each of the different countries.
China and South Korea as examples when the problem is managed ; Italy, Germany and Spain as examples when country did not yet.
https://mackuba.eu/corona/#china
https://mackuba.eu/corona/#south_korea
https://mackuba.eu/corona/#italy