5 ms·

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, a

by jjeaff 7y ago

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 to work correctly. They would have died without the ventilator in nearly 100% of cases. Like many regulations right now, they will be temporarily suspended within reason.

ksolanki 7y ago
I agree that we are in a unprecedented situation but I am not sure that the regulations will just be “damned”.
- resonantjacket5 7y ago
  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
  - rickdangerous1 7y ago
    Honestly, you're spitting the truth... and I don't understand why people don't understand this point?
- Digory 7y ago
  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.
  - fermienrico 7y ago
    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.
    - neuronic 7y ago
      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.
xyzzyz 7y ago
It seems that in time of actual crisis, we're all libertarians.
- shigawire 7y ago
  Only those who can afford medical care will receive it?
  - chmod775 7y ago
    Only if you subscribe to the weird capitalist modern bastard child of libertarianism, which should really be called something else, given that actual libertarians would probably hate it with a passion.
- srl 7y ago
  Well, maybe we're (almost) all pragmatists. I have pretty libertarian impulses. I'm pretty pleased to see a lot of pointless (or point-light) regulations get kicked to the curb, although I certainly wish the circumstances weren't necessary. I also hate immigration restrictions of all sorts. But... okay, right now, travel restrictions make some sense. I'll take it (and then fight to undo them in 12 months). It turns out, some of the things I really really care about, my preferences would do harm in a pandemic. Maybe that's true outside of a pandemic, too -- but it's a lot easier to recognize when the magnitude of the effect is large! I think at the end of the day, that's part of what's driving all this pragmatism: the effect size of "getting policy right" is suddenly much larger than it usually is. Life is no longer close to being a zero-sum game, and everybody can see it. That's what "we're all in this together" means, and people are acting like they believe it.
- jacobolus 7y ago
  Personally I’m in favor of a (partially) centrally planned emergency economy manufacturing and distributing (and possibly rationing) medical equipment, pharmaceuticals, personal protective gear, antiseptics, etc. where needed around the country; paying for medical costs of anyone who catches COVID19; directly disbursing cash to residents who are quarantined, isolated, or lose their jobs during the crisis; banning evictions, doing whatever possible to delay personal/small business expenses like rent or loan payments; directly hiring large numbers of young people without dependents to do socially necessary jobs like distributing food to quarantined people or tracing contacts of anyone infected or manning phone hotlines to call people who don’t follow mass media and to screen patients before they talk to medical personnel; forcing media outlets to play regular publicly produced informational content and shutting down media outlets spreading misinformation; and so on.. I would hardly call that libertarian, but YMMV.
mgerdts 7y ago
Sure, the regulatory regime needs to be relaxed to quickly bring on more manufacturing capacity. I believe it will be. Throwing it out entirely and allowing anybody to manufacture and sell medical devices from their garage is not going to happen. That being said, auto manufacturers likely have no experience manufacturing these devices. The don't know which optimizations will be dangerous. They may not recognize they are doing anything different from an experienced manufacturer. When quality breaks down, it will be important to have appropriate records to know which other devices are also defective so that they can be replaced, repaired, or used with appropriate caution. If manufacturing is still ongoing, corrective action in the manufacturing plant will be needed. GxP regulations require this type of record keeping for very good reason. An experienced manufacturer will be needed to get manufacturing going and to supervise it to ensure it has an acceptable level of quality. Even if the experienced medical device manufacturer has legal indemnity, failures of the temporary factory could stain its reputation. I find it unlikely that any reputable medical device manufacturer would want to take on supervision of an inexperienced workforce in an unproven facility without the force of the regulation they are accustomed to as a means to force behavior that they know leads to predictable outcomes. Surely, experienced members of a quality organization and the FDA will figure out how to right-size some of the practices called for by regulation.
- ardy42 7y ago
  > That being said, auto manufacturers likely have no experience manufacturing these devices. The don't know which optimizations will be dangerous. They may not recognize they are doing anything different from an experienced manufacturer. Given that this is a crisis, the existing ventilator manufactures need to send over a couple experienced ventilator engineers to help.
  - jacquesm 7y ago
    And open source all their blueprints, schematics and software. Getting a supply chain for parts up and running is going to be the tricky part.
    - 7y ago
Ericson2314 7y ago
There is a really simple to solution to this: the government limits prices and mandates based on how badly the regulation is skirted. Basically limit profit so it matches the dubious use-value. (Neither utility nor profit is actually linear wrt units produce, but just smart about that and know your adversary.)
nraynaud 7y ago
Maybe GM could be renting space and manpower to a ventilator manufacturer?
koheripbal 7y ago
This should apply to the vaccine testing protocols too. We cannot wait for 18 months for a vaccine.
- macNchz 7y ago
  I think there is way too much potential for unintended consequences in relaxing vaccine development regulations. The Cutter Incident in the 50s was a turning point on this: during the race to market a polio vaccine, 120k doses were produced that actually contained the live virus, infecting thousands and causing additional outbreaks. https://en.m.wikipedia.org/wiki/Cutter_incident https://en.m.wikipedia.org/wiki/Cutter_incident

by jjeaff 7y ago

ksolanki 7y ago

I agree that we are in a unprecedented situation but I am not sure that the regulations will just be “damned”.

resonantjacket5 7y ago
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
- rickdangerous1 7y ago
  Honestly, you're spitting the truth... and I don't understand why people don't understand this point?
Digory 7y ago
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.
- fermienrico 7y ago
  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.
  - neuronic 7y ago
    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.

xyzzyz 7y ago

It seems that in time of actual crisis, we're all libertarians.

shigawire 7y ago
Only those who can afford medical care will receive it?
- chmod775 7y ago
  Only if you subscribe to the weird capitalist modern bastard child of libertarianism, which should really be called something else, given that actual libertarians would probably hate it with a passion.
srl 7y ago
Well, maybe we're (almost) all pragmatists. I have pretty libertarian impulses. I'm pretty pleased to see a lot of pointless (or point-light) regulations get kicked to the curb, although I certainly wish the circumstances weren't necessary. I also hate immigration restrictions of all sorts. But... okay, right now, travel restrictions make some sense. I'll take it (and then fight to undo them in 12 months). It turns out, some of the things I really really care about, my preferences would do harm in a pandemic. Maybe that's true outside of a pandemic, too -- but it's a lot easier to recognize when the magnitude of the effect is large! I think at the end of the day, that's part of what's driving all this pragmatism: the effect size of "getting policy right" is suddenly much larger than it usually is. Life is no longer close to being a zero-sum game, and everybody can see it. That's what "we're all in this together" means, and people are acting like they believe it.
jacobolus 7y ago
Personally I’m in favor of a (partially) centrally planned emergency economy manufacturing and distributing (and possibly rationing) medical equipment, pharmaceuticals, personal protective gear, antiseptics, etc. where needed around the country; paying for medical costs of anyone who catches COVID19; directly disbursing cash to residents who are quarantined, isolated, or lose their jobs during the crisis; banning evictions, doing whatever possible to delay personal/small business expenses like rent or loan payments; directly hiring large numbers of young people without dependents to do socially necessary jobs like distributing food to quarantined people or tracing contacts of anyone infected or manning phone hotlines to call people who don’t follow mass media and to screen patients before they talk to medical personnel; forcing media outlets to play regular publicly produced informational content and shutting down media outlets spreading misinformation; and so on.. I would hardly call that libertarian, but YMMV.

mgerdts 7y ago

Sure, the regulatory regime needs to be relaxed to quickly bring on more manufacturing capacity. I believe it will be. Throwing it out entirely and allowing anybody to manufacture and sell medical devices from their garage is not going to happen. That being said, auto manufacturers likely have no experience manufacturing these devices. The don't know which optimizations will be dangerous. They may not recognize they are doing anything different from an experienced manufacturer. When quality breaks down, it will be important to have appropriate records to know which other devices are also defective so that they can be replaced, repaired, or used with appropriate caution. If manufacturing is still ongoing, corrective action in the manufacturing plant will be needed. GxP regulations require this type of record keeping for very good reason. An experienced manufacturer will be needed to get manufacturing going and to supervise it to ensure it has an acceptable level of quality. Even if the experienced medical device manufacturer has legal indemnity, failures of the temporary factory could stain its reputation. I find it unlikely that any reputable medical device manufacturer would want to take on supervision of an inexperienced workforce in an unproven facility without the force of the regulation they are accustomed to as a means to force behavior that they know leads to predictable outcomes. Surely, experienced members of a quality organization and the FDA will figure out how to right-size some of the practices called for by regulation.

ardy42 7y ago
> That being said, auto manufacturers likely have no experience manufacturing these devices. The don't know which optimizations will be dangerous. They may not recognize they are doing anything different from an experienced manufacturer. Given that this is a crisis, the existing ventilator manufactures need to send over a couple experienced ventilator engineers to help.
- jacquesm 7y ago
  And open source all their blueprints, schematics and software. Getting a supply chain for parts up and running is going to be the tricky part.
  - 7y ago

Ericson2314 7y ago

There is a really simple to solution to this: the government limits prices and mandates based on how badly the regulation is skirted. Basically limit profit so it matches the dubious use-value. (Neither utility nor profit is actually linear wrt units produce, but just smart about that and know your adversary.)

nraynaud 7y ago

Maybe GM could be renting space and manpower to a ventilator manufacturer?

koheripbal 7y ago

This should apply to the vaccine testing protocols too. We cannot wait for 18 months for a vaccine.

macNchz 7y ago
I think there is way too much potential for unintended consequences in relaxing vaccine development regulations. The Cutter Incident in the 50s was a turning point on this: during the race to market a polio vaccine, 120k doses were produced that actually contained the live virus, infecting thousands and causing additional outbreaks. https://en.m.wikipedia.org/wiki/Cutter_incident https://en.m.wikipedia.org/wiki/Cutter_incident