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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 a

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.
  - jschwartzi 7y ago
    Producing safe medical devices is about more than just schematics. It is a social process with people having a huge impact on how safe the result is. All the blueprints in the world have no value if you don’t know whether they’ve been followed and the materials used are correct. And when there are defects you need to have socialized how people are to respond to those defects or your not building a competent organization. I see many comments about blueprints on here that miss the point. It’s like saying your software product is just the source code. The reality is that you have to build a competent knowledgeable organization around those blueprints or what you’re making will kill or injure patients.
alkonaut 7y ago
> 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 produced in a mobilization shouldn't even be compared with those produced in peacetime. They should be compared to nothing at all. So when the question arises "is this device safe"? The relevant answer is "well this patient is dying on a stretcher in a tent next to a thousand others like him, so we'll use it". It follows that it's important that these devices are either destroyed or quality certified after the fact. These can't be used in five years in during a routine surgery, of course.
- ABeeSea 7y ago
  If GM makes 10,000 ventilators and they all turn out defective, that could be worse then never making the ventilators at all.
  - neuronic 7y ago
    Correct, this is also why we can skip animal trials for vaccine development but not human trials. 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.
    - alkonaut 7y ago
      A vaccine is given to healthy people. A drug that is given to a small number of people that are so sick that they will die within days and there is no other cure, has different safety requirements from a vaccine that is given to a huge number of people that are healthy. In the vaccine case, even a relatively rare (1/10000) side effect might mean that the vaccine is worse than the cure. Not so with the treatment of dying people. Safety wise, using untested equipment is the same as the drug for dying people scenario, not the vaccine scenario. A similar example is this: in normal circumstances these devices are operated by ICU doctors. In a time of crisis you can already see this delegated to doctors that have never used a ventilator, and only given a brief introduction or even just a pamphlet describing it. I suspect that within the next months there will be places where recently trained nurses perform the duties of ICU doctors. And laid off hotell staff perform nursing duties. > regulations exist for a reason. This is about health & safety after all. They do, but most regulations are surprisingly flexible in a crisis. E.g. already the rest time requirements for truck drivers are lifted in many countries to keep supply lines. In the military (where a crisis is planned for) there are two different sets of safety requirements, with a stricter one that only applies in peacetime (e.g. max speeds, minimum distances bewteeen vehicles, requirements to use ear protection and pretty much every single safety requirement there is)

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.
- jschwartzi 7y ago
  Producing safe medical devices is about more than just schematics. It is a social process with people having a huge impact on how safe the result is. All the blueprints in the world have no value if you don’t know whether they’ve been followed and the materials used are correct. And when there are defects you need to have socialized how people are to respond to those defects or your not building a competent organization. I see many comments about blueprints on here that miss the point. It’s like saying your software product is just the source code. The reality is that you have to build a competent knowledgeable organization around those blueprints or what you’re making will kill or injure patients.

alkonaut 7y ago

> 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 produced in a mobilization shouldn't even be compared with those produced in peacetime. They should be compared to nothing at all. So when the question arises "is this device safe"? The relevant answer is "well this patient is dying on a stretcher in a tent next to a thousand others like him, so we'll use it". It follows that it's important that these devices are either destroyed or quality certified after the fact. These can't be used in five years in during a routine surgery, of course.

ABeeSea 7y ago
If GM makes 10,000 ventilators and they all turn out defective, that could be worse then never making the ventilators at all.
- neuronic 7y ago
  Correct, this is also why we can skip animal trials for vaccine development but not human trials. 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.
  - alkonaut 7y ago
    A vaccine is given to healthy people. A drug that is given to a small number of people that are so sick that they will die within days and there is no other cure, has different safety requirements from a vaccine that is given to a huge number of people that are healthy. In the vaccine case, even a relatively rare (1/10000) side effect might mean that the vaccine is worse than the cure. Not so with the treatment of dying people. Safety wise, using untested equipment is the same as the drug for dying people scenario, not the vaccine scenario. A similar example is this: in normal circumstances these devices are operated by ICU doctors. In a time of crisis you can already see this delegated to doctors that have never used a ventilator, and only given a brief introduction or even just a pamphlet describing it. I suspect that within the next months there will be places where recently trained nurses perform the duties of ICU doctors. And laid off hotell staff perform nursing duties. > regulations exist for a reason. This is about health & safety after all. They do, but most regulations are surprisingly flexible in a crisis. E.g. already the rest time requirements for truck drivers are lifted in many countries to keep supply lines. In the military (where a crisis is planned for) there are two different sets of safety requirements, with a stricter one that only applies in peacetime (e.g. max speeds, minimum distances bewteeen vehicles, requirements to use ear protection and pretty much every single safety requirement there is)