8 ms·

Manufacture of medical devices has specific regulation around Good Manufacturing Processes [1] (GMP, one of many GxPs). This requires a Quality Management Syst

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 that at least some auto workers already have some taste of working under the eye of regulators and auditors and as such their adjustment to GMP has the potential to be smooth. The days of leaving empty beverage containers in the hollow of a door are long past, right? Management that is not experienced in FDA regulations will try to ignore or short-cut them. In the best of cases, this turns into fines and manufacturing delays. In the worst of cases, it turns into deaths due to defective product or manufacturing delays. Every level of management needs to be experienced in GxP. The most reasonable path to getting a QMS in place and having compliant manufacturing would seem to be to have the manufacturing capacity be leant to an established manufacturer that has a solid QMS, the expertise to adapt it to the new reality, and a solid relationship with the FDA. That is, the auto manufacturer's management would need to be out of the picture or 100% subservient to the experienced medical device manufacturer. Once that is worked out, I suspect that manufacture of the devices is comparatively easy. Put another way, it's probably easier to switch from sedans to tanks than it is to switch from SUVs to almost any medical gizmo. 1. https://en.wikipedia.org/wiki/Good_manufacturing_practice https://en.wikipedia.org/wiki/Good_manufacturing_practice 2. https://en.wikipedia.org/wiki/Quality_management_system https://en.wikipedia.org/wiki/Quality_management_system 3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR...

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.
wayne_skylar 7y ago
Wonderful. I'd rather have an unregulated ventilator and maybe live than no ventilator and die for sure.
- kevingadd 7y ago
  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 7y ago
    > 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 7y ago
      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.
adrr 7y ago
No one cares about any of this stuff. Rules need to be tossed aside to minimize loss of life. All FDA rules surrounding drugs need to be suspended for COVID19 patients. We need to start doing what china did and start using non approved anti-virals to save people's lives. We need to start vaccinating at risk populations(75 or older) with the trial vaccine if it is shown to be effective in the upcoming weeks. We cant wait a year.
- salawat 7y ago
  Woah there. Don't be so hasty to throw out the baby with the bathwater. Don't need another Thalidomide dropped on us just because things are looking a bit grim. It's one thing to ask "Do we really need to let this stand in our way right now?"; It's an entirely different kettle of fish to say "Screw it, if it kills the virus anything goes!"
  - ImaCake 7y ago
    >Woah there. Don't be so hasty to throw out the baby with the bathwater. Agreed. I may absolutely hate the documentation I have to complete as a microbiologist in a GMP company, but there is a reason for it. I just wish that GMP wasn't filled with so much BS. The parent comment here is being ridiculous and deserves to be argued against.
  - adrr 7y ago
    So when given a choice to a 65 year old to die or take an unapproved drug. We should let them die. We are going to run out ventilators and will ration them. Our hospitals are already at capacity. Italy is at 8% mortality rate and climbing. We need to do anything to cut icu rate and spread. Virus is showing long term effects even in children. Known long terms issues is worse than hypothetical issues. Cautious thinking is why western civilization has failed to contain the virus.
    - salawat 7y ago
      >So when given a choice to a 65 year old to die or take an unapproved drug. Did not say that. Allow them to elect to take the drug, however, we still need to follow up, and keep track of the outcomes. Data is critical to avoid outcomes where we end up dropping bombs on houses to put out the housefire. Again, see Thalidomide. >We are going to run out ventilators and will ration them. Likely. I also believe that there should be a much greater tolerance allowed for expediting supply chains to make components for new ones; but data is also key. A fabrication method that results in immediate complications needs to have a quickly followed audit trail to ensure remedial action can take place quickly to minimize additional harm. That doesn't mean you can't compromise on some non or less critical tolerances while you're at it. >Virus is showing long term effects even in children. Noted, let's try not to add onto that by releasing something untested that causes severe side-effects as well. >Known long terms issues is worse than hypothetical issues. Difference: the known long term issues from the virus alone would happen with or without intervention in some portion of the population. Long term issues that arise as a complication via treatment would not happen except that weren't diligent enough. Many of the GxP's are, in fact, written in blood. I'm fine with getting adventurous and experimenting, but we need to be tracking outcomes so interventions can take place at the first sign of trouble too. It isn't easy. Quality never is. There is a damn good reason for you to put in the extra work to make it happen regardless.
woofie11 7y ago
I've designed medical devices. They're not rocket science. Yes, being tolerant of a single-point-of-failure is important, but not in this climate. Military should cut through fines. And as for lives, they just need to be more safe than not having a ventilator. You don't put a healthy patient on a ventilator. I think if 10,000 come out which kill people, that's a problem, but it's not a particularly hard one to catch. If 10,000 come out where 1% kill people, that wouldn't pass any sort of bar in normal times, but these are not normal times. That's much better than not having them at all.

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.

wayne_skylar 7y ago

Wonderful. I'd rather have an unregulated ventilator and maybe live than no ventilator and die for sure.

kevingadd 7y ago
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 7y ago
  > 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 7y ago
    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.

adrr 7y ago

No one cares about any of this stuff. Rules need to be tossed aside to minimize loss of life. All FDA rules surrounding drugs need to be suspended for COVID19 patients. We need to start doing what china did and start using non approved anti-virals to save people's lives. We need to start vaccinating at risk populations(75 or older) with the trial vaccine if it is shown to be effective in the upcoming weeks. We cant wait a year.

salawat 7y ago
Woah there. Don't be so hasty to throw out the baby with the bathwater. Don't need another Thalidomide dropped on us just because things are looking a bit grim. It's one thing to ask "Do we really need to let this stand in our way right now?"; It's an entirely different kettle of fish to say "Screw it, if it kills the virus anything goes!"
- ImaCake 7y ago
  >Woah there. Don't be so hasty to throw out the baby with the bathwater. Agreed. I may absolutely hate the documentation I have to complete as a microbiologist in a GMP company, but there is a reason for it. I just wish that GMP wasn't filled with so much BS. The parent comment here is being ridiculous and deserves to be argued against.
- adrr 7y ago
  So when given a choice to a 65 year old to die or take an unapproved drug. We should let them die. We are going to run out ventilators and will ration them. Our hospitals are already at capacity. Italy is at 8% mortality rate and climbing. We need to do anything to cut icu rate and spread. Virus is showing long term effects even in children. Known long terms issues is worse than hypothetical issues. Cautious thinking is why western civilization has failed to contain the virus.
  - salawat 7y ago
    >So when given a choice to a 65 year old to die or take an unapproved drug. Did not say that. Allow them to elect to take the drug, however, we still need to follow up, and keep track of the outcomes. Data is critical to avoid outcomes where we end up dropping bombs on houses to put out the housefire. Again, see Thalidomide. >We are going to run out ventilators and will ration them. Likely. I also believe that there should be a much greater tolerance allowed for expediting supply chains to make components for new ones; but data is also key. A fabrication method that results in immediate complications needs to have a quickly followed audit trail to ensure remedial action can take place quickly to minimize additional harm. That doesn't mean you can't compromise on some non or less critical tolerances while you're at it. >Virus is showing long term effects even in children. Noted, let's try not to add onto that by releasing something untested that causes severe side-effects as well. >Known long terms issues is worse than hypothetical issues. Difference: the known long term issues from the virus alone would happen with or without intervention in some portion of the population. Long term issues that arise as a complication via treatment would not happen except that weren't diligent enough. Many of the GxP's are, in fact, written in blood. I'm fine with getting adventurous and experimenting, but we need to be tracking outcomes so interventions can take place at the first sign of trouble too. It isn't easy. Quality never is. There is a damn good reason for you to put in the extra work to make it happen regardless.

woofie11 7y ago

I've designed medical devices. They're not rocket science. Yes, being tolerant of a single-point-of-failure is important, but not in this climate. Military should cut through fines. And as for lives, they just need to be more safe than not having a ventilator. You don't put a healthy patient on a ventilator. I think if 10,000 come out which kill people, that's a problem, but it's not a particularly hard one to catch. If 10,000 come out where 1% kill people, that wouldn't pass any sort of bar in normal times, but these are not normal times. That's much better than not having them at all.