Comment by mgerdts | Hacker News Reader

Comment by mgerdts | Hacker News Reader

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 2. https://en.wikipedia.org/wiki/Quality_management_system 3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR...

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.

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

Only those who can afford medical care will receive it?

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.

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.

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.

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

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

Honestly, you're spitting the truth... and I don't understand why people don't understand this point?

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.

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.

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.

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.

> 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.

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.

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.

> 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.

If GM makes 10,000 ventilators and they all turn out defective, that could be worse then never making the ventilators at all.

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.

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)

GM won't make ventilators. They'll make plastic parts, hoses, valves etc. It's not that GM couldn't pivot to building something else, but they can't do that within weeks. They can probably start churning out metal or plastic parts whose speciifcations can be verified by the ventilator manufacturer before they are assembled into one of their ventilators.

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.

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.)

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

This should apply to the vaccine testing protocols too.

We cannot wait for 18 months for a vaccine.

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

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.

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

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...

> 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?

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.

Unfortunately the ventilator alone is insufficient. You also need a medical team to administer it, and they may choose not to expose themselves to the liability of using a ventilator of unknown provenance.

I’m not a doctor but in this setting it seems that letting you die of a disease is much more palatable than killing you in an attempt to treat it.

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.

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!"

>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.

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.

>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.

Reply on news.ycombinator.com