
Italian hospital saves Covid-19 patients by 3D printing valves - csnover
https://www.3dprintingmedia.network/covid-19-3d-printed-valve-for-reanimation-device/
======
s0rce
Seems like this is a downside of single-use sterile medical parts. In most
cases its much easier and safer to just grab a new single use part but in
times of shortage you could sanitize and sterilize multiple use metal parts in
house and get them back in use without needing to physically manufacturer more
locally, which often isn't practical - even with additive manufacturing.

~~~
callmeal
>in times of shortage you could sanitize and sterilize multiple use metal
parts in house

Got one word for you: prions. Standard sanitization procedures do not work
with them, and if the hospital is not setup to decontaminate for prions,
they're unlikely to be able to to it during the crisis.

see
[https://www.memphis.edu/ehs/pdfs/deconprions.pdf](https://www.memphis.edu/ehs/pdfs/deconprions.pdf)
for what it takes.

~~~
MPSimmons
That is a valid argument for neurological equipment, which has the highest
liklihood of infection for prions, but during this pandemic, the likelihood of
prion transmission is very remote, probably to the point that it approaches
zero, and is probably zero for these valves.

~~~
Balgair
Not all prions need to break skin to be an issue. Kuru, one of the more
infamous prions, was transmitted orally [0]. Mad Cow is also thought to be
transmitted orally, but research is on going. Though a low possibility, the
absolute _last_ thing you need is an even more complicated issue running about
during a world-wide triage/crisis. To save live you are trying to eliminate
variables, not add to them.

[0] Kuru is not something you want to research whilst eating, fyi. Hell, none
of them are.

~~~
s0rce
transmitted orally from eating neural tissues not from prions in saliva that
could contaminate medical equipment such as ventilators (that's my
understanding at least)

~~~
Balgair
Mad Cow is still active in it's research. We cannot yet rule out that salivary
contact is a transmitter of prions, though I agree that it is very unlikely.

[https://www.thelancet.com/journals/laninf/article/PIIS1473-3...](https://www.thelancet.com/journals/laninf/article/PIIS1473-3099\(03\)00578-4/fulltext)

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andrewseanryan
This crisis is moving technology to the forefront even more. From life saving
equipment, to entertainment/communication/learning for the quarantined. There
are countless ways for tech to play a large and important role.

------
TaylorAlexander
I feel like we as the tech community need to let hospitals know we’re
available to help with design and 3D printing of critical parts. But how
wouldn’t the hospitals know what parts are 3D printable and how would we ever
organize to contact them? I’m in the Bay Area and I could make myself
available to design and print anything anyone needs. Does anyone have ideas on
how to determine what parts would be helpful?

~~~
ENOTTY
I urge makers and more professionalized 3D printers to familiarize themselves
with FDA guidelines[1] on 3D printing and internalize their thinking. No doubt
this will slow you down, but you have time right _now_ to prepare before the
shortages begin. This will make things safer for patients, give confidence to
medical professionals that you have your head in the right place, and likely
demonstrate good faith in the event that the FDA comes after you (after the
COVID-19 crisis ends).

I recommend reading "Technical Considerations for Additive Manufactured
Medical Devices". Then start discussions in your professional societies to
make contact with the FDA as a group and start to develop guidance targeted
for the COVID-19 emergency.

[1]: [https://www.fda.gov/medical-devices/products-and-medical-
pro...](https://www.fda.gov/medical-devices/products-and-medical-
procedures/3d-printing-medical-devices)

------
Barrin92
it was a very good thing that someone was quick on their feet and made this
happen but 3d printing is no solution to the systematic lack of these
supplies.

The problem here, and I think this will be much worse in the weeks to come in
the US and the UK, is the institutional decline of manufacturing capacity and
the reliance on long supply chains from countries which are themselves at max
capacity.

Every country should be able to, in crisis, quickly switch to mass production
of vital goods that guarantee the physical safety of their citizens.
Globalisation and post-industrial societies might have created nice margins
for some subset of the population for a while but I doubt the corona virus
will be swayed by management consultants.

~~~
6nf
People may not realise this but we have wonderful methods to quickly mass
produce plastic parts.

These pieces might take several hours to print which means one 3d printer
could produce maybe 50 of these a week. If you have 10 printers you could do
500 in that week.

However, within one working week I can have injection dies machined - and with
a small investment ($10k ish) I can buy an injection moulding machine and pump
these parts out at a rate of 100s per hour and a cost of almost nothing.

3d printing has an extremely small window where they are useful for bulk use
parts like this.

~~~
ggm
I am in a kickstarter for an injection moulded item (a photo scanning holder)
which has run 18 months late because of massive systemic backlogged production
issues with the injection moulds requiring repeated re-re-re-re-fabrication.

its a kickstarter, and undercapitalized but please don't over-state the "ease"
with which injection moulding can work. Its true but, it has a high capital
burden up-front to "get it right" which clearly, this current medical
emergency demands and we should expect.

No, we can't just mint things with zero cost, injection moulding. It requires
craftspeople to make the moulds.

~~~
nl
Injection moulding isn't _hard_ but it's not uncommon for even experienced
teams to take a couple of goes to get it right. "Re-re-re-re-fabrication" is
excessive though and sounds like it was an inexperienced team.

Source: worked at a place that made injection moulded hardware.

~~~
ggm
its somebody else's kickstarter, not mine. Its the PIXLater, a diffuser and
three or four parts which need to all fit the same size hole, to provide the
right 35/128/70mm shaped holes for negatives, to be backlit by the diffuser,
and sit on a tablet. The problems relate to the repeated click-unclick of the
parts, which require strong corners and chamfers to insert, and friction hold.
Every single iteration of design required re-design of the injection moulding.
I think had the design been well worked out in advance it would have only been
2-3 cycles, but since the design had to overcome mechanical rigidity, re-
insertion, keystoning the parts, over-dimension outcomes, under-dimension
outcomes, it was fraught. Its finally reached production.

A large amount of the 1960s dislike of plastics vests in the super-bad job
injection moulding of the time did, with both bad plastic stock, and badly
made moulds. Now, we think its fantastic but we're standing on the shoulders
of giants who made it work. Lego's fab is pretty awesome, to maintain
dimensional fit for click-fit on millions of parts like that.

The Mint, is not exactly injection moulding, but similar: they have to replace
coin dies frighteningly often because they just wear out. The CSIRO did work
with the Australian mint doing ion beam vapour deposition to create hardened
surfaces to try and preserve the die lifetimes.

Stamping out CDs speaks to how accurately we can do this now.

(injection moulding CDs is not a thing)

~~~
Dylan16807
So when you talk about getting anywhere near lego you're talking about a type
of problem that's in a completely different ballpark. 3D printing can't even
hope to reach those tolerances. If they were making a part that could simply
be 3D printed, the type of manufacturing relevant to the article, I'm pretty
sure they wouldn't have had all those problems.

------
ck2
Can we 3D print a respirator yet?

If it was in the united states the patients would just die while the
administration insisted on waiting for the most profitable bids from various
companies while the president did a press briefing to shake the hands of the
various ceos and boast about raising their stock prices.

Actually we may just get that scenario since we are on the Italian curve and
so many people right now are out in bars, restaurants, etc.

This is going to be a year to remember.

~~~
crankylinuxuser
Well, I counter this with "Just do it anyways".

When the SHTF, we individuals, clinics, and local areas won't give a shit what
DC and their lackeys say or do. We're on our own, in a local collective way.

If the 3d printed part is good for 1 person, then I'll print 10. And my buddy
will print 10, and they'll print 10.

~~~
1996
I agree 100%. In theory, everybody cares about FDA certification and all the
legal details like HIPPA and stuff.

In practice, when SHTF ie in a situation like 9/11, most humans beings seem to
do the best they can with what they have.

------
battery_cowboy
>A reanimation device consists of a reanimation bag which is placed on the
chest of the patient and which has a tube connected to the lungs of the
patient, e.g. by a mouthpiece. When the bag is compressed heart massage may be
effected through the bag by the operator. Thus, a single person may carry out
resuscitation and heart massage alternately.

[https://patents.google.com/patent/US3882860A/en](https://patents.google.com/patent/US3882860A/en)

Just something I found on google, not sure if this is 100 percent accurate,
but it sounds like a manual, limited use heart/lung machine.

~~~
mike_d
I think it is a poor translation of "resuscitation device" like an AED or
likely a bag valve mask.

~~~
mattkrause
Yup. It's a not-quite-false cognate in French too
([https://www.collinsdictionary.com/dictionary/french-
english/...](https://www.collinsdictionary.com/dictionary/french-
english/réanimation))

Was very disappointed when the reanimation class wasn't taught by Dr.
Frankenstein and only covered CPR.

~~~
Vinnl
Huh, in Dutch as well. That might be useful knowledge if I ever get in a
situation where I need an AED in an English-speaking country.

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dt3ft
Was anyone able to download the 3D model of the said valve?

~~~
znpy
I don't think the model is going to be shared.

The people printing the valve have already technically committed copyright
infringement.

Sharing the model with other hospitals that need to get them printed might be
still borderline but still (I hope) tolerated.

But going further and sharing the model to the public could degenerate into a
serious lawsuit.

~~~
tyre
This is as good a case for jury nullification as I’ve seen in a long time.

~~~
Balgair
Italy is not a common law nation, they are a civil law nation. I'm not a
Italian attorney, but I don't think a jury would ever be involved, just
investigators and judge.

[https://en.wikipedia.org/wiki/List_of_national_legal_systems](https://en.wikipedia.org/wiki/List_of_national_legal_systems)

------
cperciva
Can someone explain what a "reanimation device" is? It sounds like a bad
translation. Some sort of ventilator?

~~~
toyg
In Italian hospitals, there is traditionally a difference between Intensive
Care Units ("Terapia Intensiva") and Reanimation ("Rianimazione") departments.
Don't ask me what the difference is. A lot of what they do, however, tends to
overlap, so in many places the two concepts were merged into a single
department - which is basically what we'd internationally call an ICU dept.

So in this case "reanimation device" is just "a device used in ICU".

~~~
1996
IIRC, "Terapia Intensiva" is for patients admitted through the ER and run by
ER physicians while "Rianimazione" is for patients transmitted from other
departments and run by anesthesiologists.

Just another case of NIH!

------
taf2
Makes me wonder what would it take to 3D print other life saving devices? And
are there designs online in the public domain ?

~~~
ssmiler
I won't be surprised if original part manufacturer sues these guys, hospitals
for IP infringement...

~~~
indymike
That would be the most tone-deaf lawsuit I've ever seen.

~~~
ssmiler
Apparently the company have already threatened them
[https://www.theverge.com/2020/3/17/21184308/coronavirus-
ital...](https://www.theverge.com/2020/3/17/21184308/coronavirus-italy-
medical-company-threatens-sue-3d-print-valves-treatments)

------
Wistar
The Verge: "Medical company threatens to sue volunteers that 3D-printed valves
for life-saving coronavirus treatments"

In this case IP might mean Intolerable Pricks.

[https://www.theverge.com/2020/3/17/21184308/coronavirus-
ital...](https://www.theverge.com/2020/3/17/21184308/coronavirus-italy-
medical-company-threatens-sue-3d-print-valves-treatments)

------
thomasfl
I except someone is already be tinkering with a fully 3d printed reanimation
machine using 3d printet plastics parts and off the shelf motors.

------
crankylinuxuser
Anybody have a link to the STL?

I have a large format 3d printer (.5m x .5m x .5m) and am in Indiana.

~~~
numpad0
There’s an update at the end of article, they already have some polymer SLS
version in hand. Probably not using FDM prototype at this point

------
jojobas
Hopefully they won't get sued for using uncertified parts. Especially if
somebody dies.

~~~
tehlike
In the US, that would likely be the case. In Italy, probably not. Desperate
time calls for desperate measures.

~~~
megous
Companies should be reminded that basis for patents is:

> Article I, section 8, which reads "Congress shall have power ... to promote
> the progress of science and useful arts, by securing for limited times to
> authors and inventors the exclusive right to their respective writings and
> discoveries."

It would certainly be interesting to see "promotion of the progress of science
and useful arts" to be pitted against "saving lives during a national
emergency" in court, where the said company refuses to provide needed
replacement parts.

Something like that surely must have happened already?

~~~
retrac
Yes. Most countries have a system for compulsorily purchasing a patent if it's
deemed in the public interest.

With the 2001 anthrax attacks, the US government ordered Bayer to lower the
cost of an antibiotic that treats anthrax, or lose their patent on the drug.
(Bayer complied.)

------
ltbarcly3
So a 5 cent part that probably costs $500 due to whatever insane economics
determines the price of medical equipment is 3d printed, and we are supposed
to think this is good? Or even ok?

This is insane.

~~~
rocky1138
I think maybe you missed the part about the reason for not having them easily
accessible wasn't cost, but simply availability:

> She explained that the hospital in Brescia (near one of the hardest-hit
> regions for coronavirus infections) urgently needed valves (in the photo)
> for an intensive care device and that the supplier could not provide them in
> a short time.

~~~
ltbarcly3
If they didn't cost $500 I bet they would have more on hand...

------
paulkrush
I have no idea, but lets just say this works 98% of the time.

It sounds like a good idea to give people a choice of nothing or something
that works 98% of the time. How do you pre-plan for this and accept 98%? I
have had this discussion with medical device QA people and they could not
acknowledge such a choice like this could ever happen.

~~~
woutr_be
I don’t really understand your reasoning, what are your arguments as to why it
would be a good idea to give the choice?

~~~
ncallaway
You can choose as a patient between the following Scenarios:

Scenario 1: No treatment option and you will die.

or

Scenario 2: Choose between the following options

A) No treatment and you will die, OR

B) Treatment with lower-quality QA standards (with a device that works, say,
98% of the time instead of the typical 99.9% of the time _).

Most people will prefer the scenario that gives them the choice.

_ Note: these numbers made up purely for the hypothetical.

~~~
CydeWeys
I think the point is more, don't even bother giving the choice. Just do the
right thing which will maximize the survival of the patient, which is B in
this case. People on the verge of death from illness aren't in the best place
to be making logical decisions, and that's assuming that they're even still
conscious or can talk (many of them are unconscious at this point and/or
intubated).

Just follow the Socratic oath and don't over-complicate things. Give the
necessary treatments.

~~~
throwaway748
I hate to be _that guy_ but you're probably referring to the _Hippocratic_
oath, although I wonder what a Socratic oath would entail :-P

~~~
LegitShady
Everyone promises to talk about and think critically of why they believe
things to be true.

~~~
CydeWeys
Y'know, this is probably a good one too!

------
bigiain
I wonder how this'll play out longer term. I'm betting the company who
designed/manufactures the ones they're copying isn't super happy about the
implications for this...

I wonder if there ought to be a 3D printed copyright license scheme kind of
like the one that exists for music (APRA here in .au) where you can pay for a
blanket licence to print copyrighted designs, and the licensing organisation
redistributes copyright payments based on usage, so you don't need to ask for
specific permission for each use?

~~~
squarefoot
In an emergency situation like this one, the patent owner company wouldn't
risk a huge PR loss by suing or even complaining, but when the crisis will be
over they might decide to act. However, if those valves are reverse
engineered, copied and given away without selling them, there would be no
profit. That should fall into fair use.

~~~
bigiain
> That should fall into fair use.

I think there's something 100% valid in what you're suggesting, but it seems
there's a fair bit of confusion here.

"Fair use" is a copyright thing, not a patent thing. I don't actually know if
a widget (whether patented, patent expired, or never-patented) is covered by
copyright - and even if it is, at least from what I know about copyright in
music/literature, "fair use" wouldn't allow for making 100% complete working
copies.

"not for profit" doesn't fly as a defence against either copyright or patent
infringement in other areas, I suspect it wouldn't here either.

I'm reasonably sure if the "owner" of these valves started making noises about
overly onerous enforcement of any patent/copyright that applies, and sane
government would step in and declare some emergency-use legal exception for
cases like this.

I wonder if the "owner" could make some obvious olive-branch offer along the
lines of:

"Hey, that's our widget you're printing, but we totally understand that for
the duration we were unable to get our version into your hands for reasons
outside both our and your control. Normally we earn $x per widget when you
source them through the usual channels, we are happy to waive that for the
duration of the supply chain disruption, but ask that once things are back to
normal, you continue to support the research and development that goes into
those and other life saving products we make, and start buying from the usual
supply chain, or paying our regular royalty on locally printed versions.
Thanks, WidgetCompany"

~~~
_-___________-_
Wouldn't the owner have to show damages though? If they couldn't supply the
widgets anyway, then what were the damages?

~~~
squarefoot
Ask this to record companies claiming losses for imaginary sales.

