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[20200319_040606 UTC Updated: Editor's note: The original story was updated subsequent to this story submission; an excerpt from the original submission appears here in a <spoiler> followed by the update. --martyb]
A medical device manufacturer has threatened to sue a group of volunteers in Italy that 3D printed a valve used for life-saving coronavirus treatments. The valve typically costs about $11,000 from the medical device manufacturer, but the volunteers were able to print replicas for about $1 (link to a TechDirt piece).
Basically, in Italy battling the wuflu epidemic, a hospital ran out of valve parts used in a treatment equipment, but the supplier weren't able to supply them. So the doctors got the local media to sound out for alternative solutions, and a 3d printing outfit stepped up. They all banged their heads together to produce the needed parts, enabling the hospital to continue treating patients.
The printed parts work to the degree they do, but it would be better to have the part's blueprint with precise specs so the printed parts can fit and function properly. So the 3d printing outfit asked the manufacturer for the blueprint. The manufacturer refused and threatened to sue the 3d printing outfit.
Here are other links covering the story, including the techdirt piece mentioned above:
https://www.techdirt.com/articles/20200317/04381644114/volunteers-3d-print-unobtainable-11000-valve-1-to-keep-covid-19-patients-alive-original-manufacturer-threatens-to-sue.shtml
https://www.businessinsider.com/coronavirus-italian-hospital-3d-printed-breathing-valves-covid-19-patients-2020-3
https://metro.co.uk/2020/03/16/firm-refuses-give-blueprint-coronavirus-equipment-save-lives-12403815/
Update, March 18th 5:30PM ET: A group of Italian volunteers distributed 3D-printed versions of a vital medical device — but it doesn't appear that the original manufacturer threatened a legal crackdown. As we reported earlier, Cristian Fracassi and Alessandro Romaioli used their 3D printer to create unofficial copies of a patented valve, which was in short supply at Italian hospitals. Business Insider Italia quoted Massimo Temporelli, the Italian professor who recruited the pair, saying that the device maker threatened them with an infringement claim.
But in an interview with The Verge, Romaioli denied they'd received threats. He said the company had simply refused to release design files, forcing them to reverse-engineer the valve. "I talked to an operator who told me he couldn't give me the files, but after that we didn't receive anything from the original company — so I can assure you we didn't get any threat," he said. "They said they couldn't give us the file because it's company property, but that's all." While earlier reporting said the original valve cost over $10,000, Fracassi also told Fast Company that this number was inaccurate.
Temporelli gave The Verge a more ambiguous account of the call, which he says he wasn't directly involved in. "The group we asked for the files refused and said it was illegal" to copy the valves, he said. He stopped short of calling the statement a threat. "Let's say the risk to be sued exists since they bypassed a patent, but that's it."
Manufacturing company Intersurgical says it had no intention of making a threat. Managing director Charles Bellm issued a statement to The Verge:
Just to confirm that recent reports from Italy are totally incorrect, we were contacted at the end of last week for manufacturing details of a valve accessory but could not supply these due to medical manufacturing regulations, we have categorically not threatened to sue anyone involved. The valve is an accessory supplied as part of a CPAP Hood system which alone costs a few euros.
Our Italian company has been doing their utmost to supply the hospitals at this time and have been supplying these free of charge in many cases to use with the CPAP Hoods. It is very disappointing that in the current climate this incorrect information is circulating, our focus as a company is to be able to supply the hospitals that require these and many other vital products and we are making every effort to ensure we can do so.
Romaioli and Temporelli have emphasized that both devices serve a purpose: the official product is the better long-term solution, but for now, hospitals can use this printed alternative to fulfill a sudden, drastic demand.
This story, in Italian, has a picture of the part in question: https://it.businessinsider.com/coronavirus-manca-la-valvola-per-uno-strumento-di-rianimazione-e-noi-la-stampiamo-in-3d-accade-nellospedale-di-chiari-brescia/.
(Score: 3, Insightful) by Bot on Thursday March 19 2020, @11:39AM (2 children)
> but [manufacturer] could not supply these [blueprints to produce valves] due to medical manufacturing regulations
suuuure because you gonna get sued for that, breaching regulation to let a guy print a valve for people dying, I mean what if something goes wrong and the guy gets infected or worse, dies? errrr
who would have the courage to sue? oh wait we are talking about pharma...
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(Score: 2) by bzipitidoo on Thursday March 19 2020, @04:57PM (1 child)
Yeah, the "it's against regulations" excuse. I noticed that too. They use that one a lot.
In the US, it's HIPAA that gets a great deal of unfair blame for why a medical provider can't do something. They think they can't tell a caller even very basic info like whether a person is in their facility, and is or is not conscious. HIPAA says no such thing. I checked.
The nursing home where my aunt is at was so obstructive and nasty, refusing to tell me anything whatsoever over the phone, that I feared they just might retaliate against me by hurting her. I don't check on her often, but still. They blamed HIPAA. They wouldn't accept my assurances that HIPAA does not forbid them from answering my questions, nor check for themselves, and became angry with me for arguing that point. They also said they couldn't tell anyone but family, as if I was not family. Didn't have a come back went I reminded them that nephews and nieces are family. Just shifted to another argument, next saying it was against company policy. After that call, I asked the police to do a welfare check, to put the nursing home on notice, as well as confirm that she was still there and doing okay. I also contacted the parent company, and in response they changed their policy to stop blaming HIPAA.
(Score: 2) by Bot on Friday March 20 2020, @02:23AM
Such things are beginning to happen here too. In a classic overton window scheme, the state is mediating family relationships. Red socialists, or righty socialists, doesn't matter, the trend continues. All a matter of control, as usual.
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