A Medical Device Maker Threatens iFixit Over Ventilator Repair Project (vice.com) 69
STERIS Corporation, a company that makes sterilization and other medical equipment, sent a letter to iFixit claiming their online database of repair manuals for ventilators and medical equipment violates their copyrights. Motherboard reports: "It has come to my attention that you have been reproducing certain installation and maintenance manuals relating to our products, documentation which is protected by copyright law," the letter said. The letter then went on to tell [Kyle Wiens, CEO of iFixit] to remove all Steris copyrighted material from the iFixit website within 10 days of the letter. As Motherboard reported in March, major manufacturers of medical devices have long made it difficult for their devices to be repaired through third party repair professionals. Manufacturers have often lobbied against right to repair legislation and many medical devices are controlled by artificial "software locks" that allow only those with authorization to make modifications.
"I'm disappointed that Steris is resorting to legal threats to stop hospitals from having access to information about how to maintain critical sterilization equipment during a pandemic," Wiens told Motherboard in an email. "No manufacturer should be stopping hospitals from repairing their equipment," Wiens said. "The best way to ensure patient safety is to make sure that equipment is being maintained regularly using the manufacturer's recommended procedures. The only way to do that is if hospitals have up to date manuals." With regards to the letter sent by Steris, Wiens said iFixit has not removed any material from its website. "We explained to Steris that what we did is a lawful and protected fair use under the U.S. Copyright act," Wiens said. "iFixit is protected by Section 512 of the Digital Millennium Copyright Act, which allows online platforms to host content contributed by users provided they comply with the Act's requirements, which iFixit does," a letter to Steris from the Electronic Frontier Foundation on behalf of iFixit said.
"I'm disappointed that Steris is resorting to legal threats to stop hospitals from having access to information about how to maintain critical sterilization equipment during a pandemic," Wiens told Motherboard in an email. "No manufacturer should be stopping hospitals from repairing their equipment," Wiens said. "The best way to ensure patient safety is to make sure that equipment is being maintained regularly using the manufacturer's recommended procedures. The only way to do that is if hospitals have up to date manuals." With regards to the letter sent by Steris, Wiens said iFixit has not removed any material from its website. "We explained to Steris that what we did is a lawful and protected fair use under the U.S. Copyright act," Wiens said. "iFixit is protected by Section 512 of the Digital Millennium Copyright Act, which allows online platforms to host content contributed by users provided they comply with the Act's requirements, which iFixit does," a letter to Steris from the Electronic Frontier Foundation on behalf of iFixit said.
Good. (Score:4, Informative)
Now the world can see what STERIS Corporation actually cares about and it's not patients.
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Re:Good. (Score:5, Funny)
The ROI is dead. Long live the ROI.
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Re:Good. (Score:5, Informative)
Of course they put money before patients, the law requires that.
No. No it doesn't. See: https://www.nytimes.com/roomfo... [nytimes.com]
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Thats good to know. I always took it as more a "The laws an ass and should be ignored or defied" thing.
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Re:Good. (Score:4, Informative)
the law requires that
Absolutely not. Please quit helping unethical people cover their tracks. It is nothing more or less than a poor excuse for people who want to put their monetary gain above and beyond all other concerns but don't want to pay the social price for that.
Although little enforced, any corporation's existence is required first and foremost to be in the public interest. The Rs and the Ds have made the enforcement lax, but profit uber alles is still not required.
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Except of course, Steris moved their HQ to Dublin, so as to not pay American taxes.
Screw 'em.
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As a corporation, they have to prioritise the interest of the board and their major investors, what ever those board members and major investors choose it to be ie this company https://www.sanitarium.com.au/ [sanitarium.com.au]. They have been routinely attacked by loobyists from American cereal company, their responce to those US corporations, hey want the economic advantages we have, become a NON-profit just like us (I do enjoy the cereal, https://www.sanitarium.com.au/... [sanitarium.com.au] with cocoa made with water and a dash of milk, (oh a
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They are a corporation, not a non-profit. Of course they put money before patients, the law requires that.
You might want to take that up with the Supreme Court [cornell.edu]:
While it is certainly true that a central objective of for-profit corporations is to make money, modern corporate law does not require for-profit corporations to pursue profit at the expense of everything else, and many do not do so.
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Liability, man. Somebody fucks up, the company gets sued.
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FUD. FUD put out as a weak argument for doing the thing that "just happens" to make them a few extra barrels of cash.
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Doesn't matter if it's "weak". The threat only has to exist.
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You can get sued for wearing a solid colored tee shirt that someone doesn't like. The argument is weak in the sense that I (and many others) aren't buying it.
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The argument is weak in the sense that I (and many others) aren't buying it.
That only matters if you are on the jury
Re: Good. (Score:2)
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Bullshit, if the ventilator breaks down because some install guy broke it, a judge isn't even going to even hear it beyond the initial conference. Its a "whats the actual legal theory here?" thing.
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You're assuming that the manuals haven't changed, and that iFixit is offering the correct manual for the specific device.
That may be the case but Steris can't properly validate that, and that could indeed put lives at risk.
While I welcome most companies opting against enforcing their copyrights on product manuals (although I do prefer to go to the manufacturer's site anyway) for medical equipment there is a reasonable argument that stronger controls are beneficial.
Re: Good. (Score:1)
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Now the world can see what STERIS Corporation actually cares about and it's not patients.
More importantly, its current and potential future customers can see what STERIS thinks of its customers.
Smooth move, outing yourself as short-sighted a-holes.
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False choice. I want a healthcare system with mandates to have the capacity in place to avoid the whole problem in the first place. No, I don't want people touching a machine unless they are factory-certified, including FDA-approval of that training program.
Re:What about mom? (Score:5, Interesting)
Well, that's not the US health system. My wife had problems with her pacemaker and the company didn't answer their phones (calls made by the hospital) for over 8 hours. They did answer eventually, and she didn't quite die, but it was debilitating. She ended up staying in the hospital a month that time.
That said, I don't think an on-line manual would have helped. They HAD the manuals. But the manuals didn't include all the needed information.
Re:What about mom? (Score:4, Informative)
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Hurry up and jump in my car, mom. I'll take you to the hospital. I just finished the brake job.
Grey area (Score:5, Insightful)
That being said the current circumstances are way out of the ordinary and in some places rather dire, therefore this becomes a less clear-cut matter.
The smart thing for this manufacturer to do is to step up in some way or other to close the 'repair gap' if there are damaged machines of theirs out there that are standing in the way of patient care. Getting litigious about it isn't helping anyone.
Indeed Steris is being assholes. EFF is questionab (Score:5, Insightful)
I can certainly understand they don't want the liability when someone who has never worked on one of these machines screws up. (They can't prove who worked on it.) They do have a legitimate interest in having only properly trained people mess with the medical equipment they make and are liable for.
But as you said the right response to that would be to put out free training material or something. Maybe offer training videos and after you complete the free videos you can save a copy of the manual. Something that solves the need.
After reading the EFF's legal arguments, I find them not entirely convincing as a matter of *law*. This putting aside the issue of "doing the right thing" and just looking at it as a legal argument. I'm not saying their argument is garbage, but it's also not a particularly strong legal position. They took the entire manual, not snippets. They are distributing it for the same purpose as the manufacturer distributes it; it's not like they cut it up and made it into a work of art or something.
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That is a different issue and already solved.
No one is suggesting they should be held liable for modifications or craftsmanship not their own.
So since "and are liable for" resolves to false, the entire statement is without point.
That's exactly what people are suggesting.
Until the day the lawyers bugger off (which is never), the blame will be pointed at the manufacturer. Whoever attempts to fix that machine off-the-books is going to deny anything or not be known to the case at all and unless you have forensic evidence of their involvement, then it will look like a 'product defect' or 'improper training' of the previous time it was serviced. Both of which blame the company. Maybe there could be super-secret "void" seals or somethi
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Until the day the lawyers bugger off (which is never), the blame will be pointed at the manufacturer.
That's because the manufacturer has more money than the repair guy. They're not going to be buying a new yacht with the proceeds of a suit against the repair guy, after all.
Steris wrote the copyright act? (Score:2)
Steris, a medical sterilization company, wrote the Copyright Act of 1976? Wow that's amazing.
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"I can certainly understand they don't want the liability when someone who has never worked on one of these machines screws up. (They can't prove who worked on it.)"
They can use seals, just like on scales or gas pumps.
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> > "I can certainly understand they don't want the liability when someone who has never worked on one of these machines screws up. (They can't prove who worked on it.)"
> They can use seals,
I pictured a sea lion and a seal trying to work on a ventilator, struggling because they have flippers instead of hands. :)
But seriously, I'm also thinking I'm on the jury and your expert shows that a Steris ventilator killed your kid because it had a safety valve installed upside down. Steris says "the sticker
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I'm sure it isn't, but it seems like starting point for a defense anyway.
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If a medical devices company were to put out free training materials as you suggest they could be liable for even misuse of that information which may result in injury or death to a patient.
Due to deep pockets laws the manufacturer could be liable for 100% of damages if the injured party can convince a jury that the training materials were not clear enough about some small thing and that contributed, even a tiny amount, to an "unauthorized repairer" failing to repair the machine correctly and that resulted
Re:Grey area (Score:5, Interesting)
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Re:Grey area (Score:5, Insightful)
Coincidentally, I design ultrasonic surgical equipment. There's a huge difference between maintenance, field repair, and factory repair. There is no one-size-fits-all solution. Any comparison to fixing your phone or a tractor or planes needs to factor in many things unique to medical equipment
We'd be happy to let hospitals do as much maintenance as possible. We make money with the disposable product used with it. But between having custom power components and surface mount electronics, it's all to likely a repair can make things worse. Sort of like trying to repair a motherboard ... with injury or death possible if you screw it up. Same with modifying software.
Simply put, I design them and even I wouldn't dare repair them. Too risky. There are a few company technicians I might trust, because they build them and have the special test equipment and procedures. They can certify it was done right. But it would never make sense to train and certify a hospital technician. Why spend weeks learning to fix a $5,000 piece of equipment that have a failure rate of 5% over 10 years (and no hazardous failure that I'm aware of).
So we offer cheap/free "repair" service. In reality, we do some testing and replace the faulty subsystem. New motherboard or power supply or LED screen. Or just a whole new unit.
And to anyone who thinks "well, just put a tamper seal": that's not going to protect the manufacturer from a lawsuit. Lawyers sue everyone with deep pockets in any way affiliated with an injury or death regardless of cause. Totally innocent companies will still pay tens of thousands of dollars in settlement to avoid legal bills 10X as much. And if they go to trial, juries often will still give the plaintiff money because, hey, the company can afford it and these people deserve something.
So medical device companies figure "Screw That!" and avoid putting their fate in the hands of some hospital technician, no matter how competent.
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> So we offer cheap/free "repair" service. In reality, we do some testing and replace the faulty subsystem.
This makes total sense. Normally.
But now say there's some major even happening where every patient needs ultrasonic surgical equipment and there's not enough and you don't have a supply chain that can keep up with components, even if equipment is FedEx'ed overnight back and forth, and if these things aren't working, people are dying.
So, do you want somebody near the hospital who is competent with m
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> So we offer cheap/free "repair" service. In reality, we do some testing and replace the faulty subsystem.
This makes total sense. Normally.
But now say there's some major even happening where every patient needs ultrasonic surgical equipment and there's not enough and you don't have a supply chain that can keep up with components, even if equipment is FedEx'ed overnight back and forth, and if these things aren't working, people are dying.
I guess if it's a national emergency and this is required they can pass a law indemnifying the medical device manufacturers against lawsuits. Otherwise the lawyers will sue no matter what the circumstances.
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"And to anyone who thinks "well, just put a tamper seal": that's not going to protect the manufacturer from a lawsuit."
Neither is a prohibition on user service. But a seal would make it much easier to win the lawsuit.
If the user actually owns the equipment then they have a legal right to repair it. In the US we have the Magnuson-Moss act to guarantee it. That's why JD uses DRM to prevent it. You may have the right to work on it, but it refuses to work if you do. And a contract can't override the law.
This brings back memories. (Score:1)
Just like John Deere Farm Equipment (Score:2)
Same thing. You can't fix your own stuff. You must wait for and "authorized" repair person to show up, even if alot of the fixes can be done by the farmer.
What would it be like if you couldn't fix your own car, or home appliance?
Re:Just like John Deere Farm Equipment (Score:5, Interesting)
Not quite. John Deere doesn't have any problems with farmers fixing their own machines physically, and selling them parts. For some reason, however, they have it in their mind that the digital, electrical domain is different, though. Intellectual property. And all companies seem to not want to sell service manuals. John Deere really thinks it is the Apple of heavy machinery companies. I don't think this all about protecting dealer networks. I'm really at a loss as to explain John Deere's paranoia and insecurity.
But this is different from the medical device world. Medical device manufacturers, for a variety of liability and legal reasons, don't want customers to even crack the box open.
A few companies have tried to DRM common household appliances, but they've been rebuffed pretty strongly by consumers. Besides, they've already managed to convince us to buy disposable appliances that never need to be repaired.
Re:Just like John Deere Farm Equipment (Score:4, Interesting)
What would it be like if you couldn't fix your own car, or home appliance?
Don't worry, at the rate things are going, that's exactly what will happen. Remember how easy it used to be to change your oil or replace a headlight bulb? Manufacturers have now made it difficult, if not impossible, for you to change your oil without specialized equipment. And forget about bulbs. More and more are moving to led lights which require the entire assembly be replaced (at high cost no less).
Sure, you can change your wiper blades or rotate your tires, but more and more it's becoming difficult to do much more. There was an article on here a while back about a car manufacturer which was considering making a car whose hood you could never open. It would have been one giant sheet of metal and the only way to service the car would have been to take it to a dealer. Don't be surprised if that doesn't happen in your lifetime. Can't find the article, but someone with a bit more search foo should be able to bring it up.
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Remember how easy it used to be to change your oil or replace a headlight bulb? Manufacturers have now made it difficult, if not impossible, for you to change your oil without specialized equipment... Don't be surprised if that doesn't happen in your lifetime.
It's already impossible for me to change the oil in my car, because it doesn't have any to change. Electric vehicles have almost no routine maintenance other than replacing wipers and tires. Electric motors have basically no regular maintenance and no user-repairable parts... but they're a couple of orders of magnitude more durable and reliable than internal combustion engines. Batteries are also not really user-repairable. Basically the whole drivetrain is non-repairable but extremely reliable and not like
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they're a couple of orders of magnitude more durable and reliable than internal combustion engines
I just re-read this and cringed at this exaggeration. I think I meant to say either "a couple of times" or "an order of magnitude" and mooshed them together. An order of magnitude is probably about right. Two orders of magnitude, not so much.
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I wish you hadn't picked headlights as an example, because considering the number of badly-adjusted headlights I encounter on the roads here, I wish people would stop trying to replace their own headlight bulbs. That, or instead the state should require an annual inspection of bulb alignment.
While I don't do my own car maintenance, in general I do agree with you that people should be able to do it themselves. However, that means we also need to hold anyone who does so to certain quality standards where it m
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OTOH, going to the dealer doesn't guarantee that the person working on it has a clue either.
The hood has already been half locked down (Score:2)
By making the windscreen really flat, which is the universal fashion that must be followed, getting to the rear of an engine has become very difficult. It is virtually impossible to change the rear spark plugs on many six cylinder cars.
Poorly researched letter (Score:5, Interesting)
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They don't have to get it right, they just need to be able to bill for their time. And hey, if they do it wrong the first time they can always bill again to fix it!
They've done worse (Score:3)
The plan was to buy them cheaply at around $3k/each from a newer supplier. One of the established players (who sold them for $10k/each) didn't like this. They bought up the new guy on the block and shut down the program. And, well, here we are.
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Clinton Administration tried to do the same, not only with equipment but PPE, antibiotics, anti-virals, pretty much everything that they could think of to stop a pandemic or a bio-terror attack. The program was killed in the first year of the Shrub Madministration, but some things are too stupid even for a Bush so it was brought back in a dramatically reduced form a few years later. Then they moved it from the CDC to FEMA, where "great job Brownie" mismanaged it pretty thoroughly.
Profits over lives (Score:2)
I wonder how they sleep at night?
Oh yeah, on a mattress stuffed with $100 bills. >:(
One day, something really bad will happen because of all of this reckless disregard for human lives, profits over people, and thousands will die.
Then we may see a violent revolition.
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Look around you, Ozymandias, and despair.
What's the EFF on about? (Score:2)
Section 512 of the DMCA doesn't allow sites to host infringing material provided by users. It allows sites to avoid being held liable for such material.
In return they must remove such material when properly notified. I'm really not sure what Steris are doing wrong here; they're enforcing a legal right that they've been granted, and doing so through polite notification and request.
The copyright system has many flaws but this is hardly an exemplar case for any of them.
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If only an artist would make a collage with the manuals, then the work would be "transformative", and no longer protected by copyright. It would be rather difficult to argue that repair manuals were created for their aesthetic appeal.
Unpopular opinion: But this is just dangerous (Score:1)