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Trained repair professionals at hospitals are regularly unable to fix medical devices because of manufacturer lockout codes or the inability to obtain repair parts. During the early days of the COVID-19 pandemic, broken ventilators sat unrepaired for weeks or months as manufacturers were overwhelmed with repair requests and independent repair professionals were locked out of them. At the time, I reported that independent repair techs had resorted to creating DIY dongles loaded with jailbroken Ukrainian firmware to fix ventilators without manufacturer permission. Medical device manufacturers also threatened iFixit because it posted ventilator repair manuals on its website. I have also written about people with sleep apnea who have hacked their CPAP machines to improve their basic functionality and to repair them.
PS: he got it repaired.
Medical devices are required to comply with 21 CFR 820 in the United States, which establishes quality management standards. This includes minimum standards for the software development lifecycle, including software verification and validation testing.
In the EU, broadly equivalent standards include ISO 13485 and IEC 62304.
If an OEM wants to do a software update, they at minimum need to perform and document a change impact analysis, verification testing, and regression testing. Bigger changes can involve a new FDA submission process.
If you go around hacking new software features into your medical device, you are almost certainly not doing all of that stuff. That doesn’t mean that your software changes are low quality–maybe, maybe not. But it would be completely unfair to hold your device to the standard that the FDA holds them to–that medical devices in the United States are safe and effective treatments for diseases.
This may be okay if you want to hack your own CPAP (usually a class II device) and never sell it to someone else. But I think we all need to acknowledge that there are some serious risks here.
Yeah, I’m a big right to repair person. But medical equipment is a different level. This isn’t just affecting yourself, if a tech screws up people die.
Sure, there are risks, but if there alternatives are pony up $100k for a new exosuit, or just don’t fucking walk again, I see why repair is an enticing option.
Where are the horse exoskeletons for horses that fall and get injured in completely unnecessary horse races?
repair techs had resorted to creating DIY dongles loaded with jailbroken Ukrainian firmware to fix ventilators without manufacturer permission
How many jailbreaks are done by Ukrainian hackers? Wasn’t the John Deere firmware from Ukraine as well? Nice job 💖
Ukraine produces more than its fair share of excellent programmers.
Russia as well, lots of former soviet states. I used to talk to a Latvian maths student who was adamant it was the access to free/cheap higher education and poor job prospects.
there is absolutely no excuse for this
For a $100k device, I would expect better long term support.
You would, but if there’s no reason for them to spend the money on it why?
This is what regulation is for, and it needs to have teeth.
Remember when people unironically said “you get what you pay for”?
They just want him to get a new one… Why repair a $20 battery on a perfectly functioning device when you can force him to get a new $100,000 exoskeleton?
This is just more capitalist ghouls doing the only thing they know
corporations are a problem we need to solve as a society.
Orrrr and hear me out. We just pass a national right to repair law.
There, problem fixed and we don’t need to burn anything!
That will fix Metas influence on foreign governments, certainly!
Uhhh we are addressing right to repair not corporate influence on the state.
Pick the right tools for the job not everything needs a hammer.
Why not fix the root of your problem instead of the symptoms tho?
Who said its the root of the problem?
Anyone who is not one of the frogs in the pot.
Careful, you might cut yourself with that edge.
aaaww but I already got my gas can and matches out
Reasonable people always ruin everyone’s fun.
Damn reasonable people pushing back the Nuclear Apocalypse, the Global Heating Armageddon, return to Dark Ages and all such major fun events/s.
I always forget that Lemmy is about everyone being very serious all the time.
Reasonable people agree that corporations are not good and need to be gone.
But apparently some reasonable people can’t take a joke.
any company who locks medical device repair should be burned to the ground. and dont bullshit me about liabilities bla it is more likely cash grab which they get in the form of “extra care packages” or exorbitant repair prices charged after the guarantee period ends.
Line must go 🆙
A right to repair is long overdue but more than that when it comes to medical devices it’s obvious battery replacement is going to be necessary and should be user accessible.
Corporations are a fucking curse.
As its paywalled I can’t see the article and any pictures clearer, but from the image shown isn’t that those tiny battery packs you can use for RC drones etc? Because those things are dirty fucking cheap, I would be furious if that was a $100,000 charge.
I think the entire exoskeleton is $100k not the battery.
Update: He temporarily gained the ability to walk again after touching a spinning steel ball, despite the recovery not lasting he will still be competing in upcoming cross country horse race.
Keeping repairs locked into your system of parts/techs can at least feign “safety” or “quality”.
But essentially just refusing to repair is an absolute fuck you.
I’ve started choosing the companies I use based much more on the experience offered when their product/service DOESN’T work, rather than when it does.
Right it begs the question.
Is me not receiving care or having access to care REALLY better for me?
If the answer can’t clearly be yes, then they are just choosing to make me ill or kill me for their perceived interests.
For me it’s a mix of what you said and how they treat their employees/where they’re making the product.
I spend extra time trying to find higher priced, higher quality, more fairly manufactured products.
That latter requirement is usually a good indicator of the former requirement. Companies that take care of their people typically end up making quality products.
I’ve started choosing the companies I use based much more on the experience offered when their product/service DOESN’T work, rather than when it does.
Easy to do for a cell phone or a toaster, but I can’t imagine there’s a ton of options for exosuits that correct your condition, covered by your insurance, that your doctor is familiar enough with to prescribe (for lack of a better term).
Some things are annoying to make abandonware, and some things should be criminal.
And it doesn’t preclude the company just deciding your product is no longer worth supporting/going bankrupt.
It might have been fine and seemingly trustworthy to begin with, and then it stops, a few years down the line.
That’s the most dangerous part of it for sure. Inherently, the more a company has a monopoly over an industry, the less incentive they have to actually do a good job with anything.
Don’t buy a Google Pixel. I’ll never get one again because of this. They wanted 250£ to even look at it so I got a new cheap Samsung out of spite.
If i buy A pixel i will buy A refurbished one because no fucking way am I gonna give google money.
Absolutely hate this shit.
It’s definitely annoying, but they have a provided decent explanation of why, imo
The reason why is that they need my email address?
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Exactly why I’m using an email proxy…
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How dare journalists be compensated for their labor!
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It’s four journalists who broke away from their former employers and started their own thing. It’s ok to charge money to run a business. The quality of their work is top notch.
It’s ok to charge money to run a business.
They’re not charging money. They’re just throwing up a big sign demanding my email address.
Medical device manufacturers also threatened iFixit because it posted ventilator repair manuals on its website.
What the fuck is wrong with people. Anyone who opposes the right to repair for MEDICAL DEVICES is irredeemable.
I kind of disagree. Medical devices should be repaired by trained professionals using OEM parts only.
How’d you feel if your pacemaker’s battery started leaking acid into your body because Kevin from accounting had made a diy drone once and he found a good deal on AliExpress specials batteries.
Of course, that means manufacturers should be liable for any issues wrt lack of parts or available repairman.
This is why there are separate rules and standard for implantable, wearable, and supporting medical devices.
When your hacked together CPAP sends asbestos directly into your lungs because Bob from maintenance had some spare time to fix it, you’ll be crying about malpractice.
So, for ventilators, I’d definitely prefer a DIY repair attempt and rolling the dice instead of having a ventilator that doesn’t work, especially when you absolutely need them but don’t have them.
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Education and healthcare should never be for profit.
Please read this next line as if it had alternating/random caps:
“But capitalism improves efficiency!”
Tap for spoiler
I’m on mobile and would rather not deal with my spellcheck “learning” anything today.
There’s this app, I don’t use it often but leave it installed for this
https://github.com/MobileFirstLLC/irregular-expressions
The option
spongemockLeTs YoU wRiTe LiKe ThIsThe sooner people stop typing like that, the better.
