Patients Are Being Left High And Dry When Medical Implant Makers Implode
from the my-heart-no-longer-gets-firmware-updates dept
Techirt has long discussed how in the modern era, the things you buy aren’t actually the things you buy. And the things you own aren’t actually the things you own. Things you thought you owned can be downgraded, bricked, or killed off entirely without much notice.
That game console with backward compatibility? It no longer has backward compatibility. That smart home hub or smart speaker at the heart of your living room setup you’ve enjoyed for years? It no longer works. The movies and books you thought were permanently in your personal catalog? Sorry, they aren’t anymore. That perfectly good two-year-old phone? It no longer gets security updates, putting you and your data at risk.
This is all bad enough when talking about smart home hubs or smart refrigerators, but it’s another thing entirely when it comes to life-saving or pain-reducing medical implants. Like in 2020, when a company named Argus shut down, leaving customers losing the gift of sight thanks to their medical implants no longer being supported.
Nature Magazine last week took a deeper look at the problem of medical implant customers suddenly being left high and dry by either incompetence, policy changes, or bankruptcies. It’s very much worth a read. They start by profiling a man who has an implant in his cheek made by Autonomic Technologies (ATI) that routinely saves him from crushing cluster headaches.
But ATI collapsed in 2019, leaving implant owners screwed; unable to access the device since the company hadn’t apparently thought that far ahead:
The company’s closure left Möllmann-Bohle and more than 700 other people alone with a complex implanted medical device. People using the stimulator and their physicians could no longer access the proprietary software needed to recalibrate the device and maintain its effectiveness. Möllmann-Bohle and his fellow users now faced the prospect of the battery in the hand-held remote wearing out, robbing them of the relief that they had found. “I was left standing in the rain,” Möllmann-Bohle says.
The story continues along these lines, highlighting similar collapses by companies that make spinal-cord stimulators, vision implants, chronic pain management systems, and other medical implant technologies that make life bearable for millions. Sometimes users had expensive alternatives they could flee too, often they did not. Even when they did, it required costly, painful new surgeries.
Few of them designed systems that could withstand company collapse, and like most modern tech companies few, if any, supported independent consumer or third-party repair. That greatly restricts not only who these patients can turn to for help, but the availability of parts and documentation.
And, even if they can find parts, they’ll often run into trouble with their insurers. Or with companies that quickly acquire the patents shortly after a medical implant company implodes, then do nothing with them.
There are some things that can be done to help these patients. Passing right to repair laws would be a good start, but so far these laws are few and far between, and often don’t include medical hardware. Advocates have also pushed for various reform changes and the creation of nonprofits to try and prevent these problems:
Suggestions include the company setting up a partner non-profit organization to manage funds to cover this eventuality; putting aside money in an escrow account; being obliged to take out an insurance policy that would support users; paying into a government-supported safety network; or ensuring the people using the devices are high-priority creditors during bankruptcy proceedings.
But there’s very little indication any of that’s happening on any real scale. Fixing this could potentially require a law that protects these users, but that’s a big ask for a comically corrupt and perpetually gridlocked U.S. Congress, and isn’t likely to happen until there’s a scandal that’s so ugly, denying the problem is not longer possible. And even then patients will likely be waiting a long while.
Filed Under: hardware, medical implants, patient rights, retinal implants, right to repair
Companies: ati, autonomic technologies
Comments on “Patients Are Being Left High And Dry When Medical Implant Makers Implode”
This could be solved with regulation to make companies account for such outcome but I just think health care should be free and if a company wants to supply medical implants it can only do so if the public entity has full access to the tools and knowledge to keep the thing working smoothly even if they fail. There are plenty of places the private sector can explore to get sweet profits that doesn’t involve people health and lives.
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There’s a few things that could be done:
Of course, any simple solution to a complex problem is unrealistic, but it’s a fun thought experiment.
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That. There’s really no single solution, a silver bullet. It’s always multiple steps.
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Thank you for purchasing your new Multi-Tech Heart stimulator!
We at Multi-Tech believe in redundancy. That is why you, the customer, have received this package. This package includes 3-D autocad files, wiring diagrams, and complete source code with compilation instructions, to allow YOU the CUSTOMER to rebuild our device in the event of our corporate demise.
Please review your device materials to ensure your package is complete. To access the packing manifest, please insert the Quarter Inch Cassette in the tape drive and execute the command “LOADDOC 1” on the terminal….
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You jest, but that would be a perfectly fine outcome. Someone would’ve likely copied that onto alternate media over the years, and perhaps eventually put it onto archive.org (which has quite the collection of old software). If not, there are still ways of accessing archaic media like this; various museums/people have collections of old computer equipment and loan it, for example, in relation to lawsuits. (“Vintage Computer Federation has substantial experience recovering data from obsolete media.”) Once the data’s been copied, most old systems have decent emulators available.
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Mmm… no. This does not solve the problem. The filer would be a person, who the company would then bind by contracts.
Better would be for the device to come with an automatically bestowed license to repair/replace, AND the necessary data to do so. Perhaps a government run escrow, and licensed device manufacturers contracted through the program to provide replacement parts, in order to cover FDA sort of requirements and satisfy the “But.. we can’t have people building pacemakers in their garages!” crowd.
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It’s a mistake to try to satisfy this crowd. When something’s implanted in a person’s body, and the person’s life depends on it, it’s absolutely unethical to use copyright law against that person. They should have the right to do whatever they want with it, and enlist help from others. It’s not good enough that they’ll only have rights if and when the manufacturer goes under.
This is an instance in which the Free Software movement doesn’t seem all that theoretical anymore. Remember that copyright is supposed to benefit the public, not corporations, and it was considered too “functional” to copyright at all till the 1970s. There’s little evidence people would stop manufacturing medical devices without copyright, which makes such copyrights little more than corporate handouts that run contrary to public interest.
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There is no problem with somebody building a pacemaker in their garage, but there is the the problem of finding a surgeon to implant it.
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I have long thought that any device vendor that makes life critical systems (medical implant… or devices approved for use in critical systems… like a vehicle) should be required to ensure that the owners/consumer (or their agent) are able to effect changes and update to the device (normally this would require source code, but not limited to that), OR they should face sever liability (aka they are incentivized to empower their users/customers due to reduced liability).
'What do you mean this can affect rich people, fix it now!'
Fixing this could potentially require a law that protects these users, but that’s a big ask for a comically corrupt and perpetually gridlocked U.S. Congress, and isn’t likely to happen until there’s a scandal that’s so ugly, denying the problem is not longer possible.
There is a lot of money to be made in ignoring the many, many problems with the patent and copyright system as it applies to software so I wouldn’t expect even that would be enough to get more than ‘Look at us Doing Something’ effort on the part of politicians, rather I suspect that it will only be given serious consideration should a rich and/or powerful person find themselves on the wrong side of the issue and can’t just buy their way out of it.
Just wait until one of the congress critters penile implant device manufacturer goes bankrupt leaving them ‘low’ and dry…
They will pass a law in a heartbeat as soon as impacts their ‘bottom’ line…
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How inconsiderate of you, speaking about Marjorie Taylor-Greene that way.
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These transphobic/misogynistic ‘jokes’ really aren’t funny.
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They aren’t. But once straight men are removed from the equation, we can finally be a truly progressive civilization.
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Did you just coin the word gaybies? It sounds like your traditions make you hate yourself for being you.
I don’t think guys even care what freaks of nature do with their time. Deformed emotions are just deformed… Not any other fancy word.
You're looking at me
I have a pacemaker that was recalled, so I have some interest in the topic.
Does it actually require an act of Congress or could the FDA just write new regulations?
Possible solution: insurers won’t reimburse healthcare providers that implant devices without some kind of backstop in case of makers’ insolvency. Nothing works as well as not getting paid in changing docs’ preferences.
Planned Obsolescence
It looks like the commissions were already paid, so its all good. Just go get an upgrade for that obsolete technology planted in your body.
Even connectivity shows the lack of resilience with most wireless technologies. Only ethernet equipped devices have maintained forward compatability for decades. Having to install antivirus and a firewall on that outdated pacemaker is by design. Anything wireless is already trash (sans that RF or IR remote control that used the same standards for decades).
Technology DNA has always been important. Notice who doesn’t have it in 2022. Outdated/obsolete software makes that whole “software eating the world” just rotted fads that serve no purpose after the commisions are paid.
Garbage in, garbage out… Just like that non-supported medical device. Go ahead and put it in the landfill with all that other trash.
I can’t wait until they come out with ad supported implants! /s
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Umm no I don’t think that this will solve the problem.
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