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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.
I’d temper that by saying a manufacturer would need to provide a reasonable option. Some things could become dangerous or even deadly if repaired incorrectly. Or it could be dangerous or deadly to even attempt to repair it.
In the medical field when a device can only be repaired by the manufacturer then you can expect long wait times, bad repair jobs and having your own equipment sent in for repair destroyed for “safety”.
We let people repair their own car’s brake pads… we shouldn’t give up ownership rights for a unwarranted claim to safety. If something is potentially dangerous then making it more difficult to repair is a bad idea.
We probably shouldn’t let people repair their own brake pads but that’s another argument. Not enough people die from randoms repairing their own brake pads. Repair an insulin pump the wrong way and it will absolutely kill you. Oxygen masks, CPAP machines, pace makers. So many medical devices that people rely on for life or death care.
I’m all for right to repair. But having seen some of the thing people have done to repair safety items I have serious doubts about the efficacy of someone repairing something wrong and killing their grandma. I can appreciate that not everyone feels the same way. I can appreciate that there are absolutely people out there who can and do repair their own devices, cars, machinery etc, and they may do it well. But there are always going to be people out there who don’t know what they’re doing but will try and then we’ll hear about them on the news because they touched a capacitor or something.
We probably shouldn’t let people repair their own brake pads
What kind of auth-dystopian nonsense is that?
Repair an insulin pump the wrong way and it will absolutely kill you
You’re just as dead if you can’t get that insulin pump repaired or replaced because the manufacturer won’t or can’t support it. When they go bankrupt because other customers have sued them into non-existence, you still own the device they manufactured, and you still need it repaired.
Further, you presume the manufacturer can provide the best repairs. It is entirely possible and plausible that a competing engineer or programmer can improve upon the device, rendering it safer or providing superior operation. Car Mechanics can install a better braking system than the cheap, generic calipers and pads provided by the factory. Repair technicians can replace generic parts of medical devices allowing superior operation.
The argument that because some people can’t, or won’t do a good job, no one should isn’t a very good one. Under that same logic you could exclude wiper blades.
You end up like New Jersey where you can’t pump your own gas. There are already guidelines and fixes for this wrapped around repairing your home power. You’re not allowed to architect major changes without the sign off of somebody who is a registered professional but you’re absolutely allowed to fix things that are already there.
For more people die from not fixing their brakes, because it’s difficult and expensive than ones who fix their brakes incorrectly.
The FDA found there isn’t evidence that 3rd party repair is any less safe than 1st party repair.
If one part needs to be replaced and the company who owns the patients/copyright tells the manufacturer to not sell it to others then the patient cost is needlessly a whole new machine. How many lives would be saved by lowering cost of getting medical equipment working?
This depends on the area of medical device. I work in medical device but totally different from this, mine get implanted into your body.
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I doubt many people have the knowledge to to truly troubleshoot our devices beyond what the doctor is allowed to do. We need a bunch of expensive and specialized hardware to troubleshoot.
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We are legally required to investigate and report any complaints(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) . If we don’t get the complaint we can’t investigate and report it.
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If a certain number(honestly I don’t know the specific number) of complaints occur we are legally required to create a corrective action to help the patients immediately (or as soon as possible) and a preventive action to ensure it doesn’t effect other patients. If a person has an issue and “repaired” it themselves they don’t get counted in this and as such could cause more patients to suffer.
While I agree with right to repair I think certain things should be exempt. That said then there should be a requirement of the manufacturer to ivestigate/repair the equipment.
When a defibrillator implant incorrectly shocks a pregnant women as an edge case she has to take meds to slow her heart so it doesn’t shock her. Doctors never think of the software running on it, and can’t get the code because it’s proprietary. People would be able to fix it, perhaps without even removing it, but can’t because business. https://www.youtube.com/watch?v=easb_6LCFDI
- A person doesn’t need to study medicine or own surgical equipment to get their body repaired. Same logic applies for the repairing of their medical devices. Right to repair does mean you have to personally repair it.
2+3. I don’t think that’s a problem. Presumably they’re already in contact with others to share information. Do that but as part of a larger, more open community.
It’s OK for manufacturers to say using aftermarket parts voids the warranty, it’s not OK for them to prevent using them entirely. Likewise if there’s a safety concern that should be handled by regulation and things like safety inspections, not by forcing all repairs to go through the manufacturer. If whatever it is is that critical to the safe operation it should be publicly documented so that third parties can manufacture it correctly to the needed tolerances.
I’m not so sure it’s actually okay for manufactures to say using aftermarket parts voids the warranty - they need to prove it’s actually your fault the device is broken (America’s Magnuson–Moss Warranty Act). If you’ve seen those little stickers over screws that say “warranty void if removed” - those are actually illegal (in America).
if there’s a safety concern that should be handled by regulation
Regulation won’t detail what a company does to that level. They might say something like “fasteners shouldn’t come loose” but it wouldn’t have a torque spec.
If whatever it is is that critical to the safe operation it should be publicly documented so that third parties…
That would run face first into proprietary info and corporate classified info.
That would run face first into proprietary info and corporate classified info.
The other side of regulation should be around purchasing. Bad repairability, delays in repairs, and proprietary parts need to be more important factors when deciding on what device to buy. Either at the government level for public institutions, or at least at the corporate level for private
That would run face first into proprietary info and corporate classified info.
Behold all the fucks I do not give. If it’s that critical they lose all claim to being proprietary. It’s just like patent, there’s no such thing as a secret patent, so anything that safety critical doesn’t get to stay secret either.
Regulation won’t detail what a company does to that level. They might say something like “fasteners shouldn’t come loose” but it wouldn’t have a torque spec.
It doesn’t now but it’s utterly trivial to fix that. Just make the regulations say that components must meet the manufacturer specifications and require manufacturers to publish and maintain all the specifications of all safety critical components. If they want to keep it secret then that means it’s not safety critical and they’re responsible for any accidents resulting from its failure.
Proprietary information and corporate classified information do not exist once they are incorporated into the device and sold to the end user. That information now belongs to the end user, who will continue to need it even if the company is out of business, or refuses service to the owner of the device.
Any attempt to conceal that information from the end user should make the company liable for any failed repair performed by any individual, including harm arising from that failed repair. The only way to avoid that liability is to release all information to the end user, so they are fully informed when making a repair decision.
Yes, dangers exist from third party repairs.
Refusal or even simple failure to provide critical repair data to the end user or their agent denies the end user the ability to make an informed decision about repairs.
The company should be liable for all damages from a botched 3rd-party repair unless they provide to the end user complete specifications and unrestricted access to the device in order to make informed decisions about repairs.
