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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.
What kind of auth-dystopian nonsense is that?
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.
If you’ve got a broken insulin pump, assuming you’re in a country with a functioning healthcare system, you should have been given a spare pump with the original, and probably some insulin pens, so when one breaks, you fall back to the spare, and get given a new one to be the new spare (or could get the broken one repaired). Using the spare is completely safe.
If you don’t have a spare, your sugars would go up over several hours, but you’d have a day or two to get to a hospital and potentially several days after that for someone to find you and get you to a hospital, so it’s not safe, but also not something you’d die from if you had any awareness that there was a problem.
If you’ve got an incorrectly-repaired pump, you could have it fail to give you enough insulin, and end up with higher sugars, notice the higher sugars, and then switch to the spare. That’d be inconvenient, but not a big deal. However, you could also have it dump its entire cartridge into you at once, and have your sugars plummet faster than you can eat. If you don’t have someone nearby, you could be dead in a couple of hours, or much less if you were, for example, driving. That’s much more dangerous than having no insulin at all.
Prosthetic legs don’t have a failure mode that kills you, so a bad repair can’t make them worse than not having them at all, but insulin pumps do, so a bad repair could.
I’m glad you mentioned insulin pumps, because there is a community of developers working on pumps, making them available to a broader audience, providing more people with better control over their blood sugar levels than manufacturers are willing or able to provide on their own.
https://openaps.org/
What you are arguing for is a threat to systems like OpenAPS, and to the people who benefit from them.
I’m not arguing for anything in the post above, just pointing out that a broken (or badly repaired) insulin pump is genuinely more dangerous than having no insulin pump. That doesn’t have to count against the right to repair one, as if you’ve got the right to repair an insulin pump, and do so badly, it doesn’t mean you’re legally forced to use it afterwards, just like I’ve got the right to inject all the insulin in my fridge with an insulin pen back to back, but I’m not legally forced to do so.
I do think the right to repair should be universal, but as I think that medical stuff should be paid for by the state, NHS-style, that would end up meaning that the NHS could repair medical devices themselves if they deemed it more economical to do so and recertify things as safe than to get the manufacturer to repair or replace them. The NHS is buying the devices, and gets the right to repair them, and that saves the taxpayer money, as even if they don’t actually end up repairing anything, it stops manufacturers price gouging for repairs and replacements, and if the manufacturer goes bust or refuses to repair something, there’re still ways to keep things working. It doesn’t mean unqualified end users can’t use their new right to repair their medical devices and risk getting it wrong, but if you’ve got an option of a free repair/replacement, most people would choose the safe and certified repair over their own bodge.
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.
That depends entirely on who’s safety is on the line. When you repair your brakes wrong (to follow the original example), and it causes a pile up that kills 4.or 8 or 10 people, someone should be held liable for that.
When you repair the electrical box in your basement wrong and it causes a fire that takes out the houses on either side of you, someone should be held liable for that.
This is like saying “just because some people who drive drunk kill people doesn’t mean that everyone shouldn’t be able to”. The difference here though is that we know there’s a statistically significant increase in the likelihood of death or serious injury from driving drunk.
There’s a statistically less likely chance of death or bodily injury when people repair their own devices, but I would wager that has a lot to do with the fact that the pool of people doing it have the knowledge to do so and aren’t completely ignorant of how those devices work, or it takes into account that right to repair also encompasses people getting a third party who is qualified to repair the device to do it, but outside of what the manufacturer allows per user agreement. Once more random laymen start doing it because they are allowed or perceived themselves to be allowed, I would expect that the number of wrongly repaired devices would go up.
Some states have mandatory car inspections. So for instance, if you repair your brakes wrong and leave a caliper bolt off or don’t grease the slides or any number of other things there’s another qualified person looking over that and noting it. So there’s less possibility that it won’t be fixed properly. We do not have anything like that for medical devices except when they are repaired through the manufacturer.
I’m not even arguing against the right to repair. I’m just pointing out the hurdles that are going to be there and saying they should be addressed. I’m actually generally for people learning how things work so that they can do simple repairs or even complex repairs if they need to.
But I still think that some things should be handled by professionals. Or at least with a professional QC’ing the work.
In the field I work in, work can be done by the owner but only with a qualified and licensed A&P present. Would you suggest that any old person off the street should be able to repair a plane and fly over your house?
I don’t think there’s any solid argument that precludes people from doing maintenance on their own car. There’s always some form of inspection or monitoring that can be done. Brakes in particular are perfectly reasonable. I particularly miss ease of maintaining drum brakes. They were literally designed to be maintained by the end user, you pull the wheel, The drum slides right off and the parts are readily available. If you want to get fancy you could buy a tool to help you remove the spring.
Things should be designed to be maintained by the end user and the end user could choose to go to a mechanic if they wanted to.
Honestly what we’re running up against at this point with car maintenance is design to cost. Every part that is maintainable on a car could be designed to be easily maintainable for a cost. Rather than the manufacturer paying that cost, there making us pay the cost at the mechanic. You can literally buy repair parts that are easy and convenient to work with that are improvements over OEM.
In the case we’re talking about for this article it’s literally a wire on a lithium ion battery pack in a wrist mounted device that failed that they’re refusing to replace.
And it’s not like he’s going to fall out of the sky and land in somebody’s backyard.
If inspection or monitoring were mandatory you’d have a point. But it isn’t mandatory. Not everywhere. Not even most places. Only 19 of the 50 states require vehicle safety inspections periodically. So at most the vast majority of vehicles probably haven’t had one since the car was new unless the state where that car is registered requires it. For a country that’s very car dependent with car accidents being one of the leading causes of death in the US, that’s terrifying.
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?
I read the article. Third party repair not being your grandson who’s replacing the seal on your CPAP mask, because that’s not what I mean not does it mean going to a third party repair place.
It being less safe for the vast majority doesn’t mean that there aren’t going to be people who get it wrong. People repair their brakes wrong all the time. It’s absolutely caused accidents. But not enough to be statistically important in the grand scheme of 8 billion people. That doesn’t mean it doesn’t happen or that it can’t.
There’s a reason a lot of YouTube videos that show you how to repair things are “for educational purposes only”. It’s because they can be held liable if something bad happens because you followed their guide.
You focus on an incompetent grandson hypothetical but it’s not as if the 1st party repair is immune from hiring people who can make negligent mistakes, or even take malicious acts. If it’s difficult to replace a seal on a mask then perhaps it’s a CRAP design.
Companies will preach safety when lobbying against right to repair but when a mask is forced to be recalled for sound/vibration dampening material entering people’s lung they will kick and scream.
Safety is not my main goal, it is the freedom to do what you want with what you paid for.
I focus on that because it is a danger of people doing the work themselves. I didn’t say that companies weren’t capable of the same problems. I said that it’s unlikely that the grandson would face the same kind of legal repercussions that a business or corporation would and that’s problematic.
If you’ll take a step back and stop assuming that I’m arguing against right to repair and just look at what I actually said you might see that I have a point.
And while I agree that there is also risk in not repairing the devices in question or being able to have them repaired by the manufacturer which is a significant risk, I still feel like it’s important that it be said that there exists a risk in people making more technical repairs themselves.
It also allows end users to install parts superior to OEM, improving braking capabilities, and preventing accidents.
Any automotive technician can tell you that manufacturers take engineering shortcuts, resulting in a product with certain deficiencies. The manufacturer’s motivation is to put out a product that widely appeals to the general public. They want nothing to do with a product specifically tailored to the needs of a particular individual.
So because some people are reckless, all people should be unable to fix their shit?
People keep ignoring the fact that I didn’t say that. I actually feel the opposite. You inferred or interpreted what I said that way and that’s on you.
This depends on the area of medical device. I work in medical device but totally different from this, mine get implanted into your body.
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.
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.
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
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).
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.
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
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.
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.
If it’s dangerous to repair it, it’s dangerous to own. That’s the domain for regulations by the government, not arbitrary software restrictions by software manufacturers.
They don’t implement these to keep you safe. They do it purely to make more money.