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(www.accessdata.fda.gov/scripts/cdrh/…/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.
atrielienz@lemmy.world 1 day ago
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.
Rivalarrival@lemmy.today 22 hours ago
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.
AnyOldName3@lemmy.world 20 hours ago
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.
Rivalarrival@lemmy.today 12 hours ago
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.
openaps.org
What you are arguing for is a threat to systems like OpenAPS, and to the people who benefit from them.
tabular@lemmy.world 1 day ago
The FDA found there isn’t evidence that 3rd party repair is 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?
atrielienz@lemmy.world 23 hours ago
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.
tabular@lemmy.world 22 hours ago
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 then when the mask is forced to berecalled for sound/vibration dampening material entering people’s lung they will kick and scream.
Safety is not my main goal, freedom to do what you want with what you paid for is.
Rivalarrival@lemmy.today 22 hours ago
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. 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.
GiveMemes@jlai.lu 22 hours ago
So because some people are reckless, all people should be unable to fix their shit?
linearchaos@lemmy.world 1 day ago
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.
atrielienz@lemmy.world 23 hours ago
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?
linearchaos@lemmy.world 22 hours ago
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.