this post was submitted on 09 May 2024
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More than 200 people with diabetes have been injured when their insulin pumps shut down unexpectedly due to a problem with a connected mobile app, the US Food and Drug Administration said Wednesday.

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[–] [email protected] 64 points 6 months ago* (last edited 6 months ago) (1 children)

"hello, I would like to inspect the firmware of the insulin pump/pacemaker/artificial heart that keeps me alive, can I have the copy of the source code?"

"no? it's proprietary? well golly! guess I'll trust ya in blind faith then!"

[–] [email protected] 20 points 6 months ago (2 children)

The problem is their insurance company may not give them another option in the American for-profit healthcare system.

[–] [email protected] 7 points 6 months ago (2 children)

Like I said. Blind faith it is.

[–] [email protected] -5 points 6 months ago (1 children)

Yes, that is true any time you are given no choice. But also an unhelpful blaming of the victim.

[–] [email protected] 17 points 6 months ago* (last edited 6 months ago)

That's not even remotely the point I was trying to make.

Medical software should not be treated the same as any old random proprietary code.

Right now we just have to trust that "the car has airbags" because no-one is allowed to open it up and check.

That shouldn't need to be the person themselves, but that's the bare minimum of what a sane situation should allow.

[–] [email protected] 6 points 6 months ago (1 children)

It's not obvious to me how these things are related, could you elaborate?

[–] [email protected] 9 points 6 months ago

they mean that the insurance would only approve one model. i don't think there are any open source pace makers though.

[–] [email protected] 50 points 6 months ago (5 children)

And this is why I will never work in biotech, finance or (especially) military software engineering

I don't want the risk of something I do causing direct harm to another person

[–] [email protected] 13 points 6 months ago

I have only written potentially life-threatening code once in my life. It had to do with voltage/current regulation in the firmware of a high-powered instrument used by field workers at the company where I work. It was a white-knuckled week I spent on just a single page of code, checking and re-checking it countless times and unit testing it in every conceivable way I could imagine.

[–] [email protected] 12 points 6 months ago (3 children)

In the military, direct harm is the only goal. Not quite like the others.

[–] [email protected] 5 points 6 months ago

I think I could get very nervous coding for the military, depending on what sort of application I was working on. If it were some sort of administrative database, that doesn't sound so bad. If it were a missile guidance system, on man! A single bug and there goes a village full of civilians. Even something without direct human casualties could be nerve-wracking. Like if it were your code which bricked a billion-dollar military satellite.

Speaking of missile guidance systems, I once met someone who worked a stint for a military contractor. He told me a story about a junior dev who discovered an egregious memory leak in a cruise missile's software. The senior dev then told him "Yeah, I know about that one. But the memory leak would take an hour before it brings the system down and the missile's maximum flight time is less than that, so no problem!" I think coding like that would just drive me into some OCD hell.

[–] [email protected] 3 points 6 months ago

yeah. doing a bad job could even save lives. it would be a moral duty to screwup /s (yes I know that is not how it works)

[–] [email protected] 1 points 6 months ago

Oh, I thought you were supposed to be protecting my country. I guess that oil money is too tempting

[–] [email protected] 6 points 6 months ago

Or aerospace

[–] [email protected] 6 points 6 months ago* (last edited 6 months ago)

That’s what I thought before but it doesn’t matter. In medical devices you need good programmers and there are a fuckton of rules and tests to make sure that devices are safe. It’s also very regulated and usually well planned.

Medical companies are the best for this because we’re all accountable directly or indirectly and we do our best. I know I would not work for another kind of coding job because they would all feel too random.

I know mistakes can happen, but it’s the best environment you can work in if you’re a developer. Also you learn a lot and are surrounded with good devs who will make you better.

Anyway, I’m not trying to convince you but we need people who doubt and could be careful. It’s not at every job but usually it’s: planning is good, overtime is not acceptable because it shows bad planning, tests are everywhere (all kinds of tests), merge requests are serious business (your merge request can sit for weeks before being integrated), doc is central and you have to be a part of it, etc.

Last but not least you can still find the PDF of the IEC 62304 which shows every step that should be made to write medical software, and it could make you a better developer even if you’re not working in that field.

[–] [email protected] 35 points 6 months ago (1 children)

And when people are so excited about cybernetic implants I’m like “hell no, i know the firmware for that will go to the lowest bidder and I don’t want to willingly connect myself to that”

[–] [email protected] 5 points 6 months ago (1 children)

You might be forced to choose between that or not being able to get a job due to having to compete with other people who perform better due to cybernetic implants

[–] [email protected] 17 points 6 months ago (1 children)

"welcome to your first day at Amazon. When you clock in, your implants will take over and complete your duties. At the end of your shift your motor function authority will be returned"

[–] [email protected] 16 points 6 months ago (1 children)

"Due to a software glitch, you worked an extra 500 hours. You will not be compensated for this extra time as it was not mandatory or compulsory."

[–] [email protected] 13 points 6 months ago

"you are responsible for your excrement, regardless of your nervous system control status. Your actions necessitated another cybernetic employee to clean the work area. You are encouraged to handle these matters when off Amazon property"

[–] [email protected] 18 points 6 months ago (1 children)

I hope the company is sued into oblivion. Cause this kind of lack of quality control and monitoring is unacceptable.

[–] [email protected] 16 points 6 months ago (2 children)

I hope not.

First: You can't avoid bugs. You simply can not.

Second: There aren't that many producers of good insulin pumps and the t:slim is a great device.

[–] [email protected] 12 points 6 months ago

Yeah, it’s probably one of the best out there. I don’t love that with their newest pump it’s 100% phone controlled (literally no screen on the device) but there is no way in fuck I am ever trying a Medtronic pump again. Had one for a day because my insurance wouldn’t cover a new tandem pump. It was such a piece of shit

[–] [email protected] 3 points 6 months ago (2 children)

The fact that an app big drains the pump and no fail safes monitor for example the battery drain on the pump itself.. hey this pump is using more battery than it should.. battery will be flat in x hours.

Next time it will inject too much or too little insulin and then?

Avoiding bugs by doing proper QA and building in double and triple checks is the name of the game, not being faultless.

[–] [email protected] 1 points 6 months ago

Yeah, I get the sentiment that you can't avoid bugs and I think to an extent they are inevitable at a certain point. But something like this is just negligence.

My company isn't medical or anything life threatening if something goes wrong, but a bug could cost someone a nice heap of money, in turn costing us a nice heap of money. So we have a rule to treat and test our software as if it were used in the medical industry. Although it seems like we should be aiming for a higher standard at this point.

[–] [email protected] -3 points 6 months ago (1 children)

and no fail safes monitor for example the battery drain on the pump itself.. hey this pump is using more battery than it should

Yeah, that was a failure. But wishing a company to be "sued into oblivion" is a tiny little bit overreacting, isn't it?

Next time it will inject too much or too little insulin and then?

How about to just move on and get yourself a model from a different company, if you don't trust them anymore instead of assuming stuff.

[–] [email protected] 4 points 6 months ago* (last edited 6 months ago)

Why is it an overreaction? The only language a company speaks is money. So the risk of not doing proper QA and safety precautions should be the shareholders losing their shirt.

Because if this is not the risk, the cost benefit analysis leans towards "fuck the lives of our customers".

If an individual caused this kind of harm to others through negligence they would never see the outside of a prison even again. So why does a group of individuals shielded behind a company get punished less? If the punishment is just a fine, it is not really a crime, is it?

And about moving on, I care about all the people that have one of these things or will get one in the future. The whole "Caveat Emptor" you seem to be preaching does not fly well with me as it exposes many vulnerable people to high risks.

[–] [email protected] 8 points 6 months ago

So 214 people let the battery on their (USB Rechargeable) insulin pump die and reported it to the FDA…

Then again Tandem is kind of a shitty company. They based their algorithm in part on data from insulin pumps that had been returned to the manufacture for a software update. Without consent.

Switched from an industry standard luer-lock connector to a proprietary one after purchase. Then required all supply ordering to go through their own sales department and a single manufacturer.

Camped on the design for a small portable pump they patented back in 2012 until there was a viable competitor with innovative technology.

You know what… I think I have a phone call to make :-)