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Jesus. QA is not a corner you should cut when it’s literally life and death.
So uh… as someone who works in biotech and understands exactly what level of rigor is required before the FDA allows you to sell a medical device - a term that has specific legal definition, regulations, and restrictions, I’m a bit suspicious this could be fake. This sort of error would indicate a systemic error and abrogation of due diligence at at least 4 different levels, and would be an apocalyptically huge lawsuit.
Edit: I stand corrected - lots of people are corroborating this whole thing. That’s kind of astounding, tbh.
I quit Insulet (I was the principal software dev for Android on OP5) because management didn’t care about this kind of thing. I couldn’t stay in good confidence.
You should reach out to the dev in the post. Your experience is going to be very interesting to any lawyers he talks to.
I’m not going to X, but if anyone contacts me I’d certainly talk.
So if I understand it, a bug has been identified that’s potentially going to make diabetics OD on insulin and die.
That’s fucked.
A story from a type 1 diabetic:
I had what we will call “an incident” where I took pretty close to this scale of extra insulin. I’m a much heavier insulin user but it varies greatly between people and the kind of person who is dosing fractions of a unit like 0.15 turning into 15 would be a massive problem. It took about an hour for me to get to the hospital and I seemed just fine at that point. I don’t know why because usually the type of insulin I use hits it’s peak within an hour for me. My only guess is that my body was overwhelmed and somehow delayed my reaction to it, which I’ve never seen before.
I got into the ER and they were very casual about it. From my past experience in medicine I’m guessing they weren’t sure if it really happened and wanted to see how it played out. My blood sugar was somewhere around 100 when they first tested me. 5 minutes later it was in the 40s. At that point the nurse said “oh fuck!” and sprinted to grab D50 (basically a sugar infusion) from where they keep their meds. I have been a paramedic (not just an EMT) and I can count the number of times I’ve seen a nurse run on my fingers.
They started an IV in both arms and were pumping sugar in to keep me alive. My memory gets kinda hazy after that. They kept checking my blood for potassium levels because burning through that much insulin + glucose uses it up and can stop your heart. Eventually they had to start a central line (like an IV but straight into your heart) in my neck to deliver insulin because they were worried all the sugar they were giving in both arms would burn my arm veins. I remember the feeling when they started it and used a probe to see if it was in the right place the “tickling” feeling literally in my heart. I ended up in the ICU on 1-to-1 with a nurse because they had to monitor me so closely. If I had been later to the ER by 10-15 minutes I wouldn’t be telling you this story. I also had the benefit of knowing what happened ahead of time, which you would not if your pump magically multiplied your dose by 100 and you didn’t notice.
All this to say, this is pretty fucking serious.
This, right here, is why “professional” software “engineers” should be licensed.
Former healthcare to software engineer working on a master’s here. My colleagues who were licensed back in healthcare weren’t all of the same quality. They all made mistakes at one point or another, some pretty bad some minor. There’s no difference though, minor could just as well become major.
The way they get around it in healthcare is by throwing more people at the problem. You have a physician who is good at pointing in the general direction of the problem and a solution, then you have all the auxiliary staff who will narrow down on the solution based on their field. But at any single point all of them could fuck up, or one of them could.
Now that I’m a software engineer and I’ve written enough code to do stuff. I can confidently say that licensing will not solve this problem. Especially if there aren’t enough people involved. Which is probably what was missed in the beginning.
Anyway long rant over.
Licensing isn’t about magically ensuring that the practitioner won’t make mistakes; it’s about holding the practitioner accountable for his mistakes, which in theory gives him more incentive to be more careful – or to change his practice’s workflows and systems so as to be better able to detect and correct mistakes.
In fact, I would argue that the “throwing more people at the problem” phenomenon in healthcare is an example of that very thing. Do you think they’d keep staffing levels equally high without licensing? 'Cause I sure don’t.
So, what you say is let’s hold the lowest level accountable, the person who may don’t have any power over the fcked up decisions about the amount of developers, presence of QA, and timeline.
No, licensing will not make “accountable” people magically incentivised enough to make no mistakes
A licensed Professional Engineer is exactly the opposite of the lowest level person. In fact, that’s part of the point: giving the experts the power to say “no” to unsafe/unethical management.
