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Comment Re: Interesting (Score 1) 756

Honestly I'd go to a Trump rally just to see the show but I'd never vote for the man. How many people show up isn't a perfect reflection of voting preference. I wouldn't bother going to a Clinton rally because I already know enough about her to know I don't really want to vote for her either. Luckily(?) if my anti-trump vote matters here in South Carolina he's already lost the country in a landslide.

Comment Re: Evidence? (Score 1) 219

The poster is referring to risk compensation. Multiple studies show that with the introduction of abs brakes people follow more closely. Similar things are observed with seat belts and some people argue w bike helmets. Check out the examples section of the Wikipedia article:

Interestingly people may actually be pretty good at the risk evaluation since the fatal accidents are still reduced even w the increase in risky behaviors.

Comment Re:The fraud called Theranos is almost dead (Score 1) 65

Check out my description of the FDA software approval process a couple comments up in this thread, but in our case, no the FDA does not run the software directly. You provide reams of documentation regarding tests you've run or had third parties run, documentation showing that you can trace failures back to faults, and documentation demonstrating that you've thought of the various ways the device can fail. I don't know how the regulation of a blood testing device would differ, but I bet it would be similar.

Comment Re:The fraud called Theranos is almost dead (Score 1) 65

I've written code for an FDA approved class 2 device. In this case class 2 means roughly that the device is used for making medical decisions but not in direct contact w the patient. A failure could mislead a physician causing serious harm, but the device can't harm the patient directly. The code actually was the product since the approved "device" was a software program. We had to submit documentation that showed the device was safe when used by the targeted user, in our case a trained physician. We also submitted a lot of paperwork showing how the product was developed w solid tracability to all design decisions for everything from the software to the packaging to the marketing materials. Probably the most important part of those docs was a large table that had to be reviewed at every meeting showing that if the risk of a certain failure was X and the event caused by that failure had severity Y and their combination was above a threshold that we did something to mitigate the risk.

All that documentation ran for hundreds of pages and thankfully my tracability was mostly pointing at source control and saying, "you can see when i did what and why based on the timestamps and what ticket or design requirement it was connected to". Beyond that we had very large data studies showing that the product worked as we claimed. Those consisted of running previously recorded clinical data through our system and showing that with all these real-world recordings we did what we claimed. This counted as real-world since the software was designed to be run against recorded patient data.

At no point along the way did the FDA actually RUN our software or test it independently. The onus of that was on us and we had to submit extensive documentation about that testing. Audits consisted of the FDA representative coming to the company, reading reams of documentation, randomly pulling records that we claimed we had to prove we REALLY did what we said, and speaking with employees to confirm that they had some idea of what they were doing and what documentation they had to produce.

Honestly I'm not sure how else the system could run given that it takes so many incredibly specialized people to reasonably test a device. I don't really see any way the FDA could have a staff capable of doing that without becoming an absolute behemoth and slowing the approval process even more (it took years when you include the testing, verification, and documentation). There's room for improvement, but it's already no walk in the park. The FDA is pretty much making sure that if you claim a product does X that you have data to back that up and then if something goes wrong that you can trace the fault back to the source and know what happened.

Comment Re:Perspective Needed (Score 1) 1144

You can and we do prevent medical errors. Look up any of the research on surgical checklists for a very specific example of preventing medical errors, but there are many others. We may not be able to prevent ALL medical errors, but we also can't prevent ALL mass shootings. There's room for improvement on both fronts.

Comment Re: And delete all the digital copies of it too? (Score 1) 287

I think we computer people over simplify the task of taking a digital genome and remaking the original cell, but it should be simpler with a virus than just about anything else. I suspect we're safe from random weirdos recreating smallpox in a home lab for quite a while but I agree that the time is coming. As for your vaccination, high immune response lasts 3-5 years with decreasing immunity after that so your probably about as screwed as the rest of us.

Comment Re: ... because more vacciness will be needed? (Score 1) 287

One missed person is not enough for two big reasons. One, we have a concept of quarantine and how diseases spread, but more critically in this case the vaccine is a different virus. We can produce that virus, vaccinia, in whatever quantity we want without any access to smallpox. People use it for lab research now without a ton of precautions. Even unattenuated vaccinia only calls for biosafety level 2, I.e. the same level as e coli or various hep strains.

Comment Re: No such thing as 'vaccination' (Score 2) 287

I'm feeding a troll here, but you know that the earliest "vaccine" for smallpox was.... smallpox. The fatality rate for that method, called variolation, was on the order of 1-2% and there are records of intentional smallpox infection to induce immunity going back to at least 1500. The first real vaccine was infection by cowpox and was introduced in 1796. I imagine your dates are a bit cherry picked, but the Jenner vaccine wouldn't have reached places like India and China immediately so I suspect they still used variolation at least for a while. A 2% death rate if enough people were "vaccinated" that way would drive up the death toll for that crappy vaccine but is still better than something like 35% death rates for natural infections.

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