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FDA: Software Failure Behind 24% of Last Year's Medical Device Recalls

Posted by timothy on from the others-mostly-about-color-coordination dept.

chicksdaddy writes "Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the U.S. Food and Drug Administration's (FDA's) Office of Science and Engineering Laboratories (OSEL). The absence of solid architecture and 'principled engineering practices' in software development affects a wide range of medical devices, with potentially life-threatening consequences, the FDA warned. In response, FDA told Threatpost that it is developing tools to disassemble and test medical device software and locate security problems and weak design."

5 of 128 comments (clear)

  1. What are they doing about the 76% HW failure rate? by sizzzzlerz · · Score: 5, Insightful

    It seems like that should be of even more concern.

  2. Demand Free Software by betterunixthanunix · · Score: 4, Insightful

    Can someone please remind me why people should be unable to examine the software in their medical devices, software that their lives may depend on? Why these programs are not open to public review?

    Oh wait, I got sidetracked thinking that the point of medical devices is to keep people healthy, rather than to rake in profits for the companies that make them.

    --
    Palm trees and 8
    1. Re:Demand Free Software by MozeeToby · · Score: 5, Insightful

      Hiding the source code is not an effective way to prevent hacking, if it were my Windows box wouldn't need a hardware firewall, a software firewall, 3rd party antivirus software, and regular sweeps initiated from a different OS.

    2. Re:Demand Free Software by glueball · · Score: 4, Informative

      The MRI machine I use has a complete circuit diagram along with design notes in a binder set next to the machine. In the US, you get the hardware manual for service. I don't believe the same is true for Europe and I have no idea about the rest of the world.

  3. Re:DMCA? by MadKeithV · · Score: 5, Funny

    In a distopian novel, the government would do this so that they could turn off your heart, if you said anything out of turn.

    It wouldn't work on politicians or lawyers. They don't have hearts.