Slashdot Mirror

← Back to Stories (view on slashdot.org)

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."

8 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:Demand Free Software by dark12222000 · · Score: 3, Insightful

      Look up "Code Signing". Then bash your head against your desk three or four times as punishment for the stupidity you typed out above.

  3. FDA should develop an open platform like NSA did by WindBourne · · Score: 3, Insightful

    Seriously, the smart thing is to develop an Open platform on Linux, with libraries for equipment to use. Likewise, offer up secured ways of updating the equipment. If FDA was smart, they would talk to NSA.

    --
    I prefer the "u" in honour as it seems to be missing these days.
  4. 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.

  5. Where does the report say this? by mcmonkey · · Score: 3, Interesting

    As a developer working for a medical device company, I am very interested in this story.

    However, I am not able to find in the linked report either that "24%" figure or the direct quote from TFA.

    The Agency is also acquiring expertise in areas like "detecting malware inside device designs...(and) reverse engineering certain types of malware to best identify the specific protective practices which manufacturers should be employing," the report reads.

    The word "malware" appears twice in the quoted passage, but not at all in the report. And 24 only appears as a page number or date.

    Am I just not hitting CTRL-F right today?