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FDA: Software Failure Behind 24% of Last Year's Medical Device Recalls
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."
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.
IP restrictions on medical devices' source code, no peer review or approval structure in place from FDA or health organisations. Complex medical devices that are implanted in humans bodies, e.g. insulin pumps, heart defibrillators etc. run software and operate more and more like computers. Here is a case of Karen Sandler, a woman who asked to see the code for the device she was to be implanted with to verify that is was safe. And what she discovered in the process.
OSCON 2011: Karen Sandler
www.youtube.com/watch?v=nFZGpES-St8
You will find that Linux is everywhere in the aviation and medical arena, except for where DO-178B is required. However, you have bluecat linux that has the same API as Lynx's DO-178B system. In addition, several groups are hard at work on doing DO-178B for Linux.
In the mean time, there are PLENTY of equipment, mainly those using Windows, in which an open platform makes far more sense. And yes, Linux does have more of a real-time OS, than is windows.