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."

Comments

What are they doing about the 76% HW failure rate?

[sizzzzlerz]

It seems like that should be of even more concern.

Demand Free Software

[betterunixthanunix]

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.

Re:Demand Free Software

[MozeeToby]

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.

Re:Demand Free Software

[dark12222000]

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

FDA should develop an open platform like NSA did

[WindBourne]

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.