Open-Source Medical Devices Could Prevent Injuries, Deaths

An article in the latest issue of The Economist advocates for open-source software coding to become standard practice in medical device development. From MR machines that contain more than 7 million lines of code to the 1.5 million devices that are individually recalled because of software failures, numerous risks could be avoided with more robust coding, the article says—and the best way to do that is to open up its development to more programmers. Yet although the FDA does not require analysis of potential coding errors in medical device software, the Economist says, the “rigorous paper trail detailing its development…is not always a good fit with the collaborative and often informal nature of open-source coding.” Still, the administration is working to cover these gaps via initiatives like the $10 million NIH-led Medical Device Plug-and-Play Interoperability Program, which could drive communication among disparate devices and manufacturers.