As medical devices get more and more complicated, so does the software coding that enables them to work. But with buggy interfaces and frequent security problems plaguing device software, many researchers say the industry would be better served by adopting an open source model for its programming.
As The Economist reports, one-third of all software-based medical devices sold in the U.S. between 1999 and 2005 were recalled for software failure, with some bugs resulting in fatal overdoses, researchers at the University of Patras in Greece discovered. In addition, in 2008, researchers from computer security firm McAfee found that they could hack implanted insulin pumps to deliver overdoses. The FDA has the authority to examine the source code of devices it considers, but the agency often declines to do so, according to The Economist.
What is the solution to these software woes? Open source development, many academics say. Researchers at the University of Wisconsin-Madison have launched the open source medical device initiative, designing and coding a combination CT/PET scanner, available to anyone who'd care to build one. The University of Pennsylvania has partnered with the FDA on the Generic Infusion Pump project, using open source development to model all the common pitfalls of the devices and facilitate more reliable models in the future. At Kansas State University, one researcher is developing a customizable platform that would feature many of the common elements of various devices, creating an open source starting point for devicemakers.
The FDA has also has lent its support to NIH's Medical Device "Plug-and-Play" Interoperability Program, which would set open source standards for device compatibility, creating a system in which implants from different manufacturers could interact and ensure they're operating in concert, The Economist reports. However, according open source advocates, it's going to take more than that to ensure the safety of device software.
- read The Economist article