Many medical devices that have failed in the past have had software defects that caused the device failure. This can be a life threatening situation when you consider that some medical devices such as pacemakers, infusion pumps, and other electronic medical devices rely on proper computer software functioning. If the software fails, the patient with the medical device may be exposed to grave danger.
According to a report published by the Software Freedom Law Center, "Killed by Code: Software Transparency in Implantable Medical Devices, addresses the potentially fatal risk of source code defects in implantable medical devices and explores why patients, doctors and the public should insist that free and open source software be the standard approach.
"The findings of the paper are important to anyone who has a friend or loved one with a pacemaker or insulin pump," said the paper’s author and SFLC General Counsel, Karen Sandler. "Clearly, we need mandatory, public, and broad safety review of code that runs these devices. At the very least, the U.S. Food and Drug Administration must require device manufacturers to submit software to the agency for review and safe keeping."
