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Software Flares Cause 24% of Device Recalls

Article-Software Flares Cause 24% of Device Recalls

CDRH says about 24% of device recalls involve software flaws. “Many software platforms lack robust code validation”, the Center’s Office of Science and Engineering Laboratories (OSEL) says in its latest annual report. “In medical devices that contain software, it can be extremely difficult to assess if a firm follows their processes for design controls, especially in the areas of validation, risk/hazard analysis, and design changes”, the report says.

OSEL’s Division of Electrical and Software Engineering (DESE) is developing software architecture analysis methods that examine a devices code by deconstructing it into its constituent components. “In this form, researchers can examine how they are organized and interconnected,” the report says. “If there are components that are overly dependent on a certain component or not even used, it can be a sign of current or future problems. The deconstruction process also facilitates analysis of design documentation.”

Another DESE project addresses infusion pump software issues that make failure modes difficult to predict. “To address this issue, we are using formal methods to investigate a means of assessing the safe execution of infusion pump software,” the report says. “The approach uses a model-based engineering development paradigm. In this methodology, software design models are derived from device safety requirements using executable modeling notations that simulate code execution. Once the models are encoded, they can be verified using rigorous mathematical methods. The verified models can then be used as unambiguous safety reference implementation standards against real world pumps.”

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