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Last month, the FDA launched the Infusion Pump Improvement Initiative to address persistent device safety problems, with software defects topping the list of reported problems. This initiative is designed to establish additional requirements for device manufacturers and improve device development processes to reduce the risks to patient safety. This includes guidance on design and engineering information that needs to be submitted to the FDA during premarket review, and a recommendation to run infusion pump software code through static analysis to identify software defects early in the development process.

Infusion pumps, like all medical devices, need to adhere to the highest levels of product safety. Over 900 customers in quality and safety-critical industries use Coverity Static Analysis to identify critical software defects which are hard, if not impossible to find through other means.

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FDA Infusion Pump Improvement Initiative

Diagnosing Medical Device Software Defects Using Static Analysis, a MD+DI article co-authored by Coverity and the FDA