FDA issued a Safety Communication on January 31, 2019, (see Safety Communication Link) warning of the risk of air being introduced in a blood vessel (air-in-line) and air embolism for infusion pumps, fluid warmers, rapid infusers, and accessory devices. This communication is directed toward users (both clinical and service personnel) and patients. However, what can system architects, system engineers, software engineers and developers, verification and validation specialists, quality assurance and other product development staff learn from these communications? We also . . .
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