FDA issues safety recommendations for programmable syringe pumps

The Food and Drug Administration today issued recommendations to reduce safety risks when using programmable syringe pumps to infuse therapies at low rates, when a lack of flow continuity can result in serious clinical consequences, including delay of therapy, over-infusion or under-infusion. Since March 2013, the agency has received more than 300 Medical Device Reports associated with programmable syringe pump use. Of the 100 MDRs that provided information on the infusion rates, the majority noted infusions at rates of 5 mL per hour or less. “Based on current information, the FDA believes that the overall benefits of programmable syringe pumps outweigh their risks,” the agency said. “Moving forward, the FDA has requested that manufacturers make labeling changes to their syringe pumps to address flow continuity concerns.”