The United States Food and Drug Administration (FDA) has issued an alert concerning programmable syringe pumps. Programmable syringe pumps deliver solutions such as fluids, medications, or blood products to patients.
From 1 March 2013 to 20 July 2016, the FDA received over 300 Medical Device Reports (MDRs) associated with programmable syringe pump use. The reports describe over- and under- infusion of high risk or life-sustaining medications, occlusion (blockage) detection failures, inadvertent boluses caused by inconsistent fluid delivery, and other mechanical malfunctions that result in delays in therapy. Of the 100 MDRs that provided information on the infusion rates, the majority of those MDRs noted infusions at rates of 5 mL per hour or less, including rates as low as 0.06 mL per hour.
Reports of serious adverse events such as abnormal or unstable blood pressure, anxiety from loss of sedation, and increased pain indicators in critically-ill infants have been associated with lack of flow continuity. The FDA believes that these concerns may extend to all programmable syringe pumps while infusing at low rates. Based on current information, the FDA believes that the overall benefits of programmable syringe pumps outweigh their risks. Moving forward, the FDA has requested that manufacturers make labeling changes to their syringe pumps to address flow continuity concerns.
Health professionals should refer to the specific recommendations in the FDA Safety Communications when using programmable syringe pumps, accessible at
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm518049.htm.
Posted on 26 August 2016