FDA Issues Safety Recommendations for Programmable Syringe Pumps
September 9, 2016 | Aging Services Risk, Quality, & Safety Guidance
The U.S. Food and Drug Administration (FDA) on August 25, 2016, issued recommendations to reduce risk when using programmable syringe pumps to infuse therapies at low rates (less than 5 mL per hour, and "especially" rates of less than 0.5 mL per hour). In these situations, a lack of flow continuity can result in "serious clinical consequences," including delay of therapy, overinfusion, or underinfusion. These problems can occur in many syringe pumps, FDA said, and are not specific to any manufacturer. The FDA received over 300 medical device reports (MDRs) associated with programmable syringe pump use between March 1, 2013, and July 20, 2016.