FDA Asks Manufacturers of Syringe Pumps to Update Labeling, Warnings

Manufacturers of syringe pumps are being asked to update their labels to address flow continuity concerns that the FDA has identified as a serious risk to health.

The agency issued an Aug. 25 safety notice warning that programmable syringe pumps used to infuse therapies at low infusion rates can result in serious consequences such as delay of therapy, over-infusion or under-infusion. 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 a lack of flow continuity.

The agency is asking manufacturers to voluntarily update their labeling to include warnings and precautions to clarify the use of the devices at low infusion rates. The notice said the FDA is working with manufacturers to ensure the appropriate information is conveyed.

The notice said that the problem is not specific to any manufacturer or model, and it may in fact extend to all programmable syringe pumps while infusing at low rates.

The FDA has received more than 300 medical device reports since March 1, 2013, associated with programmable syringe pump use. The reports highlight over- and under-infusion of high risk or life-sustaining medications, occlusion detection failures, boluses caused by inconsistent fluid delivery and other malfunctions. The majority of the reports noted infusions at rates of 5 mL per hour or less, the notice says.

The agency said it believed that the benefits of the devices still outweigh the risks, and it provided recommendations for healthcare professionals to help mitigate some of that risk. Those recommendations covered syringe size and selection, use of accessory devices, starting an infusion or changing a syringe, height and location of the syringe pump system and occlusion considerations.

Read the FDA safety notice here: www.fdanews.com/08-25-16-pumpsafetynotice.pdf. — Tamra Sami