Clinicians using programmable, or smart, syringe pumps should take precautions against mishaps that can occur at low infusion rates of high-risk, life-sustaining therapies, such as those at less than 5 mL per hour, and especially those at less than 0.5 mL per hour, the US Food and Drug Administration (FDA) announced today.
Programmable syringe pumps deliver medications, blood products, fluids, and other solutions to patients in operating rooms, emergency departments, labor and delivery units, and intensive care or critical care units for newborns and children, among other settings. For a variety of reasons, these low-infusion rates can translate into irregular flow patterns that lead to accidental boluses of solution, delays in therapy, and failure to detect blockages.
The FDA has received multiple reports of serious adverse events associated with inconsistent flow such as abnormal or unstable blood pressure, overinfusion or underinfusion of therapies, anxiety from loss of sedation, and increased pain indicators in critically ill infants, the agency said in a safety communication. "The FDA believes that these concerns may extend to all programmable syringe pumps while infusing at low rates."
Consequently, the agency is asking the manufacturers of these devices to voluntarily revise their product labeling to include recommendations and precautions that will help clinicians avoid adverse events when they are infusing therapies at low rates.
Today's safety communication spelled out some of the steps that clinicians should take to ensure that programmable syringe pumps deliver consistent, predictable flows regardless of flow rate. Among other things, clinicians should:
Ensure that syringe sizes and models are compatible with the syringe pump, and use the smallest compatible syringe that can deliver the fluid or medication. Using a larger syringe at low flow rates increases the odds of malfunction.
Use the shortest length of tubing and the smallest internal diameter of tubing possible at low flow rates.
Manually prime the syringe and tubing to remove all air before connecting them to the pump. When available, electronically prime the system before starting an infusion or after replacing a nearly empty syringe with a full one.
When working with a single syringe pump, position it level with the site of fluid delivery. In the case of a central line, the pump should be at the same level as the patient's heart. When there are multiple syringe pumps and they cannot all occupy this critical position, those delivering high-risk or life-sustaining medications take precedence.
The safety communication on programmable syringe pumps is available on the FDA website.
To report any problems with these devices, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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Cite this: Smart Syringe Pumps Can Err at Low Flow Rates, FDA Warns - Medscape - Aug 25, 2016.
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