The US Food and Drug Administration (FDA) on Thursday issued a warning to healthcare providers over serious adverse events tied to programmable syringe pumps when set to deliver drugs at lower volumes, especially for infants and critically ill patients.
In response, FDA has provided manufacturers of the devices with new language to add to their instructions for use that includes a list of warnings and considerations to mitigate the risks. The agency also says that companies wishing to modify their labels with language other than what it has provided should submit a new 510(k) for the changes.
Programmable syringe pumps are a type of infusion pump used in healthcare settings to administer a wide array of drugs to patients at various rates, and are regulated as Class II devices by FDA. These devices are also commonly used to deliver "highly concentrated" drugs to infants or patients with fluid restrictions.
According to FDA, the syringe pumps can cause "serious clinical consequences from lack of flow continuity resulting in delay of therapy, over-infusion or under-infusion," when operating at a rate of less than 5 mL per hour, "and especially at flow rates of less than 0.5 mL per hour."
Over the last three years, FDA says it has received more than 300 medical device reports (MDRs) related to programmable syringe pumps, many of which were related to issues with the devices' flow rate. "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."
As such, FDA is advising healthcare providers to carefully consider the syringes and accessories, such as tubing and filters, used with the devices in order to minimize the risk of inconsistent flow.
However, while FDA says the issues "may extend to all programmable syringe pumps capable of delivering at low infusion rates," it cautions that it is not able to definitively single out the root cause of the issues due to the limitations inherent with MDRs, varying syringe sizes used with the devices and presence of patient comorbidities.
In addition to reviewing the MDRs, FDA says it conducted a literature review and a hospital survey to gather more information on how the devices are used and the risks they pose.
Labeling Request Change