Healthcare providers have been told to be aware of serious adverse effects of using programmable syringe pumps when administering drugs at low volumes.
The US Food and Drug Administration (FDA) said the warning is particularly relevant when administering medicine to infants and patients who are critically ill. They have now issued new instructions for use that include a list of warnings and steps to minimize the risk.
A type of infusion-style pump, programmable syringe pumps are used by healthcare providers to administer a wide range of drugs at different rates. They are in widespread use in clinical settings including hospitals and nursing homes. They are capable of giving medications, blood and fluids in very small doses and are often used for those who require highly concentrated medications because of issues such as fluid intolerance.
The FDA believes these pumps can cause “serious clinical consequences” when operated at a rate of less than 5ml per hour due to a lack of flow continuity, which can lead to over-infusion or under-infusion and a delay of therapy. Rates of flow of less than 0.5ml per hour pose even more of a risk.
They FDA said it had received reports of “serious adverse events” that include abnormal blood pressure, anxiety from a loss of sedation, and increased pain indicators in infants who were critically ill. As a result, the agency now advising healthcare sites to re-examine the syringes and accessories they use in order to avoid the risk of inconsistent flows.
While the FDA says a lack of flow continuity can occur with other types of infusion pumps, it warns that it is particularly relevant to those programmable syringe pumps that infuse at low rates.
New 510k advice
The FDA is now telling companies that want to use labels with their own wording that differs from the agency’s new language explaining the measures and risks that they must submit a new 510k for any changes.
Those affected may wish to look at companies to help with FDA 510k, such as
fdathirdpartyreview, which can help with fast-tracking submissions and therefore reducing the time to market.
Making changes to the labeling of syringe pumps should address any concerns over flow continuity, the FDA advised, adding that the overall benefit still outweighs any risks.