Intelligent Infusion System

What is the problem?

More than 1 out of 2 infusions are associated with errors. From 2005 through 2009, FDA received approximately 56,000 reports of adverse events associated with the use of infusion pumps. Of these, approximately 1% were reported as deaths, 34% were reported as serious injuries, and 62% were reported as malfunctions.

Infusion pumps have contributed to improvements in patient care, allowing for a greater level of control, accuracy, and precision in drug delivery, and thereby reducing medication errors. At the same time, like other medical devices, infusion pumps are not without risks. FDA has received numerous reports of adverse events associated with the use of infusion pumps, including serious injuries and deaths. From 2005 through 2009, 87 infusion pump recalls were conducted by firms to address identified safety problems. The most popular infusion device on the market could not be sold for over 3 years due to recalls, which continue to be a problem.

Infusion pump problems have been observed across multiple manufacturers and pump types. Through analysis of pump-related adverse event reports and device recalls, FDA has concluded that many of these problems appear to be related to human factors, stemmed from deficiencies in device design and engineering. FDA has seen an increase in the number and severity of infusion pump recalls. In addition to contributing to medication errors, current infusion pumps on the market are time-consuming to setup. They also lead to frequent disruptions of care due to errors and alarms.