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Project 4. Safe Intravenous Infusion Systems
Intravenous medications are vital in the therapeutic management of hospitalized patients. Inpatients frequently receive several intravenous (IV) medications concurrently, and these are often delivered with infusion pump systems
In particular, critically ill patients frequently receive potent IV drugs that have narrow safety margins and require careful titration. Intravenous medications, especially continuous drips, are commonly managed with infusion pump systems. While these medications can be life saving, errors in administering them have a high risk for severe adverse events and have caused many fatalities.
Newer infusion pumps incorporate significant technologic improvements. Important safety advances include mechanisms to nearly eliminate the risk of free-flow, which has caused many fatalities. Other features include enhanced functionality, convenience and portability, but may also add complexity, resulting in potentially unsafe medication delivery. To attempt to "engineer out" errors, some of the newest infusion pumps have features including drug/dose calculations, programmable volume and time calculations, improved alarms and indicators, and most recently, inclusion of drug or patient-specific decision support capabilities.
Medication errors (MEs) associated with IV pump operations have received attention most often as individual case reports related to machine malfunctions. To our knowledge, there have been no prospective studies of the incidence and nature of serious MEs associated with IV infusion pump delivery systems. It is important to note that while such data are important, the FDA does not generally require them before approving devices, and such studies are thus rarely performed. This study will be performed in conjunction with Alaris, a company which has a strong commitment to improving patient safety, and they will commit substantial in-kind resources to the study.
We plan to study serious MEs associated with the use of IV infusion pump delivery systems in critically ill patients. Serious MEs are defined as adverse drug events (ADEs) and non-intercepted potential ADEs. In addition, we will conduct a prospective interventional trial to evaluate the impact of a "smart" infusion system on serious MEs. "Smart" infusion pumps have decision support capability and can provide real-time user feedback. Our study will be conducted in two phases in order to accomplish our two main aims:
Aim 1: To study the incidence and epidemiology of serious MEs associated with IV infusion pump delivery systems in critically ill patients.
Aim 2: To evaluate the impact of a "smart" infusion system on the incidence of serious MEs in critically ill patients; secondary outcomes will include mortality, length of stay, and total costs.
We hypothesize that: 1) serious MEs occur during the administration of IV medications via infusion pumps, and 2) serious MEs can be reduced with the use of "smart" pumps providing real-time, point-of-care feedback to bedside nurses.
