Physicians at Johns Hopkins University and engineers at JHU Applied Physics Laboratory (APL) are studying ways to apply systems engineering principles to improve the safety of infusion pumps. According to FDA, there have been 710 reported deaths linked to infusion pump malfunctions over the last 5 years and 87 recalls likely an underestimate given that most deaths aren’t reported as a device malfunction.
Infusion pumps are used in nearly every healthcare setting to provide critical fluids to patients including insulin to diabetics, liquid food to patients unable to eat, chemotherapy medications to cancer patients, and anesthetics via epidurals to women giving birth. However, the devices which often have a computerized screen and a number of parts are prone to mechanical and electronic malfunctions as well as user errors.
Peter Pronovost, an anesthesiologist and critical care physician at Johns Hopkins Hospital and Director of the Quality and Safety Research Group, Pete Doyle a member of the Hopkins Hospital’s Clinical Engineering Services, and Alan Ravitz an engineer in APL’s Biomedicine Business Area, have initiated a pilot program that pairs a healthcare delivery team with systems engineers to address the problem.
The project is still in its early stages and is now identifying stakeholder communities and subject matter experts, conducting literature searches along working to improve the infusion pump requirements in terms of design, implementation, testing, fielding, and support. The team has already identified several specific areas of systems engineering that if applied could help to improve patient safety.
The goal is to align the design of infusion pumps with clinician workflow which is one of the areas that FDA notes as a failing in today’s infusion pump designs. The engineers are also working to automate the system so that manual data entry is minimized, develop less ambiguous human computer interfaces, and provide for tighter integration with medical information management systems within the clinical setting.
Dr. Pronovost said, “We are asking clinicians to do a Herculean task that requires them to compensate for poor system design. Instead of telling clinicians to be more careful, we should design products that are easier to use.”