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March 12, 2012

Problems at the Pump

soldier receives medical treatment
A nurse at Johns Hopkins Medicine shows a Johns Hopkins Hospital human factors engineer what she does when an alarm goes off on an infusion pump. Credit: Johns Hopkins Medicine

In mid-January, about 50 pharmacists, nurses, physicians, anesthesiologists, engineers, patient safety analysts, and human factors experts gathered at APL to explore ways to improve the safety of infusion pumps—the medical devices that infuse fluids, medication, or nutrients into a patient’s circulatory system. Held in the Warfare Analysis Laboratory, the meeting kicked off a $1 million grant from the Agency for Healthcare Quality Research to improve the safety of the devices.

Up to 90% of hospital patients receive infusions of nutrients and medication. But in 2010, after receiving 56,000 reports of infusion pump incidents (including 710 deaths) and issuing 87 infusion pump recalls over 4 years, the Food and Drug Administration launched a sweeping program to prevent infusion pump problems and improve patient safety.

“Based on the error reports, a key shortcoming of the devices is the poor human–machine interface,” explains Alan Ravitz, of the Research and Exploratory Development Department. “Clinicians often find themselves adapting their workflow to the designs of the infusion pump, as opposed to having the machines designed to clinician needs and workflow.” This, says Ravitz, is largely due to the limited preproduction usability testing and human systems factors engineering in the design of infusion pumps.

APL has teamed up with Johns Hopkins Medicine to explore technical solutions to improve the safety associated with medication infusion pumps used in clinical settings; Ravitz is the project’s principal investigator. “We are approaching this from a systems engineering perspective,” he explains. “This will allow us to quickly develop prototyping test tools—basically hardware and software in the form of flexible, working pump mockups—that can be reused by any organization seeking to improve the design of infusion pumps.”

The project’s key milestone was the January 10 workshop with infusion pump stakeholders to prioritize top patient safety issues associated with these medical devices. Their discussion was guided, in part, by an Infusion Pump Summit held in October 2010 by the FDA and the Association for the Advancement of Medical Instrumentation. Participants also considered work begun in 2010 by systems engineering experts at APL and Peter Pronovost, an anesthesiologist and critical care physician at the Johns Hopkins Hospital and director of the Quality and Safety Research Group, exploring ways that systems engineering can provide value to medical device design and safety in particular, and to health care in general.

Ravitz says the project team is synthesizing the information and will soon select a pump component or subsystem to prototype and then test. “We are not going to develop a complete pump system,” Ravitz says. “We are going to zero in on a specific function or functions that were identified at the workshop as a key challenge to patient safety.”

APL will develop the technical specs for the prototype, and Hopkins Medicine will recruit volunteer clinicians to “run the prototype through its paces.”

“There are many challenges to resolve, some technical, some non-technical; but that is part of the power of tackling this from a systems perspective—we can look at it holistically,” Ravitz says.