JHU Physicians, Engineers Apply Systems Engineering to Improve Infusion Pump Safety

FDA officials recently announced the creation of a new safety initiative aimed at improving the safety of infusion pumps — an area of concern that physicians at The Johns Hopkins University and engineers at JHU’s Applied Physics Laboratory (APL) in Laurel, Md., are already addressing by studying how to apply systems engineering principles to the problem.

Infusion pumps are ever-present in nearly every health care setting, providing critical fluids to patients, including insulin to diabetics, liquid food to patients unable to eat, chemotherapy medication to cancer patients and anesthetics via epidurals to women giving birth. But 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.

According to the Food and Drug Administration, there have been 710 reported deaths linked to infusion pump malfunction over the last five years, likely an underestimate given that most deaths from the devices aren’t reported as device malfunctions. From 2005 to 2009, there were 56,000 reports of infusion pump malfunction and 87 recalls.

Peter Pronovost, an anesthesiologist and critical care physician at the Johns Hopkins Hospital and director of the Quality and Safety Research Group, has long been watching the trend. He is the author of the recently released “Safe Patients, Smart Hospitals: How One Doctor’s Checklist Can Help Us Change Health Care From The Inside Out.”

Inspired in part by a 2005 Institute of Medicine report identifying engineering applications that could lead to improvements in health care delivery, he says he realized his work could be even more effective with the addition of systems engineers to his team. So last fall he approached APL about creating a strategic partnership between the medical experts at JHU and the systems engineering experts at APL.

Pronovost, along with Pete Doyle, a member of the Hopkins Hospital’s Clinical Engineering Services, and Alan Ravitz an engineer in APL’s Biomedicine Business Area, launched a pilot project to pair a health care delivery team with systems engineers.

“We looked at the entire human and technology process of medication administration via an infusion pump and explored the process in fine detail, starting from the physician creating the order to the medication actually flowing into the patient,” explains Ravitz. “We created a framework to identify device design and medical procedural changes to improve the safety of infusion pumps.”

The project is still in its early stages — identifying stakeholder communities and subject matter experts, conducting literature searches, and developing representative systems engineering artifacts that can be leveraged to improve requirements definition, design, implementation, testing, fielding, and support. But the early results are very encouraging. Already the team has identified several specific areas of systems engineering that if applied could help to improve patient safety.

“We are looking at aligning the design of infusion pumps with clinician work-flow, which is one of the areas the FDA noted as a failing of today’s infusion pump designs,” Ravitz says. “We’ve also indentified areas for infusion pump design improvements, including automation to minimize manual data entry, more fault-tolerant and less ambiguous human-computer interfaces, and tighter integration with enterprise-level medical information management systems within the clinical setting.”

Says Dr. Pronovost: “From infusion pumps to radiation therapy devices, we are asking clinicians to do a Herculean task: compensate for poor system design. Rather than telling clinicians to be more careful we should design products that are easier to use.”

While the team’s immediate focus is on infusion pumps, participants say the pilot project should contribute to the awareness that systems engineering can provide value to medical device design and safety in particular, and to health care in general.

“The current focus on the safety of medical infusion pumps is a great example of the vital role that systems engineering could play in improving the safety of our health care,” says APL’s Dean Calcagni, the director of strategic planning in APL’s Biomedicine Business Area. “Like chocolate and peanut butter, medicine and systems engineering is a great combination that has great potential.”