First, Do No Harm: Making Infusion Pumps Safer Jody Lannen Brady fficially, artist Andy Warhol died from cardiac initiative, is “to support the benefits infusion pumps can arrhythmia, a complication after “routine” gall- provide while reducing associated risks.” While manu- Obladder surgery in 1987. But his family won facturers have already introduced some design changes millions in a lawsuit against the New York City hospital to cut down on errors, all parties agree that more needs where he underwent his surgery by successfully arguing to be done. that the arrhythmia was a result of water intoxication An estimated 90 percent of hospital patients receive an caused by faulty administration of an infusion pump. infusion as part of their treatment.1 The pumps deliver Other infusion errors and pump failures—from opioid nutrients and medications like pain killers, antibiotics, overdoses, to battery malfunctions, to software errors, to and chemotherapy drugs that can mean the difference dosage miscalculations—may not make the headlines, between life and death. But the powerful medications can but they seriously threaten the health and well-being of cause serious harm, even death, if improperly delivered. patients. The particularly bad news for patients is that Healthcare providers, clinical engineers, and manu- these are far from being isolated cases. After receiving facturers have long been aware of a disturbing trend in 56,000 reports of infusion pump incidents—including errors and faulty performance associated with infusion 710 deaths—and issuing 87 infusion pump recalls be- pumps. Seven years ago, a Massachusetts General Hos- tween 2005 and 2009, the U.S. Food and Drug Admin- pital infusion pump task force reported that “compelling istration (FDA) has initiated a sweeping program aimed incidents and near-misses motivated the formation of at preventing infusion pump problems and improving our team, and led to the devotion of significant energy patient safety. to preventing IV drug administration errors.”2 Twelve The goal, according to an FDA white paper on the years before that, a Harvard Medical Practice Study re- ported that infusion errors and drug complications were Jody Lannen Brady is a freelance writer the most common type of preventable adverse events based in Philadelphia, PA. E-mail: jody. reported in hospitals.3 [email protected] Until recently, end users—nurses and doctors backed by pharmacists—bore the burden of performing complex mathematical conversions of dose rate units into fluid- flow units. And if a busy floor nurse programming an IV 372 September/October 2010 COVER STORY Jody Lannen Brady First, Do No Harm: device at a patient’s bedside missed a decimal point or that manufacturers redesign intelligent pumps to focus accidentally double-pressed a key, the resulting dosage on user-defined, rather than vendor-defined, features. error could be fatal. “They recommended such functionality as teaching “Smart pumps,” complete with onboard drug libraries prompts embedded in pump controls; standardized field and dose-monitoring capabilities, were seen by many as names and dose expressions that match infusion order- the best hope to address the problem. By 2005, almost writing conventions; a pump programming sequence that one-third of hospitals had begun using smart pumps; matches the medication order sequence; and the ability four years later, more than half of the nation’s hospitals to back out of a wrong action,” explains Bona Benjamin, reported adopting the technology.4 But, as current FDA director of medication-use quality improvement at the statistics point out, nascent “smart pump” technology ASHP. “It’s puzzling that such features are not available hasn’t proven a panacea for infusion pump problems. now—or why users do not perceive them to be available. “You can still hang the wrong bag on a device and the Apparently many infusion devices are not as ‘usable’ as machine would never know,” says Marla Husch, a patient they need to be. Why not?” safety expert and project manager at Central Dupage So what’s the answer to this complicated problem? Hospital in Illinois. Previously, Husch was the project Well, not surprisingly, it’s complicated. manager responsible for implementing the conversion to smart pumps at Northwestern Memorial Hospital. What Went Wrong? “Infusion pumps that perform as stand-alone devices— For starters, experts believe that infusion pump problems no matter how ‘smart’ they are— simply leave too many are compounded by inaccurate reporting of root causes. gaps,” Husch explains. “We do not have a valid analysis of the 56,000 reports A 2005 Northwestern Memorial study led by Husch of problems with infusion pumps,” says Nat Sims, MD, reported that more than two-thirds of the infusions ob- a physician advisor to Massachusetts General Hospital’s served by investigators had one or more errors associated Biomedical Engineering Department. Raw data submit- with their administration. Only one of the 389 errors ted by hospitals, manufacturers and others has proven could have been prevented by smart pump technology.5 “difficult to analyze—even by FDA analysts—to catego- At its July 2008 Safety Summit, the American Society rize primary and secondary causes,” Sims explains. of Health-System Pharmacists (ASHP) recommended FDA experts agree with Sims that discerning the cause Biomedical Instrumentation & Technology 373 COVER STORY First, Do No Harm: Making Infusion Pumps Safer We are only at the ment that is rife with distractions and simultaneous de- “beginning of what will be a lengthy process mands on the caregiver for multiple interactions with the of focusing on infusion pumps and on patient surrounding technology,” says Scales. And with increas- safety when patients are receiving IV infusions. ingly complex technology that requires more interaction Since infusion pumps are used in so many on the part of a clinician, errors become more likely. settings and in almost every hospital bed, many “We well know that no one wants to make errors, but changes will no doubt be forthcoming the environment we place our caregivers in frequently in the next few months and years.” predisposes them to become distracted, take shortcuts, or utilize work-arounds that lead to error-prone behavior.” —Nat Sims, MD, Many of these errors are flagged by an alert message, Massachusetts General Hospital but that doesn’t necessarily mean that the problem will be fixed. “During high stress, these messages are sometimes cleared without correcting the error,” says Scales. “Post- event analysis and user interviews frequently reveal that of pump failures and use errors is the first step to improv- users were completely unaware of having passed by the ing the safety of the devices. At a public meeting con- alert.” vened by the agency in May, Division of Electrical and Clinicians override some 90 percent of alerts, accord- Software Engineering Director Al Taylor explained that ing to Husch. Some of the alerts get ignored because cli- “many failure investigations reported by pump manufac- nicians are overtaxed, but others just “don’t make sense,” turers have misidentified the root cause of adverse events she says. In some dosage situations, alerts are automatic. as ‘use error’ or ‘random component failure.’” “They know that they’re going to get an alert every time FDA-run investigations have reached a different in that situation and that they’re going to override it ev- conclusion. “Many adverse events are caused by design ery time, so they become completely desensitized to all deficiencies that were foreseeable and preventable. Pump alerts.” deficiencies place an undue burden on users, caregivers, “When a system is designed in a way where there is and support staff, adding to an already stressful environ- a potential for errors, there will be,” says Tony Easty, ment,” said Taylor. senior scientist with the Centre for Global eHealth In- Pat Baird, a principal project engineer at Baxter Inter- novation in Toronto. “Training someone not to make national Inc. and co-chair of the AAMI Infusion Device mistakes isn’t effective. You can’t do it. We’re humans, Committee, says infusion pumps shouldn’t be looked at not machines. We’re not programmed to do the right in isolation. “The industry must look at infusion systems thing every time.” holistically, as part of this ecosystem of patient care, to In a recent study looking at the impact of traditional effectively tackle the potential safety issues we all face,” and smart pump infusion technology on medication Baird says. (Read more of Baird’s comments in the Final administration,6 Easty’s group observed a trend: Problems Word on page 440.) most often occurred when multiple drugs and therapies At the Duke University Health System, patient safety were being administered. When nurses were asked to specialist Glenn Scales and his colleagues have seen “piggyback” a drug, they repeatedly made errors. Easty infusion pump incidents that range from inadequately has been talking to manufacturers about the problem, validated software errors, to defects in the manufacturing and a follow-up study has been planned to focus on the of IV administration sets due to environmental issues in issue of multiple lines. the manufacturing facility, to improper manufacturing of “The theory is that greater complexity causes greater the devices themselves. “More common problems,” says error,” Easty says. “Not much work has been done in the Scales, include entering dose values in the ml/hr field, area of multiple infusions, so none of our current tech- entering incorrect numeric values in the correct field, nologies really address this issue.” transposing digits when entering values, and substituting As infusion pump use rises with an aging population, decimal points for zeros when entering values because these issues will only multiply, says Frank Overdyk, they are next to each other on the keypad. MSEE, MD, a professor of anesthesiology at the Medi- “Our clinical staff work in a very demanding environ- cal University of South Carolina.