John BethuneTwenty years ago, Medical Device & Diagnostic Industry (MD&DI)—then, as now, the leading publication for medical device manufacturers—published a seminal article by William Hyman. Titled “The Issue Is ‘Use,’ Not ‘User,’ Error,” the article introduced a key term in medical technology design and management. Rather than blaming problems with equipment on “user error,” Hyman wrote, device makers should keep the focus on usability instead, by preferring the phrase “use error.”

As the editor of MD&DI at that time, I was present at the creation of this key terminology. Unfortunately, while much progress in human factors design has been made since then, the tendency to blame users for what is actually bad design still exists 2 decades later. This was recently brought to my attention by two 24×7 readers—one of them Hyman—in response to a recent recall of MRI machines by GE Healthcare and last month’s article on infusion pump management.

Hyman has addressed the usability issues involved in the MRI recall in an article on this website. But in the meantime, I want to address a broader issue. We know what manufacturers can do to improve the usability of their devices, through good human factors design. But what can HTM professionals like you do to deal with the problem of “use error”? To find some answers, I spoke to Hyman and a number of other notable HTM veterans.

What You Should Know

Kelly Wright, CBET, RRT, is an assistant director at Crothall Healthcare and has written on this topic for 24×7 in the past. He told me that an understanding of human factors is of the “utmost importance.” Usability, he added, is not only a safety issue: “Subjectively and objectively, there is a very large portion of work orders caused by human error that are not detrimental to the patient but definitely contribute to the creation of work orders for biomeds,” he said. “One of the Environment of Care stats we report is user error and how we manage it and deal with it. We are charged to reduce that number from a contractual standpoint. So it reduces equipment issues as well as improves user satisfaction.”

Binseng Wang, ScD, CCE, of the Milwaukee School of Engineering’s Biomedical Engineering department, noted that problems involving human factors are the “number one cause of use errors.” User errors are, in turn, the leading cause “for all patient incidents involving medical equipment (and devices in general).” Because “CE professionals are (or should be) always involved in device incident investigations,” he told me, a good knowledge of human factors is important “to determine the right root causes of those incidents and find solutions to avoid future occurrences.”

Not least important, Hyman stressed, an understanding of human factors is essential for biomeds “to avoid disparaging users (even when talking among themselves) and to instead think about why the error was made.”

What You Can Do

Although reducing use error begins with good design by the manufacturer, there is plenty that biomeds and clinical engineers can do to mitigate problems related to human factors. As Scot Copeland of Scripps/Mercy Hospital puts it, “biomeds are often the first to connect device-related clinical issues to a product design, and can provide input to immediate educational interventions in the clinical environment.”

According to Frank Painter of Technology Management Solutions and the University of Connecticut, it is the job of biomeds to figure out whether a device under consideration for acquisition “is easy to use or not.” If it is easy to use, he said, “then it’s a device they should acquire for the hospital.” But if it’s difficult to use and could cause operator error, the role of the biomed is to make a case against buying it. The equipment selection stage, Hyman added, “is a good time to be the pessimist.” This is when biomeds should “actively ask what mistakes might the user make when using this device as compared to other available designs that have the same technical performance,” he said.

Dennis Minsent, president of Healthcare Technology Management Solutions, stresses the importance of observation of users in assessing the source of problems with devices. “Understanding how a device is intended to be used,” he told me, “and then watching nurses using the device can lead to identification of potential problems.”

Giving Feedback to Manufacturers

As Wang notes, because device manufacturers perceive HTM professionals as “people with little or no influence on purchasing,” they “are seldom invited by manufacturers to provide feedback about their products.” Wright suggests “networking through proactive relationships with OEM service reps and salesmen,” which he told me has led to “limited success” in “politely pleading my case for product design change.”

A more aggressive approach is to file a complaint via FDA’s Medical Device Reporting system for healthcare professionals and device users, MedWatch. In addition, Painter suggested, biomeds may want to work with their hospital’s risk managers to reach out to device makers.

Ultimately, of course, the usability buck stops with the device maker. But armed with a good knowledge of human factors, there is much that HTM professionals can do to reduce use-related problems with devices. As Hyman urged 20 years ago, the first step is how you speak about the problem: not user error, but use error.

 John Bethune is editorial director of 24×7. Contact him at jbethune@allied360.com.