It is probable that few biomeds have met a human factors engineer, but this group is becoming a key element in making the ­simplest to the most complex medical equipment safer and easier to use.

Though it is new to the medical equipment field, human factors engineering was born more than half a century ago. During the Second World War, cognitive psychologists and others pioneered human factors engineering by improving aircraft design and use. The field expanded to include many other areas—manufacturing, business, and education—but it was not until the early 1990s that health care began to see human factors engineering entering its antiseptic halls.

And while medicine may have come to the human factors engineering game late, it quickly saw the benefits of making equipment easier and safer to use for clinicians and patients—and better to maintain.

A New Field

Human factors engineering evaluates aspects of a piece of equipment from minor aggravations to the confusing to the odd. The consequences of any of these impediments to use can be serious. “The minor annoyances and oddities can be tragic in a health care setting,” says John Gosbee, MD, MS, human factors engineering health care specialist at the University of Michigan.

Gosbee knows from experience the potential for tragic errors. Because of food allergies, his daughter has to have regular ephenephrine injections. This means that on an almost daily basis he has to educate her caregivers about the injector. The injector is poorly designed, according to Gosbee. Both ends look as if they inject the life-saving drug. This has given him an interesting perspective on his profession. “When you start to live it—it takes on an interesting [role in your life],” he says.

The role of the human factors engineer is to evaluate medical products in a very particular way. “It’s all about getting inside the head of the novice,” Gosbee explains.

But that is only the beginning. Once the initial evaluation is completed, identifying areas that might be irritating or confusing, or ultimately dangerous for a patient or a user, the human factors engineer looks at ways to improve the device. It can be as simple as making its label easier to read or finding a better way to hold it.

However, after the device has been purchased by a hospital, there is little the human factors engineering department can do to improve it. Typically, Gosbee, who also has his own human factors engineering consulting company, has to help a facility cope with equipment issues after the device is purchased.

In many cases, he has to help clients learn to use the device as it is. For instance, he has had experiences with intravenous infusion pumps that have been hard to program, particularly in the more advanced settings. In this case, he advised the hospital to discontinue training all of the nurses on the advanced functions of the pump—since only those in more critical care areas needed to know how to use it in the hard-to-function mode. In other cases, there were pumps that were difficult to hang and easy to drop—resulting in a predictable 10% loss every year. “In this case, we’re planning for the biomed,” Gosbee says.

While some hospitals have to bring in human factors engineers to help them cope with equipment after purchase, other organizations use their human factors engineers to identify problems before the equipment is acquired.

Planning Ahead

Human factors engineering continues to be an important addition to the clinical engineering department at Beaumont Hospitals, Royal Oak, Mich, greatly impacting the safety and effectiveness of the overall Beaumont organization.

“About 3 years ago, we established the Beaumont Technology Usability Center, now called the Beaumont Commercialization Center, to further emphasize the needs of the human factors applications to equipment evaluations, risk management, and design,” says Izabella Gieras, MS, MBA, CCE, director of technology management for Beaumont Services Company LLC. “We realized that this undertaking would support our goal of safe and effective devices for patients and clinicians.”

About 2 years ago, Beaumont Services Company—responsible for the design, construction, facilities management, and medical equipment needs of Beaumont Hospitals—hired a human factors engineer, who, along with the clinical engineers, helps to evaluate the equipment that is presently in the hospital and, more importantly, all of the equipment that the hospital plans to buy.

A system evaluation includes an overall look at how well the system of devices would function in a hectic clinical environment, as well as a detailed inspection of the design elements.

“We focus on all of the relevant details, especially the user interface,” Gieras says. “This includes analyzing the shape and position of every button, and even the fonts used on labels.”

The human factors and clinical engineers also work directly with medical device manufacturers to enhance product designs.

Over the last 2 years, Gieras and her team have developed an extensive testing regimen for any device that the hospital plans to purchase. First, the team compares the technical and clinical specifications for the devices they plan to consider, including parts and maintenance issues. Once the options are narrowed, the remaining devices are tested in the hospital. It is rare for only a single vendor to be considered, so usually two or three similar devices are tested and compared at the same time.

In the course of a typical 2-week “clinical trial” they evaluate and test everything about the device. The human factors engineer primarily looks at issues of usability—is the device operation logical and intuitive? Is the device simple to use, with a visual and legible layout? If there is a problem, are the warning systems adequate? If an input error is made, can it be undone? The environment that the device will be used in is also an important factor that is considered. Will the device primarily be used in a well-lit room, or a setting that is excessively hot or cold?

During this due-diligence process they also perform a simulated usability test to evaluate how effective the device is and how intuitively one can use it. Designed by the human factors engineer, the test gives two to three clinicians a set of tasks of varying difficulty, which they perform using the device.

After the 2-week trial, a multidisciplinary team of engineers, administrators, clinicians, and others gather to compare findings. The results can be surprising. “The design might look great on paper, but a thorough clinical evaluation can expose [problems],” Gieras says. “The reason why human factors engineering is good is the comprehensive approach.”

By being comprehensive, the human factors engineer has to be part psychologist, part engineer, part naïve user—in short, a sort of detective.

Proactive Investigation

As Peter A. Doyle, PhD, clinical engineering services, The Johns Hopkins Hospital, Baltimore, describes the role of the human factors engineer, it is hard not to think of Sherlock Holmes. “The methodology of the human factors engineer identifies the factors that impact human usability,” he says. “The methods we use are deductive, predicting the eventual failure of a device, and inductive, looking at the failure modes and what might occur in the hardware and in anything in the system, equipment, workplace, or human cognition. It’s a big what-if game.”

Unlike the traditional detective who waits to solve the “crime” after it happens, Doyle is proactive—always on the prowl for devices that may be suspect. For instance, he has examined the infusion pumps used at Johns Hopkins “because of events” that have occurred, he says. Doyle meets weekly with the hospital’s medical equipment improvement committee. The group is proactive and reactive—looking at equipment that may be culprits in the future and those that are already having usability problems.

The Committee also evaluates every piece of equipment that comes into the building. When Doyle examines a piece of equipment, he does so using a task analysis. This involves putting the equipment through a battery of tests from static analysis—looking at buttons, labels, controls, and on-screen menus to more dynamic tests. “We take each task and convert it into a verb,” he says.

Doyle says that he is dependent on every member of the clinical team to evaluate the effectiveness of the equipment. This group includes biomeds. “The biomeds have good diagnostic skills, they are analytical, and help improve safety,” he says. “Our biomeds log and identify issues—playing a role in patient safety at all levels.”

For hospitals that do not have a human factors engineer on staff, Doyle adds that the biomed could double in this role, since they typically track maintenance and other issues to a satisfactory resolution.

Doyle’s work is designed to help Johns Hopkins’ biomeds. For instance, he has worked extensively to identify maintenance issues with the hospital’s anesthesia machines and ventilators. “I’ve worked on preventive maintenance, determining if procedures are well-written and complete, that the equipment is properly calibrated, and that it has proper legends and visual cues,” he says.

While human factors engineering is fairly new to the medical field, Doyle notes that, unlike the nuclear power industry and other sectors, there has been no requirement that it be included in hospitals or other health care facilities. “It’s not regulated at all in medicine; it’s being done to improve safety,” he says.

But the hospital is not the only place that has human factors engineers. Manufacturers of medical equipment also rely on them to make their equipment safe and useable.

The Manufacturer

The role of the human factors engineer in the manufacturing process is as a sort of guide whose role is to keep the idea of usability at the forefront. Edmond W. Israelski, PhD, human factors program manager, Abbott, Abbott Park, Ill, has three roles at the company, which produces medical devices, pharmaceuticals, and nutritional supplements.

His first role is writing and promoting corporate procedures. His second is presenting classes on human factors engineering, including workshops on running usability tests, and conducting human factors risk analysis. Finally, and most importantly, he works with the development teams to act as a human factors engineer or—for large projects—to help them select the consultants to assist them in this area. He is responsible for writing the guidelines these consultants will work under so they do projects the “Abbott way.”

Some recent work has been with using human factors engineering to improve packaging and labeling safety and usability. He also is involved with tracking customer feedback about Abbott’s products—one of the metrics that shows whether the design teams are being successful from a human factors engineering perspective.

The process has been a success. For example, while many hospitals regularly complain about infusion pumps, Abbott used human factors engineering processes to develop a new one, which has already received two prestigious industry awards for its user interface. This product is now offered by Hospira Inc, which was spun off from Abbott several years ago. “We shadowed nurses and clinicians and noted what worked and what didn’t,” Israelski says, explaining the process he and the team used to help develop the new device. “What we produced was large color displays with touch screens that took advantage of user feedback.”

The pump went through 12 rounds of usability studies, resulting in a device with powerful software that is highly usable.

While it is sometimes difficult to put numbers on the effectiveness of human factors engineering, Israelski points to the fact that the return rate for many of Abbott’s products is low. “Part of the value of human factors engineering is the reduction of product returns and the savings associated with that,” he says.

Israelski looks at human factors engineering in a more specific way. “Sometimes it’s called user-centered design, which means that the data that we gather is incorporated into the engineering requirements and then tested for usability,” he says.

In fact, users are involved at many levels of the design process at Abbott. “Everybody has a role to play in the company and the process,” he says. “Biomeds, for instance, are another important user category. They set up the equipment and maintain it—that’s just another user interface, among many others which might include patients, lab technicians, and clinicians.”

A New Wave

The increasing use of human factors engineering and its success is the signal of a sea change in the medical field as a whole. Gosbee cites several factors that signal that the environment has been fertile for the growth of human factors engineering. The first is the growth of the patient safety movement. “It’s becoming a subject in medical schools, and end users are becoming savvy about design and safety,” he says. In fact, about one-tenth of all medical schools have a human factors engineering component.

Read more about Beaumont’s center in the July 2006 cover story.

The second is the FDA’s promotion of human factors engineering, which means that manufacturers will have the tricky task of working with the federal government to bring safe and profitable equipment to market.

Gosbee has seen firsthand how the demand has grown. “The amount of people that are calling me now has doubled in the last 5 years, and that’s double the amount of people who called me 10 years ago,” he says. “The number of people who are cold-calling me has increased tenfold in the last 2 years.”

Human factors engineering may not be a household term—yet—but human factors engineers are sure to become important members of the team biomeds interact with on a daily basis.

C.A. Wolski is a contributing writer for 24×7. For more information, contact .