Hfe Principles To Strengthen Technology Management

BEST PRACTICES

Using Human Factors Engineering Principles to Strengthen Technology Management Jill Schlabig Williams Subject: Beaumont Hospitals Locations: Royal Oak, Troy, and Grosse Pointe, MI Size: A three hospital, regional healthcare system with 1,696 licensed beds Staff: In-house clinical engineering department includes four clinical engineers, a human factors engineer, and a director with a clinical engineering background.

related recalls we received annually from FDA were due to these design problems. We knew that many of these recalls could be prevented with better designs.” The department wanted new equipment evaluations to go a step beyond electrical safety inspections and other traditional methods to examine the way users interact with equipment. “We wanted to see if there was a better way to evaluate equipment and choose the best products for our facility,” Gieras says.

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Solution

ow can the principles of human factors engineering be used to improve healthcare technology management? This is the question that Izabella Gieras, director of technology management with Beaumont Hospitals, began asking several years ago. The question has led her and her team in unexpected directions, including revamping many of the services their department offers, building a partnership with FDA to improve device safety, and launching a consulting firm—the Beaumont Technology Usability Center (BTUC)—that provides user-interface design and evaluation services to medical device manufacturers and software companies. Along the way, Gieras has strengthened her department’s services and improved patient safety facility-wide.

Gieras turned to the principles of human factors engineering (HFE) to help with equipment evaluations. “HFE looks closely at the user-device design interface,” she says. “Design is so important; the user-device interface should be as intuitive to a user as possible.” For example, on a defibrillator, if the on/off button is too close to the pacing buttons, it increases the likelihood that a caregiver may deliver an unintended shock to a patient. She discovered many resources on the topic, including materials from the Human Factors & Ergonomics Society, AAMI, FDA, and other resources. Department staff began applying these principles to their work and building a case to bring a human factors engineer on staff. Two years ago, they received approval for the new hire and found Lisa Clinical engineer Brian Vargo and Izabella Gieras conduct an infusion pump evaluation. Lau, a human factors enChallenge gineer who had been with When Gieras joined Beaumont as a clinical engineer eight the VA’s National Center for Patient Safety (NCPS). years ago, she was involved in new equipment evaluations Lau did not initially intend to work in the mediand device recalls. “As we scrutinized new equipment for cal field. She was earning a degree as a human factors possible purchase, we would identify design flaws,” she engineer when she began working at NCPS, and found says. “We also saw that about 44% of medical device- that HFE principles and medical technology were a Biomedical Instrumentation & Technology

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BEST PRACTICES Using Human Factors Engineering Principles to Strengthen Technology Management

natural fit. “The importance of human factors principles in medical equipment design, use, and management is growing quickly, but most clinical engineers don’t have HFE training in their background,” says Lau. Initially, Lau’s role was to work with BTUC, which focuses on helping manufacturers improve their device design. But once she was on staff, Lau’s expertise quickly became invaluable to Gieras and the other clinical engineers, and they began to apply HFE principles in all of their work. The most obvious application of HFE principles has been in the equipment evaluation process. “Before, our equipment evaluation process was very traditional, focused on bench testing, including electrical safety testing and other traditional equipment assessments, such as clinical trials,” says Gieras. Now, the principles of human factors engineering are infused into every step of the process, from bench testing and working with clinicians to choosing new equipment and long-range strategic equipment planning. When a new device is under consideration, Lau first looks at the user-device interface to identify any potential problems. A device evaluation checklist is used to ensure that the interface is user-friendly and that the device will work in its intended environment. Next, extensive user testing is conducted on the device. “The human factors philosophy is to get a device in front of users,” says Lau. She points out that you can identify 80% of potential problems with a checklist, but to get the real picture you have to watch a user interacting with a device. The clinical engineering team first identifies the potential end users of a device, and then sets up a test scenario in which they create a specific protocol for clinicians to follow in interacting with the device. They take the devices into the environment in which it will be used, and watch the users interacting with devices, observing and listening to identify potential problems. Although no device can be perfect, this process lets them choose the best device for their environment. Beyond equipment evaluations, Beaumont’s clinical engineering department has gotten involved in several other new projects as a result of their focus on human factors engineering. They are now conducting a workflow project with the nursing staff, examining the way the nurses use diverse communications technologies like low powered phones, pagers, Vocera two-way communication badges, 212

and other technologies to manage alarms from different medical technologies, with the intent to improve patient care delivery. “There is a human factors issue of how much a clinician can handle with regard to receiving and responding to alarms,” says Gieras. Gieras’ group, in collaboration with the Education Department at Troy and clinicians from Royal Oak, is also working with FDA on a project to reduce misconnections of catheters and other types of tubing. In addition to conducting a prevalence study, they have developed a list of different types of potential misconnections, created educational materials, developed a rating scale to classify severity of misconnections, and suggested factors that clinical engineering departments should consider in evaluating new disposable products through product simulations and usability testing. Human factors principles are being applied in Beaumont’s incident investigation program, looking at adverse events from a design perspective. Gieras’ team is applying HFE principles to construction projects in the areas of space planning and ergonomics. The department is also putting together a human factors course that will be delivered to Beaumont clinicians.

Results

How many lives have been saved by using human factors engineering principles to reduce errors at Beaumont Hospitals? “The ultimate numbers, in terms of lives that have been saved, will never be known,” says Gieras. “Our case studies provide solid data of our success. Continued improvements in the HFE program will also focus on tracking medical device incident reports on those devices that went through the human factors group, to see how much it reduced adverse events.” Overall, modifying the testing process has had a positive impact on medical technology’s safety and effectiveness in the hospital environment. The department will continue to infuse HFE principles into the diverse patient safety and process improvement initiatives across all three campuses and through the BTUC. n Jill Schlabig Williams is AAMI’s senior writer.

Device Evaluation Checklist

Visit BI&T Extra at www.aami.org/BIT to view a version of the device evaluation checklist used by Beaumont Technology Usability Center.

May/June 2008