TRENDS
Fit for Human Use Providers need safety and efficacy in medical products and equipment. Add usability, and you’re that much closer to a sale. Pharmaceutical labels and packaging that look so much like others, patients get the wrong medication. An insu-
lin pump that’s difficult to program or calibrate. Blood pressure tubing that is erroneously connected to an IV catheter, resulting in a fatal air embolus. These things happen, usually chalked up to “medical error.” But who’s responsible? The nurse? Pharmacist? Respiratory therapist? How about the manufacturer?
The fact is, manufacturers of medical devices and equipment jump through hoops with the FDA to demonstrate their products are designed with “human factors” in mind. It’s called “human factors engineering.” Basically, it refers to the ease of use of a medical product, device or piece of equipment. It’s an important point, because if it’s not easy to use, someone’s going to get hurt, either a patient or a healthcare worker. For that reason, human factors engineering – though an unlikely tagline – can be an important selling tool for medical salespeople.
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February 2022
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Warm and fuzzies? Making something usable isn’t about warm-and-fuzzy addons. Rather, usability is designed into the device. In fact, the U.S. Food and Drug Administration has a definition for human factors engineering and usability engineering: “The application of knowledge about human behavior, abilities, limitations, and other characteristics of medical device users to the design of medical devices including mechanical- and software-driven user interfaces, systems, tasks, user documentation, and user training to enhance and demonstrate safe and effective use.” Patrice Tremoulet, PhD, human factors scientist for ECRI, says she would add the word “comfortable” between “safe” and “effective.” “Clinical users (and patients) need to be able to use things not only safely and effectively but also comfortably, otherwise you set them up for either repetitive stress injuries or inadvertent misuse during times of fatigue.” “No product development occurs where the goal isn’t ease of use,” says Mary Beth Privitera, PhD, FIDSA, professor of biomedical engineering at the University of Cincinnati and co-chair of the Association for the Advancement of Medical Instrumentation (AAMI) Human Engineering Committee. “But sometimes it gets lost.” Often that’s because the people designing medical devices aren’t the ones practicing medicine. The FDA and industry groups feel a special urgency today to prevent that from happening. “Use errors caused by inadequate medical device usability have become an increasing cause for concern,” write the authors of the international standard IEC 62366, which specifies how manufacturers should analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. “Many of the medical devices developed without applying a usability engineering (human factors engineering) process are non-intuitive, difficult
