I am a healthcare consumer and caregiver. Last October, I was lucky enough to speak at the AAMI/FDA Healthcare Technology in Nonclinical Settings Summit. My panel focused on instructions for use (IFUs). My message, based on my frustrating and dangerous experiences using durable medical equipment at home, was this: You’re doing great work, but why isn’t it reaching me?
By you, I’m talking to the researchers, designers, biomedical and clinical engineers, psychologists, and manufacturers, all of whom are instrumental in the development, design, production, and maintenance of medical devices—along with the instructions that accompany them. I’m grateful for what you do. Many devices are literally life savers. But when it comes to the design of medical devices (and the clarity of instructions), I’m hearing about more good things than I’m seeing as a caregiver. In my presentation at the summit, I wasn’t just talking about IFU development and dissemination; I was also talking about human factors engineering, empathetic design—creating products that anyone can use and maintain. As I prepared for the meeting, my research revealed that rigorous work has been ongoing for at least 20 years. And more than ten years ago, the U.S. Food and Drug Administration developed pretty good guidelines for writing IFUs.
A friend I met about 40 years ago, David Pittle, was one of the first Consumer Product Safety commissioners. (He went on to head product testing at Consumers Union.) David advocated way back then that products need to be designed with the user in mind. He makes the same point today when talking about warnings on SUVs: To avoid rollovers, don’t turn the steering wheel sharply. Well, when that stove falls off the back of the pick-up in front of you, there’s just no avoiding turning that steering wheel sharply. What then?
I asked the question about the need for user-friendly medical devices and instructions back in October, but I haven’t heard any answers or explanations. What’s frustrating is the answers exist. You—the researchers, manufacturers, design experts, and others—know what needs to be done and how to do it. You know how people learn and retain information. You know the difference between user error and use error. Please, let’s also make it a priority to figure out ways to get all that wonderful empathetic design and user information to those of us at home—educated and undereducated, literate and illiterate, young and elderly, technology-savvy and don’t-own-a-smartphone (that’s me, by the way). I know there are ways. Is there the will?
Suzanne Steidl is the founder of Your Daughter’s In Town, an advocacy group for elderly patients. She sits on AAMI’s National Council for Healthcare Technology Safety.