When the human factors specialist becomes the patient
Regulatory Updates | Combination Products, In-Vitro Diagnostic Devices, Medical Devices
EMERGO BY UL SUMMARY OF KEY POINTS:
- Medical devices engineered and designed for clinical end-users often overlook the factor of patient experience.
- HFE and usability professionals should consider the impact of their designs not just for clinicians but also patients on the receiving end of such devices.
- Designing devices and systems that better foster positive patient experiences deserves closer attention.
I just had a baby – my second daughter. This means that, like over 98% of my fellow American moms-to-be, I checked into a local hospital to have nurses and doctors oversee what I hoped would be the smooth delivery of my baby. This entitled me to the firsthand experience of being hooked up to beeping machines and surrounded by clinicians; of being the patient. Spoiler Alert: it wasn’t all smooth sailing.
Having spent over a dozen years applying human factors engineering (HFE) to various medical technologies, I saw many familiar [user inter] faces. A fetal and maternal monitor, infusion pump, baby warmer, sophisticated hospital bed, and an electronic health record system – just to name a few. And, because I was being induced, I had plenty of time to (subtly) inspect, (silently) critique, and (not so silently) be pestered by these devices. I asked the nurses a few questions and they tolerated me sharing some unsolicited feedback about the products, but I mostly internalized my observations and saved key points of commentary for my husband, who I know truly appreciates my HFE “perspective” on various products and processes.
End-users versus patients
Among a chorus of beeping devices, I waited for the contraction-inducing meds to kick-in. It occurred to me that when I work on medical devices intended for use in clinical environments, I tend to focus on the devices’ end users – clinicians. I think about whether these individuals will be able to use a given device safely and effectively during setup, troubleshooting, etc. But, I quickly realized that a clinical-use device’s usability and clinician’s ability to use a device properly has a substantial impact on the patient.
Despite my extensive professional exposure to medical devices, being a patient was surprisingly unnerving. The medical device issues and potential use errors I witnessed during my brief hospital stay ranged from simply annoying, to potentially risky, to painful. For example, the fetal/maternal monitor’s transducers, wrapped around my belly with a stretchy fabric belt, kept slipping. Despite the fact that walking and changing positions are typical labor activities, it seemed that any movement led to a “lost connection” alarm. In some cases, a nurse came in relatively quickly, presumably notified by the central monitoring system at the nurse’s station. Other times, I had to call a nurse and ask them to assess and troubleshoot the system. I couldn’t help but wonder – isn’t it possible to design a medical device such that patients don’t have to monitor their own alarms?
Alarms as distractions
At some point, the infusion pump delivering the Pitocin issued an “air-in-line” alarm, a scenario I’m all too familiar with from having evaluated various infusion pumps. The warning message, which wasn’t specifically labeled on-screen as a “warning” requiring resolution, suggested that there might be an upstream occlusion and indicated checking for kinks and clamps. I resisted the urge to fix the issue myself and, again, called the nurse. It’s not that I was being nosy – quite the opposite. I was trying to mind my own business and help the time pass by watching television, but the flock of devices around me kept calling for attention. And, the infusion pump was less than a foot from the bed, oriented such that I could easily read the screen.
Use error and its aftereffects
As things progressed, I found myself on the receiving end of an unfortunate use error. I was briefly elated – and then immediately horrified – when my epidural catheter was placed, but only half of my body became numb. Trust me, you never want to hear an anesthesiologist say “epidural” and “ineffective” in the same sentence. The “harm” of the use error was pretty clear – unmitigated pain – but the “root cause” was not. All I knew, and all the clinicians knew, was that something didn’t go as expected during the epidural placement. In the name of identifying the cause – or at least resolving the issue – the nurse changed my position, adjusted the spinal catheter, and told me to simply wait. I kept waiting… and waiting… watching the clock and hoping I would feel the tingly sensation set in, but I never did. Rather, my baby girl made her rather painful entrance a few minutes later. Some clinicians and medical device manufacturers might readily accept that use errors happen and sometimes interventions like epidurals fail. However, my brief stint as a patient quickly increased my sense of responsibility to advocate for an optimized patient experience in addition to the clinician experience.
Reconsidering the patient experience
I would venture to say that only a modest percentage of individuals involved in medical device development have been the “benefactors” of an overnight hospital stay, encountering devices and user interactions that go beyond a routine check-up or maintenance visit. Don’t worry – I’m not about to recommend that people go out of their way to be admitted to a hospital. But, my experience quickly convinced me that it’s essential to look beyond the most obvious end-users of clinical use devices – namely, clinicians – and consider the impact device interactions and issues have on patients. Hearing a nurse say “that alarm always happens” or watching him press “silence” repeatedly isn’t comforting when you’re the patient. What is comforting is being treated and/or monitored by devices that facilitate safe and effective use by clinicians, leading to a smooth and comfortable patient experience. Characteristics of a positive patient experience will vary for specific devices and patients, but I’d wager that as a starting point, designing devices that are generally quiet, that call for attention only when a true issue arises, and that enable clinicians to do their job quickly, effectively, and confidently will go a long way to ensuring patients perceive high-quality care in addition to receiving it.
Allison Strochlic is Research Director at Emergo by UL's Human Factors Research & Design.
Learn more about human factors engineering and usability at Emergo by UL:
- HFE user research support for medical devices and IVDs
- Human factors design and prototype development
- Medical device usability training and consulting
- Webinar: Human factors engineering for medical devices