This month, ECRI released its annual list of the top ten health technology hazards for 2024. The list includes such varied threats as “insufficient governance of AI (Artificial Intelligence) used in medical technologies risks inappropriate care decisions” and “third-party web analytics software can compromise patient confidentiality.” I was most interested in the threat at the beginning of the list: “Medical devices may pose usability challenges for home users, risking misuse and patient harm.”
The fact that I co-wrote a book about usability and human-centered design might have something to do with my fascination with this ECRI-defined hazard. Yet I think there’s more to it than just that. It’s interesting to contemplate a dangerous usability issue that challenges home users while not necessarily causing problems for hospital professionals such as nursing staff. I tend to think of design concerns in a universal way: If the electronic health record (EHR) workflow is not intuitive, then it’s not intuitive. But I must admit that ECRI has a point.
Before digging in on medical devices that may have usability problems in the home, we should talk about why one might find said devices in the home. We don’t typically encounter IV infusion pumps or sophisticated monitors in a home environment. But they’re becoming more common because of the realization of the hospital-at-home concept. Let me explain.
Dear reader, you may remember this thing called the novel coronavirus. Or the global pandemic. Or COVID-19. Yes? Ring a bell? Well, the pandemic filled up hospital beds everywhere, causing problems cascading from the emergency department to the clinic to the home. Enterprising healthcare organizations were looking for ways to care for more patients than they could fit in their buildings, and the hospital-at-home idea gained prominence. It wasn’t brand new, to be sure. Many healthcare concepts, such as video visits with doctors or asynchronous communication via the patient portal, existed pre-pandemic but may not have been able to scale due to technology problems or regulatory or payer barriers. Those problems quickly became surmountable when society faced a global medical catastrophe.
There are many benefits for patients who may be safely cared for in their homes. Surely, we’re all much more comfortable in our typical surroundings. In fact, for the elderly, there is much less confusion at home than in a hospital room. For patients who are immunocompromised, it’s safer to be cared for at home because they are much less likely to be exposed to someone with a communicable disease. Depending on the specific needs of the patient, it can even be cheaper to be cared for in the home. Hence, if healthcare payers (both private and governmental) support hospital-at-home, it’s going to happen.
As ECRI points out in their report, there are multiple reasons why medical devices that were designed to be used in the hospital by physicians, nurses, therapists, and others with advanced training may be risky to be used at home. Clearly, we can and do train patients and their in-home caregivers how to set up and use things like IV pumps and ventilators. And under ideal conditions, things work out well. But if the caregiver is stressed (which is common) or if there are alarms going off on the devices, the human responses might be sub-optimal or even dangerous. While experienced professionals know which alarms need immediate responses, novice relatives of the patient likely do not. A lack of years of training and thousands of patient experiences can lead to trouble.
A specific usability issue with using high-tech devices in a home can be as obvious as space constraints. A hospital room, while often uninviting, is designed to house sick patients and the gear needed to care for them. There are plenty of outlets with reliable power required for sensitive machinery. Many of those outlets are connected to circuits with uninterruptable power supplies, so in the unlikely event of a power outage, while the pulse ox monitor may go dark, the ventilator will not. A bedroom lacks these features. Medical devices are not designed to work in bedrooms, so their usability problems were not foreseen.
Another missing feature contributing to potential hazards is the lack of an onsite 24-hour biomedical engineering department at home. This may seem silly. Why would anyone expect highly trained engineers who can diagnose and often fix technical and electrical problems to be at a patient’s home? The answer is that these folks are typically available in most hospitals, and medical devices are often built, deployed, and operated with the reasonable expectation that someone knowledgeable will be there when the inevitable problems crop up. When these machines are used outside of a medical facility, the opportunity for misadventure abounds. And that can be dangerous for patients and even their caregivers.
I agree with ECRI’s insistence that medical device manufacturers consider the needs of patients who might be using their machines at home. The same human-centered design principles that were undoubtedly leveraged when focusing on doctors and nurses must be focused as well on patients and their lay caregivers if reasonable. I’m convinced that the hospital-at-home concept is here to stay, so we need to do everything possible to make it as safe as possible.