Earlier this year, AAMI attended the Human Factors and Ergonomics Society’s annual symposium. Here is just a sample of new developments in the clinical setting that have our attention.
Human Factors Experts Seek Trust and Safety for AI in the Hospital
Health care is an innately human experience, but with the introduction of artificial intelligence and machine learning, keeping health care delivery human-friendly can be a challenge. It was a lesson brought up time and time again during the recent 2021 HFES International Symposium on Human Factors and Ergonomics in Healthcare.
Though it’s undeniably a burgeoning field in the health care industry, there exists some apprehension in regards to AI/ML usage. That’s why human factors experts have found themselves working at the very foundation of this doubt, devising new ways to make AI/ML-enabled medical devices more trustworthy and facilitating human-AI collaboration.
The first step to enabling trust is providing insight into how algorithms reach a decision. That’s at least according to Yuval Bitan, a human factors engineer and lecturer at the Ben-Gurion University of Negev, who spoke during the HFES Symposium.
“One of the things that affects trust is the fact that all these algorithms are basically a black box, and we in human factors, need to try and find ways to change this black box algorithm to a clear box,” said Bitan.
Another element of trust is user interaction, namely information relevancy and interactivity. If the information and the way it’s displayed by the device does not fit the needs and objectives of the clinician, then the device is of little use. As for interactivity, ideally, the device would allow for some interaction or customization of the user interface by the clinician.
Bitan and his research team were able to study such factors in a simulation where an AI was aiding the detection of bacteria in the bloodstream. Their preliminary data, which will be published at a later date, suggests that displaying relevant information and interactivity are an important element of trust in AI/ML-enabled medical devices.
“We really could see that when the physicians felt that if they had relevant information, they felt more confident about the system and had more trust in the system. We [also] saw that when they had more interactive work with the device, they had more trust in the system,” Bitan added.
High Value of Human Factors Engineer Embedded in the Clinical Setting
Human factors engineers work to understand how human involvement impacts the use and usability of medical devices. But what can they add to the mix when embedded in a clinical setting?
A lot, according to Brittany Anderson-Montoya, a human factors specialist at Atrium Health, who with other embedded human factors engineers (HFEs) discussed their role in the clinical setting and the value of HFE embeds in improving patient health and medical device usability at the symposium.
HFE professionals are tasked with understanding how human involvement impacts the use and usability of medical devices, helping end users as well as manufacturers understand how to better design devices with actual application in mind.
“Medical device use errors really continue to contribute to adverse patient events despite a lot more focus from FDA and other regulators to make devices more user-friendly,” Anderson-Montoya said.
She explained that a common driver of adverse events is that new, sophisticated technology is causing medical devices to become more complex.
But it isn’t only new devices that can be difficult for clinicians and patients to grasp. As devices are updated and tweaked, the opportunity for error is reintroduced. “I think any of us who are clinically embedded will state that even a small change, something that seems very innocuous … can have huge ramifications for the usability engineering of the device, and really can have deleterious consequences for patient safety,” Anderson-Montoya noted.
The big-picture issue, though, is the disconnect between the end users and the manufacturers. By encouraging more users — clinicians, HFEs, even patients — to actually report device-related injuries and errors, Anderson-Montoya hopes that a closed feedback loop can be created to better guide usage of potentially problematic medical devices.
Part of that starts with the procurement process, as Emily Rose, a biomedical engineer for Providence Health Care, discussed. Procurement focuses heavily on utility and cost, Rose explained, but what she has tried to do is “introduce this idea that there’s a third prong that needs to be considered, and that is usability.” Rose has worked with the Western Canada Human Factors Collaborative to help introduce this line of thinking to the organization handling medical device procurement for the Collaboratives many members.
Rose noted that there are three main benefits of embedding the human factors approach into the procurement process:
- Identify design problems that may affect patient safety and quality of care.
- Provide additional information for decision-making (e.g., implementation concerns, troubleshooting).
- Quantify level of consistency between new device and current workflow, including the degree of standardization and error potential.
“There’s still a disconnect between the industry work and the applied work creating a ‘work as imagined’ versus ‘work as done’ confound,” Anderson-Montoya noted in her own presentation about the procurement process. The sentiment was echoed by Rose. “The nice thing about being embedded is that we can really bridge this gap. We can translate some of the theory to the applied setting, and we can really tailor our approach to the unique culture and environment of our system.”
By focusing on usability from the start of the process, providers can utilize the expertise of their embedded HFEs to help prevent medical device errors before they even pop up in the clinical setting.
“We were initially very academic in our application of human factors methodologies,” Rose explained. “We’ve since had to understand [how to] deliver very actionable results to our organizations.”
For more information, find full coverage of the event at AAMI.org.
