Reflection 1 - Medical Device Safety
Part 1: Topic Engagement
One key concept from this week's lecture topics that stood out to me regarding human factors
within medical device safety and human was the idea of “user error” versus “use error”.
Traditionally, when a medical device accident occurs, the blame would typically be placed upon
the individual user, resulting in mistakes being labeled human errors. This lecture stressed that
personal mistakes are not the cause, but system-level design failures. The term “use error”
shifts responsibility from the individual toward the design of the device, its interface, and the
workflow.
This concept stood out because it challenged the common assumption within healthcare that
clinicians simply need more training or be educated for longer to avoid mistakes. The lecture
shows how bad designs cause awful results with the Seattle Hospital Electrocution case
example. A nurse used an IV pump power cord on an EKG lead since the connectors were
alike. This one error resulted in catastrophic consequences, and no amount of training could
have entirely prevented that error. What needed to be addressed was the design flaw itself.
What I found most insightful about this concept is the importance of designing for safety upfront
by incorporating human factors such as forcing functions, lockouts, and usability testing early in
the design process. These approaches reduce cognitive load, prevent predictable errors, and
ultimately protect patients and clinicians.
Thoughtful Question: How can regulatory bodies like the FDA enforce stronger human factors
integration in the early stages of a device design, rather than relying heavily on post-market
corrective actions?