Medical devices rely on proper use to be "safe and effective," which is why FDA has in recent years encouraged devicemakers to incorporate human factors engineering into their development processes. What is human factors engineering (or HFE)? FDA defines the term, simply, as the "application of human factors principles to the design of devices and systems." HFE is accounting for how users interact with a device, and the process of identifying operational or label issues that may prevent the device from being used as intended. FDA often requires that human factors data be included in premarket submissions, or the data may be reviewed in postmarket scenarios in response to a serious adverse event.
In a recent issue of Regulatory Affairs Focus magazine (subscription required), the authors give several examples of potential use errors: the smaller size of a female physician's hand, in comparison to a male physician's hand, and how that might affect product handling, or whether the device is the appropriate size for the intended patient population. A device could also be used on the wrong setting or assembled incorrectly. User interface is another consideration for the HFE process, particularly with the role of computers in device technology; for instance, the article recommends uncluttered monitors so important instructions don't go unnoticed. HFE can result in a more accurate understanding of who is using the device and how it is being used in the real world, which can help identify potential hazards.
FDA recommends that HFE take place early in the development process, and the Agency has instituted a program to offer guidance to companies implementing HFE.
HFE marks a departure from traditional risk management, which looks only at the device and its intended use, by evaluating the actual needs, limitations and expectations of users. Knowledge of and planning for how devices perform in the clinical setting are now key for FDA submissions, and the considerations promote user-friendly devices and ultimately, better patient outcomes.
