FDA's new guidance tackles device usability, safety

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Intended to improve the usability of medical devices, as well as reduce errors, injuries and product recalls, the FDA issued a draft guidance June 22 for conducting tests to see how humans interact with technology.

Referred to in the document as human factors engineering (HFE) and usability engineering (UE), the draft sets a recommended framework to improve the device user interface, according to the agency, so that errors are either eliminated or reduced.

Manufacturers conduct a risk analysis as part of their design controls to determine whether there’s a risk associated with using a particular device. If the results indicate a moderate to high risk, then the manufacturer should conduct human factors testing according to the new draft document.

Hazards typically considered in risk analysis include: chemical hazards, mechanical hazards, thermal hazards, electrical hazards, radiation hazards and biological hazards, according to the agency, and most often result from device or component failures that are not dependent on how the user interacts with the device. The report detailed user-related hazards, device-related hazards and recommendations for mitigating them.

“The advantages of optimizing device design through application of HFE/UE extend beyond improved safety. Many device manufacturers have found that the application of HFE/UE in the design of their products reduces the need for modifications and costly updates after market introduction and offers competitive advantages,” the FDA report concluded. “With increased safety, the likelihood of your incurring expenses associated with product recalls or liability is reduced; when HFE/UE approaches are used in the design of devices, particularly if the perspective of users is taken into account, the overall ease of use and appeal of a device can simultaneously be enhanced.”

The full FDA guidance can be found here.