A Closer Look At The FDA’s Human Factors Engineering Draft Guidance

In an effort to control overall risk in medical devices, the FDA has looked to Human Factors Engineering (HFE) as part of the design controls process to reduce or eliminate use-related hazards. Central to that process is the development of a risk analysis, which takes into account potential hazards that can occur through the use of a medical device.

In June of this year, the FDA published the draft guidance, “Applying Human Factors and Usability Engineering to Optimize Medical Device Design,” which provides methods for identifying, evaluating, and understanding use-related hazards.

The advantages of optimizing device design through application of HFE/UE extend beyond improved safety. Many medical 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. With increased safety, the likelihood of incurring expenses associated with product recalls or liability is reduced; when HFE/UE approaches are used in the design of medical 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The draft guidance identifies the three steps to successfully incorporating HFE/UE into the design control process:

  • Identify anticipated use-related hazards and unanticipated use-related hazards and determine how hazardous use situations occur.
  • Develop and apply strategies to mitigate or control use-related hazards.
  • Demonstrate safe and effective device use through human factors validation testing.

Information on how to follow these steps is provided in the guidance and gives the industry an insight into the process.

Aptiv Solutions can assist medical device manufacturers with incorporating HFE/UE into their design controls process and can assist them with our contacts with companies that conduct human factors and usability testing.

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adapted and republished with permission from MDCI

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