International – 10 steps to conducting a use-related risk analysis as part of your Human Factors Engineering process

Use-related risk analysis (URRA) is a cornerstone activity for a thorough human factors engineering (HFE) process that meets the expectations set forth by US FDA and international reviewers. A complete and well-considered URRA, such as a Use Failure Modes and Effects Analysis (uFMEA), helps ensure that use-related risks are considered and mitigated to an acceptable level throughout the development process. Further, URRA serves as the basis for the scope of tasks evaluated in an HF validation test, the culminative HFE activity that seeks to evaluate whether a product can be used safely and effectively.

What steps should you take to develop a URRA? Below, we outline 10 steps to conducting an effective URRA. We use a medication delivery device as an example throughout. However, these steps can readily be adapted to developing a URRA for more complex medical technology as well…