Analyzing Residual Risks of Safety-Related Use Errors in Medical Devices

Residual risk analysis is a process whereby medical device and IVD manufacturers can integrate observed use errors into their design considerations and determine whether such errors pose an unacceptable level of risk to patients or self-administering users. This paper explains how residual risk analysis fits into the larger human factors engineering process, examines hypothetical examples of potentially serious use errors, provides best practices for teams conducting residual risk analysis, and gives directions for how to proceed in response to different outcomes of the analysis.