ABSTRACT
The Food and Drug Administration (FDA) strongly promotes the implementation of human factors engineering or usability engineering processes during the design and development of medical devices. FDA’s guidance “Applying Human Factors and Usability Engineering to Medical Devices” provides a flowchart depicting the risk management process for addressing use-related hazards. The manufacturers are required to conduct a risk analysis that includes identifying the risks associated with device use and implementing controls to reduce those risks. A various processes should exist in a manufacturer’s quality management system for capturing device information in the production and post-production phases of a device’s life cycle. Risk/benefit analysis should include a review of clinical data and scientific literature on the medical benefits of the use of the device to determine if the overall benefit outweighs the overall risk. Risk review recognizes that any action taken to reduce a risk may create a new risk or hazard or increase the significance of other existing risks.
