In my opinion, it’s important to evaluate hazards and hazardous situations separately because they focus on different aspects of risk. Hazards are the potential sources of harm, like exposed electrical components or harmful chemicals, while hazardous situations occur when someone interacts with these hazards, such as a patient touching an exposed component. By considering them separately, it becomes easier to identify both the root causes and the specific scenarios where risks could arise, allowing for more precise and effective risk management strategies. This approach ensures that risks are addressed not only in the design but also in the real-world use of the device.

I completely agree that distinguishing between hazards and hazardous situations is key to effective risk management. Evaluating hazards helps us identify the inherent risks in the design or materials used, while assessing hazardous situations focuses on the interaction between the device, users, and environment.

For example, a hazard like exposed electrical components might be addressed through design controls (e.g., insulation or shielding), but evaluating hazardous situations ensures we also consider user training or environmental factors, like how the device is used in a wet environment. This separation ensures a more comprehensive risk evaluation process that captures both the "what" (hazard) and the "how" (hazardous situation).

For further discussion: When prioritizing risks, do you think teams should focus more on mitigating hazards or preventing hazardous situations, or is it always a balance between the two?