Why is it important to consider the hazards and hazardous situations as aspects to be evaluated separately?
In biomedical devices, hazards are potential dangers, such as exposed electrical components in a device or chemical substances used in manufacturing. A hazardous situation comes into being when someone is exposed to these hazards, like a patient who touches the exposed component or a healthcare worker who handles the chemicals improperly. So, understanding the difference allows the identification of where risks may occur.
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.
