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  • andria93 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 6 months ago

    I think the companies put the effort to research and prepare the labels for patients, So I think it is the personal responsibility to read it and understand what is the risk of it. Some of this medication is over the counter and there is no way for the seller to inform each patient. Also, I believe it is the same way for a surgeon, It is there responsibly to know the risk behind using a tool or drug. It is part of his/Her expertise. I think the companies should not take a blame unless the product is defective or the root cause of the incident happened. I think one of the solutions mentioned above is to focus on graphical labeling. People tend to catch it easier rather than reading. But it is your choice either to read the warning or not.