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  • aja38 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 7 years, 2 months ago

    I do agree that labeling is important but not very effective in informing the risk of the medical product being sold. The reason is that some people just read the instruction only, not the warning, which is not good. For example cough/cold medicines, some causes drowsiness while others don’t, if someone just takes the one that causes drowsiness without knowing and has to drive all night, an accident can happen. There could be many to blame but if someone buys anything that has any risk, the seller must inform the customer. Surgeons can’t use anything for surgeries, there tools must be specific to the type of surgery and they must be trained in using them, surgeons must also be informed of the risk in using, and as well inform the patient.