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dfn3 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 9 months ago
I understand the point Dr. Simon, but I would hope the surgeon and the techs know the risks of each item they use. They do not have to read it in the middle of the surgery but they should prior to surgery. I agree that it should not be the first resort for companies but as jnm22 said for example with medicine the companies explain on the label how many pills an adult or child should take but that is the only way I think the company can convey how many pills the adult or child should take. After that it is up to the adult or child to listen and not take more than advised. Another example would be labels that say do not do while pregnant. This might be extreme but not every pregnant women listens to those labels. Also if a medicine bottle says that this medicine should not be taken on an empty stomach the company cannot prevent a user from taking it on an empty stomach. Some risks are hard for the company to control because the user can only control them.