Think about a medical device being used during a surgery. The surgeon is scrubbed in and working on the patient. The techs in the OR are following the surgeon’s instructions to hand things over, rinse things off, etc. At what point do you think anyone is going to open up the device out of a package and start reading the instructions or warning labels? Not to say it does not happen, but to say that this is not common and now you might see why putting something on the label as a manner of mitigating risk should not be the first resort.