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  • kc377 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 8 years, 4 months ago

    While yes, everyone should obviously be trained properly ahead of time, this doesn’t mean that mistakes don’t happen. For instance, if for some reason someone grabbed a drug eluting stent that elutes a concentration much too high for the patient on the table, that could be problematic. All of the staff know how to implement the stent, but if that packaging doesn’t have the dosage information on the outside, this risk grows. If all of the information is written on the packaging, then the staff are able to do a final check that every piece is appropriate for the situation and reduce any further human error that is possible to occur.

    Kaitlin Connell