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  • BijinV replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 7 years, 4 months ago

    Risk mitigation begins with end user training and education, in my opinion. After a company has done all it can to make a safe and efficacious device or product, it is up to them to educate the end user population to the best of their ability. So when it comes to things like intraoperative surgical equipment, reps from the company should train all personal that would handle and use the equipment. The instructions that come should be as comprehensive as possible, but they will never be as illustrative as a live demo. The same can be said of pharmaceuticals and prescription drugs. Drug reps are used to sell the product of course, but they should also provide more than enough information to physicians and pharmacist who would be prescribing the medication to patients. As has been mentioned before, labels are important, but should not be considered the best measure to ensure risk mitigation.