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cjm64 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 5 months ago
Risk management once the product is in the hands of the end user is as you say, the largest part of risk management. Either through the use case, timing, or general negligence. As Dr. Simon pointed out, a surgeon in the operating room is not going to take the time to read the instructions when they remove the device form it’s packaging. Where changes can be made is for something like pharmaceuticals, which the end user has the time to read the instructions. In this case it is up to the company to make sure that the instructions are clearly written and are easy to find. But at the end of the day they cannot truly account for the risk that the end user will improperly use the product, because they are humans, and humans make mistakes.