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Mattie718 replied to the topic Usability Risk Analysis in the forum Risk Analysis for Medical Devices 6 years, 10 months ago
If the risk has been deemed acceptable enough to reach the end user then I believe the best way to mitigate the risk is to have a scrupulously detailed Instructions For Use (IFU). Sometimes companies will have to determine if a risk has been addressed “As Far As Reasonably Practicable”. If it has been agreed to have reached that point then the cost to modify the design of the product or the manufacturing process would probably outweigh the corresponding decrease in risk. The next best way to address the risk would be to warn the customer of the dangers of misuse through the IFU, and specify step-by-step procedures for how to correctly use the product. Especially in what’s known as the contraindications section, this explains all of the detrimental possibilities of negligent use and when the customer should not be using the product. The problem is if there is a way to misuse the product, someone out there will do it, and so the IFU needs to cover the company legally by being extremely thorough.