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  • jr377 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 10 months ago

    I’m going to use a non-BME example to help clarify my thoughts. Whenever you get a coffee, the cup will usually have a label that warns that it is in fact, hot. Seems silly right? Well it’s a result of Liebeck v. McDonald’s Restaurants. A woman sued and won because she burned herself due to spilling hot coffee on herself. These labels aren’t necessarily warnings because people don’t know about it, it’s more to protect the company from lawsuits. Yeah, a lot of labels actually impart necessary info, such as whether or not its a carcinogen, how to handle a product safely, etc. Do most people actually read these labels? No. The best alternative to labels would be training sessions and exams for BME products should be in place. It really is up to the user to make sure that they safely use the products they’ve bought.