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tilak replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
Depending on the situation or the environment in which a medical device or drug is used, its cautionary labels may not always work effectively. As Dr. Simon mentioned, in highly dynamic environments, such as an operation theatre or in an ambulance, its highly unlikely that the user will stop and read the instructions or labels. After putting it through vigorous testing and providing the proper labels, there is little a company can do to ensure the product is used safely. Companies should not be held accountable for the irresponsibility of its customers. One line of defense to increase safety is to make less products available over the counter or without prescription. Before distributing a product, companies can also require its consumers to provide certain documentation or records than reinforce their accountability with their product.