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pv223 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 4 months ago
The reason labels are the least effective tool for risk management is that they are quite obviously not read. People often use common sense when opening up a product and more often than not figure out the way to use it after a few minutes of trial and error, if not right away. However, companies can not bank on everyone having enough common sense to do so, and as such put warnings and such on labels to protect them from a legal standpoint because is the the off chance that someone doesn’t have the common sense to figure out how to use a product or something happens to them while using the product, they can get sued for not having the information there as an earlier post mentioned. There’s only so much a company can do in order to inform their patients on how to use their product correctly, but when the market chooses not to read, the companies can do nothing else but protect themselves from taking the bullet for someone else’s stupidity.
As mem42 mentioned pharmacy in his example, I have been on the other side of such encounters during my shifts at CVS. Having written directions on the prescription labels only does so much to help, but when it is a patient’s first time picking up a medication they have never taken before we make sure that the pharmacist is able to properly instruct the patient on how to take the medicine not only because we want them to be healthy as soon as possible, but so that in the off chance they do not use it correctly and suffer from some harmful results, we cannot be held liable for it. It is common practice to always prepare for the patients that do not have the common sense to use a product without directions, hence the reason labels are common practice but not very effective.