Can a physician use a medical device in a way that’s not been approved by the FDA? Watch the video below to learn the answer to this question and to learn more about the off-label use of medical devices.
0:20 “Off Label Use” Of Medical Devices
0:56 Liability For Damages
Can a physician use a medical device in a way that has not been approved by the FDA or the government?
0:20 Can A Physician Use A Medical Device In A Way That’s Not Been Approved By The FDA? Off Label Use” Of Medical Devices
And the answer is an emphatic yes, that doctor can do that. It’s done not only in the United States, it’s done in other countries. Oftentimes, that approval process is slower than the practical process of what frontline physicians are seeing, and so it is a judgment call done by the doctor. The physicians would do this at their peril.
0:56 For Damages
I mean, if they are so far in front of the standard of care or what it is that reasonable doctors are doing, and they put themselves out there on a limb and that limb breaks, more specifically, they create damages and injury to patients using a device in an unapproved way, then they open themselves up to liability. They open themselves up personally to being sued.
So yes, people do it all the time, physicians do it all the time, and again, medicine is not like putting a quarter in a newspaper, you get the same newspaper out. It’s a dynamic process and it’s just not simple. Every patient is different. Every physician is different. Their skillset and talent are different.
But just know this, in terms of proving that a medical device has entered somebody and that you should be given some accountability, that is done really on a case-by-case basis.
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