Medical professionals have a great amount of leeway in using almost any device. Surgeons often have to perform complex surgeries so they will use a tool in a new unknown way.
FDA or regulators may not care what you are telling users to do with the device if its being used in harmful ways. They still expect the OEM to solve the issue.
What could happen is an Adverse event occurs and finds it way into your QMS. You would do an investigation. If there is any patterns of misuse then they may require a solution to prevent misuse. In the example post above maybe constructing it is such a way using it as a hammer wont work...something like that.
There is another perspective though. If enough people are intentionally misusing your device it could mean there isn't any other device healthcare providers have or use to solve this problem. You might consider testing and redesign to allow the device to be hammered on. That step though would require regulatory processes.
FDA or regulators may not care what you are telling users to do with the device if its being used in harmful ways. They still expect the OEM to solve the issue.
What could happen is an Adverse event occurs and finds it way into your QMS. You would do an investigation. If there is any patterns of misuse then they may require a solution to prevent misuse. In the example post above maybe constructing it is such a way using it as a hammer wont work...something like that.
There is another perspective though. If enough people are intentionally misusing your device it could mean there isn't any other device healthcare providers have or use to solve this problem. You might consider testing and redesign to allow the device to be hammered on. That step though would require regulatory processes.
