Failure mode and effects analysis as an informed consent tool for investigational cardiothoracic devices

The informed consent process is one of the most critical segments of any device clinical trial. Informed consent requires that patients be provided with ample and accurate information about the risks and benefits of trial participation in a manner that respects their learning ability. Knowing this, the dilemma for clinical investigators lies in identifying the risks without having had clinical experience with the device in question. It is offered that the device manufacturer's FMEA (failure mode and effects analysis) document can be a valuable aid in determining the potential clinical risks of investigational devices, and thus should be available to clinical investigators for their preparation of informed consent documentation.