I was reading an article on the FDA’s website over concerns related to devices causing serious adverse events, the determination that the benefits outweigh the risks was the conclusion.  This raises some interesting questions with regards to patient safety.  The article specifically talks about devices that are used primarily as a bridge to transplant (BTT) or destination therapy in relation to severe heart failure.  Having been trained on the particular devices in question and taking care of the patient population whom received the devices, these patients have very few if any options.  Determining whether or not a device is safe is one thing but distinguishing if a device that has been shown to cause serious adverse events is acceptable in a certain patient population is another.