People who are handy around the house appreciate that there is typically a tool for every conceivable task that needs to be done. It doesn’t make much sense to use a screwdriver to pound in a nail. A wrench just won’t do to drive home a screw. Still, there are times when the best tool for the job isn’t available. A handy Oregonian might then look for something else that will do.
This happens in medicine, too. You’ve probably heard of off-label uses for certain drugs. Experts acknowledge that doctors regularly prescribe medications for things other than what they were originally approved. That’s because they’ve found it to work.
The same thing goes for medical devices. According to information from the National Center for Biotechnology Information, doctors will sometimes use a tool to do a job for which it was not approved. It might even be that a tool’s design is widely acknowledged as an ingenious piece of engineering. But that doesn’t necessarily mean that it’s the safest and most effective tool for a particular procedure.
That can create problems as a University of Pennsylvania-led study has discovered with one particular medical device. The tool is often used by cardiologists to try to block off a sac on the heart that is believed to be the source of potentially dangerous blood clots in some older patients with atrial fibrillation. It features a combination loop and suture system that lets doctors cinch and tie off the small sac.
That procedure is not one OK’d by the Food and Drug Administration. Indeed, the manufacturer never presented the device for that purpose, but doctors have found it works, and the company is now seeking a patent for it.
The problem, according to the study, is that the loop and stitch device often triggers unexpected urgent operations that put the patient at greater risk of surgical error or even death.
Every operation has its risks. If a procedure results in even more extensive surgery and greater risk, it may amount to medical negligence. If you suspect you’ve been a victim of such disregard, consider visiting our page dedicated to surgical error.