Duodenoscopes are used in more than 600,000 procedures, called endoscopic retrograde cholangiopancreatography (ERCP) in the United States each year. The procedure is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by tumors, gallstones or other conditions.
A recent article in the Wall Street Journal reported that the Food and Drug Administration (FDA) has once again dropped the ball when it comes to protecting the public from known health dangers. The FDA took 17 months to notify doctors and hospitals of “superbug” infection dangers from certain scopes used in gastrointestinal procedures. The FDA was first alerted in September of 2013 about the potential infection problem. A Seattle hospital notified the FDA about a cluster of antibiotic infections arising from the use of the duodenoscope but the FDA took no action to alert hospitals or the public until early 2015. Do the math, at 600,000 procedures a year for 17 months equals 850,000 patients were potentially exposed to this known but undisclosed risk.
I don’t know about the readers of this blog but this is information I would want to have if I, or a loved one, was faced with this procedure. I anticipate my doctors would feel the same way. I thought the FDA was charged with the responsibility to protect the American public and to make certain the drugs and medical devices used to care for us are safe. Not this time.