A recent article from The New York Times discussed the FDA’s approval of a new, fully disposable duodenoscope that aims to cut down on deadly infections. Duodenoscopes are snakelike tubes with fiber-optic cameras at the end that are inserted into 700,000 patients each year to diagnose and treat diseases of the pancreas and bile duct. Unfortunately, tests have shown that the devices couldn’t be properly decontaminated between procedures, leading to an outbreak of infections.
Once the issue became known, the FDA intervened and urged hospitals to use models with disposable parts and encouraged manufacturers to create fully disposable models. The first one to gain approval is called Exalt from Boston Scientific, which was designated a “breakthrough” device. The device received satisfactory scores from six experts who used it in a clinical trial of 60 patients. However, whether The Exalt will be widely adopted remains to be seen since it comes with a hefty price tag of $3,000, and insurance coverage is still uncertain.