duodenoscopes News

Dirty Scopes Have Infected More Than Previously Estimated

At least 300 patients have been sickened by life-threatening infections linked to contaminated medical scopes – more than previously estimated by federal regulators, according to figures released Friday. Between 2010 and 2015 more than 41 hospitals worldwide, most in the …

Report Says FDA Fails in Ensuring Safety of Medical Devices

America‚Äôs system for ensuring that medical devices are safe failed at every turn when dirty endoscopes began spreading deadly superbugs, according to a Senate investigation released today. The report, from Senator Patty Murray, a Washington Democrat, blames device manufacturers, hospitals, …

Scope Manufacturers Ordered to Provide FDA With Safety Studies

Federal health authorities are ordering manufacturers of specialized medical scopes to study how the reusable devices are cleaned following a series of life-threatening bacterial outbreaks at U.S. hospitals. The Food and Drug Administration said Monday that the three companies must …

Spread of Deadly Superbugs Prompts FDA Warning to Scope Makers

The Food and Drug Administration sent warning letters last week to three medical device manufacturers whose endoscopes have been blamed for spreading deadly bacteria. This is the agency’s strongest regulatory action yet since outbreaks in Los Angeles, Seattle, and elsewhere …

FDA Outlines Extra Steps to Clean Scopes Linked to Outbreaks

Federal health officials laid out extra safety measures that hospitals can take to clean specialized medical scopes that have been linked to sometimes deadly bacterial outbreaks across the U.S. However, Food and Drug Administration officials acknowledged on Tuesday that not …

How a Dutch Hospital Stopped a Superbug Outbreak in Its Tracks

Specialized endoscopes that are used to perform a common medical procedure have contributed to at least 13 deaths and 121 injuries in recent years by spreading bacteria among patients. A panel of medical experts at the Food and Drug Administration …