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FDA Won't Pull Duodenoscopes

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Los Angeles, CADespite the recent rash of superbug infections associated with the reusable
medical device a medical device used in several surgical procedures, the US Food and Drug Administration (FDA) has announced that it will remain on the market. Instead of pulling the device, the FDA has issued new guidance aimed at addressing the possible spread of infectious agents between uses.

“Despite the recent concerns about multi-drug resistant bacteria infections associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them. Doing so should provide greater assurance to patients that the devices used on them are safe and effective.”

The concern around these devices stems from recent outbreaks of superbug infections, the latest being a deadly antibiotic resistant bacteria at Ronald Regan Medical Center in California. The FDA subsequently issued a warning to doctors and hospitals that duodenoscopes, a commonly used type of medical scope, can be difficult to sanitize between uses and “may facilitate the spread of deadly bacteria.”

Duodenoscopes are used in hundreds of thousands of procedures annually in the US. They are a type of medical device that drains fluid from pancreatic and bile ducts that are blocked by cancerous tumours, gallstones and many other types of health conditions.

The issue with the duodenoscopes is that even if they are cleaned to specification, they can still harbour bacteria, and in some cases those bacteria may be superbugs that cause chronic illness and death.

The FDA has been aware of the duodenoscope design issue since the fall of 2013. Since that time, the agency has received at least 75 incident reports involving 135 patients. Senator Patty Murray (D-Wash.) has written to FDA Commissioner Margaret Hamburg, urging the agency to publicly address the issue.

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