FDA Warns of Infection Risk with Duodenoscope

Los Angeles, CA: Following an outbreak of a deadly antibiotic resistant bacteria at Ronald Regan Medical Center in California, the Food and Drug Administration (FDA) has 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.

"The FDA is not doing its job,"Lawrence Muscarella, a hospital-safety consultant and expert on endoscopes who has been monitoring the problem in recent years, told the Washington Post. "It' really not acceptable... These reports have been coming for at least 3 to 5 years."

Similar outbreaks to that seen in LA earlier this year, have occurred at the Advocate Lutheran General Hospital near Chicago, where 44 people were infected, and at the Virginia Mason Medical Center in Seattle, where at least 32 patients became ill, 11 of whom died.

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Last updated on Mar-11-15