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FDA Ignores 2009 Warnings: Superbugs Caused by Difficulty with Cleaning Medical Scopes

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In 2009, State and Federal health officials warned the Food and Drug Administration (FDA) to alert hospitals about the risks of contamination from specialized medical scopes.  Such contamination is to blame for a recent series of deadly “superbug” outbreaks.  A superbug is a drug resistant bacterial infection such as Carbapenem-Resistent Enterobacteriaceae, known as “CRE”.

2009 Florida Study and Warning

In 2009, a certain type of scope called a duodenoscope was linked to drug-resistant infections in Florida hospital patients. A duodenoscope is a certain type of fiber-optic scope used to examine the duodenum, or the first section of the small intestine. This scope accesses the small intestine through the patient’s mouth. In 2009, many patients in Florida had contracted “superbugs” following a duodenoscopy, and fifteen Florida patients had died from the superbug.  Epidemiologists (scientists who study diseases in a certain population) at the Florida Department of Health and the Centers for Disease Control and Prevention studied this superbug infection briefed the FDA,  stating that the superbugs were likely caused because hospitals failed to properly clean the instruments following use, even when following existing FDA guidelines.

At that time, although the issue was only studied in Florida, the scientists warned that this issue would concern all hospitals. In April of 2009, A CDC infection control expert wrote in an e-mail, “Some type of educational alert (to hospitals) will be useful … It could be brief, but it would probably be best if the alert came jointly from CDC and FDA. We also will likely want manufacturers to do an educational initiative.”

FDA Reaction

Despite this warning, The FDA did not issue a specific warning to hospitals. According to USA today, the FDA did mention duodenoscopes seven months later, in the, “57th paragraph of a general advisory on proper cleaning and disinfection of all medical scopes, including those used in colonoscopies and other common procedures.”  It was not until five years later that the FDA issued a specific warning that duodenoscopes pose exceptional contamination risks that can persist even after meticulous cleaning. The FDA began an in-depth investigation following a 2013 CRC outbreak in Illinois. At this point, many patients had become ill with superbugs such as CRE, an infection with a 40% mortality rate.  Some have criticized the FDA’s slow investigation.

As scope procedures are becoming increasingly more common, let’s hope that the FDA–and hospitals—will heed these messages before more patients are put at risk.