FDA Warns of Deadly Superbug Outbreak
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
A new bacteria called CRE (carbapenem-resistant enterobacteriacae) is becoming a growing concern in the medical community due to its high resistance to the strongest antibiotic drugs. CRE infected endoscopes, which are used to diagnose and treat liver diseases, allow for the transmission of CRE between patients, leading to an outbreak of the "superbug."
UCLA Ronald Reagan Medical Center in Los Angeles reported up to 179 patients as having been exposed to the outbreak. The contaminated scopes manufactured by Olympus Corp. have been linked to two deaths at the Ronald Regan UCLA Medical Center.
The problem at hand is the safety clearances for both the scopes and the automated reprocessors used to clean them. The Food and Drug Administration has issued a warning on the difficulty of cleaning and disinfecting these devices, which allows the bacteria to be easily transmitted. The FDA has urged health care professionals to "meticulously" clean the scopes "prior to high-level disinfection."