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Cedars-Sinai Medical Center says Four Patients Contracted CRE Superbug Between August and January

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Medical Center says 4 Patients Contracted CRE Superbug

Medical Center says 4 Patients Contracted CRE Superbug

Four patients have contracted a deadly, drug-resistant infection linked to a duodenoscope, officials from Cedars-Sinai Medical Center in Los Angeles announced on Wednesday.

Seven patients were infected with the superbug, known as carbapenem-resistant Enterobacteriaceae (CRE), at the University of California Los Angeles’ Ronald Reagan Medical Center recently. In 2013, 30 patients at Advocate Lutheran General Hospital in Park Ridge, Illinois, contracted CRE, as did 32 patients treated at Virginia Mason Hospital in Seattle, Washington, between 2012 and 2014.

Cedars-Sinai said the infected patients contracted CRE after undergoing procedures at the facility between August and January. One patient has since died. Hospital officials mailed letters to dozens of other patients who had the procedures “out of an abundance of caution,” according to The New York Times (Times).

Ronald Reagan UCLA Medical Center and Advocate Lutheran General Hospital not only follow the manufacturers’ instructions for disinfecting the devices, they now also use ethylene gas to enhance the cleaning procedure; however, ethylene oxide gas can be toxic to both patients and health care workers if the device is not thoroughly aired after disinfection. In an interview with the Times, Dr. Stephen Ostroff, chief scientist at the Food and Drug Administration (FDA), said that wouldn’t be easy to implement the added disinfecting procedures on a widespread basis, and he thinks the duodenoscopes themselves may need to be redesigned to allow better disinfection.

Duodenoscopes are long, flexible tubes with a tiny camera attached to the tip that are inserted down the throats of anesthetized patients for the purpose of examining and treating pancreatic and bile duct disorders. Microscopic crevices and the complex design of the medical devices make them very difficult to clean, and they can harbor multidrug-resistant bacteria. Duodenoscope manufacturers instruct workers to clean the crevices with tiny brushes, and then the hard-to-reach parts with a disinfecting chemical. U.S. Centers for Disease Control (CDC) inspectors who investigated the infections in Illinois said despite closely following the manufacturers’ instructions for disinfecting the devices, they found that the duodenoscopes remained contaminated.

MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program, addressed the problem in a March 4 Safety Communication, which was an update to the agency’s original Safety Communication, dated February 23, 2015. The agency said it wants “to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing.” The agency went on to explain: “Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices.”

In the Safety Alert, the FDA instructed health care providers to inform patients of the benefits and risks associated with ERCP procedures; inform patients to seek immediate medical help if they experience fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools after the procedure, and to submit a report to the FDA via MedWatch if they suspect that problems with reprocessing a duodenoscope have led to patient infections. disclaimer: This article: Cedars-Sinai Medical Center says Four Patients Contracted CRE Superbug Between August and January was posted on Friday, March 6th, 2015 at 4:30 pm at and is filed under Medical Device Lawsuits.

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