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From Health Law Daily, February 23, 2015

Superbug outbreak tied to UCLA, NC endoscopic procedures, CDC plans extermination

By Bryant Storm, J.D.

An outbreak of carbapenem resistant Enterobacteriaceae (CRE) bacteria has been linked to complex endoscopic procedures that took place at Ronald Reagan UCLA Medical Center between October 2014 and January 2015. The “superbugs,” which can spread fatal pathogens, infected certain patients because the routine cleaning of endoscopic scopes, as recommended by the manufacturer, does not completely eradicate CRE. According to a UCLA Health statement, only patients receiving particular endoscopic procedures over the specific timeframe were affected and stricter sterilization procedures have since been implemented.

Superbug. CRE is considered a superbug because it belongs to the class of antibiotic-resistant threats that can be so difficult to treat. According to the Centers for Disease Control and Prevention (CDC), because of widespread and sustained use of certain antibiotics, some bacteria have developed a resistance to traditional antibiotic treatments. Antibiotic resistant bacteria are responsible for 2 million infections and 20,000 deaths each year. Enterobacteriaceae are a class of bacteria that live in the colons of all people. However, forms like CRE, which are resistant to antibiotics, can be deadly in patients with other serious medical problems because of the bugs’ ability to cause less treatable infections. According to a CDC factsheet, healthy people do not usually get CRE infections.

HAC. Section 3008 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) established the HAC Reduction Program to encourage hospitals to reduce hospital-acquired conditions (HAC)—reasonably preventable conditions that patients do not have prior to their stay in a hospital. The program reduces hospital payments for hospitals with the highest frequency of HACs. Due to the fact that CRE-based infections are a greater risk for hospitalized patients, CRE is another bug which hospitals must be careful to prevent as part of their efforts to combat HACs.

UCLA infections. The UCLA outbreak led to notifying 178 UCLA patients of potential exposure as a result of endoscopic procedures. A total of seven patients were infected and the infections were contributing factors in the deaths of two patients. Although UCLA followed national guidelines and sterilization standards issued by Olympus Medical Systems Group, the instruments’ manufacturer, at least two of the seven Olympus scopes used by UCLA over the four-month period were transmitting CRE. The two scopes have been removed from use and have undergone multiple step decontamination, including an offsite exposure to ethylene oxide.

North Carolina. Carolinas HealthCare System hospitals have also reported incidents of CRE outbreak, with wsoctv.com reporting that the superbug has killed two people and CNN reporting that the superbug has killed one. According to wsoctv.com, three people have acquired CRE infections while in Carolinas HealthCare System hospitals this year. The hospital system is screening potentially infected patients and isolating those who have been contaminated. CNN reports that, this year, 15 patients had CRE upon admission to the hospital system. As was the case in the UCLA hospital outbreak, the Carolinas HealthCare System hospitals indicated that the outbreaks occurred after use of endoscopes despite the fact that disinfection guidelines were followed.

CDC action. The CDC is developing new protocols for duodenoscopes, the reusable endoscopic devices that were responsible for the spread of antibiotic-resistant bacteria, according to a report from Reuters. Although the CDC guidance would not create mandatory requirements for device sterilization and use—a power held uniquely by the FDA—the forthcoming CDC guidance would carry significant weight for hospitals because, according to Reuters, “hospitals that ignore them could be vulnerable to lawsuits.”

FDA. The FDA has also updated an alert related to the manner in which the design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may hinder effective cleaning. The alert, which is intended for professionals and practitioners in the fields of gastroenterology and infection control, explains that the design of duodenoscopes hinders reprocessing. The alert explains that following the CRE outbreaks, the FDA has learned that meticulously cleaning duodenoscopes and following manufacturer reprocessing instructions may be insufficient to eliminate contaminants. The FDA recommends that during reprocessing of duodenoscopes, meticulous care should used, comprehensive quality control protocols should be developed, and the Multisociety guideline on reprocessing flexible gastrointestinal endoscopes should be followed.

Companies: UCLA Health; Olympus Medical Systems Group

MainStory: TopStory MDNews AgencyNews SafetyNews FDCActNews MDeviceNews

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