National Nurses United

15 National Nurses United The hazard of contaminated endoscopes is an illumi- nating and terrifying example of how employers' lack of infection prevention programs comes together with medical device manufacturers' refusal to heed the pre- cautionary principle in search of higher profits and how patients are the ones harmed and health care workers often blamed. Here's a recent article on the issue, published by Kaiser Health News: Study: Nearly Three-Quarters Of Com- monly Used Medical Scopes Tainted By Bacteria In an ominous sign for patient safety, 71 percent of reusable medical scopes deemed ready for use on patients tested positive for bacteria at three major U.S. hospitals, according to a new study. The paper, published last month in the American Journal of Infection Control, underscores the infection risk posed by a wide range of endo- scopes commonly used to peer deep into the body. It signals a lack of progress by manufacturers, hospitals and regulators in reducing contam- ination despite numerous reports of superbug outbreaks and patient deaths, experts say. "These results are pretty scary," said Janet Haas, president of the Association for Professionals in Infection Control and Epidemiology. "These are very complicated pieces of equipment, and even when hospitals do everything right we still have a risk associated with these devices. None of us have the answer right now." The study found problems in scopes used for colo- noscopies, lung procedures, kidney stone removal and other routine operations. Researchers said the findings confirm earlier work showing that these issues aren't simply confined to duodenos- copes, gastrointestinal devices tied to at least 35 deaths in the U.S. since 2013, including three at UCLA's Ronald Reagan Medical Center. Scope-re- lated infections also were reported in 2015 at Cedars-Sinai Medical Center in Los Angeles and Pasadena's Huntington Hospital. The bacteria this latest study found weren't superbugs, but researchers said there were potential pathogens that would put patients at high risk of infection. The study didn't track whether the patients became sick from possible exposure. The study's authors said the intricate design of many endoscopes continues to hinder effective cleaning and those problems are compounded when health care workers skip steps or ignore basic protocols in a rush to get scopes ready for the next patient. The study identified issues with colonoscopes, bronchoscopes, ureteroscopes and gastroscopes, among others. "Sadly, in the 10 years since we've been looking into the quality of endoscope reprocessing, we haven't seen improvement in the field," said Cori Ofstead, the study's lead author and an epidemi- ologist in St. Paul, Minn., referring to how the devices are prepared for reuse. "If anything, the situation is worse because more people are having these minimally invasive pro- cedures and physicians are doing more compli- cated procedures with endoscopes that, frankly, are not even clean," Ofstead said. The rise of antibiotic-resistant superbugs such as CRE (carbapenem-resistant Enterobacteriaceae), which can be fatal in up to half of patients, has made addressing these problems more urgent. About 2 million Americans are sickened by drug-resistant bacteria each year and 23,000 die, according to the federal Centers for Disease Control and Prevention. "We're not moving fast enough to a safer world of reusable medical devices," Michael Drues, an industry consultant in Grafton, Mass., who advises device companies and regulators. "There is plenty of fault to go around on device com- panies, hospitals, clinicians, on basically every- body." Despite the potential risks, medical experts cau- tion patients not to cancel or postpone lifesaving procedures involving endoscopes. These snake- like devices often spare patients from the compli- cations of more invasive surgeries. "Patients should speak to their provider and think about the risks versus the benefits," said Haas, who is also director of epidemiology at Lenox Hill Hospital in New York City. The Food and Drug Administration and Olympus Corp., a leading endoscope manufacturer in the U.S. and worldwide, both said they are reviewing the study. Last month, the FDA issued warning letters to Olympus and two other scope makers for failing to conduct real-world studies on whether health care facilities can effectively clean and disinfect their duodenoscopes. The FDA ordered the man- ufacturers to conduct those reviews in 2015 after several scope-related outbreaks in Los Angeles, Seattle and Chicago made national headlines. Olympus spokesman Mark Miller said the Tokyo- based company intends to "meet the milestones set forth by the FDA. … Patient safety has always been and remains our highest priority." The latest study examined 45 endoscopes, with all but two manufactured by Olympus. The other two were Karl Storz models. Last year, researchers visited three hospitals, which weren't named, and performed visual examinations and tests to detect fluid and con-

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