Study finds nearly three-quarters of medical scopes tainted by bacteria
In an ominous sign for patient safety, 71% 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 recently in the American Journal of Infection Control, underscores the infection risk posed by commonly used endoscopes. It signals a lack of progress by manufacturers, hospitals and regulators in reducing contamination 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 risk associated with these devices. None of us have the answer right now.”
The study found problems in scopes used for colonoscopies, lung procedures, kidney stone removal and other routine procedures. Researchers said the findings confirm earlier work showing that these issues aren’t simply confined to duodenoscopes, gastrointestinal devices tied to at least 35 deaths in the U.S. since 2013, including three at Ronald Reagan UCLA Medical Center. Scope-related infections also were reported in 2015 at Cedars-Sinai Medical Center in Los Angeles and Huntington Hospital in Pasadena, Calif.
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. Those problems are compounded when healthcare 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 epidemiologist in St. Paul, Minn., referring to how the devices are pre- pared for reuse.
“If anything, the situation is worse because more people are having these minimally invasive procedures and physicians are doing more complicated 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 Centers for Disease Control and Prevention.
Despite the potential risks, medical experts caution patients not to cancel or postpone lifesaving procedures involving endoscopes since they often spare patients from the complications of more invasive surgeries.
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 healthcare facilities can effectively clean and disinfect their duodenoscopes. The FDA ordered the manufacturers 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
The study found problems in scopes used for colonoscopies, lung procedures, kidney stone removal and other routine procedures.
by Olympus. The other two were Karl Storz products.
Last year, researchers visited three hospitals, which weren’t named, and performed visual examinations and tests to detect fluid and contamination on reusable endoscopes marked ready for use on patients. One hospital met current guidelines for cleaning and disinfecting scopes, while the other two committed numerous breaches in protocols.
Nevertheless, 62% of the disinfected scopes at the top-performing hospital tested positive for bacteria, including potential pathogens. It was worse at the other two—85% and 92%, respectively.
The study painted a troubling picture at the two lower-performing hospitals, which were well aware researchers were watching.
Among the safety issues: Hospital technicians wore the same gloves for handling soiled scopes fresh after a procedure and later, when they were disinfected and employees wiped down scopes with reused towels. Storage cabinets for scopes were visibly dirty and dripping-wet scopes were hung up to dry, which is a known risk because bacteria thrive on the moisture left inside. The two hospitals also turned off a cleaning cycle on a commonly used “washing machine,” known as an automated endoscope reprocessor, to save time.
Ofstead and her co-authors recommended moving faster toward sterilization of all medical scopes using gas or chemicals. That would be a step above the current requirements for high-level disinfection, which involves manual scrubbing and automated washing. A shift to sterilization would likely require significant changes in equipment design and major investments by hospitals and clinics.
In their current form, many endoscopes aren’t built to withstand repeated sterilization. Some also have long, narrow channels where blood, tissue and other debris can get trapped.
In some cases, disposable, single-use scopes are an option, and new products are starting to gain acceptance. In other instances, certain parts of a scope might be disposable or removable to aid cleaning.
The Joint Commission, the nation’s largest healthcare accrediting body, issued a safety alert last year about disinfection and sterilization of medical devices in response to a growing rate of noncompliance. In 2016, the accreditor cited 60% of its hospitals for noncompliance and 74% of all “immediate threat to life” citations from surveyors related to improperly sterilized or disinfected equipment.
Michelle Alfa, a professor in the University of Manitoba’s medical microbiology department, said accreditors may need to conduct more frequent inspections, and endoscopy labs should be shut down “if they don’t get their act together. These results are totally unacceptable.”
This story originally appeared in Kaiser Health News, a not-for-profit health newsroom whose stories appear in news outlets nationwide. It is an editorially independent part of the Kaiser Family Foundation.