Infection Control Today

APR 2019

ICT delivers to infection preventionists & their colleagues in the operating room, sterile processing/central sterile, environmental services & materials management, timely & relevant news, trends & information impacting the profession & the industry

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24 ICT April 2019 www.infectioncontroltoday.com feature By Kelly M. Pyrek H igher than anticipated levels of duodenoscope contamination — even after proper reprocessing — are causing manufac turers to conduc t root-cause analyses to better understand preliminary culturing results from post-market sur veillance studies. Interim results from the sampling studies indicate higher-than-expected contamination rates after reprocessing, with up to 3 percent of properly collected samples testing positive for more than 100 colony forming units of low-concern organisms that are unlikely to cause serious infections (but an indication of a reprocessing failure) and an additional 3 percent of properly collected samples testing positive for "high-concern" organisms more often associated with disease. High-concern organisms are defi ned as organisms that are more often associated with disease. Examples of high-concern organisms include Gram-negative rods (e.g., Escherichia coli, Klebsiella pneumoniae or other Enterobacteriaceae as well as Pseudomonas aeruginosa), Staphylococcus aureus, Beta-hemolytic Streptococcus, Enterococcus species, and yeasts. "We expect contamination rates to be as close to zero as possible, a fraction of 1 percent," says Deborah Kotz, press offi cer in the Offi ce of Media Affairs for the Food and Drug Administration (FDA). "Any detection of contamination indicates a likely reprocessing failure." A s troubling repor ts of bacterial infections associated with the use of duodenoscopes persisted over the last several years, the FDA has worked with device manufacturers, public health authorities, hospitals and healthcare providers to better understand the origins of the scope-related adverse events. Because duodenoscopes contain numerous small parts that contact patients' bodily fl uids, they must be thoroughly cleaned and disinfected between each use to prevent transmission of infections. Duodenoscope Contamination Persists Even After Reprocessing, Manufacturers' Surveillance Data Reveals "The FDA has been involved in an extensive and ongoing effort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes," said Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health. "As part of these efforts, the FDA ordered all U.S. duodenoscope manufacturers—Olympus, Fujifi lm, and Pentax—to conduct two post-market surveillance studies to determine whether healthcare facilities were able to properly clean and disinfect the devices. Specifi cally, all three manufacturers are required to conduct two studies; one to sample and culture reprocessed duodenoscopes that are in clinical use to characterize contamination rates and to learn more about issues that contribute to contamination (the sampling studies), and one to assess how effectively the trained hospital staff follow the manufacturer reprocessing instructions (the human factors studies)." Shuren continues, "These studies are critical to our efforts to evaluate whether the devices' instructions for reprocessing (cleaning and disinfecting) are being adequately adhered to by healthcare facilities, are properly preventing transmission of infections, or should be re-evaluated. Earlier this year, the FDA issued warning letters to all three device manufacturers for failure to meet these post-marketing surveillance requirements. The manufacturers have begun collecting the required data and provided the FDA with preliminary study results." Late last year, the FDA issued a safety communication reporting on these preliminary fi ndings and providing information for hospitals and healthcare providers who use and reprocess these devices. The manufacturers are currently conducting root-cause analyses to better understand these preliminary culturing results. Some factors that may contribute to device contamination include device damage and errors in reprocessing. Shuren explained that because of the higher-than-expected contamination rates and to help protect patients from bacterial infections Ò T e FDA has been involved in an extensive and ongoing ef ort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes.

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