Early results of an ongoing assessment of reprocessed duodenoscopes reveal that the devices are contaminated at a higher rate than expected, the U.S. Food and Drug Administration (FDA) announced in a December 10, 2018, safety communication. In 2015, FDA ordered three manufacturers to conduct postmarket surveillance studies addressing rates of duodenoscope contamination after reproceessing and is providing interim results to remind healthcare facilities of the importance of manual cleaning prior to disinfection and sterilization of duodenoscopes and to inform patients of the safety issue. With 10% of samples collected, FDA has found a 3% contamination rate for both low-concern and high-concern organisms after reprocessing. FDA said the studies were designed assuming a contamination rate of less than 0.4%. High-concern organisms include those more commonly associated with disease, such as Escherichia coli and Pseudomonas aeruginosa. Root-cause analyses are under way to better understand the factors driving these results. The final results of the study will be released in 2019, FDA said. FDA recommends the following best practices for duodenoscope reprocessing: meticulously clean the elevator mechanism and surrounding recesses by hand; implement a quality control program for reprocessing endoscopes; follow the manufacturer's recommendations for inspection, leak testing, and maintenance; and be aware of previously released safety guidance from FDA. "It has become clear that following the manufacturer's reprocessing and maintenance instructions, while critical, is not sufficient to avoid all infections associated with the use of duodenoscopes," said Jeff Shuren, MD, JD, director of FDA's Center for Devices and Radiological Health in a news release. "That is why the FDA has also been working with developers on new product designs, including disposable components. Technological advances in product design hold promise to reduce the risk of contamination and enhance patient safety."

HRC Recommends: Ineffective reprocessing of flexible endoscopes can have devastating consequences for patients—and for a facility's bottom line. Inadequate disinfection can result in infectious outbreaks of disease from organisms such as E. coli and P. aeruginosa. The public has become aware of patient deaths through media attention to the matter. Consequently, disinfection practices for hard-to-clean endoscopes are being scrutinized, specifically duodenoscopes used to diagnose and treat problems in bile and pancreatic ducts. ECRI Institute recommends culturing duodenoscopes as a key step to reducing infections. Concerns about reprocessing procedures should be addressed proactively, rather than after an infectious outbreak.