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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Page 26 of 36

26 ICT April 2019 Fujiflm The study population consisted of Fujiflm model ED-530X T duodenoscopes that have been used in ERCP procedures and reprocessed by trained healthcare facility staff in accordance with the duodenoscope reprocessing manual. Duodenoscopes were subjected to sampling following completion of the cleaning and manual disinfection or disin- fection using the following automated endoscope reprocessors (AERs): ASP EvoTech ECR, Medivators Advantage Plus, Medivators DSD Edge, and Steris Corporation System 1E Liquid Chemical Sterilant Processing System. As of the interim report dated Nov. 16, 2018, of the 727 total samples required for the study, 88 samples have been analyzed: • number of samples positive for low-concern organisms >100 CFU: 1/88 (1.1%) • number of samples positive for high-concern organisms: 2/88 (2.3%) As we have seen, interim results from these studies indicate higher-than-expected contamination rates after reprocessing, with up to 3 percent of properly collected samples testing positive for enough low concern organisms to indicate a reprocessing failure and up to 3 percent of properly collected samples testing positive for high-concern organisms. Root-cause analyses are currently underway to better understand these culturing results. Some factors that may contribute to device contamination after reprocessing include device damage and errors in reprocessing. These results are preliminary, with fnal results expected by the end of 2019. Kotz says that the FDA cannot speculate further on timing but adds, "We are exploring whether supplemental measures, such as sterilization, in addition to meticulous cleaning might offer a more effective option." The FDA is actively engaged with many stakeholder groups to better understand the causes and risk factors for transmission of infectious agents and develop solutions to minimize patient exposure. On Feb. 26, 2018, the FDA, Centers for Disease Control and Prevention (CDC), and American Society for Microbiology (ASM), together with other endoscope culturing experts, released voluntary standardized protocols for duodenoscope surveillance sampling and culturing. These protocols are an update to the Interim Duodenoscope Surveillance Protocol released by CDC in March 2015 and address the concerns regarding validation of duodenoscope culturing protocols raised in ASM's April 2015 Policy Statement on Culturing of Duodenoscopes. On March 9, 2018, the FDA issued warning letters to all three manufacturers who make duodenoscopes sold in the U.S. for failure to provide suffcient data to address the post-market surveillance studies requirements under Section 522 of the Federal Food, Drug,- and Cosmetic Act. All three manufacturers responded to the warning letters and submitted plans that outline how study milestones will be achieved including enrolling new sites and collecting samples. The FDA recommends facilities and staff strictly adhere to the manufacturer's reprocessing and maintenance instructions and follow these best practices: ♦ Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessors (AERs). Raise and lower the elevator throughout the manual cleaning process to allow brushing and fushing of both sides. After cleaning, carefully inspect the elevator recess and repeat cleaning if any soil or debris is visible. ♦ Implement a comprehensive quality control program for reprocessing duodenoscopes. Your reprocessing program should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure. ♦ Follow the duodenoscope manufac- turer's recommendations for inspection, leak testing, and maintenance of the duodenoscope. ♦ Prior to each use, closely inspect and remove from service for assessment, and repair or replace any duodenoscope that shows visible signs of damage, as recommended in the duodenoscope instruction manuals. Examples of damage may include: loose parts, protrusions or abnormal bulging from the endoscope, kinks or bends in tubing, cracks and gaps in the adhesive that seals the device's distal cap or other signs of wear or damage. ♦ During each reprocessing cycle, conduct leak testing and remove from service for assessment, and repair and replace any duodenoscope that shows signs of leakage. Follow the duodenoscope manufacturer's leak testing instructions for angulating the bending section and elevator during leak testing. ♦ As recommended in the duode- noscope instruction manuals, return the duodenoscope to the duodenoscope manufacturer for inspection, servicing, and maintenance of the device at least once per year. Recommendations for Facilities and Staff that Reprocess Duodenoscopes Ò Te FDA is actively engaged with many stakeholder groups to better understand the causes and risk factors for transmission of infectious agents and develop solutions to minimize patient exposure.

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