Infection Control Today

AUG 2018

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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12 ICT August 2018 www.infectioncontroltoday.com feature As you may recall several years ago, a signifcant number of infections associated with contaminated bronchoscopes in a short time prompted the Food and Drug Administration (FDA) to issue a Safety Communication about microbial transmission and infection associated with bronchoscopes. The agency urged the strict adherence to sterile processing guidelines and pointed out that inadequate cleaning may result in the failure of high-level disin- fection (HLD) or sterilization. The FDA also recommended that bronchoscopes with signs of damage be repaired or replaced, a recommendation from the American College of Chest Physicians and American Association for Bronchology to visually inspect bronchoscopes during reprocessing. As Ofstead, Quick, et al. (2018) emphasize, "Implications of the FDA's recommendations could be profound if bronchoscope durability is similar to other endoscopes, as researchers recently reported that 100 percent of uretero- scopes had defects after a mean of 19 uses, and 100 percent of gastrointestinal endoscopes developed defects within a few months." Research published in the journal Chest and presented at the recent annual meeting of the Association of Professionals in Infection Control and Epidemiology (APIC) indicates that even when proper cleaning and disinfection protocols are followed, patient-ready reusable, fexible bronchoscopes were contaminated and damaged, and present a serious threat to patient safety. As Ofstead, Quick, et al. (2018) assert, "Infections have been linked to inadequate- ly-reprocessed flexible bronchoscopes, and recent investigations determined that pathogen transmission occurred even when bronchoscope cleaning and disinfection practices aligned with current guidelines." Their multi-site, prospective study involved direct observation of reprocessing methods for fexible bronchoscopes, multifaceted evalu- ations performed after manual cleaning and after high-level disinfection, and assessments of storage conditions. Visual inspections of ports and channels were performed using lighted magnification and borescopes. Contamination was detected using microbial cultures and tests for protein, hemoglobin, and adenosine triphosphate. Researchers assessed reprocessing practices, and storage cabinet cleanliness was evaluated by visual inspection and adenosine triphosphate tests. The researchers examined 24 clinically used bronchoscopes, obtaining samples from consecutive bronchoscopes used in procedures during site visits. Site personnel performed reprocessing in accordance with their institutional practices. (Protocols for effectively reprocessing bronchoscopes are complex and include bedside pre-cleaning, leak testing, manual cleaning, and sterilization or high-level disinfection (HLD) followed by drying.) Microbial culture samples were harvested from ports and distal ends using sterile swabs moistened with sterile, deionized water. Biochemical tests for organic residue were conducted onsite in accordance with manufacturer instructions for use for detecting adenosine triphosphate (ATP), protein and hemoglobin, and luminometers measured ATP levels in samples from ports, insertion tubes, distal ends and channel effuent; hemoglobin and protein tests were performed using spectrophotometers. After bronchoscopes were sampled, re-reprocessed, and stored overnight, visual examinations were performed using a camera and borescopes; photographs were taken at predetermined locations and whenever unique irregularities were observed. After manual cleaning, the researchers report that 100 percent of bronchoscopes had residual contamination. Protein was detected in samples from 100 percent of bronchoscopes post-manual cleaning and 100 percent post-HLD. Microbial growth was found in 14 (58 percent) fully reprocessed bronchoscopes, including mold, Stenotro- phomonas maltophilia, and Escherichia coli/ Shigella spp. Hemoglobin was detected on one manually-cleaned bronchoscope and no post-HLD bronchoscopes or negative controls. Hemoglobin levels in positive controls ranged from 0-3 µg/mL. Post-manual cleaning, the median ATP level was 31 RLU (range 17-170 RLU) for surfaces and 26 RLU (range 4-220 RLU) for effuent. Post-HLD, the median ATP level was 20 RLU (range 12-166 RLUs) for surfaces and 8 RLU (range 3-26 RLU) for effuent. Visible irregularities were observed in 100 percent of bronchoscopes, including retained fuid; brown, red, or oily residue; scratches; damaged insertion tubes and distal ends; and flamentous debris in channels. Reprocessing practices were substandard at two of three sites visited. As Ofstead, Quick, et al. (2018) observe, "The source of contamination found on bronchoscopes at study sites is unknown, and there are several potential conduits for contamination. Direct exposure to pathogens Patient-Ready Bronchoscopes Found to be Contaminated Despite Cleaning and Disinfection By Kelly M. Pyrek

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