Columbia, Maryland – Bronchoscopy is one of the most common interventional pulmonology procedures and most practitioners take it for granted that reprocessing (the multistep process of cleaning and disinfecting or sterilizing the device) of bronchoscopes is effective.
A new study, funded by 3M Company and supported by Healthmark Industries, has shown that this is not the case. Even when cleaned and disinfected according to current reprocessing guidelines, the study found that the majority of patient-ready, reusable, flexible bronchoscopes were contaminated and damaged.
"The results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune-suppression due to malignancy or chronic disease," the study said.
The study, presented at the Association for Professionals in Infection Control's annual conference APIC 2018, concludes that "shifting toward using sterilized or single-use bronchoscopes" could reduce the risk of life-threatening infection transmission among patients.
"The study validates what we have been saying for years, that single-use bronchoscopes are a better alternative than those that are cleaned and reused," says Lars Marcher, CEO and President Ambu A/S, a medical device maker that has pioneered the disposable bronchoscope. "Single-use bronchoscopes, like the ones we have been manufacturing and selling since 2009, are safe, effective and protect patients from viruses, bacteria and pathogens that can cause illness and even death."
The study will be published in an upcoming issue of Chest Journal. The work was done in collaboration with scientists at several institutions, among them Cori L. Ofstead, MSPH, Mariah R. Quick, MPH; Harry P. Wetzler, MD, MSPH; John E. Eiland, RN, MS; Otis L. Heymann, BA of Ofstead & Associates in St. Paul, Minnesota; David A. Sonetti, MD and J. Scott Ferguson, MD, FCCP of the Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health.
Ofstead and her colleagues conducted the study at three large hospitals in the United States in 2017, including two transplant centers. The researchers examined 24 clinically used flexible bronchoscopes after they were cleaned and disinfected 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.)
The researchers observed reprocessing practices, visually inspected ports and channels, and assessed storage conditions. Contamination was detected using microbial cultures and tests for protein, hemoglobin, and adenosine triphosphate. Reprocessing practices were found to be substandard at two of the three hospitals studied.
Although numerous cases of microbial transmission and infections linked to insufficient reprocessing of reusable flexible bronchoscopes have been reported, this study shows that current reprocessing guidelines – even when done properly – are “ineffective.”
After manual cleaning, the researchers found that 100% of the bronchoscopes evaluated had residual contamination. Microbial growth was found in 14 (58%) of the fully-reprocessed bronchoscopes, including mold, Stenotrophomonas maltophilia, and Escherichia coli/Shigella spp. Researchers say that even more bacteria, yet to be identified, may be found on the bronchoscopes and no tests were done to detect viruses such as Hepatitis B, Hepatitis C, or influenza.
Visible irregularities were observed in 100% of bronchoscopes, including retained fluid; brown, red, or oily residue; scratches; damaged insertion tubes and distal ends; and filamentous debris in channels. Storage conditions could also have contaminated reprocessed bronchoscopes, as visual inspections and ATP tests determined that storage cabinets were not clean.
At one of the sites, results of tests done on a new bronchoscope suggest contaminants were introduced to the bronchoscope during initial cleaning, even before any clinical use. In addition, nursing staff at two of the hospitals were observed handling and transporting patient-ready bronchoscopes with bare hands, potentially exposing the bronchoscopes to contaminants.