The Food and Drug Administration (FDA) has ordered the three manufacturers of duodenoscopes marketed in the United States to conduct postmarket surveillance studies for greater understanding of how the devices are reprocessed in real-world settings.

This action was prompted by evidence that duodenoscopes have contributed to the transmission of infections, including antibiotic resistant infections, to patients. The complex design of duodenoscopes makes it difficult to remove contaminants compared to other types of endoscopes; the FDA’s analysis to date also indicates that manufacturer’s reprocessing instructions are not always being followed correctly due to being labor intensive and prone to human error.

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Olympus America, Inc., Fujifilm Medical Systems, U.S.A., Inc., and Hoya Corp. (Pentax Life Care Division) will have 30 days to submit postmarket surveillance proposals detailing their plans to conduct studies to evaluate, among other things, how well health care personnel are following instructions to clean and disinfect duodenoscopes between patients and to better understand the rate of contamination of clinically used duodenoscopes. The studies are required to answer these questions:

  • Are user materials, such as user manuals, brochures and quick reference guides included in the manufacturers’ duodenoscope labeling and instructions for use, sufficient to ensure user adherence to the manufacturers’ reprocessing instructions?
  • After use of the manufacturer’s validated reprocessing instructions, what percentage of clinically used duodenoscopes remain contaminated with viable microorganisms?
  • For devices that remain contaminated after use of the manufacturers’ labeled reprocessing instructions, what factors contribute to microbial contamination and what steps are necessary to adequately decontaminate the device?

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