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FDA Issues Warning Letters to Duodenoscope Manufacturers

March 12, 2018

The FDA has issued warning letters to 3 duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.

In 2015, the FDA ordered U.S. duodenoscope manufacturers Olympus, Fujifilm and Pentax to conduct a postmarket surveillance study to determine whether healthcare facilities were able to properly clean and disinfect the devices. As part of their approved study plans, manufacturers are required to conduct a study to sample and culture reprocessed duodenoscopes to learn more about issues that contribute to contamination, as well as a human factors study to assess how well trained hospital staff are following the reprocessing instructions.

To date, Olympus has failed to commence data collection, and Pentax and Fujifilm have failed to provide sufficient data. If the companies fail to adequately respond to the FDA’s warning letter, the FDA may take additional action such as seizure, injunction and civil money penalties.


Food and Drug Administration (FDA). News Release: FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk. March 9, 2018. Available at: click here. Accessed March 11, 2018.