In October 2015, the FDA ordered Fujifilm Medical Systems, Olympus Medical Systems Corp., and Pentax of America to conduct postmarket surveillance studies to discover how well their duodenoscopes are reprocessed in real-world settings.
“The preliminary results as of March 2019 indicate higher than expected levels of contamination,” the agency said.
The agency found that reports of infections linked to duodenoscopes peaked in 2015 at 250 reports before decreasing to under 100 reports in 2017.
However, the agency identified 45 infections linked to the devices and 159 reports of device contamination between Oct. 15, 2018, and March 31.
“These reports indicate that although the number of reports has declined, there continues to be a need for improvement of the safety of reprocessed duodenoscopes,” the FDA said.
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