An interim FDA report on duodenoscope reprocessing indicates that the practice remains challenging, with difficulty following manufacturer instructions and a contamination rate significantly higher than expected.
Fujifilm Medical Systems USA Inc, Olympus Medical Systems Corporation and Pentax of America make duodenoscopes sold in the US. FDA ordered the three manufacturers to perform post-market surveillance studies in October 2015 after bacterial outbreaks linked to duodenoscopes caused patient deaths in Illinois and California
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