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FDA investigates infection rates for endoscope use – Olympus and Karl Storz recur in reports

The US FDA gets ready to investigate hundreds of reports on infections following reprocessed endoscopes, sometimes resulting in death. Endoscope manufacturers Olympus and Karl Storz stand out.

Photo: Ambu / PR

The US Food and Drug Administration (FDA) is currently looking into a series of reports concerning patients who have had infections in connection with reprocessed urological endoscopes, according to a press release from the FDA.

Between Jan. 1, 2017 and Feb. 20, 2021, the FDA received more than 450 reports on patients have had infections after using reprocessed endoscopes. In 3 cases the patients died.

Device manufacturers Olympus and Karl Storz keep cropping up in the reports, state the FDA.

"While some reports indicate the potential causes could be inadequate reprocessing or device maintenance issues, we’re also evaluating other possibilities, including device design or the reprocessing instructions in the labeling," the FDA writes.

"Although we believe that the risk of infection is low based on available data, we’re reminding health care providers how important it is to follow the labeling and reprocessing instructions to properly clean and reprocess the devices, including accessory components," the statement further reads.

Danish medtech company Ambu, which only produces single-use endoscopes, is not mentioned in the press release.

Olympus looks into patient injuries from duodenoscopes 

Olympus' endoscope sales retreat 

Ambu CEO on stream of launches: "Won't be easy, but we're building an ecosystem"

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