FDA Approves Fixes for Olympus Scope Linked to Infections

The U.S. Food and Drug Administration cleared a modified version of a device manufactured by Olympus Corp. that was linked to so-called superbug infections.

As a result of the approval, the camera and medical-equipment maker plans to voluntarily recall the device and expects all 4,400 in the U.S. to be repaired with the modifications by August.

The device, known as a duodenoscope, is snaked down the throat of a patient into the top of the small intestine and is used in diagnostic and treatment procedures related to cancer and other conditions.

Between procedures the devices were disinfected and cleaned, but they still sometimes spread antibiotic-resistant infections from patient to patient. In March, Olympus distributed new cleaning instructions.

Olympus is just one of several duodenoscope manufacturers linked to bacteria transfers. In March, the FDA imposed new rules on makers, requiring them to submit detailed cleaning instructions and proof that the methods work.

In August, the FDA sent warning letters to the three duodenoscope makers, including Olympus, saying the companies either didn't adequately report infections or failed to provide sufficient evidence that its cleaning procedures work.

Duodenoscopes are used in more than 500,000 procedures each year. At the University of California, Los Angeles Health System, duodenoscope-linked infections were connected to the deaths of two people and infections in nine others.

The FDA said Olympus' devices should still be used, with the new cleaning procedure being "meticulously" followed, until Olympus is able to complete the four-day upgrade procedure.

Olympus also said it would annually inspect all scopes in use to identify wear and tear.

Write to Austen Hufford at [e-mail]

(END) Dow Jones Newswires

January 15, 2016 13:35 ET (18:35 GMT)

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