FDA Approves Fixes for Olympus Scope Linked to Infections
2016年1月16日 - 3:50AM
Dow Jones News
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 austen.hufford@wsj.com
(END) Dow Jones Newswires
January 15, 2016 13:35 ET (18:35 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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