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 The Food and Drug Administration said it was not recommending that
healthcare providers cancel procedures performed with a duodenoscope
for patients who need them.
It did recommend that healthcare providers inform patients of the
risks, including infection, and benefits associated with the
procedure and report to the manufacturer and the FDA if they suspect
problems with the equipment have led to patient infections.
The alert followed news on Wednesday that four patients at the
Cedars-Sinai Medical Center in Los Angeles were infected with a
drug-resistant bacteria during endoscopic procedures that may have
exposed 64 others since August.
On Feb. 19, the UCLA Health System reported that 179 of its patients
may have been exposed to the bacteria during endoscopic procedures
since October. It said seven of those patients were confirmed to
have been infected, and two of them had died.
In a safety alert the same day, the FDA said the complex design of
endoscopes linked to the UCLA outbreak may hinder proper cleaning.
The FDA said it wanted to raise awareness among healthcare
professionals that the complex design of the devices - flexible
tubes that are threaded through the mouth, throat and stomach to
drain fluids from blocked pancreatic and biliary ducts - is
associated with a risk of multidrug-resistant infections even when a
manufacturer's cleaning instructions are followed correctly.
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Makers of the devices, known as duodenoscopes, include Olympus Corp,
Fujifilm Holdings Corp and Pentax Medical.
After outbreaks, hospitals that began sterilizing the devices more
rigorously than the FDA and manufacturers recommend have not had any
further transmissions of dangerous microbes from the devices, the
hospitals said.
(Reporting by Doina Chiacu; Editing by Eric Walsh)
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