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 Health care facilities that use duodenoscopes should meticulously
follow the manufacturer's cleaning instructions, the Food and Drug
Administration said in a safety update. Those with resources should
also take several other measures to reduce the risk of infection.
Duodenoscopes are flexible, lighted tubes inserted down the throat
during a procedure called endoscopic retrograde
cholangiopancreatography (ERCP) used to drain fluids from blocked
pancreatic and biliary ducts.
The reusable device is a more complex instrument than other
endoscopes and must be properly cleaned and disinfected after use so
that pathogens are not transferred from one patient to another.
Seven patients at the Ronald Reagan UCLA Medical Center were exposed
to antibiotic-resistant bacteria from such devices between October
and January. Two died.
In March Olympus Corp, the biggest maker of the devices, issued new
cleaning instructions to replace those on the original label. The
FDA recommended at the time that any facilities using the TJF-Q180V
device should train staff on the new instructions and implement them
as soon as possible.
In its latest safety update the FDA recommended hospitals also
consider microbiological culturing to identify any bacterial
contamination that may be present after the cleaning and
disinfecting process has taken place.
Another option recommended by the FDA includes ethylene oxide
sterilization.
"When possible and practical, duodenoscopes should be sterilized due
to the greater margin of safety," the agency said. Ethylene oxide
gas, it added, "may be an effective method for heat-sensitive
instruments, like duodenoscopes, that can be damaged by high
temperatures."
Hospitals could, alternatively, use a liquid chemical sterilizing
process, the FDA said. Because the process requires rinsing with
purified water following sterilization, "the device does not remain
completely free of all viable microbes," the FDA said. "The
concentration, exposure time and temperature of a liquid chemical
sterilant are crucial."
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Alternatively, the FDA said the standard high-level disinfection
process could be repeated after the first one is complete.
The FDA said not all health care facilities would be able to
implement any of the recommended measures, "which require specific
resources, training, and expertise."
The American Hospital Association said it would share the new FDA
guidance with its members and urge that they discuss it with their
infection control and quality experts.
"Individual hospitals should assess the rigor of the cleansing
procedures for the scopes they use and the additional advice in the
FDA guidelines to determine what will work best in their
organization," Nancy Foster, AHA vice president of quality and
patient safety policy, said in an email.
(Reporting by Toni Clarke in Washington; additional reporting by
Susan Kelly in Chicago; Editing by Bill Rigby and Ken Wills)
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