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 The scopes were linked to the exposure of 179 patients to
drug-resistant bacteria at UCLA's Ronald Reagan Medical Center in
Los Angeles and may have contributed to two deaths. Those incidents
were announced last month.
In early 2014, following a superbug outbreak at a hospital in
Illinois, the FDA asked Fujifilm Holdings Corp, Olympus Corp and
Pentax, which make the devices, to submit their test results for
review, Dr. Stephen Ostroff, the agency's chief scientist, said in
an interview.
In some cases the tests were poorly carried out. In others, they
were properly conducted but the cleaning and disinfecting protocol
failed, said Ostroff, who will become the FDA's acting commissioner
when Dr. Margaret Hamburg leaves at the end of March.
The deficiencies in the companies' tests has not been reported.
The flawed data calls into question the reliability of all current
cleaning and disinfecting protocols and expose a weakness in the
FDA's regulation of such devices - one which the agency is now
moving to close.
The FDA has said that even when hospitals adhered to the
manufacturers' instructions for cleaning scopes, patients have
contracted multidrug-resistant bacterial infections from the
devices, but the agency had not detailed manufacturers' tests of
their own procedures.
Under guidance issued in 1996, companies making duodenoscopes did
not have to submit data, but merely attest that cleaning protocols
used in their own studies were effective. The companies set their
own standards for effectiveness.
After the Illinois outbreak, the FDA said it would require
duodenoscope manufacturers to provide underlying test data at the
time they apply for marketing approval. And it has imposed specific
benchmarks by which effectiveness should be measured.
Among those benchmarks: the agency expects to see the elimination of
99.9999 percent of microbes at each of several locations on the
scope.
"We have set a higher bar to demonstrate adequate validation than
was expected in the past based on evolving science and experiences
with more recent outbreaks," Ostroff said. "What was acceptable a
few years ago is not adequate today."
A spokeswoman for Fujifilm, Diane Rainey, said it is working with
the FDA to evaluate and respond to concerns about contamination
concerns associated with the instruments and that patient safety
"is, and always will be, Fujifilm's primary consideration."
Representatives from Pentax and Olympus did not respond to requests
for comment after business hours on Sunday.
ADVISORY COMMITTEE MEETING
Ostroff told Reuters the FDA plans to convene a panel of outside
scientific advisors to review the safety of the devices "to put all
the available information on the table and have a discussion about
it."
The FDA's advisory committees counsel the agency on a variety of
scientific and regulatory issues, including drug and device
approvals and safety matters. The agency is not required to follow
recommendations made by its advisors, but typically does so.
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No date has been set for the meeting, which will be public, Ostroff
said.
The problems the advisory committee will likely be asked to consider
do not appear easy to fix.
The companies still have not come up with validated cleaning and
disinfecting protocols. The FDA found initial data submitted by the
companies inadequate and asked them to test the protocols again
using a more robust methodology. Those results were also
unsatisfactory.
They have been asked to try again, and the process will continue
until a reliably safe protocol is found, Ostroff said.
Duodenoscopes are threaded through the mouth, throat and stomach to
the top of the small intestine and are used to drain fluid from
pancreatic and biliary ducts. They have been associated with
episodic infections for more than a decade, but those infections
could often be treated with antibiotics.
That is no longer always the case. An increasing number of bacteria
are resistant to drugs, including a family of germs known as
carbapenem-resistant Enterobacteriaceae, or CRE, the bacteria
implicated in the outbreak announced last month at UCLA and the 2013
outbreak at Advocate Lutheran General Hospital near Chicago.
In addition to prompting the FDA to ask companies to submit their
underlying validation data, the Illinois outbreak prompted the
agency to examine the design of the devices. Its assessment is
ongoing but has already raised red flags, Ostroff said.
It is far from clear whether design changes would be effective:
companies have modified the devices before with no discernible
results.
In 2004 Fujifilm received FDA clearance for a change that would seal
an open channel in the device to keep out bodily fluids. In 2009,
the FDA cleared a similar change by Pentax.
Olympus, whose devices were used in the UCLA outbreak, made the
change in 2010, though it did not file for FDA clearance until last
October after being notified about the omission by the agency. The
application has not yet received clearance, but Ostroff said the FDA
has not removed the device from the market because doing so could
create a shortage.
(Editing by Peter Henderson)
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