|
 Last week the FDA warned that the complex design of the reusable
duodenoscopes, which are threaded through the mouth, throat and
stomach and used in a variety of gastrointestinal procedures, makes
them difficult to disinfect properly, even when instructions
provided by the manufacturers are followed. Pentax Medical, Fujifilm
Holdings Corp and Olympus Corp are the leading makers of these
endoscopes.
"We are working to expedite modifications to the label," Dr. William
Maisel, chief scientist in the FDA's Center for Devices and
Radiological Health, said in an interview. "We are also talking
about updating the risk information."
The urgency comes as the FDA faces some criticism for taking more
than three years to issue definitive guidelines on the instructions
manufacturers must give for disinfecting the scopes, a delay that
critics say may have contributed to the failure to keep the devices
from causing infections.
The outbreak may have exposed 179 patients to a potentially deadly,
drug-resistant strain of bacteria at UCLA's Ronald Reagan Medical
Center in Los Angeles and contributed to two deaths. The FDA said
last week that from 2013 to 2014 it received 75 reports, involving
135 patients, of possible contamination from reused duodenoscopes.
Maisel said that if a new cleaning method is established, the agency
would expect companies to reflect that in their labels. One possible
protocol is being developed by the U.S. Centers for Disease Control
and Prevention and is close to being finalized, the CDC scientist
leading the effort told Reuters on Friday.
Pentax Medical said in an e-mail it is talking to the FDA about
updating its cleaning and sterilizing instructions, known as
reprocessing. Fujifilm said it recommends strict adherence to the
company's reprocessing instructions but "reserves the right" to make
new recommendations in the future "whether as a result of new
industry practices, FDA guidance, or Fujifilm-specific updates to
best practices."
Olympus, whose devices were used in the UCLA outbreak, did not
respond to questions about labeling changes.
CRITICS SAY FDA PROCESS TOO SLOW
Label changes, which can take months to complete, have been proposed
in general terms before. But the latest outbreak has raised new
issues that may require more specific measures to guard against
infection from the flexible scopes, which are used to diagnose or
treat disorders in about 500,000 procedures a year in the United
States alone.
The FDA issued draft guidance on the labeling of reusable medical
devices in May 2011, but such preliminary advice does not carry as
much weight in the medical industry as its final guidance.
Among the draft recommendations: devices with "features that make
them difficult to clean will need to be disassembled in order to be
completely cleaned" and "instructions/diagrams for adequate
disassembly should be included in the cleaning instructions."
[to top of second column] |
The draft guidance said labels should include "any special warnings
or precautions" about the reprocessing procedure. The FDA plans to
release final guidance this spring.
Lengthy delays between the issuance of draft and final guidance are
not uncommon at the agency, and critics say the slow process is not
helping the situation.
"The draft guidance would have made a difference if it had been
finalized," said Mark Duro, director of sterile reprocessing
operations at New England Baptist Hospital in Boston.
“This was asking the manufacturers to give us more information about
how to reprocess the (duodenoscopes), and every bit of additional
information would be better than we have now."
The 2011 draft guidance may also prove to be out of date as bacteria
become more virulent and drug-resistant.
The FDA has known of infections linked to reusable devices since at
least 2009. The draft guidance was issued partly in response to
those concerns.
But the latest outbreak is novel in that the bacteria are surviving
even when manufacturers instructions are followed, Maisel said.
"In 2009 we weren't aware of outbreaks of multi-drug resistant
bacteria in these scopes happening when proper cleaning was
followed," he said.
Whatever the new labels say, some experts say they won't be enough
to protect patients without additional safeguards.
“The devices need to be designed better, the instructions need to be
more clear, the hospitals need better training, and adequate time
needs to be given in hospitals to ensure sterility is top notch,”
said Mary Logan, chief executive of the Association for the
Advancement of Medical Instrumentation, an alliance of healthcare
providers which helps develop standards for use.
AAMI will be issuing new guidelines on endoscope cleaning within the
next two months.
(Reporting by Toni Clarke in Washington; Editing by Michele
Gershberg and Stuart Grudgings)
[© 2015 Thomson Reuters. All rights
reserved.] Copyright 2015 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed. |
