|
 The new protocol for the reusable devices, called duodenoscopes, is
being developed by the U.S. Centers for Disease Control and
Prevention (CDC), whose disease detectives have investigated
duodenoscope-transmitted infections since 2013.
In the latest outbreak, duodenoscopes spread antibiotic-resistant
bacteria to seven patients at a University of California at Los
Angeles hospital, contributing to two deaths.
The CDC's guidance would not be mandatory. Only the U.S. Food and
Drug Administration has authority to require a manufacturer to
include more stringent safety instructions for medical devices. The
FDA can also order products be redesigned.
The FDA has not taken either step, despite knowing since at least
2009 that duodenoscopes have spread pathogens among patients. But
this week it warned the medical community that the devices can
transmit superbugs.
Though CDC protocols are not mandatory, they carry considerable
weight because hospitals that ignore them could be vulnerable to
lawsuits.
Experts in infectious-disease control welcomed the CDC's
involvement, though they said it raised a larger question about the
FDA.
"If the CDC, which does not have regulatory authority, is doing more
(to make duodenoscopes safe) than the FDA, which does have that
authority, it raises the question of who's running the ship here,"
said Lawrence Muscarella, an endoscopy consultant and author of a
2014 paper on the device's pathogen-transmission risk.
FDA spokeswoman Leslie Wooldridge said the agency is "actively
engaged with the manufacturers of duodenoscopes" and with the CDC
"to develop solutions to minimize patient risk associated with" the
devices.
Duodenoscopes are inserted down the throat during gastrointestinal
procedures. Problems arise when the devices, which sell for upwards
of $40,000, are not properly disinfected before being used on
subsequent patients.
The CDC is close to unveiling a detailed procedure aimed at
preventing more cases, said infectious disease expert Dr. Alexander
Kallen of the CDC.
Called a "surveillance culture," the procedure involves swabbing the
device after it has supposedly been disinfected and then allowing
any microbes to grow into detectable colonies, much as doctors take
throat swabs to determine if a patient has a strep infection.
[to top of second column] |
The protocol has undergone pilot testing at Virginia Mason Hospital
and Medical Center in Seattle with good results, Kallen said. The
Seattle hospital reported a duodenoscope-related superbug outbreak
last month.
"We feel right now that we have a protocol people could use," Kallen
said. "Our goal is to have this available very soon if people think
this is the right way to go."
The duodenoscopes are made by Olympus Corp <7733.T>, Fujifilm
Holdings Corp <4901.T> and Pentax.
The manufacturers have been criticized for failing to redesign the
scopes six years after their potential to transmit infections came
to the attention of physicians and regulators.
Olympus and Fujifilm did not immediately respond to requests for
comment. Pentax spokesman Mariano Franco said the company is working
with the FDA and others “to determine potential approaches that
would contribute to the mitigation of pathogen transmission with
duodenoscopes,” but had not yet identified one “that would address
these concerns.”
In an ironic twist, the CDC protocol would likely increase sales of
the devices, according to Muscarella. Waiting for the results of the
surveillance culture sidelines an instrument for days, so a hospital
would likely need to have extra ones on hand to meet demand for the
procedures.
(Reporting by Sharon Begley in New York and Toni Clarke in
Washington; editing by Andrew Hay)
[© 2015 Thomson Reuters. All rights
reserved.] Copyright 2015 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
