Antibiotic-resistant Enterobacteriaceae - USA: (WA) fatal, ERCP endoscopes
ANTIBIOTIC-RESISTANT ENTEROBACTERIACEAE - USA: (WASHINGTON) FATAL,
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ENDOSCOPES
******************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>
[1]
Date: Thu 22 Jan 2015
Source: GreenwichTime, AP (Associated Press) report [edited]
<http://www.greenwichtime.com/
A multidrug-resistant superbug has sickened dozens of people at a
Seattle [Washington] hospital, spread from patient-to-patient through
contaminated equipment.
The Seattle Times reports (<http://is.gd/m4JVhK>) investigators found
the rare bacteria known as CRE -- carbapenem-resistant
Enterobacteriaceae -- was likely spread through specialized endoscopes
that had been cleaned according to manufacturers' directions but still
had some of the deadly germs.
Virginia Mason Medical Center officials say they've changed their
cleaning protocol for the devices, even though federal officials found
no problem with their infection-control practices.
Doctors say 11 of the at least 35 patients infected at the hospital
died, but it's not clear what role, if any, the infection played in
their deaths.
--
Communicated by:
ProMED-mail from HealthMap Alerts
<promed@promedmail.org>
******
[2]
Date: Wed 21 Jan 2015
Source: Seattle Times [edited]
<http://seattletimes.com/html/
An outbreak of multidrug-resistant superbugs spread by contaminated
endoscopes infected at least 32 patients at Virginia Mason Medical
Center between 2012 and 2014. Neither the hospital nor health
officials notified patients or the public.
Eleven of those patients died, but it's not clear what role, if any,
the infections played, doctors said.
The rare bacteria likely were transmitted from patient to patient by
specialized endoscopes, flexible tools used to treat pancreatic cancer
and other gut problems, which had been cleaned according to
manufacturers' directions but still harbored the potentially deadly
germs.
The Seattle outbreak appears to be among the worst so far in the US,
where problems with dirty endoscopes have been tied to superbug
infections in Chicago [Illinois] and Pittsburgh [Pennsylvania] in
recent years. Although the bacteria weren't exactly the same, the
situation raises new questions about the design, disinfection and
regulation of the devices, critics charge.
Investigators found a rare type of multidrug-resistant bacteria on
some scopes after disinfection that matched the same dangerous germs
detected in dozens of already critically ill patients who had
undergone a specific procedure.
Some of the bacteria were resistant to some carbapenem antibiotics,
drugs of last resort, echoing other outbreaks of CRE --
carbapenem-resistant Enterobacteriaceae, which may have a mortality
rate as high as 50 percent, according to the Centers for Disease
Control and Prevention [CDC].
Virginia Mason officials say they've overhauled their cleaning
protocol for the devices, known as duodenoscopes, even though
investigations by local and federal health officials found no breach
in infection-control practice at the hospital. "This makes us the
safest place in the country to have this done," said Dr. Andrew Ross,
section head for the gastroenterology department.
Some patients may have been aware of their infections. However,
neither the patients nor their families have been notified
specifically about the outbreak or its source -- not by Virginia Mason
nor by Public Health-Seattle & King County. Officials said Wednesday
[21 Jan 2015] there's little the very sick people could have done in
response to this information.
"Are you going to create unnecessary fear in the public about
something we can't do anything about?" said Dr. Chris Baliga, Virginia
Mason's medical director of infection prevention. "Patients are at the
same or higher risk all across the country," said Dr. Jeffrey Duchin,
King County interim health officer, who helped investigate the
outbreak. "We didn't feel like it was a new issue that warranted
emergency notification."
That couldn't be further from the truth, said Lawrence F. Muscarella,
a Philadelphia infection-control expert who has been monitoring
endoscope-associated superbug outbreaks for several years. "My concern
now is that when we talk about there being a risk, there is no longer
just a risk. It's a reality. People are dying from it," Muscarella
said. He's worried that growing numbers of patients undergoing a
special procedure known as endoscopic retrograde
cholangiopancreatography, or ERCP, which examines and treats disease
of the bile or pancreatic ducts, may be contracting the dangerous,
hard-to-treat CRE infections spread by the medical devices.
Worse, Muscarella said, he's convinced that the design of the scopes
is to blame. The distal ends of the long, flexible scopes include
so-called "elevator wire channels," or tiny flaps that hold stents and
other accessories -- but may also harbor bacteria that can't be
cleaned, even with recommended disinfection techniques, Muscarella
said.
That's a view shared by officials at Public Health, Virginia Mason and
the Centers for Disease Control and Prevention. In a report on
Seattle's outbreak, CDC officials said the complex design of the
scopes "makes them difficult to clean with the potential for
contamination persisting following reprocessing and subsequent
transmission of pathogenic bacteria to patients."
The CDC has reached out to officials at the Food and Drug
Administration [FDA], which regulates medical devices. But so far, the
FDA has issued no warning or recalls. Leslie Wooldridge, an agency
spokeswoman, said the FDA is aware of and closely monitoring the
association between CRE infection and reprocessed endoscopes. But, she
added, the design of the devices, including the elevator mechanism,
allows changes in the angle of the accessory instruments that make
certain treatments possible. "The FDA feels that the lifesaving nature
of ERCP, performed on more than 500 000 patients annually in the US,
makes it important for these devices to remain available." The risk of
infection is very low, she added.
News of the rare, multidrug-resistant infections at Virginia Mason was
released this fall, more than 2 years after the 1st infections were
detected, in a small abstract published at a conference of the
Infectious Diseases Society of America.
Investigators with Public Health, Virginia Mason and the CDC said
they'd identified at least 30 cases of a rare type of
multidrug-resistant bacteria known as a hyper-AmpC producer, or HAC.
Ten cases showed resistance to some carbapenem antibiotics, but most
did not. That meant the infections were difficult, but not impossible
to treat, doctors said. Seven patients died within 30 days of
collection of the superbug samples, health officials said.
Investigators now say they have identified at least 32 cases and 11
deaths through March 2014, although they emphasize that the patients
were critically ill, mostly with terminal pancreatic or colon cancer,
and it's not clear whether the superbug infections were to blame.
Since spring [2014], however, Virginia Mason has taken steps to
culture and quarantine all the duodenoscopes used in some 1800 ERCP
procedures performed there each year. Each device is held for 48 hours
to make sure it's free of CRE and other dangerous bugs. Virginia Mason
has bought 20 additional USD 37 500 devices made by the Olympus
Medical System Corp., to allow time for some to be out of service.
"It's way beyond what anybody else in the country is doing," Duchin
said. "We think that the steps they've put in place to culture and
quarantine the scopes have been effective."
CRE infections have been associated with scopes made by all 3 top
manufacturers.
Art Caplan, a bioethicist at New York University's Langone Medical
Center, said hospital and public-health officials should have notified
patients and the public about the outbreak far sooner. "People have a
right to know that's intrinsic or inherent," Caplan said. "If my
spouse died because of an infected piece of medical equipment or
dental equipment, I would like to know. I would even like to examine a
lawsuit."
Virginia Mason's problem was 1st revealed by voluntary CRE
surveillance conducted by state and local health officials, but the
hospital is not alone in facing problems with potentially contaminated
endoscopes, Duchin added. "The truth is, nobody else is looking," he
said. Dr. Michael Gluck, Virginia Mason's chief of medicine, said the
hospital would like to join groups putting pressure on the FDA and
manufacturers to change the scopes to allow thorough cleaning. "What
we would like to see is a better design of the elevator," he said.
Mark A. Miller, a spokesman for Olympus, said the firm is aware of
reports of CRE infections after ERCP procedures and is "monitoring the
issue closely. All types of endoscopes require thorough reprocessing
after patient use, and customers who purchase Olympus duodenoscopes,
as with all of our products, receive instruction and documentation to
pay careful attention to cleaning and reprocessing steps to ensure
effective reprocessing," he said in an email.
Meanwhile, health experts said patients who might need endoscopic
exams or treatment, particularly ERCP procedures, should discuss the
issue with their doctors. The procedures carry risks and benefits that
must be considered, Duchin said. The risk of transmission of a
multidrug-resistant bug must be weighed against the risk of not
receiving a necessary treatment. "If you need the procedure because
you have an obstructed biliary duct and are going to die without it,
it's worth the risk," Duchin said.
[Byline: JoNel Aleccia]
--
Communicated by:
ProMED-mail
<promed@promedmail.org>
[A discussion of carbapenemases produced by Enterobacteriaceae can be
found in my comments in prior ProMED-mail posts Enterobacteriaceae,
carbapenem resistant - Europe: survey 20130712.1822582 and ampC
beta-lactamase hyperproducers in Enterobacter cloacae - Belize: (BZ)
fatal, neonatal ICU 20130525.1736926.
A discussion of the nosocomial transmission of carbapenemase-producing
Enterobacteriaceae (CPE) via contaminated endoscopes that are used to
perform endoscopic retrograde cholangiopancreatography (ERCP), which
is a type of upper gastrointestinal (GI) endoscopic procedure, can be
found in my comments in another prior ProMED-mail post: NDM-1 carrying
E. coli - USA: (IL) ERCP 20140104.2151607. Also see
<http://endoscopereprocessing.
for a description of other outbreaks of CPE associated with ERCP
endoscopes. The design of ERCP endoscopes poses a problem for cleaning
and disinfection when reused for multiple patients. A CDC discussion
of transmission of CPE linked to use of contaminated endoscopes used
for ERCP can be found at
<http://www.cdc.gov/mmwr/
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ENDOSCOPES
******************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>
[1]
Date: Thu 22 Jan 2015
Source: GreenwichTime, AP (Associated Press) report [edited]
<http://www.greenwichtime.com/
A multidrug-resistant superbug has sickened dozens of people at a
Seattle [Washington] hospital, spread from patient-to-patient through
contaminated equipment.
The Seattle Times reports (<http://is.gd/m4JVhK>) investigators found
the rare bacteria known as CRE -- carbapenem-resistant
Enterobacteriaceae -- was likely spread through specialized endoscopes
that had been cleaned according to manufacturers' directions but still
had some of the deadly germs.
Virginia Mason Medical Center officials say they've changed their
cleaning protocol for the devices, even though federal officials found
no problem with their infection-control practices.
Doctors say 11 of the at least 35 patients infected at the hospital
died, but it's not clear what role, if any, the infection played in
their deaths.
--
Communicated by:
ProMED-mail from HealthMap Alerts
<promed@promedmail.org>
******
[2]
Date: Wed 21 Jan 2015
Source: Seattle Times [edited]
<http://seattletimes.com/html/
An outbreak of multidrug-resistant superbugs spread by contaminated
endoscopes infected at least 32 patients at Virginia Mason Medical
Center between 2012 and 2014. Neither the hospital nor health
officials notified patients or the public.
Eleven of those patients died, but it's not clear what role, if any,
the infections played, doctors said.
The rare bacteria likely were transmitted from patient to patient by
specialized endoscopes, flexible tools used to treat pancreatic cancer
and other gut problems, which had been cleaned according to
manufacturers' directions but still harbored the potentially deadly
germs.
The Seattle outbreak appears to be among the worst so far in the US,
where problems with dirty endoscopes have been tied to superbug
infections in Chicago [Illinois] and Pittsburgh [Pennsylvania] in
recent years. Although the bacteria weren't exactly the same, the
situation raises new questions about the design, disinfection and
regulation of the devices, critics charge.
Investigators found a rare type of multidrug-resistant bacteria on
some scopes after disinfection that matched the same dangerous germs
detected in dozens of already critically ill patients who had
undergone a specific procedure.
Some of the bacteria were resistant to some carbapenem antibiotics,
drugs of last resort, echoing other outbreaks of CRE --
carbapenem-resistant Enterobacteriaceae, which may have a mortality
rate as high as 50 percent, according to the Centers for Disease
Control and Prevention [CDC].
Virginia Mason officials say they've overhauled their cleaning
protocol for the devices, known as duodenoscopes, even though
investigations by local and federal health officials found no breach
in infection-control practice at the hospital. "This makes us the
safest place in the country to have this done," said Dr. Andrew Ross,
section head for the gastroenterology department.
Some patients may have been aware of their infections. However,
neither the patients nor their families have been notified
specifically about the outbreak or its source -- not by Virginia Mason
nor by Public Health-Seattle & King County. Officials said Wednesday
[21 Jan 2015] there's little the very sick people could have done in
response to this information.
"Are you going to create unnecessary fear in the public about
something we can't do anything about?" said Dr. Chris Baliga, Virginia
Mason's medical director of infection prevention. "Patients are at the
same or higher risk all across the country," said Dr. Jeffrey Duchin,
King County interim health officer, who helped investigate the
outbreak. "We didn't feel like it was a new issue that warranted
emergency notification."
That couldn't be further from the truth, said Lawrence F. Muscarella,
a Philadelphia infection-control expert who has been monitoring
endoscope-associated superbug outbreaks for several years. "My concern
now is that when we talk about there being a risk, there is no longer
just a risk. It's a reality. People are dying from it," Muscarella
said. He's worried that growing numbers of patients undergoing a
special procedure known as endoscopic retrograde
cholangiopancreatography, or ERCP, which examines and treats disease
of the bile or pancreatic ducts, may be contracting the dangerous,
hard-to-treat CRE infections spread by the medical devices.
Worse, Muscarella said, he's convinced that the design of the scopes
is to blame. The distal ends of the long, flexible scopes include
so-called "elevator wire channels," or tiny flaps that hold stents and
other accessories -- but may also harbor bacteria that can't be
cleaned, even with recommended disinfection techniques, Muscarella
said.
That's a view shared by officials at Public Health, Virginia Mason and
the Centers for Disease Control and Prevention. In a report on
Seattle's outbreak, CDC officials said the complex design of the
scopes "makes them difficult to clean with the potential for
contamination persisting following reprocessing and subsequent
transmission of pathogenic bacteria to patients."
The CDC has reached out to officials at the Food and Drug
Administration [FDA], which regulates medical devices. But so far, the
FDA has issued no warning or recalls. Leslie Wooldridge, an agency
spokeswoman, said the FDA is aware of and closely monitoring the
association between CRE infection and reprocessed endoscopes. But, she
added, the design of the devices, including the elevator mechanism,
allows changes in the angle of the accessory instruments that make
certain treatments possible. "The FDA feels that the lifesaving nature
of ERCP, performed on more than 500 000 patients annually in the US,
makes it important for these devices to remain available." The risk of
infection is very low, she added.
News of the rare, multidrug-resistant infections at Virginia Mason was
released this fall, more than 2 years after the 1st infections were
detected, in a small abstract published at a conference of the
Infectious Diseases Society of America.
Investigators with Public Health, Virginia Mason and the CDC said
they'd identified at least 30 cases of a rare type of
multidrug-resistant bacteria known as a hyper-AmpC producer, or HAC.
Ten cases showed resistance to some carbapenem antibiotics, but most
did not. That meant the infections were difficult, but not impossible
to treat, doctors said. Seven patients died within 30 days of
collection of the superbug samples, health officials said.
Investigators now say they have identified at least 32 cases and 11
deaths through March 2014, although they emphasize that the patients
were critically ill, mostly with terminal pancreatic or colon cancer,
and it's not clear whether the superbug infections were to blame.
Since spring [2014], however, Virginia Mason has taken steps to
culture and quarantine all the duodenoscopes used in some 1800 ERCP
procedures performed there each year. Each device is held for 48 hours
to make sure it's free of CRE and other dangerous bugs. Virginia Mason
has bought 20 additional USD 37 500 devices made by the Olympus
Medical System Corp., to allow time for some to be out of service.
"It's way beyond what anybody else in the country is doing," Duchin
said. "We think that the steps they've put in place to culture and
quarantine the scopes have been effective."
CRE infections have been associated with scopes made by all 3 top
manufacturers.
Art Caplan, a bioethicist at New York University's Langone Medical
Center, said hospital and public-health officials should have notified
patients and the public about the outbreak far sooner. "People have a
right to know that's intrinsic or inherent," Caplan said. "If my
spouse died because of an infected piece of medical equipment or
dental equipment, I would like to know. I would even like to examine a
lawsuit."
Virginia Mason's problem was 1st revealed by voluntary CRE
surveillance conducted by state and local health officials, but the
hospital is not alone in facing problems with potentially contaminated
endoscopes, Duchin added. "The truth is, nobody else is looking," he
said. Dr. Michael Gluck, Virginia Mason's chief of medicine, said the
hospital would like to join groups putting pressure on the FDA and
manufacturers to change the scopes to allow thorough cleaning. "What
we would like to see is a better design of the elevator," he said.
Mark A. Miller, a spokesman for Olympus, said the firm is aware of
reports of CRE infections after ERCP procedures and is "monitoring the
issue closely. All types of endoscopes require thorough reprocessing
after patient use, and customers who purchase Olympus duodenoscopes,
as with all of our products, receive instruction and documentation to
pay careful attention to cleaning and reprocessing steps to ensure
effective reprocessing," he said in an email.
Meanwhile, health experts said patients who might need endoscopic
exams or treatment, particularly ERCP procedures, should discuss the
issue with their doctors. The procedures carry risks and benefits that
must be considered, Duchin said. The risk of transmission of a
multidrug-resistant bug must be weighed against the risk of not
receiving a necessary treatment. "If you need the procedure because
you have an obstructed biliary duct and are going to die without it,
it's worth the risk," Duchin said.
[Byline: JoNel Aleccia]
--
Communicated by:
ProMED-mail
<promed@promedmail.org>
[A discussion of carbapenemases produced by Enterobacteriaceae can be
found in my comments in prior ProMED-mail posts Enterobacteriaceae,
carbapenem resistant - Europe: survey 20130712.1822582 and ampC
beta-lactamase hyperproducers in Enterobacter cloacae - Belize: (BZ)
fatal, neonatal ICU 20130525.1736926.
A discussion of the nosocomial transmission of carbapenemase-producing
Enterobacteriaceae (CPE) via contaminated endoscopes that are used to
perform endoscopic retrograde cholangiopancreatography (ERCP), which
is a type of upper gastrointestinal (GI) endoscopic procedure, can be
found in my comments in another prior ProMED-mail post: NDM-1 carrying
E. coli - USA: (IL) ERCP 20140104.2151607. Also see
<http://endoscopereprocessing.
for a description of other outbreaks of CPE associated with ERCP
endoscopes. The design of ERCP endoscopes poses a problem for cleaning
and disinfection when reused for multiple patients. A CDC discussion
of transmission of CPE linked to use of contaminated endoscopes used
for ERCP can be found at
<http://www.cdc.gov/mmwr/
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