Staff Writer
Two superbug related deaths were reported last
month in North Carolina and the Food and Drug Administration (FDA) now believe
that an unapproved scope model released on the market in 2010 may have been
involved. The superbug is contracted upon coming in contact with
carbapenem-resistant enterobacteriaceae (CRE). Symptoms of CRE include severe
pneumonia, high fever and sepsis (Blood poisoning). In North Carolina, 18
people have become infected with the superbug this year, 15 had it upon
admission to the hospital in Charlotte and three contracted it in the hospital.
It is unclear how they became infected because it is difficult to track the
spread of the bacteria. In Los Angeles, seven patients contracted CRE after
routine endoscopic procedures, and hospital officials say the outbreak was
caused by two medical scopes still carrying the bacteria even after disinfection
guidelines were followed.
Federal
Health officials have known about CRE since 2001 but have found it difficult to
trace and connect cases. There are an estimated 9,000 infections and 600 deaths
annually, yet health experts suggest that federal and state data collections
fail to show how serious of a threat CRE is. The Centers for Disease Control
and Prevention (CDC) says CRE has been found in 48 states. Of these states, 19
require certain medical facilities to report cases to public health
departments, online registries, etc. Only three states are close to requiring
CRE cases to be reported. No federal requirements force states and health care
facilities to report CRE cases to state or federal agencies. “We get no
national picture [of CRE infections]. It’s very hard to work with that
information,” says Nancy Hailpern, director of regulatory affairs at the
Association for Professionals in Infection Control and epidemiology.
Few
state hospitals submit possible CRE infections to the CDC. Dr. Jean Patel,
deputy director of the CDC’s office of antimicrobial resistance says, “You can
imagine that … we are not catching every single CRE case that happens in the
U.S.” There are a wide range of testing methods for CRE, none of which the FDA
has approved for detecting CRE specifically, because it’s an entire family of
bacteria. Patel says, “There are laboratory tests that detect most, if not all,
of the types of carbapenem-resistant enterobacteriaceae, and then there are
some tests that are very sensitive but they produce a lot of false positive
results.”
Olympus,
the manufacturer of the endoscope involved in two superbug deaths at Ronald
Reagan UCLA Medical Center, never got permission to sell the device. Olympus
began selling the TJF-Q180V duodenoscope in 2010, but the FDA didn’t notice
until late 2013 or early 2014. The problem with this device, used to examine
the beginning of the small intestine, is it is difficult to clean. This is why
hospital officials believe the two medical scopes carried the deadly bacteria
after disinfection guidelines were followed and the patients caught CRE after
routine endoscopic treatments. Over 179 others who had these procedures
performed between October and January have been contacted and offered home
tests to screen for the bacteria.
Pentax
and Fujifilm manufacture scopes similar to the one Olympus produces, and the
FDA is asking all three companies to submit evidence that the scopes can meet
their standard for disinfection. Karen Riley, deputy director of strategy for
the FDA’s Office of External Affairs, says the companies have submitted data
failing to show that the cleaning equipment could remove 99.9999% of all
microbes on the scope.
Combatting
the superbug requires isolating the infected and using special cleaning
procedures in rooms they’ve stayed in. It is difficult to treat because some
CRE bacteria are resistant to most antibiotics. The bacteria is believed to
kill 50% of those infected, and more than 100 people may have been potentially
exposed. North Carolina hospital officials say that patient privacy laws are
the reason the deaths weren’t reported earlier. Kevin McCarthy, spokesman of
the Carolinas HealthCare System says the state follows standard protocols for
disinfecting equipment and all scopes have been tested and have shown negative
for CRE.
Riley
isn’t sure if the FDA will penalize Olympus for selling the device without
permission. Diana Zuckerman, a device safety expert, believes they should,
“It’s like with kids. How do you teach your children to behave if there are no
consequences when they misbehave?”
