It's likely that you've seen at least one
news article to do with the spate of recent CRE
(Carbapenem-Resistant Enterobacteriaceae)
outbreaks across several states and facilities that have been linked to Endoscopic retrograde
cholangiopancreatography (ERCP) procedures using duodenoscopes.
ERCP is a relatively common diagnostic procedure that examines diseases
of the liver, bile ducts and pancreas.
Duodenoscopes
are long, flexible, viewing instruments that are inserted through the mouth and
fed down into the top of the small intestine (duodenum). They contain a hollow
channel that allows the injection of contrast dye or the insertion of other
instruments to obtain tissue samples for biopsy or treat certain abnormalities.
Unlike most other endoscopes, duodenoscopes also have a movable “elevator”
mechanism at the tip. The elevator mechanism changes the angle of the tip of
the duodenoscope, which allows the instrument to access the ducts to treat
problems with fluid drainage as a result it is a complex instrument than other
endoscopes and unsurprisingly can be more difficult to clean and disinfect.
Reprocessing is a detailed, multi-step process to clean and
disinfect or sterilize reusable devices. First, meticulous cleaning must
occur which requires the removal of adherent visible soil, blood, protein
substances, and other debris from
the surfaces, crevices, serrations, joints, and lumens of instruments, devices,
and equipment by a manual or mechanical process that prepares the items for
safe handling and/or further decontamination using a detergent and water. As a semi-critical device,
duodenoscopes require high-level
disinfection which is intended to reduce the risk of transmitting
infection, but may not entirely eliminate it.
High-Level disinfection is
generally completed using a germicide that inactivates all microbial pathogens,
except large numbers of bacterial endospores, when used according to labeling.
The FDA and Health Canada further define a high level disinfectant as a
sterilant used under the same contact conditions except, for a longer contact
time.
The complex design of duodenoscopes allows for improved
patient outcomes for diagnosis and treatment; however, it does cause challenges
for cleaning and disinfection as some parts of the scope can be extremely
difficult to access. For example, the
moving parts of the elevator mechanism contain microscopic crevices that may not
be reached with a brush allowing residual body fluids and organic debris to
remain in these crevices after cleaning and disinfection. This remaining soil can lead to transmission
of disease causing organisms and can be transmitted to subsequent patients.
While the
prevalence of such pathogens is increasing in hospitals, it is important to
understand that antibiotic resistance does not translate to chemical
resistance. It is also important to
remember that disinfectants have been used for well over 100 years without loss
of effectiveness. While there is a hierarchy with respect to some bacteria such
as spore-formers or Mycobacteria spp.
being less susceptible to chemicals than their gram negative or gram positive
cousins. In fact, as shown by numerous
studies, antibiotic resistant pathogens are not more resistant to disinfectants
than antibiotic sensitive pathogens.
In accordance
to recent communications from the FDA with respect to the best practices for
cleaning and disinfection of duodenoscopes while they acknowledge that
duodenoscopes are inherently difficult to reprocess, strict adherence to the
manufacturer’s reprocessing instructions will minimize the risk of infection. Facilities should have processes in place to
ensure staff that are responsible for reprocessing do not deviate from the
manufacturer's instructions for reprocessing as this may contribute to
contamination.
The long and the short of it is....meticulous cleaning is
paramount to patient safety, and similar to baking, cutting corners or skipping
ingredients is bound to lead to disaster!
Bugging Off!
Nicole
