A endoscope manufactured by
Olympus was responsible for the outbreak of superbug “CRE” (or carbapenem-resistant
Enterobacteriaceae), which was transmitted during certain
endoscopy procedures. CRE is rare but has recently caused two patient fatalities
and about seven patient infections at the UCLA Medical Center in California.
In addition, as many as 180 patients might have been exposed between early
October 2014 and late January 2015, according to
other news sources).
The Centers for Disease Control (CDC) says that
CRE infections are tough to treat because it’s highly resistant to certain drugs
and antibiotics. “E-coli” is a well-known example.
Symptoms include pneumonia, severe urinary tract infections (UTIs), high fever,
sepsis (blood poisoning) and septic shock (very low blood pressure). According
to the CDC, this superbug more frequently affects patients in acute or
long-term healthcare settings, like hospitals.
The medical device is Olympus America’s
TJF-Q180V duodenoscope, “[a] flexible, lighted tube which threads through the mouth, throat,
stomach, and into the top of the small intestine” using fiber optics
for visual examination, according to the
FDA. Over 500,000 procedures using duodenoscopes are performed annually in the U.S.
Most troubling is Olympus never actually obtained
to market the scope.
In recent years, Olympus redesigned the scope to improve and make it safer
for patients. Unfortunately this had the opposite effect. The channel
in the “ movable elevator mechanism” located at the tip (see
below) is now sealed, causing microscopic bacteria to get stuck in hard-to-access
grooves and crevices. Per the FDA, this makes effective
cleaning, disinfection and sterilization extremely difficult. As a result, CRE
can be transmitted once the device is subsequently used on other patients.
It is critical for healthcare providers to strictly adhere to FDA, manufacturer,
etc., requirements, perhaps go above and beyond, to ensure that medical
devices are safe for use in patient procedures. As patients receiving
treatment/services, we should ideally have peace of mind that the devices
aren’t harmful and that our providers are taking the necessary care.
It is also important we can be informed and feel comfortable communicating
with our providers, whether asking questions or voicing any concerns we
The FDA has now issued two
Safety Communications that identify Olympus’ scope as well as scopes manufactured by other
companies. The government agency urges all healthcare professionals and
patients to report adverse events or side effects related to the use of
these products to the FDA's MedWatch Safety Information and Adverse
Event Reporting Program:
Complete and submit the report online:
Download the form or call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
If you were injured as a result of these endoscopes, please
get in touch with our firm right away!