failed to ensure their scopes could be properly cleaned.
• Last month the FDA recalled an estimated 2,800 automatic endo-
scope reprocessors made by Ivyland, Pa.-based Custom Ultrasonics.
• To top it off, the ECRI Institute, an independent healthcare
research firm in suburban Philadelphia, has tabbed dirty endoscopes
as the top technology hazard for 2016.
Duodenoscope doubts
Patients who have undergone endoscopic retrograde cholangiopan-
creatography (ERCP) have become infected with carbapenem-resis-
tant Enterobacteriaceae (CRE) that remained in improperly cleaned
duodenoscopes. Highly publicized outbreaks have occurred at the
UCLA Medical Center in Los Angeles, the University of Pittsburgh
Medical Center, Advocate Lutheran General Hospital in Park Ridge,
Ill., and Virginia Mason Medical Center in Seattle, Wash. Last month,
the widow of a 55-year-old man who was allegedly exposed to CRE
during an ERCP performed at Carolinas Medical Center in Charlotte,
N.C., filed a wrongful death lawsuit against duodenoscope manufac-
turer Olympus and Custom Ultrasonics.
In August, the FDA sent warning letters to Olympus, Fujifilm and
Pentax, informing the manufacturers that their duodenoscopes are
misbranded. Then, in October, the FDA gave the companies a month
to submit written plans for assessing how their scopes are being
reprocessed and what steps can be taken to improve the process.
Another bombshell hit last month when the FDA ordered the imme-
diate recall of nearly 3,000 AERs manufactured by Custom
Ultrasonics. According to the recall, Custom Ultrasonics must validate
the ability of its AERs to effectively clean and disinfect specific duo-
denoscopes. The company says in a statement that it is complying
with the request, that its washer/disinfecter has not been linked to any
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