Outbreaks of potentially deadly bacterial infections caused by defective
duodenoscopes have been identified in 25 separate locations nationwide,
affecting dozens of patients, according to a recent U.S. Senate investigation.
The scopes are used to examine the duodenum, or the upper part of the
TheLos Angeles Times reports that the 301-page Senate document focuses on Olympus Corp., the
manufacturer of the scopes. The investigation determined that the manufacturer
knew that the scopes had a design defect that greatly increased the risk
of infection during surgeries, but it continued to make and sell the devices
without alerting hospitals or the U.S. Food and Drug Administration (FDA)
about the risks.
Olympus Corp., a Japanese company, sells 85 percent of the duodenoscopes
used in the U.S., according to the Times. In June 2012, the company received
concerns about the scope, questioning whether the device's design
made it too hard to sterilize properly.
Per the investigators: "The faith that patients, doctors, hospitals
and public health officials placed in Olympus to thoroughly test their
cleaning instructions before putting devices in the marketplace was clearly
The report also noted that: [Olympus] failed at every level to meet basic
expectations of transparency and openness and to actively engage with
FDA to address contamination issues... This disregard for the spirit,
and sometimes the letter, of the law resulted in potentially preventable
serious and potentially fatal illnesses in hospitals around the world."
Olympus allegedly did not warn about this increased risk of infection until
February 2015, after a "superbug" infected seven patients at
the Ronald Reagan Medical Center at the University of California Los Angeles
(UCLA). Nationwide, at least 141 patients reportedly suffered similar effects.
In March 2015,
the FDA issued a safety alert that addressed the steps Olympus had promised to take in order to correct
the problem. These included offering more detailed information about the
scopes' design and labeling and fixing defective scopes in order to
reduce the risk of cross-contamination and infection.
Defective medical equipment can cause serious harm, but hospital errors
overall may thankfully be on the decline. What's causing this positive
trend, and will it continue? Learn more:
Are Hospital Errors Really Becoming Less Common?
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