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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 small intestine.
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 misplaced.”
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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