Dive Brief:
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Last week, Olympus announced it plans to recall its duodenoscope after reports tying it to numerous outbreaks that infected at least 141 U.S. patients with illnesses, including sometimes-fatal CRE superbug infections, the Los Angeles Times reported.
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The company says it will collect the scopes, and replace the internal elevator mechanism in the device that has been proven to harbor bacteria, even after being cleaned. The FDA-approved redesign aims to create a tighter seal to keep bodily fluids and tissue from entering the closed channel.
- Olympus is also slated to perform annual inspections of hospitals' scopes to help identify signs of wear or debris, and to replace parts as needed, the FDA said.
Dive Insight:
While technically voluntary, the recall and redesign come after mounting pressure. The issue was made public last year when the Los Angeles Times reported the company had known of the risks since 2012, but had not notified U.S. hospitals or regulators. Olympus also disclosed last spring the DOJ was investigating its role in the outbreaks.
The company blamed the issue on hospitals' improper cleaning, but three investigations found proper cleaning does not always remove bacteria, and the U.S. Senate released a scathing report on the issue just two days prior to Olympus' recall announcement.
The report concluded Olympus and two other duodenoscope manufacturers, Pentax and Fuji, “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," the report stated.