The scopes that spread a superbug at UCLA last winter had previously led to outbreaks in Holland and Germany and raised concerns at European regulators, according to a doctors' report in the medical journal Endoscopy.
That outbreak at Ronald Reagan Medical Center led to multiple deaths and exposed dozens of patients to the deadly bacteria. But information about the faulty scopes, manufactured by Olympus Corporation, was unknown to American regulators.
According to a story in the Los Angeles Times:
Olympus Corp. failed to demonstrate a safe cleaning procedure, according to a new report. As a result, the Dutch hospital that suffered the outbreak, which sickened 22 patients, abandoned the scope for another model without the troublesome design.
The case shows how American regulators and hospitals were left in the dark even as regulators elsewhere concluded that the scopes may be impossible to use and clean safely.