Three Japanese companies known more for cameras than medical devices have been called on the U.S. FDA carpet to explain why their medical scopes may be associated with at least two "superbug" deaths.
The agency requested Fujifilm Holdings, Olympus and Pentax, all makers of medical scopes that come with instructions for cleaning and disinfecting the instruments, to produce test results of the procedures.
The cleaning and disinfecting protocol failed in several instances and the incidents were not reported, an official said in an interview with Reuters. The companies' scopes have been linked to exposure of 179 patients at one medical center, and the deaths of two of them may have been associated with the at least one of products.
- here's the Reuters piece