In a recommendation often followed by the U.S. FDA, an advisory panel asked that the agency require sterilization after each use of a duodenoscope, directly affecting at least three Japan makers.
The action stems from "superbug" infections, some fatal, in U.S. hospitals where the Olympus TJF-Q180V was used. The infections were traced to insufficient disinfection treatment as instructed by Olympus.
Fujifilm and Pentax also make duodenoscopes and similarly would be affected by having to switch from disinfection to more thorough sterilization to prevent spread of the hospital infection.
No vote was taken by the advisory panel since it was only asked to review the issue, but it nonetheless recommended the agency do what it can, probably by convincing the devicemakers to require sterilization in their instruction manuals.
The Wall Street Journal added that ethylene oxide used by workers for sterilizing was toxic to them if exposed to it, increasing the burden on the makers and the hospitals.
- here's the story from the Wall Street Journal