A review of Olympus presentations to the U.S. FDA over its duodenoscopes suggests the Japan-based medical-device maker may have been "hoist with his own petard" in its attempt to have cleaning guidelines watered down, Bloomberg reported.
Olympus duodenoscopes have been linked to recent hospital superbug outbreaks, apparently because the cleaning and sterilizing instructions in its packaging for the devices was inadequate. The FDA warned the endoscopes may be incapable of being sanitized effectively because of their construction.
Similar devices made by Fujifilm Holdings and Pentax also have FDA clearance and are used by hospitals.
The Bloomberg report cited Olympus efforts to have wording changed after the agency published a draft of new instrument guidelines in 2011. Olympus suggested the word "will" be changed to "may," from mandatory to advisory, in one guideline direction: "Devices with features which may result in soil retention, or have features that make them difficult to clean, will need to be disassembled in order to be completely cleaned."
In another part of the FDA draft guideline, Olympus suggested trusting the makers of the device and of the sterilization chemical to provide a joint validation of the efficacy of the cleaning process used.
The guidelines are still in the draft stage at the FDA. The report on the Olympus efforts to change the wording said it "could shift some of the blame for the scopes that spread deadly pathogens away from device manufacturers and onto the companies that make the cleaning systems."
- here's the story from Bloomberg