Olympus issued new cleaning instructions to healthcare professionals to sterilize its duodenoscope blamed for an outbreak of the "superbug" in some hospitals, leading to at least two deaths. The FDA approved the new instructions and urged they be implemented "as soon as possible."
"Possible" apparently will not occur, however, until Olympus, "no later than May 8," ships a new small-bristle cleaning brush to be used in the new cleaning procedure. Until then, Olympus said, health workers should continue following the original cleaning instructions.
The letter did not note that the original instructions may be insufficient to sterilize the device, allegedly allowing the superbug to spread among hospital patients. The FDA has alleged the instructions were inadequate for the job, but Olympus has insisted otherwise.
In addition to using the new brush, the new set of instructions adds other procedures the healthcare worker could use to help clean the instrument. Most of the processes, though, still involve using the new brush.
- here are the Olympus letter and FDA Notice
- get FierceMedicalDevices' take