March 26, 2015 — Olympus Corp., the manufacturer of a duodenoscope that has recently been linked to deadly outbreaks of antibiotic-resistant “superbug” infections, has issued an urgent update on how to clean the device.
Olympus has sent a 13-page letter with detailed instructions for cleaning the scopes, including extra steps that must be taken to ensure the scope is properly disinfected between uses.
The new instructions require longer pre-cleaning, additional flushing, the use of a new bristle cleaning brush, and more. Hospitals are asked to “train staff on the new instructions and implement them as soon as possible.”
Last month, the FDA warned that the complex design of duodenoscopes may impede effective cleaning. Since 2009, the scopes have been linked to several outbreaks of infection, even when the manufacturer’s cleaning instructions were followed correctly.
The FDA has been working with duodenoscope manufacturers to modify the cleaning instructions to enhance the safety margin.
The FDA has signed off on the new instructions, and issued a Safety Communication:
“The agency has reviewed this data and believes that, when followed, the new, validated reprocessing instructions for the Olympus TJF-Q180V duodenoscope are robust, and demonstrate consistent and reliable cleaning and high-level disinfection. “
However, the FDA and Olympus stopped short of recommending the use of ethylene-oxide gas, which some hospitals have implemented after outbreaks of Carbapenem-resistant Enterobacteriaceae (CRE). The gas is very effective at sterilizing the scopes, but renders them unusable for 24-48 hours and is extremely flammable and toxic.