March 26, 2015 — Olympus Corp., the Japanese manufacturer of an embattled medical scope linked to several deadly infection outbreaks, has sent hospitals an “urgent” update to the instructions for sterilizing the scope.
If the scope is not properly cleaned, residual body fluids and debris can remain embedded in microscopic crevices in the device. If they contain bacteria, subsequent patients may be exposed to antibiotic-resistant “superbug” infections.
In a 13-page letter, Olympus detailed a number of steps for pre-cleaning, manual cleaning, and high-level disinfection. The instructions include additional brushing and flushing, especially in the complex “elevator” mechanism and the instrument channel.
Olympus will also be shipping hospitals a new, smaller bristle cleaning brush, which they anticipate shipping to facilities no later than May 8, 2015.
In an updated Safety Communication, the FDA stated:
“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. “
These recommendations were issued just weeks after 200 people were exposed to Carbapenem-resistant Enterobacteriaceae (CRE) at a UCLA hospital in Los Angeles, including seven who were infected and two who died.
Officials at the hospital said the infections occurred despite following Olympus’ instructions for cleaning the scope. Since then, the FDA has been working with scope-manufacturers to improve the cleaning instructions.
However, the new instructions stop short of the rigorous sterilization procedures implemented at UCLA. The hospital now uses ethylene-oxide gas, which is very effective at cleaning the scope but is also extremely toxic, flammable, and renders the scope unusable for 24-48 hours.