The medical endoscope manufacturer linked to several recent outbreaks of drug-resistant bacteria released new recommended procedures Thursday for reprocessing its devices that federal regulators say demonstrate “consistent and reliable cleaning and high-level disinfection.”
But devicemaker Olympus America also warned healthcare professionals that the new manual cleaning procedures will require the use of a new brush that the company says will not be available until May.
“In response to current events, concerns raised by healthcare professionals and medical societies, and in consultation with the U.S. Food and Drug Administration, Olympus is today forwarding an Urgent Safety Notification to its customers regarding new, validated reprocessing instructions for the Olympus TJF-Q180V duodenoscope,” company spokesman Mark Miller stated in an email Thursday.
“In addition to the current reprocessing procedures, customers are receiving instruction for immediate action regarding additional high-level disinfection steps—customers are also being notified now that in May, an additional cleaning brush will be made available to further facilitate new recommended manual-cleaning procedures,” Miller wrote.
Olympus issued the new cleaning recommendations for the TJF-Q180V duodenoscope at the request of the FDA, according to the agency. The request came after the FDA reviewed and validated data Olympus submitted in February that showed its revised reprocessing instructions could effectively disinfect the devices.
“The FDA has reviewed these new reprocessing instructions and the validation data as part of its ongoing review of the 510(k), and recommends that any facilities that are using Olympus' TJF-Q180V duodenoscope train staff on the new instructions and implement them as soon as possible,” the agency stated in a safety communication posted on its website Thursday.
Changes to the reprocessing procedure include additional rinsing and flushing steps for pre-cleaning and high-level manual disinfection, as well as a new manual-cleaning process that requires the use of two different-sized brushes, one of which, Olympus stated, it anticipates sending to providers no later than May 8.
“Health care professionals, including those working in reprocessing units in health care facilities, are encouraged to implement the instructions as soon as possible,” the FDA stated. “The high-level disinfection procedure and pre-cleaning step can be put in place immediately. The new manual cleaning instructions can be implemented when a new brush becomes available.”
The revised recommendations come in the wake of incidents involving contaminated duodenoscopes in Los Angeles at Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center, where as many 250 patients were potentially exposed to carbapenem-resistant enterobacteriaceae, or CRE, between August 2014 and January 2015. In all, 11 individuals were infected and two patients died from CRE as a result of undergoing procedures in which the contaminated duodenoscopes were used.
Both facilities have contended that the disinfection procedures recommended at the time by Olympus and endorsed by the FDA were strictly followed but were inadequate to effectively disinfect the devices.
The FDA has acknowledged that design characteristics of the duodenoscopes, which are used for such procedures as draining fluids from pancreatic and bile ducts, made cleaning and disinfecting the devices difficult. The agency stated a risk for infection still existed even when recommended processes were accurately followed.
Earlier this month, the FDA issued final rules for the cleaning and disinfecting of reusable medical devices such as the duodenoscopes four years after drafting its initial guidance in 2011. A public meeting is scheduled for May 14 and 15 to discuss the infection outbreaks that occurred from procedures in which the duodenoscopes were used.