Complex parts make duodenoscopes difficult to clean properly, and their usage has been linked to superbug outbreaks at hospitals in the United States and Europe.
Fujifilm Medical Systems has recalled its ED-530XT model duodenoscopes in an effort to “help reduce the potential risk to health that may be associated with inadequate reprocessing of the device.”
The complicated parts in reusable duodenoscopes make them difficult to clean properly, and their usage has been linked to superbug outbreaks at hospitals in the United States and Europe.
The scope is used for viewing the duodenum and upper digestive tract. Fujifilm Medical Systems’ action includes replacing several parts and issuing a new operations manual.
The threat of infections related to scopes has plagued the medical device industry repeatedly in recent years. In its safety communication about the new recall, the FDA pointed to its February 2015 Safety Communication, which noted that the “complex design of duodenoscopes may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices.”
Related: Congressman Decries Olympus’ Failure To Warn U.S. Hospitals About Tainted Scopes
Fujifilm Medical Systems said it was issuing the voluntary recall out of “an abundance of caution.”
A proactive approach is evidently needed. The FDA notes that in fall 2013, CDC “alerted the FDA to a potential association between multi-drug resistant bacteria and duodenoscopes” and that “these cases of infection were occurring despite confirmation that the users were following proper manufacturer cleaning and disinfection or sterilization instructions.”
In fact, contaminated duodenoscopes manufactured by Olympus Corp. have been linked to at least 35 deaths since 2013, reports Kaiser Health News and L.A. Times.
Related: Olympus' Redesigned Scope is Linked to Infection Outbreak
Their joint investigation also revealed internal emails showing that Olympus Corp. opted not to issue a broad warning to American hospitals about the potential for infection, even though outbreaks were popping up throughout the country. Among those outbreaks was one at Ronald Reagan UCLA Medical Center, where patients suffered carbapenem resistant Enterobacteriaceae (CRE) bacteria infections.
Related: The Throwaway Scope: A Way To Ditch Superbugs?
According to the report, Olympus had, however, warned European hospitals about the infection risks.
Eventually, Olympus recalled its TJF-Q180V duodenoscopes in order to replace certain parts in an effort to prevent infections. Despite the changes to its scope, though, the infection problem resurfaced earlier this year, when five patients at a facility outside the United States tested positive for OXA-48 producing klebsiella pneumonia; one patient died, according to the FDA.
Fujifilm Medical Systems also removed certain older duodenoscope models from clinical use earlier this year.
Investigations and efforts into how to make duodenoscope reprocessing safer are ongoing, the FDA says.
Alexandra Wilson Pecci is an editor for HealthLeaders.
