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.”
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.”
Alexandra Wilson Pecci is an editor for HealthLeaders.