Santa Clara, CAAn urgent recall of all Fujifilm ED-530XT duodenoscopes has been issued, due to the difficulty in what the US Food and Drug Administration (FDA) refers to as “reprocessing.” Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The voluntary recall of the duodenoscopes also includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new Operation Manuals. The FDA has previously issued a warning that duodenoscopes could be linked to the spread of deadly bacteria.
According to the federal agency, validated instructions when reprocessing Fujifilm ED-530XT duodenoscope models must be used and if followed correctly, are intended to effectively clean and high-level disinfect the Fujifilm ED-530XT duodenoscope. However, the recalled versions prove difficult to properly clean and disinfect.
On February 19, 2015, the FDA warned that the complex design of ERCP endoscopes may prevent them from being properly sanitized, even when manufacturer recommended sanitation guidelines are followed.
"Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it," the FDA warned. This warning concerns ERCP endoscopes, also known as duodenoscopes, and followed reports of serious multi-drug resistant bacteria in patients who had medical procedures involving the medical devices. Duodenoscope lawsuits have now been filed after patients reportedly developed infections linked to devices.