Last February, the FDA warned that the complex design of duodenoscopes is extremely difficult to clean.
In May, Fuji began testing the reprocessing procedure for the ED-530XT and submitted validation reports to the FDA in July.
In August, the FDA cited Fuji for failing to ensure that reprocessing procedures for their scopes actually worked. In a separate letter (PDF), the FDA said Fuji did not have permission to market the ED-530XT duodenoscope in the United States.
The agency confirmed the procedures met expectations in October and continued to work with Fuji to develop revised instructions.
The new instructions can be used to enhance the pre-cleaning, manual cleaning, and high-level disinfection procedures for the ED-530XT, 250, and 450 duodenoscopes. They also incorporate a new brush to scrub the tip of the scope, where tiny crevices in medical instruments are more likely to hide disease-causing microbes.
The FDA asks hospitals to train staff on the new instructions as soon as possible. According to the agency:
“If not properly reprocessed, residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high level disinfection. If these residual fluids contain microbial contamination, subsequent patients may be exposed to serious infections.”
Every year, duodenoscopes are used in about 500,000 procedures known as endoscopic retrograde cholangiopancreatography (ERCP). Since 2012, the scopes have been linked to several deadly outbreaks of antibiotic-resistant infections at hospitals in Seattle and Los Angeles. The FDA has not issued any recalls because the risk of disease-transmission is low and the scopes are used in life-saving procedures like cancer biopsies.