January 4, 2016 — The FDA has approved new instructions for cleaning the Fujifilm ED-530XT duodenoscope to reduce the risk of infection.
In February 2015, the FDA announced that they were working with duodenoscope manufacturers to validate cleaning instructions to improve safety.
Fujifilm began testing the ED-530XT in May and submitted validation reports in July. The FDA approved the changes in October and continued working with the company as they developed instructions.
The new instructions recommend more thorough pre-cleaning, manual cleaning, and high-level disinfection. They also incorporate the use of a new brush to manually clean the tip of the scope.
The FDA asks healthcare facilities using the ED-530XT to train staff on the new instructions as soon as possible. The agency also recommends using the instructions to clean Fujifilm’s 250 and 450 duodenoscopes. According to the FDA:
“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.”
Duodenoscopes are used in about 500,000 procedures known as endoscopic retrograde cholangiopancreatography (ERCP) every year. The devices consist of a long, flexible tube with a light and a camera at the tip.
The problem is that complex mechanisms in the tip of the scope are extremely difficult to clean, which increases the risk of disease transmission between patients. The scopes have been linked to several deadly outbreaks of antibiotic-resistant infections, but the FDA has refused to issue any recalls because there are no alternative devices available.