The frequency of duodenoscope infection has brought renewed attention to the significance of disinfectant practices and medical device safety, prompting a government investigation. Despite strict sanitation protocols, dangerous bacteria can easily spread from reused medical devices. A commonly used scope device, reprocessed and employed in more than 500,000 procedures annually, the duodenoscope has now been linked to serious, life-threatening infections across the United States.
What is a duodenoscope?
A duodenoscope is a flexible tube threaded through the mouth and into the duodenum small intestine in endoscopic retrograde cholangiopancreatography (ERCP). Duodenoscopes are a minimally invasive method of draining fluids impacted by cancerous tumors, gallstones, and other conditions. Also known as an ERCP endoscope, the device is sanitized and reused on multiple patients.
Duodenoscope Infection: Ineffective Sanitation Protocols
Hospitals must clean and disinfect each endoscopic device before performing a procedure on another patient, following a strict set of manufacturer guidelines. Scopes and other medical devices are sanitized and reprocessed by a team of hospital staff focusing on infection control.
In 2014, an outbreak at UCLA Medical Center prompted the realization that current safety methods were ineffective. Nearly 250 patients became infected with carbapenem-resistant Enterobacteriaceae (CRE).
Hospital staff at UCLA followed sanitation protocols, but bacteria remained embedded in the scope. Three patients have died from ERCP-related infections.
“Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly,” the FDA wrote in a safety communication. “Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.”
Duodenoscope Infection: Complex Scope Design
In Feb. 2015, the FDA issued a safety communication asserting the design of duodenoscopes “may impede effective cleaning.” Duodenoscopes are designed with hollow channels that allow for biopsy and tissue collection.
The scope’s “elevator” mechanism alters the angle of channel, creating a crevice for bacteria to hide. In Oct. 2015, the FDA ordered scope manufacturers to postmarket surveillance studies to determine the risk-benefit and safety of scope and its design.
“Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection, according to the FDA. “If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.”
The FDA is involved in an ongoing investigation, though many patients have already been injured by unsanitary duodenoscopes.