February 19, 2016 — Pentax has updated the instructions for cleaning the ED-3490TK Video Duodenoscope to reduce the risk of disease-transmission among patients.
Pentax sent a letter to healthcare facilities outlining the new protocol, which includes more rigorous pre-cleaning, manual cleaning, high-level disinfection, and liquid chemical sterilization procedures. The instructions focus on the “elevator” mechanisms, internal channels, and instrument channel.
In February 2015, the FDA issued a Safety Communication to warn that the complex design of duodenoscopes makes them hard to clean. The problem is that bacteria can hide in microscopic crevices and cause outbreaks of antibiotic-resistant “superbug” infections.
After the warning, Pentax began modifying the instructions and started validation testing in May 2015. Three months later, the company submitted reports to the FDA. The agency reviewed the reports and requested additional cleaning tests, which Pentax provided. In January 2016, the FDA concluded that the instructions were adequate.
Last year, the FDA sent Pentax a warning for failing to ensure the cleaning instructions for the ED-3490TK duodenoscope actually worked. The agency also ordered Pentax to study how well the scopes are actually cleaned in real-world settings.
Duodenoscopes are medical scopes that are inserted down a patient’s throat in a procedure known as Endoscopic retrograde cholangiopancreatography, or ERCP. They are commonly used to study the bile ducts, pancreatic duct, and gallbladder during treatment for gallstones and cancer.