February 19, 2016 — Pentax has issued new instructions for cleaning the ED-3490TK Video Duodenoscope, according to a Safety Communication from the FDA.
The new instructions should reduce the risk of body fluids and organic debris hiding in microscopic crevices, which could transmit serious infections among patients. The FDA issued a warning about this risk in February 2015.
Pentax immediately began updating and testing instructions after the warning. In October, the company submitted validation reports to the FDA. The agency asked for more cleaning tests, which Pentax provided, and approved the new instructions in January 2016.
Pentax has sent a letter to healthcare providers with the new instructions. They include a more rigorous protocol for pre-cleaning, manual cleaning, high-level disinfection, and liquid chemical sterilization procedures.
The instructions focus on carefully cleaning the complex mechanisms in the tip of the scope, such as the “elevator” mechanism, instrument channel, and internal channels.
The scopes have been under scrutiny after several deadly outbreaks of antibiotic-resistant infections. Last year, the FDA issued a Warning Letter to Pentax for failing to make sure the cleaning instructions actually worked. Pentax also must study how effectively the scopes are cleaned in real-world settings.
Duodenoscopes are inserted down a patient’s throat during the treatment of diseases like gallstones and pancreatic cancer. They are also commonly used to open blocked bile ducts in a procedure known as Endoscopic retrograde cholangiopancreatography, or ERCP.