Olympus (TYO:7733) announced that it won FDA clearance for its TJF-Q190V duodenoscope with a sterile, disposable distal endcap.
The new duodenoscopes are designed to improve the cleaning and reprocessing of the device to reduce contamination. The device is a result of the FDA’s call for more duodenoscopes that are disposable.
FDA in August 2019 recommended that healthcare providers move away from infection-prone duodenoscopes in favor of devices that are more easily sterilized.
“Infection prevention is an ongoing mission that we at Olympus are committed to fulfilling, working in partnership with our customers, medical society and regulatory authorities to keep patients safe while providing physicians the most advanced tools and technology for accurate and effective diagnosis and treatment,” VP of endoscopy at Olympus America Kurt Heine said in a news release.
The TJF-Q190V duodenoscope features a sterile, clear, single-use distal endcap cover that can be removed and discarded after a procedure to prevent reuse. It also offers improved visualization of and access to the distal end for manual cleaning and disinfection. The distal-end flushing adaptor enables cleaning of the elevator mechanism and the sealed elevator wire channel port doesn’t require separate cleaning.
“A goal of our innovation is to expand the capabilities of our physician customers while making it easier to achieve patient safety standards,” chief medical safety officer Ross Segan said. “The further into the body we can go with minimally invasive equipment, the more power we will have to diagnose life-threatening conditions and treat them, which can lead to critical benefits, including reduced costs and improved patient outcomes and satisfaction.”
Traditionally, duodenoscopes have been intended for use on multiple patients and required cleaning and disinfecting before each procedure. Since the devices are complex and have many small moving parts, contaminated tissue or fluids can become trapped in its crevices. The devices have also sparked controversy in recent years because they can transmit infection-causing bacteria between patients, if not thoroughly cleaned.
The Olympus clearance comes after Pentax and Boston Scientific won clearance for disposable duodenoscopes late last year.
