PENTAX Medical Video Duodenoscope ED34-i10T2 receives FDA clearance

Hamburg, November 28^th, 2019 - Conventional duodenoscopes are linked to infection risk, despite proper reprocessing after endoscopic retrograde cholangiopancreatography (ERCP) procedures. In a recent safety communication published by the US Food and Drug Administration (FDA), it was stated: “FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection […] The best path to reducing the risk of disease transmission by duodenoscopes is through innovative device designs, such as those with disposable components, that make reprocessing easier, more effective or unnecessary.”¹ In light of this recommendation, the FDA recently cleared the PENTAX Medical Video Duodenoscope ED34-i10T2 in the US. The duodenoscope allows physicians to simply and safely dispose of the elevator, the component most vulnerable to enteric bacteria.^2,3

“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Disposable elevator
The PENTAX Medical Video Duodenoscope ED34-i10T2 features a sterile, disposable distal cap PLUS disposable elevator—helping to reduce the risk of bio burden remaining on conventional elevator components after reprocessing. This reduces the burden of time-intensive reprocessing (aka cleaning) as a result of fewer steps in the reprocessing process.

“The PENTAX Medical Video Duodenoscope ED34-i10T2 represents a significant clinical innovation both in device design and patient safety due to its sterile and disposable distal end cap with integrated elevator, and also a human factors-validated approach to both reprocessing and competency-based training,” said Dr. Hudson Garrett, Global Chief Clinical Officer for PENTAX Medical. “The PENTAX Medical Video Duodenoscope ED34-i10T2 was specifically designed in response to the evidence-based recommendations released by the FDA and Centers for Disease Control and Prevention (CDC) and represents a critical step forward in improving patient safety, reducing contamination, and optimizing endoscope reprocessing programs.”

Exceptional performance globally 
Since its global launch, the PENTAX Medical Video Duodenoscope ED34-i10T2 has offered exceptional performance and advanced design. As a duodenoscope with HD imaging, it helps the endoscopist confidently diagnose, as well as visualize the mucosa in detail, identify abnormal tissue, and locate the papilla for cannulation. The PENTAX Medical Video Duodenoscope ED34-i10T2 includes a lightweight, ergonomic control body offering comfortable handling and optimal maneuverability.

“The new detachable cap (OE-A63) is one of the solutions to reduce the risk of bacterial contamination. This duodenoscope is a huge advancement and development for PENTAX Medical,” said Dr. Marc Giovannini, Institut Paoli-Calmettes, Marseille, France.  

About PENTAX Medical

PENTAX Medical is a division of HOYA Group. Its mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community. Headquartered in Japan, PENTAX Medical has a worldwide focus and presence with R&D, regional sales, service, and in-country facilities around the globe. For more information, please visit: 

www.pentaxmedical.com; http://www.the-hygiene-solution-that-fits.com/

About HOYA

Founded in 1941 in Tokyo, Japan, HOYA Corporation is a global technology and med-tech company and a leading supplier of innovative high-tech and medical products. HOYA is active in the fields of healthcare and information technology, providing eyeglasses, medical endoscopes, intraocular lenses, optical lenses, as well as key components for semiconductor devices, LCD panels, and hard disk drives. With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 37,000 people. For more information, please visit: http://www.hoya.com

Footnotes

1.     https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication

2.     https://www.gastro.org/press-release/how-to-stop-duodenoscope-infections

3.     https://www.fda.gov/news-events/press-announcements/fda-clears-first-duodenoscope-disposable-elevator-piece-reducing-number-parts-needing-disinfection