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PENTAX MEDICAL LAUNCHES DEC HD DUODENOSCOPE IN U.S.

PENTAX Medical, a healthcare industry leader in diagnostic and therapeutic endoscopy, has announced the United States launch of its DEC HD Duodenoscope, an advanced, high-definition duodenoscope that features multiple disposable components, including the sterile distal cap and elevator lever, for unit reprocessing. The DEC HD Duodenoscope is designed to provide physicians a solution aligned with recent FDA guidance on reducing endoscope reprocessing, as well as deliver tangible “Triple Aim”1 value (by improving clinical outcomes, reducing care costs, and enhancing physician and patient experiences). The device has been available in global markets since 2017 and recently received FDA clearance, facilitating its US commercial launch.

Conventional duodenoscopes are linked to infection risk, despite proper reprocessing after ERCP procedures. In a recent safety communication published by the 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.”[2]

“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.[3]

Responding to the FDA’s and CDC’s call for advancement in duodenoscope design to increase patient safety, PENTAX Medical developed the DEC: an advanced, hygienic endoscopic solution that maintains the imaging and handling performance physicians need during endoscopic retrograde cholangiopancreatography (ERCP) procedures.

The DEC allows physicians to simply and safely dispose of the elevator, the component most vulnerable to enteric bacteria.[4] The DEC HD Duodenoscope features a sterile, disposable distal cap PLUS disposable elevator—helping to reduce the risk of bioburden 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 DEC 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 DEC was specifically designed in response to the evidence-based recommendations released by the FDA and CDC and represents a critical step forward in improving patient safety, reducing contamination, and optimizing endoscope reprocessing programs.”

Since its global launch, the DEC HD Duodenoscope 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 DEC includes a lightweight, ergonomic control body offering comfortable handling and optimal maneuverability.

“The new detachable cap 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.

All DEC™ HD Duodenoscopes are protected by the proactive and cost-saving PENTAX ServiceWorks™ program providing customers Access to board-certified Infection Preventionists and Patient Safety Professionals, Certified Field Reprocessing Professionals, and accredited continuing education programs to assist Healthcare Providers and Facilities in meeting evidence-based standards, clinical guidelines, and regulatory/accreditation requirements.[5]

References and Notes:

[1] http://www.ihi.org/Engage/Initiatives/TripleAim/Pages/default.aspx

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

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

[4] https://www.gastro.org/press-release/how-to-stop-duodenoscope-infections

[5] Meets the recommendations and requirements from the Centers for Disease Control and Prevention, US Food and Drug Administration, Society for Gastroenterology Nurses and Associates, Association for periOperative Registered Nurses, American Society for Gastrointestinal Endoscopy, and American Gastroenterological Association.

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