PENTAX Medical Receives FDA Clearance for Duodenoscope with New Sterilization Technology in Collaboration with Advanced Sterilization Products
Tokyo, Japan, August 5, 2024 – PENTAX Medical, a division of HOYA group, proudly announces FDA clearance of the DEC™ Duodenoscope (ED34-i10T2s) compatibility with the STERRAD™ 100NX Sterilizer, the flagship product from Advanced Sterilization Products (ASP), a division of Fortive.
The collaboration between PENTAX Medical and ASP has resulted in a groundbreaking advancement in addressing the ongoing challenges of duodenoscope reprocessing. Reducing the risk of cross-contamination with duodenoscopes has been a point of focus in the joint project. The DEC Duodenoscope (ED34-i10T2s) is the world’s first GI endoscope compatible with hydrogen peroxide gas plasma sterilization, a technology that has revolutionized infection prevention across various medical specialties.
"The low, but persistent risk of duodenoscope contamination post-reprocessing emphasizes the need for a reliable sterilization solution," said Klaus Mergener, MD, PhD, MBA, Global Head, Medical & Scientific Affairs and Chief Medical Officer at PENTAX Medical. "The partnership between PENTAX Medical and ASP has produced a method that also considers the workflow aspects that matter just as much as meeting sterilization efficacy standards."
FDA clearance of the ED34-i10T2s duodenoscope represents PENTAX Medical’s second pioneering milestone in enhancing infection prevention and patient safety through innovative design. The launch of the DEC (Disposable Elevator Cap) marked the first medical device manufacturer's response to the FDA's and CDC's call for advancement in duodenoscope design to reduce the risk of cross-contamination. The DEC allows physicians to simply and safely dispose the elevator, the component most vulnerable to enteric bacteria, while maintaining image quality, performance and handling of a reusable duodenoscope in each procedure.
"The collaboration with ASP marks a pivotal step forward in our continued effort to enhance patient safety through innovative endoscope designs; the compatibility with STERRAD technology ensures easier access to sterilized duodenoscopes with a lower environmental impact" said Harald Huber, Chief Product Officer at PENTAX Medical.
About PENTAX Medical
PENTAX Medical is a division of HOYA Group. The company's 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. PENTAX Medical strives to align with the healthcare community's Triple Aim goals through transparent partnerships with its customers and by providing the highest quality solutions to help them reach their goals, including enabling customers to improve patient outcomes by offering evidence-based solutions across the continuum of care; ensuring value by supporting the customers to improve their efficiency and minimize their healthcare costs; and enriching patient and provider's experience by empowering every member of the care team to achieve optimal outcomes through products, education, and support. Focused on the outcome instead of technological features, PENTAX Medical listens to the healthcare community and their patients, understands their daily obstacles and helps improve endoscopy with smart innovations.
For more information: https://www.pentaxmedical.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 lifecare 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: https://www.hoya.com/en/
Media contact:
Kaori Kawashima
GM, Global Marketing
PENTAX Medical
Tokyo, Japan
Email kaori.kawashima@pentaxmedical.com
MKGI-4749EN-U Rev 1 (v1.0)
