Advanced Sterilization Products Announces FDA Clearance for Revolutionary Sterilization Cycle for Duodenoscopes in Partnership with PENTAX Medical
Advanced Sterilization Products (ASP), a Fortive (NYSE: FTV) division, in collaboration with PENTAX Medical, has received FDA clearance for the ULTRA GI™ Cycle in its STERRAD™ 100NX Sterilizer with ALLClear™ Technology. This innovative cycle is specifically designed to reprocess duodenoscopes using hydrogen peroxide gas plasma sterilization, addressing concerns about high contamination rates in these devices.
The new sterilization method aims to revolutionize patient safety and set a new industry standard. Chad Rohrer, President of ASP, emphasized the importance of this development in reducing patient risk. Dr. Ivan Salgo, Chief Medical & Scientific Officer at ASP, highlighted that the ULTRA GI™ Cycle represents a significant shift towards making hydrogen peroxide gas plasma the gold standard for duodenoscope sterilization, improving safety for patients, technicians, and the environment.
Advanced Sterilization Products (ASP), una divisione di Fortive (NYSE: FTV), in collaborazione con PENTAX Medical, ha ricevuto l'
Il nuovo metodo di sterilizzazione mira a rivoluzionare la sicurezza dei pazienti e stabilire un nuovo standard nel settore. Chad Rohrer, Presidente di ASP, ha sottolineato l'importanza di questo sviluppo nella riduzione del rischio per i pazienti. Il Dr. Ivan Salgo, Chief Medical & Scientific Officer di ASP, ha evidenziato che il ciclo ULTRA GI™ rappresenta un cambiamento significativo verso la creazione del perossido di idrogeno gas plasma come standard d'oro per la sterilizzazione dei duodenoscopi, migliorando la sicurezza per pazienti, tecnici e l'ambiente.
Advanced Sterilization Products (ASP), una división de Fortive (NYSE: FTV), en colaboración con PENTAX Medical, ha recibido la autorización de la FDA para el ciclo ULTRA GI™ en su esterilizador STERRAD™ 100NX con tecnología ALLClear™. Este ciclo innovador está específicamente diseñado para reprocesar duodenoscopios utilizando la esterilización por plasma de gas de peróxido de hidrógeno, abordando las preocupaciones sobre las altas tasas de contaminación en estos dispositivos.
El nuevo método de esterilización tiene como objetivo revolucionar la seguridad del paciente y establecer un nuevo estándar en la industria. Chad Rohrer, presidente de ASP, enfatizó la importancia de este desarrollo para reducir el riesgo para los pacientes. El Dr. Ivan Salgo, director médico y científico de ASP, destacó que el ciclo ULTRA GI™ representa un cambio significativo hacia hacer del gas de peróxido de hidrógeno el estándar de oro para la esterilización de duodenoscopios, mejorando la seguridad para los pacientes, técnicos y el medio ambiente.
Advanced Sterilization Products(ASP)는 Fortive(NYSE: FTV) 부서로 PENTAX Medical과 협력하여 STERRAD™ 100NX 살균기에서 ALLClear™ 기술을 사용한 ULTRA GI™ 사이클에 대해 FDA 승인을 받았습니다. 이 혁신적인 사이클은 듀오데노스코프를 재처리하기 위해 수소 퍼옥사이드 가스 플라즈마 살균을 사용하도록 특별히 설계되어, 이 장비에서의 높은 오염률에 대한 우려를 해소합니다.
새로운 살균 방법은 환자 안전을 혁신하고 새로운 산업 표준을 설정하는 것을 목표로 합니다. ASP의 회장인 Chad Rohrer는 이 개발이 환자의 위험을 줄이는 데 얼마나 중요한지를 강조했습니다. ASP의 최고 의료 및 과학 책임자인 Dr. Ivan Salgo는 ULTRA GI™ 사이클이 수소 퍼옥사이드 가스 플라즈마를 듀오데노스코프 살균의 기준으로 삼기 위한 중요한 변화라고 강조하며, 환자, 기술자 및 환경에 대한 안전성을 향상시킵니다.
Advanced Sterilization Products (ASP), une division de Fortive (NYSE: FTV), en collaboration avec PENTAX Medical, a reçu l'
La nouvelle méthode de stérilisation vise à révolutionner la sécurité des patients et à établir une nouvelle norme dans l'industrie. Chad Rohrer, président d'ASP, a souligné l'importance de ce développement pour réduire le risque pour les patients. Dr. Ivan Salgo, directeur médical et scientifique chez ASP, a mis en avant que le cycle ULTRA GI™ représente un changement significatif vers le fait de faire du plasma de gaz de peroxyde d'hydrogène le standard d'or pour la stérilisation des duodénoscopes, améliorant ainsi la sécurité pour les patients, les techniciens et l'environnement.
Advanced Sterilization Products (ASP), eine Division von Fortive (NYSE: FTV), hat in Zusammenarbeit mit PENTAX Medical die FDA-Zulassung für den ULTRA GI™ Zyklus in ihrem STERRAD™ 100NX Sterilisator mit ALLClear™ Technologie erhalten. Dieser innovative Zyklus ist speziell dafür konzipiert, Duodenoskope zu reprocessen und nutzt dabei die Sterilisation mit Wasserstoffperoxid-Gasplasma, um Bedenken hinsichtlich hoher Kontaminationsraten in diesen Geräten zu adressieren.
Die neue Sterilisationsmethode zielt darauf ab, die Patientensicherheit zu revolutionieren und einen neuen Branchenstandard zu setzen. Chad Rohrer, Präsident von ASP, betonte die Wichtigkeit dieser Entwicklung zur Reduzierung des Patientennrisikos. Dr. Ivan Salgo, Chief Medical & Scientific Officer von ASP, hob hervor, dass der ULTRA GI™ Zyklus einen bedeutenden Schritt in Richtung einer Wasserstoffperoxid-Gasplasma-Sterilisation als Goldstandard für die Sterilisation von Duodenoskopen darstellt, wodurch die Sicherheit für Patienten, Techniker und die Umwelt verbessert wird.
- FDA clearance received for ULTRA GI™ Cycle, a new sterilization method for duodenoscopes
- Collaboration between ASP (Fortive division) and PENTAX Medical to address a critical healthcare safety issue
- Potential to set a new industry standard for duodenoscope sterilization
- Improved safety for patients, technicians, and the environment through hydrogen peroxide gas plasma sterilization
- None.
The FDA clearance of ASP's ULTRA GI™ Cycle for the STERRAD™ 100NX Sterilizer is a significant advancement in duodenoscope reprocessing. This innovation addresses a critical patient safety concern in endoscopy. Duodenoscopes have been associated with high contamination rates, leading to potential infections. The new hydrogen peroxide gas plasma sterilization method offers a higher level of sterility assurance compared to traditional reprocessing techniques.
This development could reduce healthcare-associated infections and potentially lower liability risks for healthcare facilities. It may also streamline workflows in endoscopy departments, possibly reducing turnaround times. However, healthcare providers will need to consider the cost of implementation and staff training for this new technology. Overall, this clearance represents a positive step for patient safety in gastrointestinal procedures.
This FDA clearance is a positive development for Fortive (NYSE: FTV), ASP's parent company. It positions ASP as a leader in medical device sterilization, potentially driving increased market share and revenue growth in the healthcare sector. The collaboration with PENTAX Medical, a division of HOYA, could lead to strategic partnerships and cross-selling opportunities.
Investors should note the potential for increased sales of STERRAD™ 100NX Sterilizers and related consumables. This innovation may also strengthen Fortive's competitive position in the medical technology market. However, the financial impact will depend on adoption rates and pricing strategies. Keep an eye on upcoming quarterly reports for indications of how this clearance translates into revenue and profit growth for Fortive's healthcare segment.
The ULTRA GI™ Cycle represents a paradigm shift in duodenoscope reprocessing. Traditional methods have been inadequate in fully eliminating contamination risks, leading to patient infections and costly outbreaks. This new sterilization cycle addresses a critical gap in infection prevention protocols.
Healthcare facilities adopting this technology may see a reduction in healthcare-associated infections related to endoscopic procedures. This could lead to improved patient outcomes, shorter hospital stays and reduced healthcare costs. Additionally, the use of hydrogen peroxide gas plasma is environmentally friendly, aligning with sustainability goals in healthcare.
However, implementation will require careful planning, including staff training and workflow adjustments. Facilities should conduct a cost-benefit analysis, considering both the initial investment and long-term savings from reduced infection rates.
Revolutionizing Sterilization Practices
The FDA clearance marks a significant milestone in advancing patient safety and addressing the challenges associated with current reprocessing methods for duodenoscopes. This groundbreaking sterilization cycle is set to revolutionize sterilization practices in healthcare facilities, ensuring a new standard of safety and efficacy.
Addressing Contamination Concerns
Duodenoscopes have been under scrutiny due to their relatively high contamination rates, prompting the urgent need for a robust sterilization solution. The collaborative effort between ASP and PENTAX Medical has resulted in an innovative method that not only meets but exceeds industry standards, providing healthcare professionals with a powerful tool to enhance patient safety.
“We’re proud and excited to receive FDA clearance for our new ULTRA GI™ Cycle, developed in partnership with PENTAX Medical,” said Chad Rohrer, President of ASP. “Both of our organizations are deeply committed to ensuring the safety of patients, and duodenoscopes have historically presented one of the greatest risks to patients in healthcare facilities. By using hydrogen peroxide gas plasma sterilization to reprocess duodenoscopes, we are achieving an increased level of certainty of sterility for healthcare professionals.”
“The use of hydrogen peroxide gas plasma represents a significant shift in making it the gold standard of sterilization for duodenoscopes and thereby improving safety for patients, technicians, and the environment,” said Ivan Salgo, MD, Chief Medical & Scientific Officer at ASP. “The ULTRA GI™ Cycle sets a new benchmark for the entire industry on sterilization and environmental safety and will give healthcare professionals and their patients a heightened level of assurance that the duodenoscopes used are now being sterilized in a safe and effective way.”
About Advanced Sterilization Products (ASP)
Advanced Sterilization Products (ASP) has a long track record of designing and delivering innovative infection prevention solutions that dramatically raise the level of health care and safety for those who matter most. Our pioneering technology, global distribution and established leadership position enable us to simplify the process of buying and operating infection prevention products and services every day for thousands of medical facilities around the world. This enables our customers to focus on what they do best – preventing infection and saving lives. For more information, please visit www.asp.com.
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Source: Advanced Sterilization Products
FAQ
What is the ULTRA GI™ Cycle and what has it received from the FDA?
How does the ULTRA GI™ Cycle address concerns about duodenoscope contamination?
Who developed the ULTRA GI™ Cycle for duodenoscope sterilization?
What are the potential benefits of the ULTRA GI™ Cycle for healthcare facilities?
