Hygiene Commitment
PENTAX Medical strives to continuously improve patient safety and infection prevention. That’s why we are using innovative products, optimizing processes, and integrating feedback from the market. By offering solutions like the DEC™ Duodenoscope, we are reinforcing our strong commitment to these vital topics. But real change comes from understanding the landscape – and reshaping it. This is why improved hygiene and safety are the pillars that support all our research and development. We work closely with experts for market insights to ensure that all products are directly based on this need. Then we innovate for even better clinical outcomes – because a commitment is nothing without action. Find out more about ensuring safety in endoscopy in this article. Read more here: • Proper reprocessing, drying and storage of endoscopes is crucial for patient safety • New developments to enhance hygiene safety of endoscopic interventions • Supporting hospitals with advanced endoscope drying and effective storage
THE HYGIENE SOLUTION THAT FITS.
Designed for PENTAX Medical
Flexible endoscopes are still among the most complex medical devices. Maintaining the product quality is crucial, and requires using dedicated PENTAX Medical endoscope accessories. Our engineers’ dedication to the assurance of our endoscopes’ quality and optimal hygiene levels has resulted in specific hygiene-related products. They follow the DESIGNED FOR PENTAX Medical rationale to support you in: • Increasing confidence in the safety of the reprocessing outcome • Fulfilling compliance requirements within hygiene departments • Reduce risk of infection and cross-contamination PENTAX Medical supports you with cleverly engineered technology and dedicated services. Welcome to a world where you will always find smart and sophisticated answers to your daily challenges.
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PROfILE single-use cleaning brushes
Product Overview
Manually pre-cleaning flexible endoscopes is key to ensuring reliable reprocessing as an end result. Even with magnification, visual assessment of the manual pre-cleaning results is insufficient to detect microorganisms. As such, PENTAX Medical provides a verified and validated solution to improve confidence in manual pre-cleaning, with the new PROfILE single-use cleaning brushes.
One product range that fits every PENTAX Medical endoscope
Proven cleaning efficiency
Designed and validated to meet PENTAX Medical's quality standards
Compliant with the industry's highest reprocessing standards
Another important advantage of our Triple Aim Commitment to our customer
PROfILE Single-Use Cleaning Brushes
Cleaning Brush Compatibility
PENTAX Medical is delivering a unique and innovative advancement in cleaning capabilities to reduce the risk of cross-contamination: the Video Duodenoscope ED34-i10T2 and Slim Video Duodenoscope ED32-i10, with the single-patient use, sterile, disposable elevator cap (DEC™). This pioneering solution for diagnostic and therapeutic endoscopic retrograde cholangio-pancreatography (ERCP) procedures combines improved medical device hygiene clinical control with HD image quality (HD+) and procedural performance. DEC™, with its disposable elevator, responds to the FDA's guidance to move toward disposable elements with duodenoscopes. This need comes as a result of increasing incidences of Carbapenem-resistant Enterobacteriaceae (CRE) and other infections, which may also be linked to improper cleaning and/or disinfection of a duodenoscope’s elevator mechanism. The PENTAX Medical Video Duodenoscope ED34-i10T2 combines a sterile disposable elevator cap (DEC™) for single-patient use and simple disposal that advances cleaning capability of the duodenoscope to help reducing risk of cross-contamination and improve patient care with High-Definition image quality for detailed endoscopic visualization during ERCP procedures.
Raising the standard of health
LOCK IN. ELEVATE YOUR CARE.
DEC™ Video Duodenoscope ED34-i10T2 Slim DEC™ Video Duodenoscope ED32-i10
Enhance infection prevention, reduce risk
Reliable therapeutic performance
Reprocessing operational efficiency
The DEC™ allows simplified reprocessing and increased cleaning capability, and thus helps reducing the risk for cross-contamination.
PENTAX Medical’s first duodenoscope with a disposable elevator that offers HD+ image quality for detailed visualization and high precision in ERCP procedures.
35% reduction of distal end reprocessing* due to better access for cleaning and disinfection as well as disposbility of the elevator.
*In comparison to the standard duodenoscopes of the major manufacturers. Source: PENTAX Medical internal benchmarking.
Read our white paper to learn more about how the DEC™ Duodenoscope relates to patient safety, infection control, and user satisfaction.
Download the white paper
Risks factors associated with endoscope infection outbreaks
The PENTAX Medical solution
The innovative design of the PENTAX Medical DEC™ Duodenoscope introduces a unique solution in the market and simplifies the overall reprocessing process.
The elevator cap is designed as a disposable component
The elevator area of the duodenoscope is one of the most difficult components to clean. With the DEC™ Duodenoscope design, this challenge is overcome through the elevator integration into the disposable distal end cap.
"Manufacturers may consider enhanced design to ensure the adequate reprocessing of ERCP endoscopes and other complex reusable instrumentation, to further minimize the risk of disease transmission during GI endoscopy."
Muscarella et al. World J Gastrointest Endosc 2014 October 16; 6(10): 457-474 ISSN 1948-5190
ERCP is associated with the highest risk of infectious complications among all gastrointestinal endoscopic procedures."
Verfaillie et al, Endoscopy 2015; 47: 493–502
Confidence when delivering therapy
The ED34-i10T2 is a duodenoscope providing High-Definition endoscopic images for routine and therapeutic ERCP procedures. HD+ combined with i-SCAN allows for better visualization and facilitates easier cannulation. Combined with i-SCAN and i-SCAN OE, detailed visualization of the mucosal structures is possible to support detection and characterization of target.
Precise control
Material couplings and the disposable design allow the use of a new elevator every time a procedure is performed, with no risk of wear-out-effects. The improved elevator shape and ergonomic design of the duodenoscope facilitate easy cannulation as well as precise and controlled positioning of devices during ERCP procedures.
Optimized visualization
HD+ imaging allows better visualization and anatomical interpretation of papillary structures, for an easier cannulation of the ducts. i-SCAN can be used to highlight and assess target.
i-SCAN facilitates the visualization of the orifice of the papilla i-SCAN OE increases contrast and visualizes vascular patterns i-SCAN can be used to highlight pit pattern structures i-SCAN OE can help to precisely visualize the area to be ablate
The re-engineered and innovative distal end of the PENTAX Medical DEC™ Duodenoscope allows direct access and exposure to critical surfaces for brushing, cleaning and disinfection.
The disposable elevator cap: better benefit through disposability
Thanks to the distal end cap’s single-patient-use design with its integrated elevator there is no need for elevator reprocessing.
Distal end with open access
The DEC™ Duodenoscope distal end, with disposable elevator cap, has been designed to offer a reduced risk of cross-contamination. PROfILE single-use cleaning brushes were made to meet the high-quality standards of PENTAX Medical engineering. These brushes have been specifically designed for PENTAX Medical and were tested to reduce residual soil compared to legacy brushes. PENTAX Medical recommends to reprocess the DEC™ Duodenoscope by using PROfILE single-use cleaning brushes.
35% reduction in steps for distal end reprocessing*
*In comparison to the standard duodenoscopes of the major manufacturers.
Source: PENTAX Medical internal benchmarking.
ServiceWorks
DEC™ Duodenoscope
PlasmaTYPHOON & PlasmaBAG System
The DEC™ Duodenoscope is PENTAX Medical’s fervent response to the FDA safety communication that calls for a transition to duodenoscopes that reduce cross-contamination through single-use components. The ongoing post market surveillance sampling & culturing study results for the DEC Duodenoscope indicate you can be confident that this ERCP solution is a safer alternative than traditional duodenoscopes. With 20% of properly collected samples analyzed there are: • 1.0% High Concern Organisms detected • 0.5% Low/Moderate Concern Organisms > 100 CFU’s detected Be a part of the solution with us. Learn about our limited time DEC Duodenoscope trade-in incentive program from your local rep or through our customer support team here.
Conventional duodenoscopes are linked to higher infection risk. Are you ready to offer your ERCP patients a higher standard of care?
In 2011, PlasmaBiotics was founded in Paris, France, as a young and innovative company specialized in the drying and storage of endoscopes. Its core products: the PlasmaTYPHOONdry is an ultra-fast drying unit for endoscopes. Today known as the PlasmaTYPHOONdry system. The product delivers efficient performance by reducing conventional endoscope drying cycle times. With fast drying cycle times of 1-5 minutes, the PlasmaTYPHOONdry system can easily be added to your reprocessing process with limited interruption in your daily routine. In 2017, PlasmaBiotics was awarded the first prize at the Innovative Medical Companies Awards by the Alliance for Biologic and Medical Engineering. In 2018, PENTAX Medical, a division of the HOYA Group, acquired a controlling interest in PlasmaBiotics SAS, to strengthen the hygiene portfolio and the continued focus on reducing cross-contamination risks.
Research shows that to create and maintain an endoscope's disinfected state, complete drying is an absolute necessity.* As part of our Triple Aim Commitment to our customers, PENTAX Medical is excited to bring this innovative system for fast drying of endoscopes to our customers.
The creation of an innovation
The unique solution for fast drying of endoscopes
Download the PlasmaTYPHOON white paper
FOR ULTRA-FAST AND COMPLETE DRYING
FOR ACTIVELY STORING ENDOSCOPES
Perfect drying
Reduced drying time
Fully adaptable
Benefits
PlasmaTYPHOONdry is designed to perfectly dry endoscopes. Insufficient drying can be a source of microbial contamination and the transmission of infectious material.
Quick drying cycle times make it easy to ensure dry endoscopes prior to each use and prior to storage.
PlasmaTYPHOONdry fulfills your needs by adapting to the number of endoscopes in your fleet, it is fast and requires limited working space.
“Accurate endoscope drying is crucial, whereas a humid environment facilitates microbial growth during storage. The final drying steps greatly reduce the risk of remaining pathogens.”*
PlasmaTYPHOONdry is a versatile solution that enables fast drying of endoscope channels. After the completion of the drying process, the endoscope can be utilized on the next patient or placed into storage. With fast drying cycle times of 1-5 minutes, PlasmaTYPHOONdry can easily be added to your reprocessing process with limited interruption in your daily routine.
The PlasmaTYPHOONdry uses an innovative approach in this crucial step in endoscope reprocessing to offer complete drying, quickly and efficiently. One to five minutes (depending on the model of the scope) is all that is needed to completely dry an endoscope. While high velocity flow would break fluid, making it more difficult to dry, PlasmaTYPHOONdry uses a combination of a laminar flow and a heated turbulent flow to completely dry endoscope channels.
"Get the most out of your time and space while also improving hygiene control. Managing endoscopic fleets today is highly complex. This is why the PlasmaTYPHOON & PlasmaBAG System was developed to optimize your efficiency.”
*Julia Kovaleva,a Frans T. M. Peters, b Henny C. van der Mei, c John E. Degener, April 2013 Volume 26 Number 2 Clinical Microbiology Reviews, Transmission of Infection by Flexible Gastrointestinal Endoscopy and Bronchoscopy
* User will need to confirm drying cycle parameters prior to use.
PlasmaTYPHOONdry System
Our customers are asking for quality and the promotion of patient safety, not only in the initial purchase and use of our equipment but also throughout the lifetime of the device.
At PENTAX Medical, we are continuously engaged to improve our products and services towards infection prevention and patient safety. This is why, with continuous innovation and the ServiceWorks program, PENTAX Medical has decided to focus on the three most critical areas related to the Endoscopic biliopancreatic retrograde procedure (ERCP) clearly described in recent studies and publications*:
PENTAX Medical
In response to the need for enhanced patient safety, PENTAX Medical is combining its duodenoscopes with the ServiceWorks package for essential duodenoscope hygiene compliance inspections. This package includes: • Annual service inspection of your duodenoscopes • Duodenoscope hygiene performance check • Elevator mechanism sealing O-ring exchange annually • Delivery of a loaner instrument and repair by PENTAX Medical • Validated and tested PROfILE single-use brushes Your duodenoscope will always be kept “State of the Art”, minimizing the risk of crosscontamination and providing reliable therapeutic performance for improved Patient Care.
Leading innovation and service for improved patient safety.
A specific O-ring design provides sealing of the elevator mechanism and prevents body fluid and other fluids from entering into the completely sealed elevator wire channel. Proper functioning of this O-ring depends on its perfect condition.
Manual cleaning of an endoscope’s channel is key to ensuring reliable reprocessing as an end result. As such, with the new PROfILE single-use cleaning brushes, PENTAX Medical provides a verified and validated solution** (performed by an independent laboratory) to improve confidence in the manual pre-cleaning outcome.
The elevator area of a duodenoscope is one of the most difficult components to clean. With the Removable Cap and now with the DEC™ Duodenoscope design, this challenge has been addressed and overcome by integrating the elevator into the disposable distal end cap.
Elevator
O-ring sealing
Channel
* Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosa. Verfaillie et al. Endoscopy 2015; 47: 493–502 ** Validated according to DIN EN ISO 17664 by an accredited independent laboratory
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