• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    I-VASC Raises 1.8M Euros in Series A Funding

    Endotronix Shares Positive SIRONA 2 Heart Failure Trial Data

    FDA Clears Truvic's Prodigy Thrombectomy System

    Medical Device CEO Charged With Tax Evasion

    MPO's Most-Read Stories This Week—May 21
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Injecting Neurostimulators into Blood Vessels (We Swear, It’s Not Sci-Fi)

    Understanding the Costs of Care in the OR

    Sick of Being Sick: Pandemic Fatigue Flares at AAOS

    Managing Critical Healthcare Supply Chains in Turbulent Times

    To Drive Value, Human Capital Leaders Turn to Outsourced Solutions
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    Concise Engineering

    Fusion Biotec Inc.

    Trademark Plastics Inc.

    Xact Wire EDM Corp.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing in Dental Prosthodontics, Orthodontics, and Surgery

    What New Tech Can Improve Your Medical Manufacturing Plant?

    Why Medical Device Firms Must Navigate the Muddy Waters of ESG Requirements

    Medical Device Servicing vs. Remanufacturing

    Digital Marketplaces for Medical Equipment Come of Age
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    Concise Engineering

    Fusion Biotec Inc.

    Trademark Plastics Inc.

    Xact Wire EDM Corp.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA OKs GI Scientific's Single-Use Duodenoscope Protective Device

    Provides a sterile disposable barrier to protect from patient-to-patient cross-contamination.

    FDA OKs GI Scientific
    Images of ScopeSeal Protective Device. Image courtesy of Business Wire.
    Related CONTENT
    • FDA OKs Ambu's Sterile, Single-Use Duodenoscope
    • Forest Devices Named 2019 Global Competition Winner
    • FDA Encourages Patient Engagement in Medical Device Clinical Investigations
    • FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)
    • Update on Integrated Delivery Networks and Physician Employment
    Business Wire10.25.19
    GI Scientific, LLC, a developer of transformative innovations for gastrointestinal disease, announced that the U.S. Food and Drug Administration (FDA) cleared its ScopeSeal Duodenoscope Protective Device, the first Endoscopic Shield for protecting the distal end of a duodenoscope from contamination during ERCP procedures. ScopeSeal is a single-use disposable infection control device that preserves duodenoscope optics and other key functionality while sealing the infection prone distal end of the Olympus duodenoscope used in ERCP (Endoscopic Retrograde Cholangio-Pancreatography) procedures. ScopeSeal is the only device cleared for human use by the FDA that seals the elevator area of the scope and significantly reduces duodenoscope distal end contamination during use.
     
    “It is very difficult to consistently clean and disinfect duodenoscopes between patients because of the intricate moving parts at the distal end of these advanced technology instruments. This is true regardless of whether high level disinfection or terminal sterilization is used to reprocess. Buildup of bacteria and other biomatter in recessed areas on these scopes between patients is almost certainly the cause of recent outbreaks. The best way to truly prevent difficult-to-remove contamination at the distal end of the scope is to protect against contamination in the first place, by sealing the distal end, which is exactly what ScopeSeal does. I am excited and relieved that the FDA cleared this device. It will be a game-changer for ERCP infection prevention, complementing existing hospital investments in advanced technology duodenoscopes and sophisticated scope reprocessing,” said Dr. Romney Humphries, former Section Chief, Clinical Microbiology, UCLA Medical System and current Clinical Professor of Pathology, University of Arizona.
     
    Over 700,000 U.S. ERCP procedures and nearly 2 million global ERCP procedures are performed annually as an important less invasive treatment alternative to invasive surgery for assessing and treating critical liver, pancreas, and gallbladder conditions. These highly beneficial, less invasive procedures rely on reusable duodenoscopes as the central enabling technology for these treatments; however, hard-to-clean recessed areas at the distal end of the scope, especially the recessed elevator area, have been linked to failures to remove biomatter contamination from the scope through scope disinfection and reprocessing efforts, resulting in patient-to-patient cross contamination and multiple drug-resistant infections. Significant infection outbreaks and multiple deaths have been reported from drug-resistant infections linked to contaminated duodenoscopes.
     
    ScopeSeal easily and securely attaches to the distal end of a reusable duodenoscope to create Two-Way Protection for the scope: an “Outside-In” barrier designed to significantly reduce biomatter soiling of the distal end of the scope during use and “Inside-Out” protection which seals the elevator area of the scope and provides a sealed passageway allowing instruments to be passed through the duodenoscope into the patient’s GI tract without contacting the elevator area of the scope. ScopeSeal’s Two-Way Protection is analogous to a physician wearing gloves for surgery, which along with vigorous scrubbing and washing before and after the procedure, protects both the patient and the surgeon from contamination and potential infection.
     
    “The clearance of ScopeSeal for human use is a reminder of the FDA’s continued commitment to creating a safe environment for patients undergoing these critical, highly beneficial procedures. We are excited about the introduction of this important single-use disposable technology to address infection concerns with reusable duodenoscopes,” said Scott Miller, CEO and co-founder of GI Scientific.
     
    ScopeSeal is cleared for use on the Olympus TJF-Q180V duodenoscope, the duodenoscope used in approximately 85% of U.S. ERCP procedures, and is compatible with instruments used in ERCP up to 10.7 Fr in diameter. ScopeSeal is not a replacement for careful adherence to the important and valuable duodenoscope reprocessing steps and related scope maintenance requirements specified by the reusable duodenoscope manufacturer.
     
    The ScopeSeal infection control technology is a platform applicable to other scopes and indications, including duodenoscopes with non-sealing disposable caps, which the company is evaluating with respect to pursuing additional, future regulatory clearances.
    Related Searches
    • clearance
    • adherence
    • protection
    • duodenoscopes
    Related Knowledge Center
    • Surgical
    • Packaging & Sterilization
    Suggested For You
    FDA OKs Ambu FDA OKs Ambu's Sterile, Single-Use Duodenoscope
    Forest Devices Named 2019 Global Competition Winner Forest Devices Named 2019 Global Competition Winner
    FDA Encourages Patient Engagement in Medical Device Clinical Investigations FDA Encourages Patient Engagement in Medical Device Clinical Investigations
    FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k) FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)
    Update on Integrated Delivery Networks and Physician Employment Update on Integrated Delivery Networks and Physician Employment
    FDA Advises Transition to Disposable Duodenoscopes FDA Advises Transition to Disposable Duodenoscopes
    The 2019 Top 30 Global Medical Device Companies The 2019 Top 30 Global Medical Device Companies
    19. Olympus 19. Olympus
    Selecting the Right Manufacturer to Ensure Reduced Sterilization Risk Selecting the Right Manufacturer to Ensure Reduced Sterilization Risk
    FlexDex Names Chief Executive Officer FlexDex Names Chief Executive Officer
    FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting
    Connected Quality Systems Reduce Risks Connected Quality Systems Reduce Risks
    FDA OKs Neonatal Indication for Masimo FDA OKs Neonatal Indication for Masimo's O3 Regional Oximetry
    FDA OKs ControlRad FDA OKs ControlRad's Radiation Reduction Technology that Integrates into Mobile C-arms
    FDA Warns Against Use of Unauthorized Diabetes Management Devices FDA Warns Against Use of Unauthorized Diabetes Management Devices

    Related Content

    • Surgical
      FDA OKs Ambu

      FDA OKs Ambu's Sterile, Single-Use Duodenoscope

      Consists of a single-use endoscope and a reusable processor unit.
      GlobeNewswire 07.17.20

    • Cardiovascular | Diagnostics | Neurological
      Forest Devices Named 2019 Global Competition Winner

      Forest Devices Named 2019 Global Competition Winner

      Receives $350K grand prize for portable device.
      Business Wire 10.01.19

    • FDA Encourages Patient Engagement in Medical Device Clinical Investigations

      FDA Encourages Patient Engagement in Medical Device Clinical Investigations

      The agency is releasing draft guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.
      U.S. Food and Drug Administration 09.24.19


    • FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)

      FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)

      FDA publishes draft guidance documents to provide device-specific performance criteria for the Safety and Performance Based Pathway.
      U.S. Food and Drug Administration 09.20.19

    • Update on Integrated Delivery Networks and Physician Employment

      Update on Integrated Delivery Networks and Physician Employment

      The top five IDNs employ 135,913 MDs and DOs in the U.S., approximately 15 percent of all active physicians in the country.
      Maria Shepherd, President and Founder, Medi-Vantage 09.06.19


      Breaking News
      • I-VASC Raises 1.8M Euros in Series A Funding
      • Endotronix Shares Positive SIRONA 2 Heart Failure Trial Data
      • FDA Clears Truvic's Prodigy Thrombectomy System
      • RSIP Vision Develops New AI Tool for Prostate MRI Analysis
      • Medical Device CEO Charged With Tax Evasion
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Cybersecurity Challenges Leave Medical Device Makers Insecure
      • Contract Design for Medtech
      • Diabetes Medical Device Technology Update
      • Medtech Full-Service Outsourcing Q&A 2022

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      Vitafoods Europe 2022 Attendance Returns to 2019 Level
      Beyond Raw Launches Concept X Pre-Workout Line
      Botanical Ingredient MorActive Evidenced to Relieve Back Discomfort
      Coatings World

      Latest Breaking News From Coatings World

      PPG’s Diane Kappas Recognized as ‘Woman of Influence’ by Pittsburgh Business Times
      BEHR Launches COPPER FORCE Interior Paint
      A New Kind of Primer: Demand for Interior and Exterior Paint Experts Remains High, J.D. Power Finds
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      I-VASC Raises 1.8M Euros in Series A Funding
      Endotronix Shares Positive SIRONA 2 Heart Failure Trial Data
      FDA Clears Truvic's Prodigy Thrombectomy System
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Thermo Fisher, Qatar Genome Program Partner to Advance Precision Medicine
      CPC Launches AseptiQuik Genderless Connector
      Aptamer Group and PinotBio Extend Collaboration Agreement
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      L’Oréal USA Names Han Wen as Chief Digital & Marketing Officer
      NPD Group Reports on Rising E-commerce Sales in China for Prestige Beauty
      Noon Aesthetics Celebrates Ten Years with New Skincare Products
      Happi

      Latest Breaking News From Happi

      Gabriel Letizia Jr. Sentenced to 60 Months in Prison for Falsifying Sunscreen Test Results
      Coptis Appoints Marie Renee Thadal Vice President of Sales and Operations
      Han Wen Appointed L’Oréal’s New Chief Digital, Marketing Officer
      Ink World

      Latest Breaking News From Ink World

      Weekly Recap: Zeller+Gmelin, Sun Chemical and Kornit Top This Week’s News
      Nazdar Celebrates 100 Years with a New Look
      hubergroup Chemicals Exhibits at Paint India for First Time
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Avery Dennison announces Core Series Portfolio Tape Selector App
      HP Indigo reaches 2,000th active install milestone
      Brook + Whittle's new acquisition, SunDance goes to HP and more
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Ahlstrom-Munksjö Announces Reorganization of Decor Business Ownership
      Jones Names COO
      Ontex Conducts Pilot Program of Digital Incontinence Care Solution
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Tom Hedman Named Senior Principal Scientist at Spinal Simplicity
      ODT's Most Read Stories This Week—May 21
      FDA Clears Anika Therapeutics' X-Twist Knotless Fixation System
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Weekly Recap: Graphene Flagship, Japan Display and LG Display Top This Week’s Stories
      Evonik Launches New Processing Aids for PV Wafer Cutting
      NREL Creates Highest Efficiency 1-Sun Solar Cell

      Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login