Skip to main content
Sister Publication Links
  • ESG: THE NEW IMPERATIVE
Subscribe
  • My Account
  • Login
  • Subscribe
  • News
    • Current News
    • COVID-19
    • Providers
    • Insurance
    • Government
    • Finance
    • Technology
    • Safety & Quality
    • Transformation
    • People
    • Regional News
    • Digital Edition (Web Version)
    • Patients
    • Operations
    • Care Delivery
    • Payment
    • Midwest
    • Northeast
    • South
    • West
  • Digital Health
  • Insights
    • ACA 10 Years After
    • Best Practices
    • Special Reports
    • Innovations
  • Data/Lists
    • Rankings/Lists
    • Interactive Databases
    • Data Points
  • Op-Ed
    • Bold Moves
    • Breaking Bias
    • Commentaries
    • Letters
    • Vital Signs Blog
    • From the Editor
  • Awards
    • Nominate/Eligibility
    • 100 Most Influential People
    • 50 Most Influential Clinical Executives
    • Best Places to Work in Healthcare
    • Excellence in Governance
    • Health Care Hall of Fame
    • Healthcare Marketing Impact Awards
    • Top 25 Emerging Leaders
    • Top 25 Innovators
    • Diversity in Healthcare
    • Women in Healthcare
    • - Luminaries
    • - Top 25 Diversity Leaders
    • - Leaders to Watch
    • - Luminaries
    • - Top 25 Women Leaders
    • - Women to Watch
  • Events
    • Conferences
    • Galas
    • Virtual Briefings
    • Webinars
    • Custom Media Event: ESG Summit
    • Transformation Summit
    • Women Leaders in Healthcare Conference
    • Social Determinants of Health Symposium
    • Leadership Symposium
    • Health Care Hall of Fame Gala
    • Top 25 Women Leaders Gala
    • Best Places to Work Awards Gala
    • Top 25 Diversity Leaders Gala
    • - Hospital of the Future
    • - Value Based Care
    • - Supply Chain Revenue Cycle
    • - Hospital at Home
    • - Workplace of the Future
    • - Strategic Marketing
    • - Virtual Health
  • Listen
    • Podcast - Next Up
    • Podcast - Beyond the Byline
    • Sponsored Podcast - Healthcare Insider
    • Video Series - The Check Up
    • Sponsored Video Series - One on One
  • MORE +
    • Advertise
    • Media Kit
    • Newsletters
    • Jobs
    • People on the Move
    • Reprints & Licensing
MENU
Breadcrumb
  1. Home
  2. Technology
September 21, 2017 01:00 AM

Duodenoscope intended to curb hospital-acquired infections approved by FDA

Maria Castellucci
  • Tweet
  • Share
  • Share
  • Email
  • More
    Reprints Print

    The Food and Drug Administration approved Wednesday for the first time a duodenoscope with a disposable cap, which the agency said will make the device easier to clean and lower the risk of infection.

    The duodenoscope, a tool physicians commonly use to examine patients' small intestine, has been subject to several warnings by the FDA because its use has been linked to serious hospital-acquired infections. Experts say its challenging to properly disinfect medical devices like duodenoscopes despite efforts by the FDA to approve devices that are easy to clean and follow strict guidelines

    The FDA said this new duodenoscope — called ED34-i10T and manufactured by medical-device maker Pentax — should be easier to clean because of its disposable caps.

    "We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices," said Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, in an FDA news release.

    In a statement, Pentax said, its new devices "represents a significant advancement in infection control." The statement didn't disclose the cost of the device or when it will launch in the U.S. market.

    Duodenoscopes are used in more than 500,000 procedures each year as a less invasive way to treat patients. The FDA said a duodenoscope is hard to clean because it's a "complex medical device with many small working parts." If the device isn't properly disinfected, it can pass along tissue or fluids to other patients and transmit infections.

    In January, the FDA issued a warning for another of Pentax's duodenoscopes, saying cracks and gaps in the device could lead to an increased risk for infections. In 2016, device maker Olympus voluntarily recalled its duodenoscopes at roughly 4,400 healthcare facilities.

    Scopes have been linked to 25 infection incidents between 2012 and 2015 in the U.S., where as many as 250 patients acquired antibiotic-resistant infections, according to a Senate committee minority staff report.

    The end of the duodenoscope is hardest to disinfect because that is where the camera, light, air nozzle, catheter and elevator are located, said Linda Greene, president of the Association for Professionals in Infection Control and Epidemiology. Because the new duodenscope has a disposable cap, it will likely make the cleaning process a lot easier. "But it by no means eliminates all the challenges to this high level cleaning process," she said.

    Dudodenscopes go through a high-level disinfection cleaning process but errors can still occur. Technicians or support staff complete a complex, multi-step process to clean the scope after each use. "The more steps you have in the process the easier it is for the process to break down," Greene said. "There are human beings cleaning these devices."

    The disposable nature of the device also might not be appealing for physicians, she said.

    Disposable devices are known to be less durable., and the cost effectiveness of disposable devices is another issue to consider.

    The link between infections and duodenoscopes will likely spur more design changes like the one from Pentax Medical. Manufacturers and stakeholders are interested in finding ways to make the cleaning process of devices easier. "I think it's important to realize that manufacturers have listened and are trying to come up with ways for better cleaning to take place," Greene added.

    Letter
    to the
    Editor

    Send us a letter

    Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.

    Recommended for You
    google_sized_getty_i.jpg
    Democrats ask Google to protect abortion-patient privacy
    Cue Health COVID test
    High-tech’s business model hasn’t worked for the Cue COVID test
    Sponsored Content
    Health IT Strategist (HITS) Newsletter: Sign up for the latest IT and medical technology news delivered 3 days a week (M, W, F).
     
    Get Newsletters

    Sign up for enewsletters and alerts to receive breaking news and in-depth coverage of healthcare events and trends, as they happen, right to your inbox.

    Subscribe Today
    MH Magazine Cover

    MH magazine offers content that sheds light on healthcare leaders’ complex choices and touch points—from strategy, governance, leadership development and finance to operations, clinical care, and marketing.

    Subscribe
    Connect with Us
    • LinkedIn
    • Twitter
    • Facebook
    • RSS

    Our Mission

    Modern Healthcare empowers industry leaders to succeed by providing unbiased reporting of the news, insights, analysis and data.

    Contact Us

    (877) 812-1581

    Email us

     

    Resources
    • Contact Us
    • Advertise with Us
    • Ad Choices Ad Choices
    • Sitemap
    Editorial Dept
    • Submission Guidelines
    • Code of Ethics
    • Awards
    • About Us
    Legal
    • Terms and Conditions
    • Privacy Policy
    • Privacy Request
    Modern Healthcare
    Copyright © 1996-2022. Crain Communications, Inc. All Rights Reserved.
    • News
      • Current News
      • COVID-19
      • Providers
      • Insurance
      • Government
      • Finance
      • Technology
      • Safety & Quality
      • Transformation
        • Patients
        • Operations
        • Care Delivery
        • Payment
      • People
      • Regional News
        • Midwest
        • Northeast
        • South
        • West
      • Digital Edition (Web Version)
    • Digital Health
    • Insights
      • ACA 10 Years After
      • Best Practices
      • Special Reports
      • Innovations
    • Data/Lists
      • Rankings/Lists
      • Interactive Databases
      • Data Points
    • Op-Ed
      • Bold Moves
      • Breaking Bias
      • Commentaries
      • Letters
      • Vital Signs Blog
      • From the Editor
    • Awards
      • Nominate/Eligibility
      • 100 Most Influential People
      • 50 Most Influential Clinical Executives
      • Best Places to Work in Healthcare
      • Excellence in Governance
      • Health Care Hall of Fame
      • Healthcare Marketing Impact Awards
      • Top 25 Emerging Leaders
      • Top 25 Innovators
      • Diversity in Healthcare
        • - Luminaries
        • - Top 25 Diversity Leaders
        • - Leaders to Watch
      • Women in Healthcare
        • - Luminaries
        • - Top 25 Women Leaders
        • - Women to Watch
    • Events
      • Conferences
        • Transformation Summit
        • Women Leaders in Healthcare Conference
        • Social Determinants of Health Symposium
        • Leadership Symposium
      • Galas
        • Health Care Hall of Fame Gala
        • Top 25 Women Leaders Gala
        • Best Places to Work Awards Gala
        • Top 25 Diversity Leaders Gala
      • Virtual Briefings
        • - Hospital of the Future
        • - Value Based Care
        • - Supply Chain Revenue Cycle
        • - Hospital at Home
        • - Workplace of the Future
        • - Strategic Marketing
        • - Virtual Health
      • Webinars
      • Custom Media Event: ESG Summit
    • Listen
      • Podcast - Next Up
      • Podcast - Beyond the Byline
      • Sponsored Podcast - Healthcare Insider
      • Video Series - The Check Up
      • Sponsored Video Series - One on One
    • MORE +
      • Advertise
      • Media Kit
      • Newsletters
      • Jobs
      • People on the Move
      • Reprints & Licensing