Skip to main content
Sister Publication Links
  • Sustainable Plastics
  • Rubber News
Subscribe
  • Sign Up Free
  • Login
  • Subscribe
  • News
    • Processor News
    • Suppliers
    • More News
    • Digital Edition
    • End Markets
    • Special Reports
    • Newsletters
    • Videos
    • Injection Molding
    • Blow Molding
    • Film & Sheet
    • Pipe/Profile/Tubing
    • Rotomolding
    • Thermoforming
    • Recycling
    • Machinery
    • Materials
    • Molds/Tooling
    • Product news
    • Design
    • K Show
    • Mergers & Acquisitions
    • Sustainability
    • Public Policy
    • Material Insights Videos
    • Numbers that Matter
    • Automotive
    • Packaging
    • Medical
    • Consumer Products
    • Construction
    • Processor of the Year
    • Best Places to Work
      • 2023 winners
    • Women Breaking the Mold
    • Rising Stars
    • Diversity
    • Most Interesting Social Media Accounts in Plastics
  • Opinion
    • The Plastics Blog
    • Kickstart
    • One Good Resin
    • Pellets and Politics
    • All Things Data
    • Viewpoint
    • From Pillar to Post
    • Perspective
    • Mailbag
    • Fake Plastic Trees
  • Shop Floor
    • Blending
    • Compounding
    • Drying
    • Injection Molding
    • Purging
    • Robotics
    • Size Reduction
    • Structural Foam
    • Tooling
    • Training
  • Events
    • K Show Livestream
    • Plastics News Events
    • Industry Events
    • Injection Molding & Design Expo
    • Livestreams/Webinars
    • Editorial Livestreams
    • Ask the Expert
    • Plastics News Events Library
    • Processor of the Year submissions
    • Plastics News Executive Forum
    • Injection Molding & Design Expo
    • Plastics News Caps & Closures
    • Women Breaking the Mold Networking Forum
    • Plastics in Automotive
    • Bioplastics Live
    • PN Live: Mergers and Acquisitions
    • Polymer Points Live
    • Numbers that Matter Live
    • Plastics in Politics Live
    • Sustainable Plastics Live
    • Plastics Caps & Closures Library
    • Plastics in Healthcare Library
    • Women Breaking the Mold Networking Forum Library
  • Rankings & Data
    • Injection Molders
    • Blow Molders
    • Film Sheet
    • Thermoformers
    • Pipe Profile Tubing
    • Rotomolders
    • Mold/Toolmakers
    • LSR Processors
    • Recyclers
    • Compounders - List
    • Association - List
    • Plastic Lumber - List
    • All
  • Directory
  • Resin Prices
    • Resin Prices Overview
    • Commodity Thermoplastics
    • High Temperature Thermoplastics
    • Engineering Thermoplastics
    • Recycled Plastics
    • Thermosets
  • Custom
    • Sponsored Content
    • LS Mtron Sponsored Content
    • Conair Sponsored Content
    • KraussMaffei Sponsored Content
    • ENGEL Sponsored Content
    • White Papers
    • Classifieds
    • Place an Ad
    • Sign up for Early Classified
MENU
Breadcrumb
  1. Home
August 17, 2017 02:00 AM

Medical device industry ready for ENFit transition

Catherine Kavanaugh
LSR World
  • Tweet
  • Share
  • Share
  • Email
  • More
    Reprints Print
    Spectrum Plastics Group
    Designed by Xerdiem Medical Devices, this G-tube has ENFit connectors to deliver food and medicine to patients.

    A doctor ordered a feeding tube for a patient who was 35 weeks pregnant and hospitalized for vomiting and weight loss.

    A nurse mistakenly hooked the tube for the liquid-food bag to the woman's vein instead of inserting it through her nose to her stomach. The patient, 24-year-old Robin Rodgers, and her unborn baby died soon after the thick nutrition was delivered directly into her bloodstream.

    The Kansas woman left behind a 3-year-old son and a distraught family as her name was added to a growing list of victims of hospital tube mix-ups.

    That was in 2006. The incident drew more attention to the deadly consequences resulting from physically compatible connectors for medicine, gases and fluids. In other cases, intravenous fluids were connected to tubes meant to deliver oxygen, causing suffocation, and when a tube to inflate a blood pressure cuff was connected to an intravenous line, the patient died of an air embolism.

    A long-time global call for new standards that would make tubes for different functions incompatible eventually got traction and is slowly being implemented. The effort has been likened to gas stations having different pump nozzles so drivers don't use the wrong fuel. To improve patient safety, the ISO 80369 series of standards was developed to address the design changes needed for the various devices that access different points of the body, including the bloodstream, stomach, airway, spine and bladder.

    An important section of the standard, which covers enteral (feeding) tubes and gastric applications (ISO 80369-3), is about to roll out in the United States. Products that meet the standard are listed under the trademarked name of ENFit connectors.

    "The medical device industry is ready, has been ready, and is shipping products, mostly outside the U.S., but we believe that's going to change in the fourth quarter of this year," Paul Melnychuck, senior director of business development and innovation for Spectrum Plastics Group, said in a telephone interview. "In the last year, much of Europe has converted from the legacy product to ENFit. Now the medical devices industry expect clinicians and their institutions will begin the conversion in the U.S."

    Based in Tuscon, Ariz., Xeridiem Medical Devices, which is a part of Spectrum, has been focused on meeting ISO 80369-3 requirements since 2013. Melnychuck said the business is an original design manufacturer and a contract manufacturer within the group's $200 million medical division.

    Getting ready

    When the ISO standard was in its infancy, Xeridiem prepared for change on two fronts.

    "We anticipated the market would transition to these new connectors so we invested in the engineering and tooling to start producing these connectors," Melnychuck said. "Secondly, we developed a fully Xeridiem-owned G-tube and got the regulatory clearance."

    Xeridiem G-tubes meet requirements for 510(k), CE Mark and Health Canada and are available under private labels.

    The manufacturing and assembly of the device starts with a multi-lumen silicone extrusion. The silicone access-ports housing is over molded on one end of the extrusion and a silicone balloon is bonded over an inflation outlet on the other end. An adjustable silicone retention bolster, which is made via liquid injection molding, then is slid over the extrusion. The bolster acts as a wound barrier and protects stomach incisions for feeding tubes from infection.

    "The result is a platform from which you can take it off the shelf with just the private label customization or with several engineering improvements made to the shaft, bolster and most notably the balloon," Melnychuck said.

    The end of the G-tube that contains the small balloon is inserted into an incision in the stomach and then is blown up through an inflation port. The inflated balloon prevents the feeding tube from being pulled out.

    Xeridiem designed G-tubes used in Spectrum Plastics Group's proprietary OptimaX silicone process, which the company says extends the life of the balloon under harsh stomach acid conditions.

    "We started in 2013 and began with the connectors and G-tube design, the regulatory clearance, which isn't trivial, and then the business development cycle of working with our customers," Melnychuck said. "Now we service all the major Tier 1 companies in the industry."

    Xeridiem began supplying its customers in 2015 but most of the product has ended up overseas, where the market has been to date. However, that appears to be changing.

    Switch is on

    Last July, the state of California began prohibiting health facilities from using enteral feeding connectors that are compatible, but adoption has been slow in part because there was no immediate enforcement to meet the mandate.

    An ENFit summit was held at Children's Hospital Los Angeles in January to determine what was impeding the transition there and elsewhere. Task forces were created to handle supply concerns and educate end users.

    Then, in April, a "critical notice" about preventing tube misconnections was issued by the ECRI Institute, a nonprofit group that works to improve patient care through research.

    "To prevent any more errors, ECRI is urging facilities to move to the new connectors as soon as practicable — ideally by the end of 2017," Tom Ritter, a senior project engineer at the nonprofit ECRI Institute, said in the notice.

    The Pennsylvania-based institute supports efforts of the Global Enteral Device Supplier Association (GEDSA), a nonprofit trade group that consists of 40 companies, including Xeridiem. The aim of GEDSA has been to give device makers, suppliers and distributors a voice about issues as well as help everyone transition to the new standard. Their initiative to reduce medical tubing mishaps is called "Stay Connected."

    "Change takes time, especially with hospitals that have certain protocols for their standard of care and committees meeting to determine safety and cost implications," Melnychuck said.

    Making connections

    Home care service providers also are preparing for the transition. About 500,000 children and adults in the United States rely on feeding tubes and the number is expected to rise by 8 percent over the next three years, according to Pediatric Home Services in Roseville, Minn.

    The business has 1,800 patients affected by the ENFit conversion, and it began educating users in February about the changes coming to the connector ends on all feeding bags, enteral syringes and extensions.

    "These changes are happening to avoid incorrect connections to IV lines, trach tubes and other medical tubing," Katie Dahlberg, a clinical specialist, said in a news release. "We've seen one such example at PHS where a patient's mom unintentionally administered enteral products into their child's IV line, a potentially life-threatening situation. Thankfully the patient is OK, but it goes to show that this can happen even with the most skilled and careful of caregivers."

    The U.S. rollout of the ENFit conversion will continue into 2018 and likely begin in Japan and Latin America in 2019.

    "Japan is notable because of the aging population," Melnychuck said. "People are living longer and there are improved health care options for that population. We see enteral feeding being a big growth area there."

    RECOMMENDED FOR YOU
    Conference covers advances in materials, machinery, cold runners
    Letter
    to the
    Editor

    Do you have an opinion about this story? Do you have some thoughts you'd like to share with our readers? Plastics News would love to hear from you. Email your letter to Editor at [email protected]

    Most Popular
    1
    Texas Injection Molding expands again
    2
    Germany's Stratec buys medical molder Natech to boost US presence
    3
    Plastics treaty urged to include EPR for flexible packaging ‘to make it work'
    4
    Phillips-Medisize closing Medford, Wis., plant, cutting 83 jobs
    5
    Resin Prices
    SIGN UP FOR OUR FREE NEWSLETTERS
    EMAIL ADDRESS

    Please enter a valid email address.

    Please enter your email address.

    Please verify captcha.

    Please select at least one newsletter to subscribe.

    Get our newsletters

    Staying current is easy with Plastics News delivered straight to your inbox, free of charge.

    Subscribe today

    Subscribe to Plastics News

    Subscribe now
    Connect with Us
    • LinkedIn
    • Facebook
    • Twitter
    • Instagram

    Plastics News covers the business of the global plastics industry. We report news, gather data and deliver timely information that provides our readers with a competitive advantage.

    Contact Us

    1155 Gratiot Avenue
    Detroit MI 48207-2997

    Customer Service:
    877-320-1723

    Resources
    • About
    • Staff
    • Editorial Calendar
    • Media Kit
    • Data Store
    • Digital Edition
    • Custom Content
    • People
    • Contact
    • Careers
    • Sitemap
    Related Crain Publications
    • Sustainable Plastics
    • Rubber News
    • Tire Business
    • Urethanes Technology
    Legal
    • Terms and Conditions
    • Privacy Policy
    • Privacy Request
    Copyright © 1996-2023. Crain Communications, Inc. All Rights Reserved.
    • News
      • Processor News
        • Injection Molding
        • Blow Molding
        • Film & Sheet
        • Pipe/Profile/Tubing
        • Rotomolding
        • Thermoforming
        • Recycling
      • Suppliers
        • Machinery
        • Materials
        • Molds/Tooling
        • Product news
        • Design
      • More News
        • K Show
        • Mergers & Acquisitions
        • Sustainability
        • Public Policy
        • Material Insights Videos
        • Numbers that Matter
      • Digital Edition
      • End Markets
        • Automotive
        • Packaging
        • Medical
        • Consumer Products
        • Construction
      • Special Reports
        • Processor of the Year
        • Best Places to Work
          • 2023 winners
        • Women Breaking the Mold
        • Rising Stars
        • Diversity
        • Most Interesting Social Media Accounts in Plastics
      • Newsletters
      • Videos
    • Opinion
      • The Plastics Blog
      • Kickstart
      • One Good Resin
      • Pellets and Politics
      • All Things Data
      • Viewpoint
      • From Pillar to Post
      • Perspective
      • Mailbag
      • Fake Plastic Trees
    • Shop Floor
      • Blending
      • Compounding
      • Drying
      • Injection Molding
      • Purging
      • Robotics
      • Size Reduction
      • Structural Foam
      • Tooling
      • Training
    • Events
      • K Show Livestream
      • Plastics News Events
        • Plastics News Executive Forum
        • Injection Molding & Design Expo
        • Plastics News Caps & Closures
        • Women Breaking the Mold Networking Forum
        • Plastics in Automotive
      • Industry Events
      • Injection Molding & Design Expo
      • Livestreams/Webinars
        • Bioplastics Live
        • PN Live: Mergers and Acquisitions
      • Editorial Livestreams
        • Polymer Points Live
        • Numbers that Matter Live
        • Plastics in Politics Live
        • Sustainable Plastics Live
      • Ask the Expert
      • Plastics News Events Library
        • Plastics Caps & Closures Library
        • Plastics in Healthcare Library
        • Women Breaking the Mold Networking Forum Library
      • Processor of the Year submissions
    • Rankings & Data
      • Injection Molders
      • Blow Molders
      • Film Sheet
      • Thermoformers
      • Pipe Profile Tubing
      • Rotomolders
      • Mold/Toolmakers
      • LSR Processors
      • Recyclers
      • Compounders - List
      • Association - List
      • Plastic Lumber - List
      • All
    • Directory
    • Resin Prices
      • Resin Prices Overview
      • Commodity Thermoplastics
      • High Temperature Thermoplastics
      • Engineering Thermoplastics
      • Recycled Plastics
      • Thermosets
    • Custom
      • Sponsored Content
      • LS Mtron Sponsored Content
      • Conair Sponsored Content
      • KraussMaffei Sponsored Content
      • ENGEL Sponsored Content
      • White Papers
      • Classifieds
        • Place an Ad
        • Sign up for Early Classified