• 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
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    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
    Top News
    Butterfly Network Appoints New Leader

    BD Names Chairman of Board

    Interplex Acquires OCP Group

    FDA Clears a Portable Hemodialysis System

    Solid Growth Forecast for India's HER2 Amplification Tests Market
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    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
    PTI Engineered Plastics Inc.

    FUTEK Advanced Sensor Technology Inc.

    maxon

    Qosina Corp.

    Creganna Medical, part of TE Connectivity
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Element

    FUTEK Advanced Sensor Technology Inc.

    maxon

    K-Tube Technologies

    Medicoil
    • 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
    • Podcasts
    • Resources
    • eBook
    • 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 Aims to Prevent Shortages Following Sterilization Shutdowns

    The agency will work to ensure safe and effective sterilization amid the shutdown of a large contract sterilization facility and the planned shutdown of another.

    Related CONTENT
    • The Top 30 and M&A in 2021: What’s Next?
    • The FDA Wants to Bring Manufacturing ‘Home’
    • RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device
    • FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System
    • FDA OKs Masimo’s Rad-G Pulse Oximeter
    U.S. Food and Drug Administration03.27.19
    A critical focus for the FDA is preventing and mitigating potential medical product shortages. As part of these efforts, we’re taking steps to address potential medical device shortages due to the recent closure of a large sterilization facility in Illinois. We’re working to ensure that safe and effective sterilization of medical devices continues and hospitals, health care providers and patients have access to critical devices.
     
    Earlier this year, the FDA became aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility. The state EPA order was due to the presence of levels of ethylene oxide higher than the EPA found to be acceptable in air around the facility.
     
    As the agency responsible for ensuring the safety and efficacy of all medical devices, the FDA has been closely monitoring the situation and working with device manufacturers affected by the closure to minimize any impact to patients who need access to these medical devices.
     
    Certain medical devices need to be sterilized to reduce the risk of those devices causing infections in patients from living microorganisms. Sterilization of medical devices is a well-established and scientifically-proven method of preventing harmful microorganisms from reproducing and transmitting infections. It’s critical to our health care system. And ethylene oxide is a commonly used method of medical device sterilization. It’s considered a safe and effective method that helps ensure the safety of medical devices and helps deliver quality patient care. Devices sterilized with ethylene oxide range from wound dressings to more specialized devices, like stents, as well as kits used in routine hospital procedures or surgeries that include multiple components made of different materials. However, the FDA recognizes the environmental considerations that are currently impacting manufacturers’ ability to use this process.
     
    To that end, and in light of the recent state EPA order, the FDA has been working to quickly and proactively secure alternative locations and methods for the sterilization of devices that were previously processed at the Willowbrook facility in order to mitigate potential product supply issues. We’re taking steps to prevent patient harm from potential device shortages that could delay or disrupt critical care. At the same time, we’re undertaking new efforts to encourage innovative and improved sterilization options.
     
    Steps to Prevent Potential Shortages
    First, the FDA is actively working to prevent potential medical device shortages that may arise from the closing of the Willowbrook facility. Upon learning that the facility was ordered to stop sterilizing hundreds of various types of medical devices, we immediately reached out to the medical device manufacturers that relied on Sterigenics’ services to better understand which devices were affected by the facility ceasing operations and to assess the potential impact to patients. We are working directly with manufacturers, as needed, to help them transition to another sterilization site or sterilization method.
     
    According to the FDA’s Establishment Registration & Device Listing database, Sterigenics listed a total of 594 types of devices that undergo an ethylene oxide sterilization process at the Willowbrook facility and therefore could be affected by the closure. These include products such as sutures, clamps, knives, stents, and needles. At this time, the FDA isn’t aware of any device shortages attributable to the Willowbrook facility closure. We’re closely monitoring the situation and will continue to provide updates. There’s a risk that for some sterile packaged products that are already in distribution, existing supply may be diminished—or even depleted—as health care facilities use their inventory before alternative arrangements can be made accommodate the sterilization of new products coming off manufacturing lines. This could lead to temporary or “spot” shortages of some products until sterilization can be restored. 
     
    In addition, the FDA is aware that Viant, another contract sterilizer, recently made public that their Grand Rapids ethylene oxide sterilization facility is scheduled to close later this year after receiving attention from the Michigan Department of Environmental Quality for air quality issues. According to the FDA’s Establishment Registration & Device Listing database, Viant listed a total of 46 types of devices that undergo an ethylene oxide process at the Grand Rapids facility which, in the future, could be affected by the closure of the facility. These include devices such as catheters and surgical mesh. 
     
    Because of the shutdown of the Sterigenics Willowbrook facility and the planned closing of the Viant Grand Rapids facility, the FDA is urging medical device manufacturers that use these facilities to begin assessing any potential downstream impacts of the closures on device distribution through their supply chain to end users (such as health care facilities), and ultimately on patient care. We’re also encouraging medical device manufacturers to consider alternative contract sterilizers that can process their devices. We’ve already communicated the steps manufacturers need to take to make changes to their contract sterilizers and maintain availability of their devices. We’re committed to working closely with manufacturers to expedite our review of any site change submissions to ensure they can efficiently switch to other contract sterilizer facilities while still ensuring safe and effective sterilization of their devices.
     
    Second, while every effort is being taken to prevent a potential shortage, we’re monitoring the situation closely and stand ready to act quickly with strategies intended to limit the impact of device supply interruptions on patients. These include looking at making devices available from other sources if needed. 
     
    Early awareness of a potential shortage enables us to be proactive and develop a plan to mitigate its effects on patient care. We’re taking steps to proactively identify potential shortages. Among other steps, we’ve established a device shortages mailbox so that any user, patient or organization within the supply chain that’s aware of a delay in distribution of new product, and/or anticipates a shortage, can notify us.
     
    Third, as we continue to monitor any shortages associated with facility closings, we’re also working with stakeholders—including sterilization experts, medical device manufacturers, and other government agencies—to identify innovative ways to sterilize medical devices that don’t raise the same concerns as those identified at the Willowbrook facility. About half of all sterilized medical devices undergo sterilization using ethylene oxide. In view of the concerns about the environmental impact of this method, we recognize the importance of identifying new and improved ways of sterilizing medical devices.
     
    We’ve already started exploring ways we can continue to ensure sterilization processes are safe and effective and evolving with the current science. This includes considering validation of methods that would support using lower levels of currently-used agents like ethylene oxide gas, thereby reducing environmental exposure risks, while still ensuring effective device sterilization. There may also be ways to employ—and eventually validate—new sterilization agents or processes that don’t come with the same environmental risks but still enable the safe and effective sterilization of devices.
     
    To advance these efforts, we plan to discuss this issue with the infection control community at the May 2019 Healthcare Infection Control Practices Advisory Committee (HICPAC). We will also host a public advisory committee meeting that will be announced later this year dedicated to discussing how best to encourage innovation in medical device sterilization. In addition, later in 2019, we will announce a public innovation challenge to encourage the development of novel sterilization methods, which could include new devices or new modalities that are safe and effective for sterilizing medical devices. 
     
    Finally, we recognize that new challenges may arise from the current situation. To help ensure transparency and communication about the use of ethylene oxide in medical device sterilization, today we launched a new FDA web page to act as a resource on this sterilization method as well as any future actions we take regarding shortages or other activities associated with this issue. We’ll update this site as new information becomes available. We’ll continue to act to help ensure patient access to safe and effective medical devices. And we’ll work directly with manufacturers, contract sterilizers, government agencies, and other public health stakeholders to evaluate potential impacts and take additional steps as needed to avert device shortages. We’re seeking to not only limit the immediate impact of these facility closures but also to identify new and improved methods for medical device sterilization.
    Related Searches
    • sterile
    • hospitals
    • development
    • user
    Related Knowledge Center
    • Packaging & Sterilization
    Suggested For You
    The Top 30 and M&A in 2021: What’s Next? The Top 30 and M&A in 2021: What’s Next?
    The FDA Wants to Bring Manufacturing ‘Home’ The FDA Wants to Bring Manufacturing ‘Home’
    RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device
    FDA OKs SentiAR FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System
    FDA OKs Masimo’s Rad-G Pulse Oximeter FDA OKs Masimo’s Rad-G Pulse Oximeter
    FDA Clears Scientia Vascular FDA Clears Scientia Vascular's Zoom Wire
    FDA Authorizes First Point-of-Care COVID-19 Antibody Test FDA Authorizes First Point-of-Care COVID-19 Antibody Test
    FDA OKs Surmodics FDA OKs Surmodics' Pounce Thrombus Retrieval System
    FDA Launches the Digital Health Center of Excellence FDA Launches the Digital Health Center of Excellence
    Acutus AcQMap Catheter Cleared by FDA Acutus AcQMap Catheter Cleared by FDA
    FDA OKs Varian FDA OKs Varian's Eclipse v16.1 Proton Therapy Treatment Planning Software
    FDA Approves Expanded Use of Roche FDA Approves Expanded Use of Roche's CINtec PLUS Cytology Test
    FDA Publishes COVID-19 Molecular Dx Test Comparative Performance Data FDA Publishes COVID-19 Molecular Dx Test Comparative Performance Data
    HD Medical Awarded FDA Clearance for HD Steth HD Medical Awarded FDA Clearance for HD Steth
    FDA OKs Minnetronix FDA OKs Minnetronix's MindsEye Neurosurgical Access Platform

    Related Breaking News

    • Packaging & Sterilization
      STERIS to Buy Cantel Medical for $4.6B

      STERIS to Buy Cantel Medical for $4.6B

      Complementary to STERIS’s product and service portfolio, focused on infection prevention.
      GlobeNewswire 01.12.21

    • Packaging & Sterilization | Surgical
      Olympus Releases ScopeLocker Endoscope Storage Cabinet

      Olympus Releases ScopeLocker Endoscope Storage Cabinet

      HEPA hinged door endoscope storage system addresses infection prevention needs in busy GI suites.
      Olympus 01.06.21

    • Packaging & Sterilization
      Nelipak Promotes President & COO to CEO

      Nelipak Promotes President & COO to CEO

      Pat Chambliss will succeed Roger Prevot as the company’s CEO.
      Globe Newswire 01.04.21


    • Packaging & Sterilization
      Centerpiece to Open New North American ETO Sterilization Facility

      Centerpiece to Open New North American ETO Sterilization Facility

      The company will launch the new ethylene-oxide sterilization facility in Tijuana, Mexico early next year.
      Centerpiece 12.14.20

    • Packaging & Sterilization
      Spectrum Plastics Group Acquires PeelMaster Medical Packaging Corporation

      Spectrum Plastics Group Acquires PeelMaster Medical Packaging Corporation

      Increases its sterile medical flexible packaging capabilities.
      Spectrum Plastics Group 12.02.20

    • Packaging & Sterilization
      Brenda Chamulak named President of Tekni-Plex Packaging Products

      Brenda Chamulak named President of Tekni-Plex Packaging Products

      Comes from Jabil Packaging Solutions where she was CEO, SVP and president.
      Tekni-Plex 10.08.20


    • Packaging & Sterilization
      Sotera Health Acquires Iotron Industries

      Sotera Health Acquires Iotron Industries

      Complements Sotera Health's Sterigenics business.
      PRNewswire 08.03.20

    • Packaging & Sterilization

      'Bug Zapper' UV-C Light Enables N95 Mask Sterilization, Reuse

      Can decontaminate 200 N95 masks every eight minutes.
      Lehigh University 05.11.20

    • Packaging & Sterilization
      FDA OKs ASP

      FDA OKs ASP's STERRAD Cycles to Sterilize N95 Respirators

      Has potential to decontaminate four million N95 or N95-equivalent respirators per day in the U.S.
      U.S. Food and Drug Administration 04.13.20


    • Packaging & Sterilization
      FDA OKs STERIS Systems to Decontaminate N95 Respirators

      FDA OKs STERIS Systems to Decontaminate N95 Respirators

      Will support decontamination of approximately 750,000 N95 respirators per day in the U.S.
      U.S. Food and Drug Administration 04.13.20

    • Packaging & Sterilization
      FDA Clears 15-Minute Hydrogen Peroxide Sterilization System

      FDA Clears 15-Minute Hydrogen Peroxide Sterilization System

      Advanced Sterilization Products claims process is 38 percent faster than competitors.
      Business Wire 03.09.20

    • Packaging & Sterilization
      EPA Ethylene Oxide Value at Odds with Public Health

      EPA Ethylene Oxide Value at Odds with Public Health

      AdvaMed calls for revision to EtO risk assessment standard.
      AdvaMed 02.19.20


    • Packaging & Sterilization
      QTS Receives MedAccred Accreditation

      QTS Receives MedAccred Accreditation

      Receives Global First in Sterile Device Packaging accreditation.
      Quality Tech Services 01.29.20

    • Packaging & Sterilization
      Viant to Halt EtO Sterilization at Michigan Plant by End of Year

      Viant to Halt EtO Sterilization at Michigan Plant by End of Year

      EGLE had been investigating over the past year and issued Viant several violations for inadequate capture and control of ethylene oxide emissions.
      Michigan Department of Environment, Great Lakes, and Energy (EGLE) 12.04.19

    • Packaging & Sterilization | Surgical
      Devices Modified with Nanoscale Beam Thwart Dangerous Bacteria

      Devices Modified with Nanoscale Beam Thwart Dangerous Bacteria

      Practical use of the technology is believed to be close at hand.
      AVS: Science and Technology of Materials, Interfaces, and Processing 10.28.19


    Trending
    • Senseonics Forges Strategic Collaboration With Ascensia Diabetes Care
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Top 10 Trends In The Medical Device And Equipment Industry
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    Breaking News
    • Butterfly Network Appoints New Leader
    • BD Names Chairman of Board
    • Interplex Acquires OCP Group
    • FDA Clears a Portable Hemodialysis System
    • Solid Growth Forecast for India's HER2 Amplification Tests Market
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • View More >

    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

    Omega-3s Evidenced to Reduce Low-Grade Inflammation in Elderly Men
    MIND and Mediterranean Diets Linked to Later Onset of Parkinson’s Disease
    Kerry Launches Web-Based Tool for Plant-Based Formulation Challenges
    Coatings World

    Latest Breaking News From Coatings World

    Keyland Polymer UV Powder, LLC Launches UVMax Defender
    Scott McLaughlin to Race in PPG Colors During Rookie INDYCAR Season
    Vink Chemicals Offers parmetol PSG
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Butterfly Network Appoints New Leader
    BD Names Chairman of Board
    Interplex Acquires OCP Group
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Adare Pharma Solutions Opens New Small-Scale Lab
    Stevanato Group Launches After-sales Service Offering
    X-Chem Acquires IntelliSyn and AviSyn
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Estée Lauder Companies Announces Game-Changing Sustainability Goals for Travel Retail
    Aura Introduces Customizable Hair Care
    Corpack Creates Custom Packaging for Marlies Möller Hair Care Line
    Happi

    Latest Breaking News From Happi

    Nice-Pak Receives EPA Approval for Disinfectant Wipes
    FDA Takes Major Action on Hand Sanitizers from Mexico
    Symrise Shares 2020 Sales Figures
    Ink World

    Latest Breaking News From Ink World

    Epson Partner Creates Label Applicators for Pharmaceutical Products
    Smurfit Kappa Sets New Sustainability Targets with Better Planet 2050
    Paragon Expands Direct Mail Capabilities with Ricoh Pro VC70000
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Great Lakes Label debuts new website
    Epson partner creates label applicators for pharmaceutical products
    ACTEGA removes chemicals from laminating adhesives
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    American Made Production Equipment for Mask Manufacturers
    Kimberly-Clark Releases Q4, Full Year Results
    Freudenberg to Establish Apparel Interlining Competence Centers
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Spinal Elements' Lucent XP-Curved Expandable TLIF Gains FDA Nod
    FDA OKs OrthoSpin's 2nd Gen Robotic, Digital External Fixation System
    Nextremity Solutions Enters Supply Agreement with Fort Wayne Metals
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    North American Semiconductor Equipment Industry Posts December 2020 Billings
    First Solar Signs Definitive Agreement to Sell US Development Platform to Leeward
    PRINTING United Alliance Announces TAGA Presents Virtual Event

    Copyright © 2021 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