• Resources
  • Blog
  • Journalists
  • Log In
  • Sign Up
  • Data Privacy
  • Send a Release
Cision PR Newswire: news distribution, targeting and monitoring home
  • News
  • Products
  • Contact

 

When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All News Releases
      • All Public Company
      • English-only
      • News Releases Overview

      • Multimedia Gallery

      • All Multimedia
      • All Photos
      • All Videos
      • Multimedia Gallery Overview

      • Trending Topics

      • All Trending Topics
  • Business & Money
      • Auto & Transportation

      • All Automotive & Transportation
      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation
      • Auto & Transportation Overview

      • View All Auto & Transportation

      • Business Technology

      • All Business Technology
      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • Business Technology Overview

      • View All Business Technology

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Financial Services & Investing

      • All Financial Services & Investing
      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • Financial Services & Investing Overview

      • View All Financial Services & Investing

      • General Business

      • All General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News
      • General Business Overview

      • View All General Business

  • Science & Tech
      • Consumer Technology

      • All Consumer Technology
      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • Consumer Technology Overview

      • View All Consumer Technology

      • Energy & Natural Resources

      • All Energy
      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities
      • Energy & Natural Resources Overview

      • View All Energy & Natural Resources

      • Environ­ment

      • All Environ­ment
      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • Environ­ment Overview

      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • All Heavy Industry & Manufacturing
      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • Heavy Industry & Manufacturing Overview

      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • All Telecomm­unications
      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • Telecomm­unications Overview

      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • All Consumer Products & Retail
      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • Consumer Products & Retail Overview

      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Health

      • All Health
      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • Health Overview

      • View All Health

      • Sports

      • All Sports
      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • Sports Overview

      • View All Sports

      • Travel

      • All Travel
      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • Travel Overview

      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • All Policy & Public Interest
      • Advocacy Group Opinion
      • Animal Welfare
      • Congressional & Presidential Campaigns
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy
      • U.S. State Policy
      • Policy & Public Interest Overview

      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • All People & Culture
      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • People & Culture Overview

      • View All People & Culture

      • In-Language News

      • Arabic
      • español
      • português
      • Česko
      • Danmark
      • Deutschland
      • España
      • France
      • Italia
      • Nederland
      • Norge
      • Polska
      • Portugal
      • Россия
      • Slovensko
      • Suomi
      • Sverige
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • Sponsored Placement
  • All Products
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • PR Newswire: news distribution, targeting and monitoring
  • Send a Release
    • ALL CONTACT INFO
    • Contact Us

      888-776-0942
      from 8 AM - 10 PM ET

  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • News in Focus
    • Browse All News
    • Multimedia Gallery
    • Trending Topics
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • All Products
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on concerns with medical device availability due to certain sterilization facility closures

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

News provided by

U.S. Food and Drug Administration

Oct 25, 2019, 12:50 ET

Share this article

Share this article


SILVER SPRING, Md., Oct. 25, 2019 /PRNewswire/ -- As the agency responsible for ensuring the safety and effectiveness of all medical devices, the U.S. Food and Drug Administration has been closely monitoring the supply chain effects of closures and potential closures of certain large-scale sterilization facilities that use a gas called ethylene oxide to sterilize medical devices prior to their use. The recent closure of a Sterigenics ethylene oxide sterilization facility in Illinois, the temporary closure of another Sterigenics facility in Georgia, and the potential closure of a large Becton Dickinson sterilization facility in Georgia could affect the availability of some sterile medical devices used by health care delivery organizations and patients. We have been working diligently with impacted device manufacturers and health care delivery organizations to ensure that they are aware of these developments and preparing to minimize adverse effects on patients whose care could be negatively affected if medical devices sterilized at these large facilities were not accessible. Medical devices that are sterilized to remove potentially harmful germs and other microorganisms prior to use are critical to our health care system and a shortage—especially of life-saving, life-sustaining, or other critical devices—can be a detriment to public health. In light of the possibility of continued ethylene oxide sterilization facility closures, we are again alerting the public to growing concerns about the future availability of sterile medical devices and impending medical device shortages.

Although medical devices can be sterilized by several methods, ethylene oxide is the most common method of sterilization of medical devices in the U.S. and is a well-established and scientifically-proven method of preventing harmful microorganisms from reproducing and causing infections. More than 20 billion devices sold in the U.S. every year are sterilized with ethylene oxide, accounting for approximately 50 percent of devices that require sterilization.

Medical devices made from certain polymers (such as plastic or resin), metals, or glass—or devices that have multiple layers of packaging or hard-to-reach crevices—are likely to be sterilized with ethylene oxide to avoid product damage during the process. These include surgical kits used in emergency procedures such as emergency Caesarean sections ("C-sections") and in routine procedures such as cardiac surgery and hip or knee replacement surgeries. Without adequate availability of ethylene oxide sterilization, we anticipate a national shortage of these devices and other critical devices including feeding tube devices used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices. It's important to note at this time there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices. In short: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices.

The FDA recognizes that there are concerns associated with release of ethylene oxide into the environment if emissions were to occur at unsafe levels. Concerns about ethylene oxide emissions have resulted in certain state actions against sterilization facilities that are currently impacting manufacturers' ability to use the ethylene oxide process to sterilize their medical devices. In February, the FDA became aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop Sterigenics from sterilizing medical products and other products with 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 the air around the facility. This closure caused a temporary shortage of pediatric breathing tubes.

Another Sterigenics contract sterilization facility, in Atlanta, Georgia, has been closed since August while it undergoes construction to reduce ethylene oxide emissions. In October, the Sterigenics Willowbrook, Illinois, facility announced they would not reopen. As a consequence of these two large sterilization facilities being unavailable, the FDA continues to coordinate with multiple stakeholders on any impacts to medical device availability and to communicate with Sterigenics and medical device companies that may be affected. Because the number of ethylene oxide contract sterilization facilities in the U.S. is limited, we are very concerned that additional facility closures could severely impact the supply of sterile medical devices to health care delivery organizations that depend on those devices to take care of patients. The impact resulting from closure of these and perhaps more facilities will be difficult to reverse, and ultimately could result in years of spot or nationwide shortages of critical medical devices, which could compromise patient care.

This is why today we are urging medical device manufacturers that use ethylene oxide facilities to assess their inventory for any potential downstream impacts of sterilization facility closures on their product distribution. We are committed to working with manufacturers to look for alternative sterilization options. When manufacturers keep the FDA apprised of progress and obstacles encountered, it helps ensure that everyone's best efforts are being made to mitigate any shortages and prevent potential shortages. When U.S. manufacturers are not able to resolve a shortage and it involves a critical device needed for U.S. patients, the FDA may look for a firm that is willing and able to redirect safe and effective product into the U.S. market to address a shortage.

We also encourage health care facilities to perform similar inventory assessments of critical medical supplies that undergo contract terminal sterilization via ethylene oxide prior to shipping and reach out to the FDA so we can assist in any way we can to help identify sources of potential substitute devices. Hospitals and other health care delivery organizations should also work with their purchasing departments, group purchasing organizations and distributors, as appropriate, to help obtain product needed for patient care. So as to not exacerbate anticipated product availability concerns, we urge facilities to work together and not hoard product or attempt to purchase larger quantities of devices beyond their normal purchase volume.

We also encourage device manufacturers and health care providers to provide us with information on potential supply issues. We have a device shortages mailbox so that any user, patient, manufacturer, or organization within the supply chain that is aware of a delay in distribution of new product, and/or anticipates a shortage, can notify us. It's never too early to contact us – the sooner we are aware of a potential shortage, the better we can assist in proactively developing a plan to mitigate its effects on patient care.

Since we first became aware of this issue earlier this year, we have continued to focus intently on addressing the immediate impacts of these closures and potential closures to help ensure patients can have access to the safe, effective, and high-quality medical devices they need today. We continue to communicate directly with manufacturers and monitor the supply of devices sterilized in facilities that have closed or that may close, paying special attention to life-saving, life-sustaining, and other critical devices. For instance, in the case of Smiths Medical's Bivona tracheostomy breathing tubes that were processed at the now-closed Sterigenics facility in Illinois, we helped mitigate that shortage by helping the manufacturer get a timely site change that kept supply interruptions to a minimum.

We share the public's objective to reduce over-reliance on ethylene oxide for medical device sterilization. And therefore, in addition to our shortage mitigation efforts, we have also been addressing the broader need for innovation and improvements to medical device sterilization techniques in general. For example,  earlier this year we announced two new innovation challenges to encourage ideas from stakeholders, academics, industry and others about novel solutions for improving sterilization processes. This includes a call to identify new or alternative sterilization methods and technologies that are alternatives to those that use ethylene oxide, and another to develop new strategies to reduce ethylene oxide emissions.

In addition, we've previously announced we're holding a public advisory committee meeting on November 6 and 7, 2019, dedicated to discussing how best to encourage innovation in medical device sterilization. We also continue to collaborate with the U.S. EPA, the entity responsible for reviewing and enforcing Clean Air Act regulations for sterilization facilities that emit ethylene oxide to ensure that facilities protect the public from significant risks, providing the U.S. EPA with updates on FDA activities in this area. And we'll continue to update stakeholders and the public as new information becomes available.

We want to be clear that we understand that there are very real consequences that medical device shortages have on patients, and we're committed to doing everything in our authority to help mitigate the adverse patient impact these sterilization facility closures are expected to have. We're also calling on all stakeholders—manufacturers, contract sterilizers, government agencies and other public health advocates—to join us and do your part to avert new device shortages and ensure patients have access to important and life-saving medical devices.

More Information:

  • FDA: Ethylene Oxide Sterilization for Medical Devices
  • FDA: Ethylene Oxide Sterilization Facility Updates

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Brittney Manchester, 301-796-1026, [email protected]
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Related Links

http://www.fda.gov

Modal title

Also from this source

Consejos de inocuidad alimentaria para el día del juego

Consejos de inocuidad alimentaria para el día del juego


Food Safety Tips for Game Day

Food Safety Tips for Game Day

Explore

More news releases in similar topics

  • Medical Pharmaceuticals
  • Pharmaceuticals
  • Health Care & Hospitals
  • Biotechnology
  • Medical Equipment

Contact Cision

  • Cision Distribution 888-776-0942
    from 8 AM - 9 PM ET

  • Chat with an Expert
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices

Products

  • Cision Communication Cloud®
  • For Marketers
  • For Public Relations
  • For IR & Compliance
  • For Agency
  • For Small Business
  • All Products

About

  • About PR Newswire
  • About Cision
  • Become a Publishing Partner
  • Become a Channel Partner
  • Careers
  • COVID-19 Resources
  • Accessibility Statement
  • Asia
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

My Services

  • All New Releases
  • Online Member Center
  • ProfNet

Contact Cision

Products

About

My Services
  • All News Releases
  • Online Member Center
  • ProfNet
Cision Distribution Helpline
888-776-0942
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2023 Cision US Inc.