• 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
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    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
    January AI Raises $8.8 Million in New Funding

    FDA Clears Ava Fertility Tracking Wearable Device

    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System

    Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably

    Japan to Lead APAC Assisted Reproductive Technology Devices Market
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Rethink Your Medtech ASC Strategy, Part 1

    Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

    Tips for Reigniting Your MDR/IVDR Preparation

    Three Major Innovation Opportunities for Biomedical Textiles

    Use Vertical Integration to Increase Productivity, Drive Innovation
    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.

    Medbio LLC

    Medicoil

    Forefront Medical Technology

    MW Life Sciences
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Refurbished Medical Equipment Testing and Certification Under the NEC

    Taking the First Step with Metal Components

    4 Trends Driving Medical Manufacturing in 2021

    Pioneering AI Solutions to Reinforce Healthcare Services

    The 8 Major Types of PPE Supply Chain Fraud
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    FUTEK Advanced Sensor Technology Inc.

    Creganna Medical, part of TE Connectivity

    PTI Engineered Plastics Inc.

    Medicoil

    Qosina 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
    • 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 OKs STERIS Systems to Decontaminate N95 Respirators

    Will support decontamination of approximately 750,000 N95 respirators per day in the U.S.

    Related CONTENT
    • The 8 Major Types of PPE Supply Chain Fraud
    • Report: Emergency Use Authorization a Top Health Hazard for 2021
    • Steady Growth Expected for APAC Sterilization Market Through 2030
    • The Lost Year: 2020 Year in Review
    • Fixing Face Mask Form and Function
    U.S. Food and Drug Administration04.13.20
    The U.S. Food and Drug Administration issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by healthcare workers in hospital settings. This EUA will support decontamination of approximately 750,000 N95 respirators per day in the U.S.
     
    “Authorizing this sterilization system will make it easier for hospitals to ensure that heroic healthcare workers on the frontlines have the protection they need,” said HHS Secretary Alex Azar. “Thanks to rapid work by the men and women of the FDA and President Trump’s vision for an all-of-America response, innovators are giving our healthcare warriors new tools nearly every day to fight the COVID-19 pandemic.”
     
    “This EUA is another game changer. It will allow hospitals to decontaminate compatible N95 respirators using vaporized hydrogen peroxide sterilizers that are readily available in approximately 2,000 U.S. hospitals,” said FDA Commissioner Stephen M. Hahn, M.D. “It’s another important step forward in helping to reduce shortages in critical N95 respirators, by allowing for these important devices, when decontaminated, to be reused by healthcare personnel on the front lines of the COVID-19 pandemic.”
     
    The FDA granted an emergency use authorization to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide. Hydrogen peroxide sterilization is a low temperature sterilization process that utilizes hydrogen peroxide vapor. The vapor fills the sterilization chamber, penetrates the device and sterilizes exposed surfaces. The STERIS V-PRO Decontamination Cycle is capable of processing 10 respirators at one time through a process that takes approximately 28 minutes to complete. Each respirator can be processed up to 10 times for single-user reuse.
    Related Searches
    • fda
    • u.s. food and drug administration
    • device
    • forward
    Related Knowledge Center
    • Packaging & Sterilization
    Suggested For You
    The 8 Major Types of PPE Supply Chain Fraud The 8 Major Types of PPE Supply Chain Fraud
    Report: Emergency Use Authorization a Top Health Hazard for 2021 Report: Emergency Use Authorization a Top Health Hazard for 2021
    Steady Growth Expected for APAC Sterilization Market Through 2030 Steady Growth Expected for APAC Sterilization Market Through 2030
    The Lost Year: 2020 Year in Review The Lost Year: 2020 Year in Review
    Fixing Face Mask Form and Function Fixing Face Mask Form and Function
    Heated Face Mask Filters and Inactivates Coronaviruses Heated Face Mask Filters and Inactivates Coronaviruses
    Will Industry’s COVID-19 Recovery End Prematurely? Will Industry’s COVID-19 Recovery End Prematurely?
    The Current COVID-19 Environment and Emergency Use Authorizations The Current COVID-19 Environment and Emergency Use Authorizations
    OralDNA Labs Gains EUA for Saline Oral Rinse COVID-19 RT-PCR Test OralDNA Labs Gains EUA for Saline Oral Rinse COVID-19 RT-PCR Test
    Saliva Tests Could Spot Silent COVID-19 Carriers Saliva Tests Could Spot Silent COVID-19 Carriers
    Cepheid Cepheid's Combo COVID-19, Flu A/B, RSV Test Earns EUA
    Hologic Granted EUA for Asymptomatic COVID-19 Testing Hologic Granted EUA for Asymptomatic COVID-19 Testing
    FDA Authorizes First Point-of-Care COVID-19 Antibody Test FDA Authorizes First Point-of-Care COVID-19 Antibody Test
    UK Study Reveals the Accuracy of a 90-Minute COVID-19 Test UK Study Reveals the Accuracy of a 90-Minute COVID-19 Test
    Rapid Test for COVID-19 Shows Improved Sensitivity Rapid Test for COVID-19 Shows Improved Sensitivity

    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 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

    • Packaging & Sterilization
      Georgia Bio Responds to Potential BD EtO Sterilization Plant Shutdown

      Georgia Bio Responds to Potential BD EtO Sterilization Plant Shutdown

      The association is concerned the closure may lead to a medical device shortage and impact patients.
      Business Wire 10.28.19


    Trending
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Common Issues And Their Solutions In Health Application Development
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • January AI Raises $8.8 Million in New Funding
    • FDA Clears Ava Fertility Tracking Wearable Device
    • First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    • Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably
    • Japan to Lead APAC Assisted Reproductive Technology Devices Market
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • Seeking a Revolution in Clinical Care Through AI
    • Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit
    • Addition by Subtraction: The Latest of Machining for Medtech
    • Innovation Incubators: An R&D Roundtable
    • Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    • 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

    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet
    Refined Grains Linked to Heart Attack Risk, Early Death
    Kappa Bioscience Extends Research Partnership For COVID-19 Research
    Coatings World

    Latest Breaking News From Coatings World

    Nippon Paint Marine Wins Korea Export Award
    Universal Display Corporation, PPG Expand Global Production of UniversalPHOLED Materials
    PPG Introduces Premium Iso-free Primer Surfacer, Catalyst
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    January AI Raises $8.8 Million in New Funding
    FDA Clears Ava Fertility Tracking Wearable Device
    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Spark Therapeutics Appoints CTO
    Cryoport Launches ESG Program
    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Top Beauty Products of 2021, According to HelloGiggles
    Estée Lauder Taps Ana de Armas as Global Brand Ambassador
    Sephora Announces Significant Expansion
    Happi

    Latest Breaking News From Happi

    What You're Reading on Happi.com
    Cosmetic Chemical Sales To Post CAGR 5.8% To 2025
    ACI Urges Senate to Approve Regan as EPA Administrator
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Marshall & Bruce Adds Koenig & Bauer Rapida 106 41-Inch Seven-Color Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    FTA converts Forum & INFOFLEX to virtual events
    Xeikon launches two new digital label printing presses
    UFlex adds capacity in packaging films
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Texas Medical Technology Partners with My Protect Kit
    Mexico City Single-Use Plastics Ban Leads to Tampon Shortage
    Believe Diapers Launch in U.S.
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    First Implantation of CTL Amedica's Minimally Invasive Flex Tower
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    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