• 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
    20 Years: A Discussion on the Past & Future of Medical Product Outsourcing

    A Combined Effort for Drug Delivery & Combo Product Technology

    Examining Medical Packaging & Sterilization on Multiple Fronts

    Medical Molding Modernized

    Computer Concepts for Medical Device Design
    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
    Regulatory
    Financial/Business
    Top News
    Merit Medical Acquires AngioDynamics' Catheter Portfolio

    iCAD Strengthens Leadership Team

    HeartFlow's RoadMap Analysis Debuts in the U.S.

    Study Shows Medtronic's Sphere-9 Catheter Successfully Treats Afib

    Implicity Introduces New Algorithm to Address Alert Fatigue in AF Care
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    20 Years: A Discussion on the Past & Future of Medical Product Outsourcing

    A Combined Effort for Drug Delivery & Combo Product Technology

    Examining Medical Packaging & Sterilization on Multiple Fronts

    Medical Molding Modernized

    Computer Concepts for Medical Device Design
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Elizabeth Holmes’ Pre-Prison Public Persona

    Trending in Healthcare Dealmaking: Creativity, Diversification, and Distress

    How Human Factors Engineering Can Contribute to Medical Device Packaging

    How Companies Can Create a Unique Selling Proposition

    Updating Medical Device Software in the Field
    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
    Halkey-Roberts Corporation

    LEMO USA Inc.

    JBC Technologies

    Arthur G. Russell Co. Inc., The

    Medbio LLC
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Redefining Healthcare Spaces with Built-in Antimicrobial Product Protection

    How the CHIPS Act and R&D Tax Credits Will Shape the Medtech Manufacturing Landscape

    Solving the Skills Gap Stalling the March of UK Life Sciences

    5 Ways to Reduce Nearshoring & Reshoring Costs Using Automation

    The Future of Hearing Aids: xMEMS Develops All-Silicon, Solid-State Micro Speaker
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Halkey-Roberts Corporation

    LEMO USA Inc.

    JBC Technologies

    Arthur G. Russell Co. Inc., The

    Medbio LLC
    • 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
    • eBook
    • Resources
    • Podcasts
    • 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
    Online Exclusives

    Is Your Biocompatibility Program on the Edge?

    Regulatory changes in both Europe and the U.S. have created uncertainty among device makers.

    Is Your Biocompatibility Program on the Edge?
    Lichtenstein Castle
    Thor Rollins, B.S., RN (NRCM), Senior Scientist, Nelson Laboratories05.18.17
    I recently had the opportunity to visit the Lichtenstein Castle in southern Germany. The original castle was built in approximately 1100 A.D. The foundation of the current edifice was constructed in 1390 A.D. and appears to be dangerously close to the edge. Though these places were built for security, this location lends an ironic feeling to this aim.
     
    The biocompatibility regulatory arena has also started to feel like it is on edge, and we are at a tipping point. Recently, we have seen changes in the Medical Device Regulations (MDR) in Europe, a new guidance document from FDA, and soon we will have the new versions of ISO 10993-1, -17, and -18.
     
    Though there appears to be significant changes to the landscape regarding how regulatory bodies view biocompatibility, a deeper look into the documents and regulations uncovers many similarities. Leveraging these similarities helps manufacturers develop a plan to meet the needs of today’s complex global marketplace—including the need to develop a Biological Evaluation Plan (BEP) that centers on the foundation of risk assessment. The “check box” approach to biocompatibility is no longer appropriate (e.g., we must now understand the materials and process residuals of a device to accurately mitigate the biocompatibility risks to the end user). The following represents the highlights of a deeper look into each of the documents:
     
    Changes to the MDR
    The latest MDR draft directives stick to the same basic framework; however, more detail has been added to almost every section. For example, the original 14 essential requirements are now replaced with 23 “General Safety and Performance Requirements” that are more thorough than previously published. Some other important points in the draft are:
     
    • Comprehensive requirements were added for risk management, post-market monitoring, and clinical evaluation. These fundamental aspects of regulation are now more tightly integrated.
    • Controls for reprocessing of single-use devices were added.
    • Classifications were reworked, including new devices that are now categorized as Class III and the introduction of special requirements for Class I reusable surgical instruments.

    FDA Guidance on the Use of ISO 10993
    FDA released the highly-anticipated guidance document regarding the use of ISO 10993. The document doubled in length, so I have listed ten significant changes.
     
    1. Device Examples: The document includes more communication and examples to support device companies in their submissions. Evidence is in the five additional attachments and the 30-page increase over the previous draft.
    2. Practitioner Contact: Assessing risk based on practitioner contact with devices now falls under ISO 10993-1, which expands the scope beyond patient safety.
    3. Recognized Standards: It is important to note U.S. FDA references other standards that are relevant to biocompatibility testing (ASTM, OECD, ICH and USP).
    4. Risk Management Guidance: Section III Risk Management for Biocompatibility Evaluations is a new lengthy 10-page section with great examples and discussion of how to approach and assess risk.
    5. Decision Trees: As described in the document, assess risk BEFORE testing begins.
    6. FDA ISO Biocompatibility Matrix Updates: FDA Modified matrix is “…not a checklist…” Added separate column for Material-Mediated Pyrogenicity.
    7. Cytotoxicity Tests: Extraction time for cytotoxicity testing is identified as 24-72 hours extraction. This differs from the standard and possibly implies that all permanent implants should be extracted for longer periods (72 hours).
    8. Hemolysis Tests: Only indirect hemolysis testing is now allowed for devices with indirect blood contact. Complement Activation no longer requires analysis of C3a. Serum is now preferred over plasma.
    9. Genotoxicity Tests: Genotoxicity testing may be waived if chemical characterization testing and literature research indicate that a genotoxic risk does not exist. However, genotoxicity testing and research cannot be used to mitigate carcinogenic risk.
    10. Pyrogenicity Tests: Pyrogenicity testing is expanded to include the Bacterial Endotoxin Test (BET) for sterile devices having direct/indirect contact with the cardiovascular system, lymphatic system, or Cerebral Spinal Fluid (CSF)—regardless of contact duration.
     
    New Drafts of ISO 10993-1, 10993-17, and 10993-18
    These essential medical device evaluation guidelines are currently undergoing needed updates. Though I cannot go into the details of the upcoming changes to the documents, I can say that medical device manufacturers can expect to see heightened scrutiny around both the risk assessment and the use of chemistry to evaluate risk. These assessments will be a paramount part of biocompatibility testing.
     
    Step Away from the Edge
    In response to the changing landscape, my peers and I developed a three-tiered approach to help medical device manufacturers satisfy the updated (and upcoming) regulatory requirements. This process is comprehensive and available today: identify risk, mitigate risk through testing, and compile the results.
     
    A Biological Evaluation Plan (BEP) is developed to identify the risks associated with a medical device including: considerations for its intended use, failure possibilities, construction materials, and processing impact. Once these risks have been identified, a testing plan is established to mitigate the risks. Upon completion of the testing, a Biological Evaluation Report (BER) summarizes the identified risks, reviews the results of the testing, and outlines a conclusion of safety for the device. Going through this process puts manufacturers in harmony with the new regulations and ensures that they are on solid ground with regulatory biocompatibility burden—and not living too close to the edge.
    Related Searches
    • harmony
    • fda
    • research
    • risk management
    Related Knowledge Center
    • Testing
    Suggested For You
    MEDICAL & BIOTECH MANUFACTURING MEDICAL & BIOTECH MANUFACTURING
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    Accu-Tube Appoints Matthew Haddle as CEO Accu-Tube Appoints Matthew Haddle as CEO
    Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    CE Mark Granted to Predictive Software for Kidney Allograft Survival CE Mark Granted to Predictive Software for Kidney Allograft Survival
    Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech
    Precision Coating Merges with N2 Biomedical Precision Coating Merges with N2 Biomedical
    Presidio Medical Names Michael Onuscheck as CEO Presidio Medical Names Michael Onuscheck as CEO
    Medical Devices Market to Top $671.49 Billion by 2027 Medical Devices Market to Top $671.49 Billion by 2027
    Indago Announces $10 Million Financing Close and Name Change Indago Announces $10 Million Financing Close and Name Change
    Molli Surgical Molli Surgical's Breast Tumor Marker
    Vertigo Treatment Receives FDA Breakthrough Device Designation Vertigo Treatment Receives FDA Breakthrough Device Designation
    RapidPulse Closes $15 Million Series A Financing RapidPulse Closes $15 Million Series A Financing
    Midwest Products & Engineering Acquires MindFlow Design Midwest Products & Engineering Acquires MindFlow Design
    Vicarious Surgical Opens New Corporate Headquarters in Massachusetts Vicarious Surgical Opens New Corporate Headquarters in Massachusetts

    Related Literature / Brochures

    • MEDICAL & BIOTECH MANUFACTURING

      ISO 13485:2016 • FDA Registered

    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.
      Business Wire 09.22.21

    • Tubing & Extrusion
      Accu-Tube Appoints Matthew Haddle as CEO

      Accu-Tube Appoints Matthew Haddle as CEO

      Haddle has a track record of leading organizations through strategic expansions across the medical device, aerospace, and industrial sectors.
      Accu-Tube 09.22.21


    • Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

      Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

      The two deals will strengthen Heraeus' healthcare and medtech portfolio.
      Heraeus 09.22.21

    • CE Mark Granted to Predictive Software for Kidney Allograft Survival

      CE Mark Granted to Predictive Software for Kidney Allograft Survival

      Algorithm gives the probability the graft will still be functional at three, five, and seven years after evaluation by a healthcare professional.
      Cibiltech 09.21.21

    Loading, Please Wait..

    Trending
    • Olympus To Establish Digital Excellence Centers
    • Study Shows Medtronic's Sphere-9 Catheter Successfully Treats Afib
    • Philips Names New Supervisory Board Chairman
    • A New Approach To Post-Market Surveillance
    • Labcorp's Clinical Development Spinoff To Be Called Fortrea
    Breaking News
    • Merit Medical Acquires AngioDynamics' Catheter Portfolio
    • iCAD Strengthens Leadership Team
    • HeartFlow's RoadMap Analysis Debuts in the U.S.
    • Study Shows Medtronic's Sphere-9 Catheter Successfully Treats Afib
    • Implicity Introduces New Algorithm to Address Alert Fatigue in AF Care
    View Breaking News >
    CURRENT ISSUE

    June 2023

    • 20 Years: A Discussion on the Past & Future of Medical Product Outsourcing
    • A Combined Effort for Drug Delivery & Combo Product Technology
    • Examining Medical Packaging & Sterilization on Multiple Fronts
    • Medical Molding Modernized
    • 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

    Women in Nutraceuticals Names Global Lead in India Ahead of Nutrify C-Suite Summit
    Batory Foods Acquires Tri-State Companies
    Blue Diamond, Brightseed Partner To Discover New Almond Bioactives
    Coatings World

    Latest Breaking News From Coatings World

    AkzoNobel to Supply Porsche China with Complete Water-Based Refinish Range
    Evonik Earns ACC’s Sustainability Leadership Award
    Sandrine Garnier Joins ChemQuest as a Director
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Merit Medical Acquires AngioDynamics' Catheter Portfolio
    iCAD Strengthens Leadership Team
    HeartFlow's RoadMap Analysis Debuts in the U.S.
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Quell Therapeutics, AstraZeneca Partner on Engineered Treg Cell Therapies
    Charles River, INADcure Collaborate on Gene Therapy Manufacturing
    Lotus Clinical Research, Trialogics Partner for Clinical Trial Software Services
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Guerlain's 'Secret' Archive—the World's 1st Lipstick, Perfume, & Nivea Jar
    Mary Kay Supports Ocean Conservation & Coral Reef Protection
    TerraCycle and Wrinkles Schminkles Announce Recycling Program
    Happi

    Latest Breaking News From Happi

    Sabinsa Wins 2023 Technology Innovation Award in China for LactoSpore
    Cepsa Química’s Sustainable Lab Slashes Carbon Footprint Up to 80%
    CPL Aromas Launches 2022 Sustainability and Impact Reports
    Ink World

    Latest Breaking News From Ink World

    ITMA 2023 Opens with Mega Showcase of Innovative Solutions
    Kornit Digital Shows Enhanced Presto MAX at ITMA 2023
    Kornit Digital Unveils Apollo Platform, Enhanced Atlas MAX PLUS at ITMA 2023
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    AWT Labels & Packaging acquires ASL Print FX
    Avery Dennison announces new cohort of startups for AD Stretch Accelerator Program
    Appvion unveils new film label facestock
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Rascal + Friends Expands Distribution with Walmart
    ITMA ASIA + CITME Announce Second Location
    Andritz Partnership with Pellenc ST and Nouvelles Fibres Enters New Phase
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    SurGenTec's TiLink-L SI Joint Implant Gains FDA Nod
    Orthopedic Prosthetic Market to Eclipse $3.39 Billion by 2030
    Osso VR Launches Virtual Reality Training Program
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Sensirion Air Quality Sensors Harmonized with RESET Air Standard
    Identiv Introduces Industry’s First Battery-Free Metal Sensor IoT Devices
    Heliatek Joins European Solar PV Industry Alliance (ESIA)

    Copyright © 2023 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