• 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
    TPI Partners with Zeiss

    PPE Moves into New Manufacturing Facility

    Neurent Medical Closes $25 Million Series B Financing

    Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.

    FDA OKs Canon Medical's AI-Powered, 90cm Bore CT
    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
    Medicoil

    PTI Engineered Plastics Inc.

    Medbio LLC

    Concise Engineering

    K-Tube Technologies
    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
    K-Tube Technologies

    Unicep

    maxon

    Creganna Medical, part of TE Connectivity

    MW Life Sciences
    • 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
    Columns

    Coming Clean: Developing Standards for Cleaning Reusable Devices and Instruments

    ...

    Related CONTENT
    • TPI Partners with Zeiss
    • Freudenberg Medical Expands Injection Molding Operations
    • Eitan Medical Receives FDA Clearance for Sapphire Infusion System
    • CHF Solutions Appoints CEO
    • Medtech Matters: Surgeons Scrubbing In Virtually
    Dawn A. Lissy, President & Founder, Empirical07.26.18
    Five years ago, I shuddered to read the headlines about “dirty” endoscopes being used in colonoscopies and the speculation that followed. Are colonoscopies really safe? Is this what’s creating new superbugs? Why weren’t hospitals doing a better job of removing biomaterial and debris on these reusable devices?

    I’ll respectfully bow out on debates over those first two questions. My answer to that third query is yet another, larger question: How can we hold hospitals accountable without comprehensive criteria established by a major regulatory agency to determine what qualifies as a clean instrument?

    As a professional in the medical device development industry, that last issue keeps me up later at night than the fear of virulent new bacteria lurking in hospital halls. So, I take great comfort in the fact that my colleague Don Tumminelli is working on changing that. As senior technical manager of Client Services for HIGHPOWER Validation Testing & Lab Services, Tumminelli is part of a core group of professionals working on standards that will eventually be blessed by the U.S. Food and Drug Administration (FDA) and the Association for Advancement of Medical Instrumentation (AAMI).

    “Cleaning is huge right now,” he said. “Here at HIGHPOWER, we sit on about 20 different committees for standards, so we help develop them and get the right validation methods in there. It’s been many years in the making. We’ve been talking about this for at least five years, probably longer.”

    Sterilization standards have been well vetted and set since about 2005. Low-temperature and steam sterilization processes have proven their effectiveness and manufacturers, designers, and device developers all know what markers of accountability they’re held to.

    “There are parameters that you need to claim,” Tumminelli said. “The FDA now has what they consider to be traditional sterilization cycles. So everyone knows what they’re working toward.”

    But errors occur even with those relatively new sterilization standards. Tumminelli has seen some clients default to instructions for a similar device rather than developing processes specific to their new project.

    “I think some people, one of the biggest mistakes they make, they will go back and look at a competitor’s instructions and cut and paste,” he said. “A lot of these competitors’ products have been around 20 to 30 years, so just copying and pasting what they did years ago doesn’t work. There used to be no sterilization standards, so (that older device) might’ve been grandfathered in.”

    When it comes to cleaning standards, Tumminelli and his crew are starting from scratch. It’s a daunting undertaking given the range of reusable devices. To put that in perspective, consider how many devices a single hospital might reuse—instruments, scopes, storage, among many others. Each item likely has separate and differing requirements for cleaning, he said.

    “If you’re a hospital and you have 1,000 different surgical devices and each surgical device has a different set of cleaning instructions, logistically, you can imagine what goes into that,” he said. “It’s like washing dishes—you have 20 plates, 20 pieces of silverware, and each piece of silverware has to be washed differently.”

    So, Tumminelli and his colleagues are working closely with the AAMI to come up with standards that will work for a very broad user base.

    “It’s been the wild, wild west of cleaning,” he said. “We just started the process. It’s at least a year out. When that’s done, it will allow everyone to be on the same page when it comes to evaluating your device for cleaning.”

    Though we appreciate that sterilization and validation standards are already in place, that can essentially create a false sense of security, he explained. Yes, you can sterilize instruments to those standards, but without a baseline for cleanliness, it raises questions about how safe the instrument or reusable device actually is. How does it affect patient health if a device or instrument is sterilized, but debris remains?

    “Nobody really knew where to start—there was a lot of fear and confusion out there,” Tumminelli said. “Because there are so many different types of devices on the market, some do require different ways to clean.”

    Simpler pieces can be cleaned fairly easily, but more complex devices pose greater challenges, he said.

    “You get these really complicated things like a colonoscope,” Tumminelli said. “These things will have multiple channels that are a millimeter in diameter and six, seven feet long with biopsy ports. If you leave debris in the channel, sterilization won’t do its job.”

    Tumminelli has seen that first-hand in his lab, and that experience plays into the work he and his team are putting into developing cleaning standards. Each instrument or device that receives clearance to market must have a set of instructions for cleaning and sterilization. For clients, Tumminelli’s review of those instructions includes simulating the type and location of soil most likely to occur as the device is used. For items such as bronchial scopes, the test soil is mucus. For intravenous devices, it’s blood. Orthopedics are evaluated with bone chips.

    “What we do is we soil the devices as clinically close as possible,” he said. “Once we soil the device the way it’s used clinically, then we have to clean it. We clean it with those factory instructions. When we’re done cleaning it, then we extract the device and we look for residual soil.”

    The acceptable level of residual soil varies with the instrument and use, he said, so it’s a painstaking process to establish criteria that will apply to the industry as a whole, perhaps even more so than when sterilization standards were established.

    “We’re working to bring order,” Tumminelli said. “Manufacturers are confused—there’s not a lot of guidance out there. It’s more of a learned thing. We’re just trying to get everyone on the same page.”  


    Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
    Related Searches
    • quality
    • colonoscope
    • bacteria
    • regulatory
    Related Knowledge Center
    • Packaging & Sterilization
    • Testing
    Suggested For You
    Medtech Matters: Medtronic Medtech Matters: Medtronic's Robotic Surgery Status
    TPI Partners with Zeiss TPI Partners with Zeiss
    Freudenberg Medical Expands Injection Molding Operations Freudenberg Medical Expands Injection Molding Operations
    Eitan Medical Receives FDA Clearance for Sapphire Infusion System Eitan Medical Receives FDA Clearance for Sapphire Infusion System
    CHF Solutions Appoints CEO CHF Solutions Appoints CEO
    Medtech Matters: Surgeons Scrubbing In Virtually Medtech Matters: Surgeons Scrubbing In Virtually
    Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    CMS Expedites Breakthrough Device Access; Industry Applauds CMS Expedites Breakthrough Device Access; Industry Applauds
    Researchers Receive Funding to Develop Smart Vaccine Device Researchers Receive Funding to Develop Smart Vaccine Device
    Medtech Matters: Talking Robotic Surgery with Zimmer Biomet Medtech Matters: Talking Robotic Surgery with Zimmer Biomet
    Vonco Products Receives ISO 13485:2016 Certification Vonco Products Receives ISO 13485:2016 Certification
    Study Shows Lungpacer System Improves Diaphragm Strength by More Than 300 Percent Study Shows Lungpacer System Improves Diaphragm Strength by More Than 300 Percent
    New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System
    Quantitative Transmission Ultrasound Outperforms Mammography Quantitative Transmission Ultrasound Outperforms Mammography
    BioSerenity Achieves FDA Clearance for Wearable Device System BioSerenity Achieves FDA Clearance for Wearable Device System

    Related Columns

    • Testing
      Going Beyond the Regulations to Evaluate Relevant Medical Device Risk

      Going Beyond the Regulations to Evaluate Relevant Medical Device Risk

      Companies need to review their testing plan so it supports a successful submission, saves time, and ensures the long-term success of their product.
      Sherry Parker, Ph.D., Senior Director of Regulatory Toxicology, WuXi AppTec Medical Device Testing 06.04.20

    • Packaging & Sterilization
      Six Key Design Features to Ensure Medical Device Packaging Meets ASTM D4169

      Six Key Design Features to Ensure Medical Device Packaging Meets ASTM D4169

      Well-thought-out packaging is an oft-delayed but essential part of ensuring a medical device operates safely and effectively in the field.
      Nigel Syrotuck, Mechanical Engineering Team Lead, StarFish Medical 06.04.20

    • Testing
      The Importance of Usability/Human Factors Testing

      The Importance of Usability/Human Factors Testing

      When is the work of human factors over, and how does your team know they are prepared for summative testing?
      Maria Shepherd, President and Founder, Medi-Vantage 03.04.20


    • Materials | Testing
      Particle Particulars: Why this Analysis Is Foundational for Successful Devices

      Particle Particulars: Why this Analysis Is Foundational for Successful Devices

      In the mid-2000s, medical device experts were hopeful they’d found one solution to longer-lasting implants.
      Dawn A. Lissy, President & Founder, Empirical 03.04.20

    • R&D & Design | Testing
      FDA Guidelines for Employing X-ray Inspection in Medical Device Development

      FDA Guidelines for Employing X-ray Inspection in Medical Device Development

      Different materials exhibit different radiopacity as a function of material composition (i.e. atomic weight) and thickness.
      Gil Zweig, President, Glenbrook Technologies 01.29.20

    • Testing
      Managing Risks for Medical Devices:  A Guide to Understanding ISO 14971

      Managing Risks for Medical Devices: A Guide to Understanding ISO 14971

      The intent of ISO 14971 is to provide a general “bird’s-eye view” approach to designing and implementing a risk management plan for medical devices.
      Helin Räägel, Ph.D., Biocompatibility Expert, Nelson Labs 10.08.19


    • Testing
      Preparing for MDR: Test In-House or Outsource?

      Preparing for MDR: Test In-House or Outsource?

      As the EU MDR deadline draws near, manufacturers are under pressure to bring products into compliance and get submissions in front of regulators ASAP.
      Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi Medical Device Testing 10.08.19

    • Materials | Packaging & Sterilization | R&D & Design
      Case in Point: Robust Sintered PTFE Material Helps to Reduce Risk of HAIs

      Case in Point: Robust Sintered PTFE Material Helps to Reduce Risk of HAIs

      ...
      Jack Chan, Global Marketing Director—Medical, Porex 07.30.19

    • Packaging & Sterilization
      Package Testing and Validation: Interplay Between ISO 11607 Updates and MDR

      Package Testing and Validation: Interplay Between ISO 11607 Updates and MDR

      ...
      Britt Jones, Manager of Package Testing Services, WuXi AppTec 06.13.19


    • Packaging & Sterilization
      Sterilization Facility Shutdown Sparks Device Shortage

      Sterilization Facility Shutdown Sparks Device Shortage

      ...
      Michael Barbella , Managing Editor 05.01.19

    • Testing
      Why Big Companies With Internal Labs Should Outsource Testing

      Why Big Companies With Internal Labs Should Outsource Testing

      ...
      Dawn A. Lissy, President & Founder, Empirical 03.07.19

    • Packaging & Sterilization
      Is Your Packaging Provider Prepared If Disaster Strikes?

      Is Your Packaging Provider Prepared If Disaster Strikes?

      ...
      Wilfredo Mercado, Vice President of Operations, Latin America, Prent Thermoforming 01.31.19


    • Packaging & Sterilization
      How the Right Logistics and Repair Vendor Can Drive Supply Chain Value

      How the Right Logistics and Repair Vendor Can Drive Supply Chain Value

      ...
      Matthew Riehl, General Manager, Columbus GSC, Flash Global 06.04.18

    • 3D/Additive Manufacturing | Testing
      The Final Four: My Top Headlines for 2017

      The Final Four: My Top Headlines for 2017

      ...
      Dawn A. Lissy, President & Founder, Empirical 11.07.17

    • Packaging & Sterilization | Testing
      Packaging Validations—Looking Beyond ISO 11607

      Packaging Validations—Looking Beyond ISO 11607

      ...
      Christopher Scott, Vice President, Eurofins Medical Device Testing 10.05.17


    Trending
    • Telemedicine, Regulatory Changes To Characterize Medtech Industry In 2021
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • Philips Buys Capsule Technologies In $635M Deal
    • Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
    • Medtech Matters: Surgeons Scrubbing In Virtually
    Breaking News
    • TPI Partners with Zeiss
    • PPE Moves into New Manufacturing Facility
    • Neurent Medical Closes $25 Million Series B Financing
    • Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.
    • FDA OKs Canon Medical's AI-Powered, 90cm Bore CT
    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

    NIH Study Compares Low-Fat, Plant-based to Low-Carb, Animal-Based Diet
    Gadot Positions Mineral Line for Vegan Market
    Nutritfy India to Launch Global Broadcast Channel Covering Nutrition
    Coatings World

    Latest Breaking News From Coatings World

    IGL Coatings Launches Graphene Reinforced Dual System Ceramic Coating
    Miller Paint Declares Simple Serenity its 2021 Color of the Year
    TAUBMANS Paint by PPG Releases ‘Chromatic Joy’ Palettes
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    TPI Partners with Zeiss
    PPE Moves into New Manufacturing Facility
    Neurent Medical Closes $25 Million Series B Financing
    Contract Pharma

    Latest Breaking News From Contract Pharma

    WDSrx Expands Warehouse Network
    Piramal Inks Clinical Supply Deal with Theratechnologies
    Recipharm Signs Manufacturing Deal with Enzymatica
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Lageen Tubes Launches Mono-Material PE Tube Solutions
    Jason Jones Loses Battle with Covid-19
    Weleda Celebrates 100 Years By 'Opening' Its Gardens
    Happi

    Latest Breaking News From Happi

    NY's 1,4-Dioxane Law May Impact Concentrated Cleaners
    Sabinsa's Top Scientist Addresses US FDA
    Ipsy Adds New Personal Care Brand
    Ink World

    Latest Breaking News From Ink World

    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    THIMM Group Installs 1st Koenig & Bauer CorruFLEX
    Cowan Graphics Adds Fujifilm Inca OnsetX3 HS
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Lemu Group engineers mask-making machine
    Niagara Label upgrades with Nilpeter flexo press
    Soma partners with Moore & Moore in US
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Lemu Group Engineers Mask-Making Machine
    Armbrust American Adds Meltblown Manufacturing
    P&G Reports 8% Sales Increase
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Siemens Healthineers’ DR Systems Cleared by FDA
    Former Medtronic Exec Appointed Zimmer Biomet's Chief Transformation Officer
    SeaSpine Launches Regatta Lateral Plates
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Graphene Flagship Launches Redesigned Website

    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