• 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
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    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
    Varian Receives IDE Exemption from FDA to Advance Flash Clinical Research Program

    Enhatch Partners with Holo-Light to Deliver New Extended Reality Streaming Platform

    Study Confirms Safety, Accuracy of Vectorious' V-LAP In-Heart Sensor

    Norman Noble Achieves ISO 13485:2016 Certification

    Indian SMEs Gaining Access to Russian Medtech Market Amid Ukraine Conflict
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Theranos Fraud Trial, Part II: The Blame Game Continues

    An Update on Surgical Robotics

    Letting the Light In: How Failure Analysis is the Cornerstone of Success

    Three Talent Strategies to Attract High-Demand Skills

    The Advantages of Bioburden Screening for Sterilization Validation
    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
    Arthur G. Russell Co. Inc., The

    Cirtec Medical

    Xact Wire EDM Corp.

    Trademark Plastics Inc.

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    ‘Right to Repair’: Separating Fact from Fiction

    Taking a Holistic Approach to Decentralized Clinical Trials (DCTs)

    Investment in Health Startups Drops

    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    Cirtec Medical

    Xact Wire EDM Corp.

    Trademark Plastics Inc.

    Fusion Biotec Inc.
    • 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
    Editorial

    In Pursuit of Device Safety or a Call for Whistleblowers?

    ...

    In Pursuit of Device Safety or a Call for Whistleblowers?
    Implementing a revised reporting system that reduces the burden put on hospitals would improve the current system and ultimately enhance patient safety.
    Related CONTENT
    • Breakthrough Device Designation Granted for New Neuromodulation Platform
    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    • First CellFX Procedure Performed in Canada
    • RedDress’ ActiGraft System Receives New FDA Clearance
    • FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests
    Sean Fenske, Editor03.07.17
    Late last year, Jeffrey Shuren, M.D., J.D., the U.S. Food and Drug Administration’s (FDA) director of the Center for Devices and Radiological Health, penned a blog for the FDA Voice (http://bit.ly/mpo031750) regarding the coordination between the FDA and hospitals to collect data on medical devices. While a process is already in place to enable hospitals and doctors to report information on a medical device to the manufacturer and/or FDA when it is responsible for an adverse event, there is no check in place to ensure this is happening. Unfortunately, based on a review of 17 hospitals by the FDA, it appears not to be occurring in a significant number of instances.

    In December 2015, the FDA initiated inspections on 17 hospitals due to incidents related to morcellators (tied to the spread of uterine cancer) and duodenoscopes (associated with the spread of infections). Neither event generated a corresponding adverse event report within the agency’s MAUDE (manufacturer and user facility device experience) database. According to Shuren, the FDA did, however, gain valuable insight into a number of challenges regarding medical device incident reporting. These included:

    • There is a significant lack of reporting by hospitals to the FDA and/or manufacturers overall. Some healthcare facilities even lack the procedure for this reporting to take place.
    • Hospital staff has not been properly trained to report device incidents.
    • A new system to enable better lines of communication between the hospital and the FDA is required.
    While device safety is the ultimate goal of any such reporting system, there is one aspect of Shuren’s message that did give me pause—does the agency have a possible ulterior motive for improving the reporting system? In his FDA Voice blog, Shuren stated, “At the time of premarket evaluation, however, it is not feasible to identify all possible risks or to have absolute certainty regarding a technology’s benefit-risk profile. Among other reasons, studies required to do so would likely be prohibitively large in order to capture less frequent and more unpredictable effects or consequences. In addition, such larger studies still may not reflect the true benefit-risk profile of the device. Once a device is on the market, for example, doctors may use it beyond the FDA cleared intended use. In addition, subsequent modifications to the device or changes in how the device is used in practice can result in new safety risks or greater frequency of known risks.”

    Sure, off-label use is a problem and manufacturers should be made aware of any such use of their device. If it hasn’t been cleared for a therapy for which it is being used, it could certainly create a headache for the manufacturer, even if they aren’t found to be promoting such use. Might a revised reporting system not only review events where a device may have caused an injury or death, but also be used to seek out off-label use of medical devices in the healthcare environment? Of course, depending upon with whom you speak, a system that looks for such use cases would not necessarily be a bad thing. If the result of such a review simply leads to a penalty against the manufacturer, then I don’t see it as a positive; however, if the review could be used to potentially better position the manufacturer to seek clearance for the off-label use with the FDA, that would ultimately be a benefit—an extension of real-world data collection, if you will.

    Ultimately, a revision to the current reporting system would likely be welcomed by all stakeholders. Putting in place a solution that reduces the burden on hospital personnel to conduct the reporting would alleviate the need for training on the system and proper procedures being put in place. The manufacturer could be made aware of a potential flaw in a device and enable them to address it before the problem becomes more widespread. The FDA would gain more information on medical devices already on the market, enhancing their postmarket surveillance efficiency.

    One tool that might be leveraged to accomplish this would be electronic health records (EHRs) and the data provided from them. If an algorithm could be created to comb through EHRs to seek adverse events that might be tied to medical devices, great value could be gained. What’s done with this information will then be the next challenge to be solved. Does the manufacturer face a penalty or would the system be used to truly enhance the quality of care that’s being delivered with the information being effectively utilized by both device maker and FDA?

    Let’s first fix the reporting system and then that next challenge can be addressed.
    Related Searches
    • medical
    • market
    • postmarket
    • therapy
    Related Knowledge Center
    • Neurological
    • Testing
    • Digital Health
    Suggested For You
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    First CellFX Procedure Performed in Canada First CellFX Procedure Performed in Canada
    RedDress’ ActiGraft System Receives New FDA Clearance RedDress’ ActiGraft System Receives New FDA Clearance
    FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests
    FDA Clears Inova Diagnostics FDA Clears Inova Diagnostics' Digital Multi-Analyte System
    FDA Approves Abbott FDA Approves Abbott's Portico with FlexNav TAVR System
    Vicarious Surgical Business Combination with D8 Holdings Approved Vicarious Surgical Business Combination with D8 Holdings Approved
    Indago Announces $10 Million Financing Close and Name Change Indago Announces $10 Million Financing Close and Name Change
    Siemens Healthineers’ Somatom X.ceed Tomography Scanner Cleared by FDA Siemens Healthineers’ Somatom X.ceed Tomography Scanner Cleared by FDA
    Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe
    Vertigo Treatment Receives FDA Breakthrough Device Designation Vertigo Treatment Receives FDA Breakthrough Device Designation
    Quanta Raises $245 Million in Series D Funding Round Quanta Raises $245 Million in Series D Funding Round
    Thermo Fisher Scientific Launches Updated COVID-19 Test Thermo Fisher Scientific Launches Updated COVID-19 Test
    Midwest Products & Engineering Acquires MindFlow Design Midwest Products & Engineering Acquires MindFlow Design

    Related Breaking News

    • Breakthrough Device Designation Granted for New Neuromodulation Platform

      Breakthrough Device Designation Granted for New Neuromodulation Platform

      In a pilot study treating refractory epilepsy with Neuroelectrics’ Starstim platform, patients experienced a 44 percent median reduction in seizure frequency.
      Business Wire 09.22.21

    • 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

    • First CellFX Procedure Performed in Canada

      First CellFX Procedure Performed in Canada

      Pulse Biosciences expands its controlled launch of the CellFX System into the country.
      Business Wire 09.22.21


    • RedDress’ ActiGraft System Receives New FDA Clearance

      RedDress’ ActiGraft System Receives New FDA Clearance

      ActiGraft Ver.02 System is intended for the safe and rapid POC preparation of an in-vitro blood clot.
      Globe Newswire 09.22.21

    • Diagnostics
      FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests

      FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests

      May be related to current mixing parameters of the PCR reaction mixture.
      U.S. Food and Drug Administration 09.20.21

    Loading, Please Wait..

    Trending
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • FDA OKs J&J Vision's AcuVue Oasys Max 1-Day Contact Lenses
    • How To Overcome The Top 6 Medical Device Manufacturing Challenges
    • Cepheid, BioGX Partner To Create GeneXpert Monkeypox Test
    • Intermountain Healthcare & Siemens Healthineers Open 3 Tellica Outpatient Imaging Centers
    Breaking News
    • Varian Receives IDE Exemption from FDA to Advance Flash Clinical Research Program
    • Enhatch Partners with Holo-Light to Deliver New Extended Reality Streaming Platform
    • Study Confirms Safety, Accuracy of Vectorious' V-LAP In-Heart Sensor
    • Norman Noble Achieves ISO 13485:2016 Certification
    • Indian SMEs Gaining Access to Russian Medtech Market Amid Ukraine Conflict
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • OEMs Seek Molders Offering Timely Techniques
    • Robotic Surgery: Cutting Through to the Latest
    • Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    • 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

    Kensing Acquires Vitae Naturals
    CoQ10 and Royal Jelly Supplementation May Improve High Intensity Exercise
    Shiitake Mushroom Extract Appears Helpful in HPV Infections
    Coatings World

    Latest Breaking News From Coatings World

    PPG to Increase U.S. Aerospace Products Manufacturing Output to Meet Rising Demand
    Solvay to Discontinue Use of Fluorosurfactants for Production of Fluoropolymers
    AkzoNobel Names New CEO
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Varian Receives IDE Exemption from FDA to Advance Flash Clinical Research Program
    Enhatch Partners with Holo-Light to Deliver New Extended Reality Streaming Platform
    Study Confirms Safety, Accuracy of Vectorious' V-LAP In-Heart Sensor
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Shimadzu Scientific Instruments Extends HQ Campus
    Vetter’s Newest Clinical Manufacturing Site Completes First Customer Fills
    Batavia Enters Commercial Manufacturing Business
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Naples Soap Company to Open New Store in Venice, Florida
    Nectar Recruits 8-Year-Old YouTube Star to Launch Her Own Bath & Body Line
    L'Oreal Exec Joins Function of Beauty
    Happi

    Latest Breaking News From Happi

    Rhode Island’s Department of Health, Raw Elements and Partners Expand Touch-Free Mineral Sunscreen
    Julee Wilson Named Executive Director of BeautyUnited
    Arey Launches Unisex Leave-In Conditioner
    Ink World

    Latest Breaking News From Ink World

    Amcor Lift-Off Initiative Shortlists Start-ups for Seed Funding
    Barentz Highlights Lincoln MFG’s New ISO 9001:2015 Certification
    Ingevity Appoints Christine Stunyo as Chief Human Resources Officer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Eaglewood introduces Sitexco Label L10 anilox cleaning system
    Germark makes double press investment in Bobst
    UPM Raflatac to enhance service capabilities at Mills River factory
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Rockline's Springdale Campus Achieves 15 Million Safe Work Hours
    Emmanuelle Picard to Join Ahlstrom-Munksjö's Executive Management Team
    Alkegen Completes Luyang Acquisition
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Researchers Develop Microfluidic Sensors to Improve Implant Survival Rates
    Lawrence Yellin Appointed as Fuse Medical CFO
    Researchers Discover Novel Patching Material for Bone Defects
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Avery Dennison Highlights New Approach to Apparel with ADX Lab
    trinamiX Face Authentication Protects Users from Fraud Attacks During Mobile Payments
    Hugo Boss Partners with Nedap for Global RFID Roll-out

    Copyright © 2022 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