• 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
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    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
    MPO's Most-Read Stories This Week—June 3

    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA

    LifeQ Unveils New 24-Hour Sleep Solution

    Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll

    EvoEndo Names CEO and Chief Operating Officer
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Checking Up on Surgical Robotics

    Building a Network: How Synchron Is Developing a New Device—and a New Market

    Six Lessons Learned on Developing a Strong Company Culture

    As Hiring Slows, Companies Look Inward to Fulfill Talent Needs

    Artificial Intelligence: Medtech Opportunity or Health Danger?
    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
    Fusion Biotec Inc.

    Arthur G. Russell Co. Inc., The

    Cirtec Medical

    NDH Medical Inc.

    Medbio LLC
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    6 Considerations for Companies on the Cusp of Being Acquired

    3 Key Elements to Consider When Managing a Medtech Sales Force

    Tech-Enabled Virtual Speech Therapy Improves Speech & Communication Skills

    Practical Strategies for Digitization and Integration in Medtech Manufacturing

    Sensors: The Heart of Minimally Invasive Equipment Technology
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Halkey-Roberts Corporation

    JBC Technologies

    LEMO USA Inc.

    Medbio LLC

    Cirtec Medical
    • 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
    Columns

    Employee Feedback Should Be Part of a Product Safety Plan

    ...

    Employee Feedback Should Be Part of a Product Safety Plan
    Chris Harvey, Director, Recall Solutions, Stericycle Expert Solutions11.07.17
    Whistleblower lawsuits in the medtech and pharmaceutical industries are often settled for multiple millions of dollars, but not before they potentially cause harm to patients, caregivers, and quite often, the reputation of manufacturers. How then, can medical device companies better ensure patient safety and avoid costly litigation? Simple communication.

    As counter-intuitive as it sounds, manufacturers should strongly encourage their employees to speak up about illicit activity or upon discovering a product could potentially harm a user, or lead to a product recall. One of the best methods to overcome all possible internal concerns and hesitations is through a system that allows employees to report a problem anonymously (e.g., an employee hot line). Institutionalizing employee communication is key to a comprehensive recall readiness plan and also helps create a positive culture that demonstrates a company’s commitment to quality user expectation fulfillment.

    U.S. Food and Drug Administration (FDA) regulatory compliance expert Gale Prince contended that whistleblower protections should be an integral part of corporate business ethics and social responsibility policies. “Companies that give employees a safe, anonymous forum to voice concerns or point out potentially dangerous issues opens the lines of communication and could help mitigate any risk to customers or damage to the company’s brand well before the product is in market,” he noted.

    To prove his point, Prince cited a “60-Minutes” exposé on a drug company lab worker who warned his supervisor about a steroid pain medication that could possibly cause fungal meningitis. With the warnings ignored, the medication killed 48 Americans and sickened more than 700 others in the worst pharmaceutical mishap in decades. The FDA ultimately shut down the manufacturer’s operation. A company executive receiving such an alarming red flag must fix the problem; failure to do so will only force conscientious employees to disclose their concerns to outside sources like the media or a federal regulatory agency.

    Keeping whistleblower communications internal is significantly less damaging for companies than forcing employees to publicly disclose their product safety fears. Last fall, the FDA launched its own whistleblower website to encourage company employees to anonymously alert the agency about product concerns and potential regulatory misconduct inside their respective organizations. The website does not replace the agency’s current MedWatch reporting system, though. MedWatch will continue to collect reports of adverse events, product quality issues, and therapeutic failures from the public.

    The FDA inevitably involves itself in all medical device recalls. However, it shouldn’t initiate the corrective action based on an in-house whistleblower lead for several reasons. Perhaps most importantly, FDA-initiated product recalls cause companies to lose control of messaging as well as the type of data revealed. Think about it: Employees who anonymously report alleged misconduct to the FDA must provide a plethora of significant details to help the agency properly assess an allegation. These details might reveal proprietary, unnecessary, or unrelated information that could competitively compromise a company.

    Lawsuit-chasing attorneys may also try to court medical device whistleblowers due to the significant monetary rewards offered for medical device fraud reporting.

    Fostering Productive Employee Feedback
    Companies that want to encourage noncompliance reporting can start by eliminating the overall stigma of workplace informants. The term “whistleblower” itself is often disparaged, conjuring up negative connotations of a disgruntled worker gone rogue.

    Incorporating employee feedback as part of a corporate product recall preparedness strategy can address this problem by simply removing “whistleblower” from the corporate lexicon. Include a provision for “product anomaly reporting” or a similarly positive alternative label as part of an early recall readiness plan. Employees will feel more comfortable raising issues if the reporting step is institutionalized.

    Training is also essential to ensure that employees’ concerns about product safety are handled properly within a company, according to Prince. “Medical device companies should train employees on what problems to look out for, as well as how to report their concerns privately. Having strong product safety messaging supported by training will provide the mechanism through which everyone feels comfortable in doing the right thing for the company,” he explained.

    Prince recommended that companies establish a hotline where employees can file a report without fear of retaliation. This may be a done through a contracted service or employee professional who is trained to gather the appropriate information. It can be executed by phone or electronically, such as a website. Such a vehicle allows anonymous information to be shared with a designated person in the company who “owns” the process and contracts with an outside agency to provide an anonymous 800 number for reporting warnings confidentially. Typical job positions for managing these scenarios could include the chief cultural officer, chief auditing officer, or the head of personnel. 

    Employees on a manufacturing line can be the eyes and ears for the executive team, flagging potential issues without fear of retribution, as long as a clear policy is in place. But front-line workers can be intimidated or averse to bypassing their managers for fear of reprisal. It is critical that device manufacturers provide an anonymous reporting mechanism through an online form, phone number, or email so employees can feel confident their identities will be protected.

    In the same vein, companies should establish such openness at the executive level by encouraging or incentivizing managers to solicit feedback on problems or irregularities from their direct reports.

    It is important to change the corporate culture by providing processes and mechanisms for reporting product problems. It is equally vital that a company’s executive team creates an open culture that puts safety first and encourages speaking up. Employees should be made to understand that reporting a product issue is not about snitching, but rather motivated by a genuine desire to help their company improve and potentially prevent even greater future misfortune. A good business culture policy should clearly convey to all stakeholders the significance of voicing their concerns early, so needed corrections can be implemented to prevent product recalls. 


    Chris Harvey leads a team of recall strategists and works with clients to ensure flawless implementation and customer integration throughout the entire product recall process. He assists in the scoping, plan development, and recall execution for a diverse set of industries, including pharmaceutical, medical device, food and beverage, and consumer products.

    Throughout his career, he has managed more than 1,000 recalls, including hundreds of high-profile recalls and withdrawals for the nation’s largest pharmaceutical and CPG companies. With his wide range of experience, Harvey offers Stericycle clients proven and efficient solutions to challenges arising from every aspect of the recall process, from initial planning and preparation to the full-scale execution of a product recall. Additionally, Harvey works with numerous law firms and PR firms across all industries to help their clients mitigate recall related risk. Harvey is recognized as an expert in the recall industry and routinely speaks on best practices for recall planning and execution at trade shows, conventions, and conferences. He is a graduate of Purdue University, where he earned his bachelor’s degree in law and society.
    Related Searches
    • medtech
    • medical device
    • recalls
    • brand
    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
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • Philips Names New Supervisory Board Chairman
    • A New Approach To Post-Market Surveillance
    • FDA Clears Sanara MedTech's Advanced Surgical Solution
    • Titan Medical Licenses Most IP To Intuitive; CEO Steps Down
    Breaking News
    • MPO's Most-Read Stories This Week—June 3
    • CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    • LifeQ Unveils New 24-Hour Sleep Solution
    • Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll
    • EvoEndo Names CEO and Chief Operating Officer
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Computer Concepts for Medical Device Design
    • IVD Manufacturers Are Being Put to the Test
    • The New State of Medtech Outsourcing
    • 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

    Stefan Pasiakos, PhD, Selected to Lead NIH Office of Dietary Supplements
    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    BGG Receives Patent for Saw Palmetto ID Method
    Coatings World

    Latest Breaking News From Coatings World

    Indorama Ventures and Carbios Reaffirm Partnership to Build PET Biorecycling Plant
    AkzoNobel Powder Coatings Enhances Digital Services with Launch of My Interpon Portal
    PPG Opens Color Creation Lab with Chery Automobile in China
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—June 3
    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    LifeQ Unveils New 24-Hour Sleep Solution
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Terran Biosciences, Pierre Fabre Ink Exclusive Licensing Deal for Idazoxan
    ASM Research Chemicals Launches Development Packs for API Manufacturing
    WuXi Increases Manufacturing Capacity in Germany
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L'Oréal North Asia President Discusses China's Consumer Sector Recovery & Premium Beauty Trends
    Kiehl’s Celebrates Pride by Supporting The Trevor Project
    L’Oréal & UNESCO Announce 2023 Laureates of the For Women in Science International Awards
    Happi

    Latest Breaking News From Happi

    Color Street Celebrates Pride Month with Limited-Edition ‘Over the Rainbow’ Nail Strips
    Olay Rolls Out Sensitive Skin Line
    World Taste & Smell Association's June 6 Webinar Looks at Smell and Multisensory Design
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: INX Digital, hubergroup and HP Top This Week’s Stories
    Mactac Acquires Canadian Roll Label Distributor Label Supply
    WestRock Advances its Commitment to a Sustainable Future
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Schreiner's Pharma-Comb IL Label supports clinical trial cancer medication
    First Anytron ANY-JET III digital label press installed in Korea
    FPA announces Kasie Fairbarn as elected ELC co-chair
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Harper Hygienics Launches Hemp-Based Intimate Care Wipes
    What You’re Reading on Nonwovens-Industry.com
    Biodiapers Signs Agreement with Sicam
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—June 3
    Augmedics Debuts New Features, Indications for xvision Platform
    Artelon Closes $20M Series B Funding
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: Francisco Melo, Smart Skis, onsemi Top This Week’s Stories
    DIC Acquires Photoresist Polymers Manufacturer PCAS Canada
    Arkema Collaborates with Habitat for Humanity Philadelphia

    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