We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » HEART RHYTHM SOCIETY ISSUES SWEEPING RECOMMENDATIONS FOR HEART DEVICE REGULATIONS

HEART RHYTHM SOCIETY ISSUES SWEEPING RECOMMENDATIONS FOR HEART DEVICE REGULATIONS

May 1, 2006

The Heart Rhythm Society (HRS) has issued a series of recommendations for industry, the FDA and physicians to consider in revising the processes for postmarket surveillance and analysis of pacemakers and implantable cardioverter-defibrillators (ICDs).

The HRS proposal comes in the wake of newly publicized studies that look at pacemaker and ICD malfunctions in the U.S., as well as the risk factors associated with ICD replacement in Canadian patients. Both studies were published in the April 26 issue of the Journal of the American Medical Association (JAMA).

While pacemaker malfunctions have declined in recent years, implantable cardioverter-defibrillator (ICD) malfunctions have increased, according to one of the JAMA studies. Researchers analyzed postapproval annual reports submitted to the FDA by pacemaker and ICD manufacturers from 1990 to 2002 to determine the number of device malfunctions and assess performance trends.

During that time, 2.25 million pacemakers and 415,780 ICDs were implanted, representing a threefold increase in pacemaker implantations and a tenfold increase in ICD implantations. Of the total number of devices explanted, over half of those extractions resulted from battery or capacitor abnormalities and electrical issues, the article states.

The recommendations by the HRS focus on the need for transparency in postmarket surveillance, analysis and reporting of device-related information, new systems to more quickly identify malfunctioning devices, and the use of standardized formats and language by industry to notify physicians and patients of devices that could malfunction. ()a href="http://www.fdanews.com/ddl/33_18/" target=_blank>

KEYWORDS FDAnews Device Daily Bulletin

Upcoming Events

  • 15Apr

    Five Telltale Signs You’re Ready for an Electronic TMF System

  • 21Apr

    CDER’s Most Significant Guidance Priorities for 2021: Biosimilars/Biologics, Generics/Exclusivity, Real-World Evidence, Drug Development and Digital Health

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • CE mark

    Roche Receives CE Mark for Elecsys Cancer Test

  • team up

    Biogen and Bio-Thera Solutions Partner Over Actemra Biosimilar

  • FDA logo blue

    Former Indivor Executive Seeks FDA Hearing to Avoid Debarment

  • FDA clears text

    FDA Clears Activ Surgical’s Imaging Module for ActivEdge Platform

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing