Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Medical device vigilance at FDA.

T P Gross1, L G Kessler

  • 1Office of Surveillance and Biometrics, Food and Drug Administration, Rockville, MD 20850, USA.

Studies in Health Technology and Informatics
|December 9, 1995
PubMed
Summary

The U.S. Food and Drug Administration (FDA) manages medical device vigilance, analyzing over 100,000 annual reports to identify safety signals and implement actions. New initiatives focus on improved report triage and international nomenclature harmonization.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Hip resurfacing as an outpatient procedure: a comparison of overall cost and review of safety.

Musculoskeletal surgery·2020
Same author

Vertebroplasty and kyphoplasty are associated with an increased risk of secondary vertebral compression fractures: a population-based cohort study.

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·2008
Same author

Medical device tracking: results of a case study of the implantable cardioverter defibrillator.

The American journal of cardiology·2000
Same author

Study design in the evaluation of breast cancer imaging technologies.

Academic radiology·2000
Same author

Comparison of risk estimates for selected diseases and causes of death.

Preventive medicine·1999
Same author

Improving patient care by reporting problems with medical devices.

CRNA : the clinical forum for nurse anesthetists·1998

Area of Science:

  • Medical device regulation
  • Public health surveillance
  • Pharmacovigilance

Background:

  • The U.S. Food and Drug Administration (FDA) oversees medical device vigilance.
  • The FDA's reporting program receives over 100,000 reports annually.
  • Effective vigilance is crucial for patient safety and medical device efficacy.

Purpose of the Study:

  • To provide an overview of the FDA's medical device vigilance program.
  • To explain the process of data analysis and signal detection.
  • To highlight new initiatives in medical device safety monitoring.

Main Methods:

  • Review of FDA's medical device reporting regulations and programs.
  • Analysis of data patterns from over 100,000 annual reports.

Related Experiment Videos

  • Description of FDA's signal identification and response strategies.
  • Introduction of new initiatives like report triage and international nomenclature.

    • Main Results:

    • The FDA's medical device vigilance program is extensive, handling a high volume of reports.
    • Data analysis enables the identification of safety signals within the reporting database.
    • The FDA takes action to address identified device-related problems.
    • New methods are being developed to enhance the efficiency and harmonization of the vigilance process.

    Conclusions:

    • The FDA's medical device vigilance system is a critical component of ensuring device safety.
    • Continuous improvement and adaptation of the program are essential.
    • International collaboration, such as harmonized nomenclature, is a key future direction.