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[Medical devices vigilance].

B Crickx1

  • 1Université Denis-Diderot Paris 7 et Service de Dermatologie, Groupe hospitalier Bichat-Claude-Bernard, AP-HP, 46 rue Henri-Huchard, 75018 Paris. beatrice.crickx@bch.aphp.fr

Annales De Dermatologie Et De Venereologie
|May 6, 2008
PubMed
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The French Agency for Health Products (AFFSSAPS) monitors medical device safety through vigilance reporting. This system collects incident data from manufacturers, users, and third parties to ensure post-market safety.

Area of Science:

  • Medical Device Vigilance
  • Public Health Surveillance
  • Regulatory Affairs

Context:

  • The French Agency for Health Products (AFFSSAPS) operates a dedicated section for medical device evaluation, distinct from pharmaceutical and biological product oversight.
  • Medical device vigilance is crucial for monitoring post-market safety and identifying potential hazards.
  • Reporting is mandated for manufacturers, users, and any third party aware of incidents or risks associated with medical devices.

Purpose:

  • To establish and describe the medical device vigilance system within the AFFSSAPS.
  • To outline the reporting requirements and information necessary for investigating medical device-related incidents.
  • To highlight the broad scope of medical devices covered, from small instruments to implantables, and the importance of timely reporting.

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Summary:

  • The AFFSSAPS medical device vigilance section systematically collects data on incidents and hazards.
  • Mandatory reporting by manufacturers, users, and third parties ensures comprehensive data gathering.
  • Reports include informant details, device specifics (name, batch/serial number), and incident characteristics (date, consequences, actions taken).

Impact:

  • Enhances post-market surveillance of medical devices to ensure patient safety.
  • Provides critical data for regulatory agencies to assess and mitigate risks associated with medical device use.
  • Facilitates a proactive approach to medical device safety, involving all stakeholders in the reporting process.