Role of a Vigilance Officer

Role and responsibilities of the Vigilance Officer should be defined locally but could include:

  • Participate in local vigilance committee
  • Act as a champion for vigilance issues
  • Act as the contact person for medical device issues including targeted mailings
  • Close the loop on field safety corrective actions where appropriate (incomplete FSCAs)
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User Reporting

The HPRA actively encourages users of medical devices to report incidents reporting to medical devices.  Increased levels of reporting from healthcare professionals and other device users may help in the early detection of adverse trends or safety issues.

All incidents should be reported as soon as possible.  Serious incidents should be reported to us by the fastest means available using the on-line report form.