Vigilance 

The medical device vigilance system was set up to minimise risks to the safety of patients, users and others. Medical device safety issues can be identified through manufacturer, healthcare professional or through members of the public submitting reports to the HPRA. This would include the reporting of an adverse incident. This is an event during the use of the device which might lead to, or might have led to, the death of a patient, user or of other persons or to a serious deterioration in their state of health. In addition, the HPRA can identify safety issues through information sharing with other EU competent authorities.

The Medical device vigilance system achieves its objectives through:

  • Manufacturers and users submitting reports to the relevant competent authorities (the HPRA in Ireland);
  • Through the evaluation of vigilance reports and data by the competent authorities;
  • Through the dissemination of information, which may be used to prevent recurrence of the incident, or to alleviate the consequences of such incidents;
  • Manufacturers initiating field safety corrective actions (FSCAs). 

A field safety corrective action (FSCA) is a corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of an adverse incident occurring in relation to a device made available on the market. The FSCA may include, for example:

  • device modification;
  • advice given by the manufacturer regarding the use of the device and/or the follow up of patients, users or others; 
  • the return of a medical device to the supplier.

 

Such actions, whether associated with direct or indirect harm, should be reported and should be notified via a field safety notice (FSN). Please visit our Safety Notices page for further information on field safety notices and safety communications.

 

Analysis of Vigilance Data 

As part of the HPRA’s ongoing measures to reinforce and enhance its post market surveillance and vigilance systems, all vigilance data received is being analysed under a new signal detection process. The aim of the signal detection process is to identify trends and signals in the data submitted to the HPRA, to detect if there are new risks associated with a medical device or whether known risks have changed. 

Once a potential signal is identified it has to be validated before a decision on the most appropriate regulatory action can be made; such as an in-depth signal detection investigation, referral of the information for market surveillance activities, or referral of information for inspection activities. The HPRA may also follow up with various stakeholders; the manufacturer, the distributor, the importers, the clinical community, the notified body and in some instances other European competent authorities on the results of the trends through safety communications such as safety notices, press releases, brochures etc.