Definition Vigilance - What is the definition of "Vigilance"?

M

mr.mike

#1
Just want to clarify: with respect to quality systems, "vigilance" seems a pretty broad term for a system that encompasses the following:

  • Post-market surveillance
  • Incident reporting to regional regulatory authorities (e.g. adverse event reporting, MDR)
  • Advisory notice issuance
  • Product Recall and/or Field Safety Corrective Actions (FSCA)

Am I correct that "vigilance" encompasses these activities? Anything else?
 
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Ajit Basrur

Staff member
Admin
#3
Vigilance refers to incidents that can occur with medical devices and in-vitro diagnostic medical devices, when they do not perform as intended, thereby leading in the worst case to injury or death.

Tyoically, the Postmarket activities can be divided in two types:

1.Proactive - Post Market Surveillance
2.Reactive - Vigilance

Thus Vigilance are always "reactive" unlike the Post Market Surveillance.
 

Sam Lazzara

Trusted Information Resource
#4
In the European context.....

Article 10 of the 93/42/EEC Medical Device Directive (MDD), titled "Information on incidents occuring following placing of devices on the market" describes the "Vigilance" requirements under the MDD. The requirements of Article 10 are primarily binding on the National Competent Authorities based on "incident" information reported to them by Manufacturer's and/or Authorised Representatives. The MDD Annexes cover obligations for post-production incident reporting.

The following paragraph from the MDD introduction sheds some more light:

Whereas the protection of health and the associated controls may be
made more effective by means of medical device vigilance systems
which are integrated at Community level;


Article 14a speaks to vigilance as well.

European databank
1. Regulatory data in accordance with this Directive shall be stored
in a European database accessible to the competent authorities to enable
them to carry out their tasks relating to this Directive on a well informed
basis. The databank shall contain the following:
(c) data obtained in accordance with the vigilance procedure as defined
in Article 10;
 
Last edited:
M

medgar

#5
Along the same lines as Ajit;

Post-market activities can be divided in two categories:
1. Proactive - Post Market Surveillance
2. Reactive - Vigilance

Post-Market Surveillance is defined as: "the pro-active collection of information on quality, safety or performance of Medical Devices after they have been placed on the market."

Regulatory authorities allow medical devices to be placed on the market based on data supporting the reasonable assurance that the proposed device is both safe and effective. These data comprise prospective premarket information generated by using ideal devices under ideal conditions. Retrospective post-market data derived from devices and conditions may differ from the premarket testing in ways both obvious and subtle. An effective post-market surveillance program monitors the performance of the full range of actual devices under all actual usage conditions, to ensure that the assumptions and estimates applied during the product development process were accurate and remain so throughout the total product lifecycle.

Conversely, Post-Market Vigilance refers to incidents that can occur with medical devices when they do not perform as intended, thereby leading in the worst case to injury or death. The medical device directives require timely, coordinated action and provision of information between the manufacturer and the regulatory authorities in relation to (near) incidents that are related to the device.

The purpose of medical device vigilance is to protect the health and safety of patients; evaluate incidents to prevent recurrence; determine the effectiveness of corrective actions and preventive actions; and monitor and learn from experience.
 
M

mr.mike

#6
Thanks for all the input!

So to edit my original "encompassing activities" definition, I would remove the proactive "post-market surveillance". The remaining activities are all reactive, and thus still would be part of a vigilance system:

  • Incident reporting to regional regulatory authorities (e.g. adverse event reporting, MDR)
  • Advisory notice issuance
  • Product Recall and/or Field Safety Corrective Actions (FSCA)

I think I got it. :)
 
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