The medical device vigilance system was set up under the medical device directives to minimise risks to the safety of patients, users and others.
Medical device safety issues can be identified through manufacture or health professional reporting, through identification and reporting of issues by members of the public or through information sharing with other competent authorities.
The Medical device vigilance system achieves its objectives in several ways:
- Through manufacturers and users submitting vigilance reports to the relevant competent authorities (the HPRA in Ireland).
- Through the evaluation of reported incidents 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, in cases when it’s necessary to do so.
- By the device being updated, modified or taken off the market in cases when it’s necessary to do so.
Vigilance issues can be related to an adverse incident or to a field safety corrective action.
An adverse incident is an event during use of the device which might lead to or might have lead to death of a patient, or user or of other persons or to a serious deterioration in their state of health should be reported to the HPRA.
A field safety corrective action (FSCA) is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. Such actions, whether associated with direct or indirect harm, should be reported and should be notified via a field safety notice (FSN). The FSCA may include, for example:
- the return of a medical device to the supplier;
- device modification;
- advice given by manufacturer regarding the use of the device and/or the follow up of patients, users or others.
The Medical Device Safety Notices that are circulated to healthcare professionals and medical device ‘users’ may be divided into two main groups:
There is a mandatory requirement for manufacturers to report vigilance issues to the appropriate national Competent Authority; the European guidelines for a medical devices vigilance system are outlined in MEDDEV 2.12-1
. In relation to user reporting, the HPRA currently operates a voluntary system whereby a user, healthcare professional or any other person who identifies a medical device safety issue can report it to the HPRA.