Field safety notices (FSNs) are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market.
The HPRA puts these notices on our website for information. A summary list of these notices are published by the HPRA in the first week of the month.
If you have product that is impacted by these notices you may have already been contacted directly by the manufacturer.
Please note:
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The notices included in the monthly listing may not be complete. The listing only includes FSNs that have been notified to the HPRA. Should you receive a FSN from a manufacturer that is not included on the HPRA listing, please let us know by email devicesafety@hpra.ie.
- The summary lists up until November 2010 includes all FSNs communicated to the HPRA. From December 2010, the summary list only includes FSNs where the manufacturer has confirmed that the issue has an impact on the Irish market and cases where the impact on the Irish market is undetermined because the manufacturer has failed to confirm that there is no impact on the Irish market.
Field Safety Notices - Outstanding Actions
When a field safety notice is issued by a medical device manufacturer on the Irish market, the HPRA seek confirmation from the manufacturer that the required action has been completed. Sometimes, completion of the action is delayed or hampered due to issues experienced by the manufacturer. For example, difficulties in obtaining access to the device or in tracing the location of the device. Users of the affected medical devices should review the relevant information and follow the guidance provided.
The document below provides details of field safety notices that have been circulated to the Irish market for which action remains outstanding.
Field Safety Notices - Outstanding Actions
The recipient of the safety communication, (FSN, HPRA safety notice) should ensure that the communication reaches the most appropriate personnel within his organisation. He should also ensure that the issue outlined in the notice is considered, the risks assessed and the appropriate / recommended actions are completed.
Safety communication, (FSN, HPRA safety notice) should be forwarded to other organisations or persons where the devices have been transferred.
In some instances, the recipient of the notice may not be the most appropriate person to deal with the issue. Therefore a well defined, effective mechanism for managing the communications is necessary. Some organisations, hospitals and the community care setting have found that it is very beneficial to have one designated medical device vigilance contact, a local medical device vigilance team that meet to assess the issues that arise, local medical device vigilance procedures and a database to support the management of such communication. Such structures and defined responsibilities and processes help to ensure that the communications are dealt with in a timely manner.
(See Medical Devices newsletters February 2004 Vol. 1 No. 7 and IMB newsletter May-August 2004 Vol. 1 No. 18 for more information.)