Safety Notices/Communications

Information relating to device safety, performance and quality can be provided directly by the device manufacturer or by the HPRA.

The methods of communication are:

  • HPRA Safety Notices;
  • HPRA Information Notices;
  • Manufacturer Field Safety Notices (FSNs).

 

Further information on the difference between HPRA Safety Notices and manufacturer’s FSNs, and what actions should be taken on receipt of them, is outlined here.  

HPRA Safety Notices and Information Notices

The HPRA publishes notices relating to the safety and/or quality of medical devices. The issues covered by these notices will range from quality defect information to product recalls, to updated information on the appropriate usage of the medical devices.

HPRA information notices inform healthcare professionals and/or users of medical devices about concerning trends or emerging issues, and can also be issued to highlight specific aspects of medical devices legislation. HPRA information notices may not be related to any one particular field safety corrective action being conducted by a manufacturer.

HPRA Safety Notices generally refer to issues recently identified through vigilance and/or market surveillance activities and are often accompanied by a field safety notice (FSN) from a manufacturer. The HPRA Safety Notice may serve to highlight additional details that are relevant to the Irish market, or to remind Irish customers to complete the corrective action identified by the manufacturer.

The HPRA circulates safety notices in many instances:

  • To highlight a serious public health issue
  • To draw attention to medium / high risk field safety corrective actions / field safety notices
  • To highlight an issue where the manufacturer, importer and/or distributor has experienced difficulty reaching all customers
  • To highlight an issue when either the device manufacturer, importer or distributor to the Irish market no longer exists.
  • To communicate concerning trends identified by the HPRA in relation to particular product families

 

Further information on the format of the HPRA’s safety notices can be found here.

The HPRA’s latest safety notices and information notices can be found below.

Manufacturer's Field Safety Notice

Field safety notices (FSNs) are communications sent out by medical device manufacturers or their representatives in relation to corrective actions for devices on the market to prevent or reduce the risk of a serious incident occurring. A summary list of these notices is published by the HPRA the first week of each month.

Please note:

  1. 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.
  2. The summary lists up until November 2010 includes all FSNs communicated to the HPRA. From December 2010, the summary list only includes FSNs where:
    1. the manufacturer has confirmed that the issue has an impact on the Irish market, or
    2. the impact on the Irish market is undetermined, because the manufacturer failed to confirm that there is no impact on the Irish market.

If you have product that is impacted by these notices you may have already been contacted directly by the manufacturer. 

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 and/or distributor that the required action has been completed. Sometimes, completion of the action is delayed or hampered due to issues experienced by the manufacturer. The HPRA publishes details of field safety notices that have been circulated to the Irish market for which action remains outstanding. Please see below for further details. 

Receiving and Circulating Safety Communications

If you would like to receive copies of HPRA Safety Notices at the time of publication via e-mail please forward an e-mail request to devicesafety@hpra.ie

The recipients of the safety communication, (FSNs, HPRA safety notices) should ensure that the communication reaches the most appropriate personnel within their organisation. They should also ensure that the issue outlined in the notice is considered, the risks assessed and the appropriate / recommended actions are completed.

Safety communications (such as FSNs and HPRA safety notices) 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.

 

Date Title Type
26/08/2020 Covidien Endo GIA™ Auto Suture™ universal articulating loading units, Priority 1 – For Immediate Action For Immediate Action
19/08/2020 Datascope/Getinge/Maquet Intra-Aortic Balloon Catheters: Priority 2 – Warning Warning
13/08/2020 TOP-Q Super Fine Line, TOP-Q Super Derm Line, TOP-Q Super Deep Line. Priority 2 – Warning Warning
10/08/2020 Lifepak 500 Automated External Defibrillator. Priority 2 – Warning Warning
05/08/2020 Summary of Field Safety Notices - July 2020 3rd Party Publications
02/07/2020 Summary of Field Safety Notices - June 2020 3rd Party Publications
24/06/2020 Lifeguard LG20, LG50, LG55. Priority 2 - Warning Advisory
17/06/2020 ACTIV.A.C.™ Therapy Units. Priority 2 – Warning Advisory
11/06/2020 Philips HeartStart XL Defibrillator/Monitor. Priority 2 – Warning Warning
11/06/2020 Risk of harmful reactions in laboratories using certain chemicals in combination with bleach. Priority 2 – Warning Warning
08/06/2020 Caution When Purchasing Thermometers Advisory
03/06/2020 Summary of Field Safety Notices - May 2020 3rd Party Publications
05/05/2020 Summary of Field Safety Notices - April 2020 3rd Party Publications
02/04/2020 Summary of Field Safety Notices - March 2020 3rd Party Publications
01/04/2020 MAGEC Spinal Bracing and Distraction System. Priority 2 – Warning Warning
13/03/2020 Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy Advisory
12/03/2020 T34 Ambulatory Syringe Pumps - Priority 2 – Warning Warning
11/03/2020 Programmable Ventriculo-Peritoneal (PVP) / Programmable Cerebrospinal Fluid (CSF) Shunts. Priority 3 – Advisory Advisory
06/03/2020 Giraffe Omnibed, Giraffe Incubator, Giraffe Omnibed Carestation, Giraffe Incubator Carestation. Priority 2 – Warning Warning
02/03/2020 Summary of Field Safety Notices - February 2020 3rd Party Publications