Safety communications

This page is for patients, the public and healthcare professionals.

It describes the different communications issued for device safety issues.

How is device safety information communicated?

There are two main types of safety communications:

  1. Field safety notices (FSNs), published by manufacturers.
  2. HPRA safety notices (SNs), published by us.

For more details on these communications, click the menu below. 

Field safety notices

Manufacturers must inform device users if they find a safety issue with their device.

Manufacturers issue FSNs to device users if they find a safety issue.

If your device is affected by a safety issue and you receive a FSN, read it carefully and follow the instructions.

FSNs may have key information or actions, such as:

  • Removal of a device from the market.
  • Updated instructions on how to use a device safely.
  • A patient recall (where patients are to be brought back for re-testing).

We publish a summary of FSNs affecting the Irish market during the first week of each month.

We also publish a list of FSNs circulated to the Irish market where actions remain outstanding.

We can only publish FSNs notified to us.

If you receive an FSN not on our list, please let us know by email at devicesafety@hpra.ie.

 

 

HPRA safety notices

If you receive a FSN from a manufacturer, act on it at once.

Do not wait for a HPRA safety notice . Most FSNs are not accompanied by a HPRA safety notice.

We issue HPRA safety notices to device users when we consider it necessary.

This includes:

  • To give more information to users in Ireland (FSNs often accompany SNs).
  • To raise awareness of a high risk FSN.
  • To raise awareness of an FSN where the manufacturer has not been able to contact all device users.
  • Where a company no longer exists.

More details on our safety notices, including how they are formatted, can be found here.

Anyone can sign up to receive HPRA safety notice by emailing devicesafety@hpra.ie.

What should I do if I receive a HPRA safety notice?

If you are a patient or member of the public, you should:

  • Review the safety notice.
  • Discuss any problems or concerns with your doctor.

If you are a healthcare professional, you should:

  • Ensure the notice reaches the correct person in your organisation.
  • Share the notice with other affected organisations or persons.
  • Review the notice and complete actions as needed.

 



Date Title Type
01/07/2021 Summary of field safety notices- June 2021 3rd Party Publications
02/06/2021 Summary of Field Safety Notices - May 2021 3rd Party Publications
05/05/2021 Summary of Field Safety Notices - April 2021 3rd Party Publications
01/04/2021 Summary of Field Safety Notices - March 2021 3rd Party Publications
01/04/2021 MiniMed 780G Insulin Pump System. Priority 2 – Warning Warning
12/03/2021 Infusion Sets for Alaris™ Pumps (GP, VP, CC, GW/GW800, SE, IVAC 590 series) and Gravity Infusion sets & connectors. Priority 1 – For Immediate Action For Immediate Action
03/03/2021 Summary of Field Safety Notices - February 2021 3rd Party Publications
25/02/2021 Emicizumab (Hemlibra®) interference with blood coagulation tests - Priority 2 – Warning Warning
02/02/2021 Summary of Field Safety Notices - January 2021 3rd Party Publications
27/01/2021 Various Endotherapy products - Priority 1 – For Immediate Action For Immediate Action
04/01/2021 Summary of Field Safety Notices - December 2020 3rd Party Publications
03/12/2020 Summary of Field Safety Notices - November 2020 3rd Party Publications
03/11/2020 Summary of Field Safety Notices - October 2020 3rd Party Publications
02/11/2020 Contour Test Strips / Contour TS Test Strips 50. Priority 1 – For Immediate Action For Immediate Action
02/10/2020 Summary of Field Safety Notices - September 2020 3rd Party Publications
24/09/2020 LAP-BAND Adjustable Gastric Banding System and Accessories. Priority 3 – Advisory Advisory
02/09/2020 Summary of Field Safety Notices - August 2020 3rd Party Publications
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