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
05/06/2024 Summary of Field Safety Notices - May 2024 3rd Party Publications
13/05/2024 iPAD CU-SP1, iPAD CU-SP1 AUTO AEDs - Priority 2 – Warning Warning
02/05/2024 Field Safety Notice Summary Sheet - Outstanding Actions 3rd Party Publications
02/05/2024 Summary of Field Safety Notices- April 2024 3rd Party Publications
02/04/2024 Summary of Field Safety Notices - March 2024 3rd Party Publications
21/03/2024 Guardian™ 4 Sensor. Priority 2 – Warning Warning
01/03/2024 Summary of Field Safety Notices - February 2024 3rd Party Publications
01/02/2024 Summary of Field Safety Notices- January 2024 3rd Party Publications
04/01/2024 Summary of Field Safety Notices- December 2023 3rd Party Publications
05/12/2023 Summary of Field Safety Notices- November 2023 3rd Party Publications
03/11/2023 Summary of Field Safety Notices - October 2023 Advisory
04/10/2023 Summary of Field Safety Notices - September 2023 3rd Party Publications
13/09/2023 SCHILLER CARDIOVIT AT-102 ECG - Priority 2 – Warning Warning
04/09/2023 Summary of Field Safety Notices - August 2023 3rd Party Publications
03/08/2023 Summary of Field Safety Notices - July 2023 3rd Party Publications
05/07/2023 Summary of Field Safety Notices- June 2023 3rd Party Publications
02/06/2023 Summary of Field Safety Notices - May 2023 3rd Party Publications
04/05/2023 Summary of Field Safety Notice - April 2023 3rd Party Publications
05/04/2023 Summary of Field Safety Notice - March 2023 3rd Party Publications
02/03/2023 Summary of Field Safety Notice - February 2023 3rd Party Publications