My HPRA: Register

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
12/06/2007 Clearview HCG Pregnancy Test Kit Recall
10/05/2007 Shelhigh Implantable Devices Recall
20/11/2006 K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs Warning
29/09/2006 Diagnostic Kits for Self-Testing Warning
05/09/2006 Avantgarde Wheelchair Warning
21/06/2006 Scooter Sungift 500 Recall
20/06/2006 Reusable Needle Holders / Blood Tube Holders Advisory
01/06/2006 The Procurement and Commissioning of Medical Equipment for Hospitals Advisory
21/04/2006 Bausch and Lomb ReNu with MoistureLoc Multi-Purpose Solution 3rd Party Publications
14/03/2006 Profile Respiratory System CR60 and Porta-Neb Advisory
12/01/2006 Hospital Beds in Paediatric Wards Advisory
12/12/2005 Cardio Respiratory Monitors Advisory
26/10/2005 Illegally CE Marked Medical Devices Advisory
09/06/2005 'Tulip' Condoms Advisory
14/03/2005 Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms Recall
15/11/2004 AccessAED PAD, AccessAED and AccessALS Automated External Defibrillator Devices Recall
14/10/2004 Sterile Devices Advisory
20/09/2004 Invasive Blood Pressure Monitoring Devices with Transducers Advisory
13/08/2004 Haemodialysis Equipment Advisory
13/08/2004 Instructions for Use provided by the Medical Device Manufacturer Advisory
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